Atellica® Solution Key Tasks for Basic Operation Job Aid Version 1.26 and Above

SIEMENS Healthineers = == 10 10 % 3W 5 6 9CH thingers Atellica Solution Atellica® Solution Key Tasks for Basic Operation Job Aid 1 Template Effective Date: 10 Aug 2021 | HILS 2223 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution Key Tasks for Basic Operation SIEMENS Introduction Healthineers This document supports the key tasks for basic operation for the most common Atellica Solution modules: Sample Handler, Chemistry, and Immunoassay. Additional content is provided in the Appendices for the Decapper, Direct Load, Asa, and high volume configurations with multiples of the same module. Utilize the appropriate sections based on your lab’s unique configuration. 2 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution Key Tasks for Basic Operation SIEMENS Table of Contents Healthineers Sign Out and Sign In 4 Tool Bar Overview 5 Online Help 6 Notification Center 7 Checking System Health 8 Maintenance 9 Checking and Loading Reagents 21 == Checking and Loading Supplies 25 Maintaining Cal-QC Storage 37 Calibration 39 Quality Control 52 Processing Patient Samples 61 Searching for a Sample 72 Service Support Request 73 Appendix A –Asa 74 Appendix B – Configurations with Multiples of the Same Module 75 Appendix C – Decapper – Emptying Waste 78 Appendix D – Direct Load – Processing Samples 79 3 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Signing out of the System / Signing into the System Healthineers Each Atellica Solution operator should sign into the SIEMENS workstation using a unique username and password. Healthineers Signing out of the System 1. On the Access bar, select the Account icon LabManager 2. Select Sign Out Stan Out 3. Select Sign Out again Atellica Solution Sign Out Operator IDA LabManager 4. If you want to continue, select Yes Password" ............... Signing in to the System Password Help Forgot Password ? Restart Shutdown Login 1. At the Sign In window, enter the Operator ID and password 2. Select Sign in @ 2021 Siemens Medical Solutions, Inc All rights reserved. NOTE: System Display Optimization is run during the sign out process and is NOTE: If an incorrect password is entered too many times, the account will be locked. After approximately also automatically performed by the system after the Database Optimizing 10 minutes the account will automatically unlock so the operator can use the account to try again to sign automated maintenance activity. It does not affect any current processing or into the system. The operator can sign in during that time with an alternate account if needed. system operation. 4 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Tool Bar Healthineers A. Navigator* – comprehensive list of screens I. Teamviewer – allows the service provider remote access to B. Online Help* – displays online help the system C. Search* – searches for a specific sample J. Minimized Guided Workflow Window D. Print – print options for the current screen K. Shortcut* – creates a shortcut of the currently-viewed screen, E. File Explorer – to access system files including any active filters, and adds it to the Dashboard F. Volume – adjusts the volume of the system alerts L. LAS Communication G. Keyboard – displays an on-screen keyboard for text input M. LIS Communication H. Teamviewer – enables remote access to the system after N. Ticketing System operator acceptance I -J– Only appear when windows are minimized L-M– Change color based on status B D F H J M A C E G I K L N A-H – Standard Tool Bar Functions K – Convention to create a shortcut Placeholder – 5 Please insert Effective Date: 16-FEB-2022 | HOOD05162003255836 text Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Online Help Healthineers The Online Help can be accessed by selecting: SIEMENS Healthingers Abellica Solution ? • The help icon in the Tool bar Abelsca Help The Troubleshooting button in the System ? • Status Area Cuerent Statin < * • The account area dropdown menu Alellen' Salution Online Help When using the Online Help icon in the tool bar, the PPerforming Replacing the Source Lamp in ... help topic specific to the screen currently displayed 1 0 will appear. Performing Replacing the Source Lamp in Operator EP Diagnostics To find another topic in Online Help, perform a search. Enter words, phrases, or questions for quick access to information. Maintenance 10 i¢ ------ 6 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Notification Center Healthineers 8 SH1-SCI1 LabManager The Notification Center icon in the Access Bar will alert the operator Notification Center × to tile alerts as well as other errors or warnings. B Acknowledge All STATS • A green banner color indicates there are no issues. Red or yellow IM-01 indicate errors or warnings exist. The color will match the highest 1 Reagent loader contains reagent packs that are expiring severity alert soon. Ensure that the analyzer uses before expiration of the packs. Sample • The number in the icon is the number of tiles with alerts plus the 10 minutes ago Troubleshoot Interventions number of additional messages shown in the notification center CH-01 A 1 WU • Select the notification center icon to view alerts and perform Cannot read barcode on reagent packs In the reagent loader. Remove the reagent packs from the reagent acknowledgements loader and manually scan. Reload the reagent packs. Supply Needs A. Select the Hand icon to acknowledge an alert 10 hours ago Troubleshoot 2 6 B. Select the tile shortcuts to access the screen related to the alert Reagent Needs Maintenance 10 % 7 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking System Health Healthineers System Status Map A. To view alerts for a module, select the appropriate module and view the alerts • To view details for an alerts, select the alert and then select Troubleshooting to view details in the Operator Event Log B. To change the status of a module, select the appropriate module and then select to shut down, stop processing, or resume sample processing NOTE: The System Status Area is shared with the Asa tablet CH-01 software. Be aware that if another operator is making changes System SH-02 Stopped SH-01 connected to PCC CH-02 IM-01 CI-01 using the Asa tablet software, the updated status will be reflected here on the system display. Alerts A Alert Desription Category Time Analyzer stopped due to Supply CH Conditioner is empty Supplies 10:30 AM Troubleshoot Analyzer stopped due to a Supply A-LYTE Multisensor is empty Supplies 10:30 AM B 2 IM-01 CH-01 CH-02 Troubleshooting Connected to POC CI-01 Initiate Ticket Unlock Front Cover Unlock Back Cover Service Diagnostics Patient Sample Processing Patient Sample Processing Suspended Initiate Ticket O Patient Sample Processing Unlock Front Cover Unlock Back Cover Service Diagnostics 8 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Monitor Maintenance Activities Healthineers The system monitors maintenance activities and provides notification when a scheduled activity is due. Maintenance When a maintenance activity fails or is due, an alert displays in the Maintenance tile on the Dashboard: • Red: Immediate operator intervention required. At least 1 automated maintenance activity failed .10 % o The tile remains red until these activities successfully complete, are marked Not A Performed, or the operator reschedules them to a new day* • Yellow: One or more Inprocess or Due activities exist within the configured reminder time • Green: No Failed, Inprocess, or Due maintenance activities exist to automatically start within the Inprocess: CH-02 B configured reminder time C 0 Activity Failed The tile body displays: D 8 Activities Due A. Total number of maintenance activities that are due and failed within the current calendar day B. The module with an Inprocess maintenance activity C. Number of current calendar day maintenance activities complete with a failed status D. Number of current calendar day maintenance activities not completed and due Select the Maintenance tile to display the Maintenance Overview screen to review a list of the maintenance activities for each day (see next slide). *NOTE: The system tracks activities from Midnight until Midnight. Any maintenance activity that is not completed within its frequency duration (for example, by midnight for a daily activity) will be marked Not Performed. 9 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Monitor Maintenance Activities Healthineers Filters Tx Clear Filters: Frequency : All Module : All Activity Type : All Activity Status : All Thursday, 11th March 2021 Module Activity Frequency Status - The Maintenance Overview screen displays the maintenance View By Day Week Month C By Count Weekly Monthly IM-0 M Weekly Maintenance Weekly Inprocess (3 minutes remaining) activities and their status. March 2021 CI-01 CI Daily Maintenance Inprocess (23 minutes remaining) V Sunday Monday Tuseday Wednesday Thusrday Friday Saturday CH-02 CH Daily Maintenance Due Now A. In the calendar on the left, the current day is highlighted 26 27 28 29 30 31 CH-01 Replacing the IMT Peristallic Pump Tubing y Count Due at 7:30 AM V • Select a date from the calendar view to display the CH-02 Hardware Check Maintenance Monthly Due at 8:00 AM activities due to be completed that day CH - 03 Checking the Lamp Coolant Weekly Due at 8:00 AM 10 X 11 12 13 14 15 10 System Database Acrhiving and Deleting Due at 9:30 AM B. The activities listed on the right can also be filtered by 16 17 19 20 21 22 A IM-01 IM Autocheck Due at 10:30 AM Frequency, Module, Activity Type, and Activity Status 23 24 26 27 28 29 CH-01 Replacing the CH Reaction Ring Cuvette Segments Monthly Due at 11:30 AM 30 31 2 System Database Optimizing Weekly Due at 6:00 PM 3 C. The colored dots (grey, teal, purple) indicate frequency CH-01 Cleaing the Exterior of the Reagent Probe Weekly Not Performed with Comment requency (by count, monthly, weekly) System Database Backup V Completed B Module All VMM Atellica Magline Transport Autocheck V Completed Activity Type Activity Status: All CH-02 CH Weekly Maintenance Weekly V Completed Activity Status SHO SHC Autocheck Completed Inprocess activity or waiting for the module to be in Related Review & Approve Maintenance Log All Activities Ready state to complete the maintenance task Failed activity that requires completion Activity Types: Due / Due with time Manual activity - performed by the operator Automated activity - performed by the system Not Performed Service activity - performed by Customer Service Engineer Not Performed with comment Completed ‹ XX GF NOTE: The number of activities Due and Failed will match the number on the Maintenance tile. 10 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Review and Approve Maintenance Healthineers The Review and Approve screen provides a report of the completion Maintenance > Review and Approve LabManager of maintenance activities, displayed one month at a time. From this Vis Module : All Frequency : All Activity Status : All March 2021 Activities Not Completed V V screen the following tasks can be completed: Module Activity Approval Status Not Approved System 3/17/2021 Filters System in Dally 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 X Not Performed Check that all required maintenance for the month is completed Database Acrhiving and Deleting • System Database Backup v V V V Activity to be Performed by Operator was not completed System Database Acrhiving and Deleting V V × Modify activity status to document that activities were completed System if weekly Week 1 Week 2 Week3 Week Week5 SH-01 3/17/2021 • Not Performed with Comment System Database Optimizing / 05/03/2019 / 05/10/2019 SH Autocheck or not performed, and add comments to not performed activities VMM Dally 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Activity marked as Not Performed by LabOperator1 VMM Atellica Magline Transport Autocheck. Operator : LabOperator1 SH-01 Dally 2 13 14 15 16 17 18 19 20 21 22 25 2 24 2 25 26 2 27 28 29 30 31 CH-01 3/17/2021 • If the activity is completed or marked as complete on a day Not Performed with Comment SH-01 SH Autocheck IMT Daily Cleaning other than the scheduled day, the V is on the scheduled date. Dally 5 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Activity marked as Not Performed by LabOperator1 CH-0 IMT Daily Cleaning Operator : LabManager The Status displays the date and time when the maintenance CH-01 CH Daily Maintenance Ch-01 3/17/2021 CH-01 CH Autocheck vv v v v X Not Performed Inspecting th washer Probes was performed CH-01 Weekly Week 1 Week 2 Week 3 Week 4 Week5 Activity to be Performed by Operator was not completed CH-01 Cleaing the Exterior of the Reagent Probe / 05/03/2019 / 05/10/2019 05/17/2019 CH-01 Inspecting th washer Probes / 05/03/2019 X System 3/12/2021 • Generate internal or external maintenance reports. External CH-01 Monthly X Not Performed Database Acrhiving and Deleting reports can be used for presentation to inspection agencies CH-01 Hardware Check Maintenance Activity to be Performed by Operator was not completed CH-01 Clean the dilution trav cuvettes / 05/1 1/2019 System 3/11/2021 Approve • Appropriate security level approves the displayed month Tuesday 3/16/2021 1:14 PM Version 1.26.0.33012 SP1 NOTE: Review and Approve includes 3 completed months and the partial current month of maintenance activities, 1 month at a time. The default view is the current month. NOTE: Maintenance performed today displays on the report the following day. The system tracks activities from Midnight until Midnight. 11 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS CH Daily Maintenance Healthineers A 2 Troubleshooting Inspecting CH Washer Probes System SH-01 SH-02 CH-01 CH-02 IM-01 CI-01 The CH Inspecting the Washer Probes activity alerts the operator to inspect the washer B C 0 x probes daily Operator Diagnostics CH1-SCI1 Enter diagnostic state: Subsystems Diagnostic Name Activity Description 1. 4 Ticketing All Unlocks the CH cover and initializes reagent loader. Manually clean the reagent loader. Cleaning the Reagent Loader Perform System Select Troubleshooting* Lamp The automatic system fluids cycling stops. Manually clean the system fluids drawer. Cleaning the System Fluids Drawer Cancel A. Autocheck Unlocks the CH cover and positions washer probes in up position. Manually clean the washer probes. Cleaning the Washer Probes B. Select Operator Diagnostics Operator Event Lod Cuvette 3 Unlocks the CH cover and positions washer probes in up position. Manually inspect the washer probes. nspecting the Washer Probes Mixer Unlocks the CH cover and positions probes and impellers in up position. Manually inspect and clean the probes and mixer Inspecting and Cleaning the CH Probes and Mixer Impellers C. Select the appropriate CH analyzer 2 IMT impellers. Inspect and Clean Unlocks the CH cover and positions all probes. Manually module inspect and clean the probe wash stations. Inspecting and Cleaning the Probe Wash Stations IS Log Probes D. Select Enter Diagnostics > Yes. The Fluid Enter Diagnostics button will toggle to Exit Diagnostics E. Wait for the module to enter diagnostic state 2. Select Inspect and Clean under Subsystems D Exit Diagnostics 3. Select Inspecting the Washer Probes 4. Select Perform > Yes NOTE: This is the only manual CH daily maintenance activity. All other daily maintenance activities are automated. 5. Wait for the analyzer to prepare for *NOTE: This is one option for how to navigate to Operator Diagnostics. maintenance Other options include using the Navigator from the Tool bar or by 12 *This procedure is continued on the next slide. setting up a shortcut tile on the Home screen. Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS CH Daily Maintenance Healthineers Inspecting CH Washer Probes (continued) 6. The covers will automatically unlock. When unlocked, the cover automatically relocks unless the operator opens or removes the cover within 30 seconds. If the covers lock, select Unlock Covers 7. Open the CH back cover 8. Check the outside of each washer probe for residue buildup 9. If residue buildup is present on the wash probe: A. To protect the cuvettes from debris, cover the cuvettes with a paper towel B. Wipe the washer probes with a lint-free tissue dampened with special reagent water if residue is present C. Remove the paper towel from the cuvettes 10. Close the CH back cover 11. Select Continue > Close 12. Select Exit Diagnostics > Yes 13. Mark Inspecting the Washer Probes as completed by selecting Maintenance, then setting the Frequency filter to Daily Select Inspecting the Washer Probes > Mark as Completed > OK 13 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS IM Weekly Maintenance Healthineers Inspecting and Cleaning the IM Sample Tip Drip Tray The operator must inspect the sample tip drip tray weekly and clean as needed, in order to prevent dry serum build up and possible improper ejection of sample tips, resulting in sample tips lying outside of the exit chute. If after inspection the sample tip drip tray needs to be cleaned, follow these steps: 1. Unlock the IM back cover: Note: If the analyzer is processing samples, after selecting the Stop button, A. In the System Status map, select the appropriate IM analyzer select the option to stop the analyzer after processing the pending samples. B. Ensure the analyzer is in the stopped state C. Select Unlock Back Cover D. Wait for the lock glyph to indicate that the cover is unlocked. When unlocked, the cover automatically relocks unless the operator opens or removes the cover within 30 seconds 2. Lift open the back cover *This procedure is continued on the next slide. SIEMENS.: Healthineers Atellica Solution 6 LabManager A 1 IM-01 System SH-01 SH-02 CH-01 CH-02 Processing CI-01 NOTE: There are additional weekly Connected to PCC maintenance activities. Refer to Current Status Dav Needs Samples C Online Help or the Maintenance Patient Sample Processing screen in the software. Unlock Front Cover Unlock Back Cover Service Diagnostics 14 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS IM Weekly Maintenance Healthineers Inspecting and Cleaning the IM Sample Tip Drip Tray (continued) 3 3. Remove the 2 thumbscrews securing the drip tray and set aside, ensuring that loose debris does not fall into the incubation ring 4. Remove the sample tip drip tray, lifting up and to the left 5. Remove and discard loose debris 6. Soak the sample tip drip tray in 10% bleach solution for 5 minutes 7. To clean the sample tip drip tray: A. Remove the remaining debris with a damp sponge or paper towel B. Ensure there is no residue inside the drip tray C. Rinse the drip tray with tap water D. Dry the drip tray using a lint-free tissue 8. Install the sample tip drip tray 9. Tighten the 2 thumbscrews to secure the drip tray 10. Close the IM back cover *This procedure is continued on the next slide. 15 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS IM Weekly Maintenance Healthineers Inspecting and Cleaning the IM Sample Tip Drip Tray SIEMENS Healthineers". Atellica Solution 6 LabManage (continued) A 11. Enter IM diagnostic state: 1 Troubleshooting System SH-01 SH-02 CH-01 CH-02 IM-01 CI-01 A. Select Troubleshooting ‹ Â Troubleshooting 6 LabManager B. Select Operator Diagnostics ? Operator Diagnostics OX Online Help C. Select the appropriate IM analyzer module C 13 IM-01 B Operator Subsystems Diagnostic Name D. Select Enter Diagnostics > Yes Diagnostics Activity Description 14 All Empty Ring Empty all the cuvettes from the incubation ring Perform Ticketing 13 System Cuvette Loader E. Wait for the module to enter the diagnostic state Empty and Fill Ring Simultaneously empty the cuvettes from the incubation ring and load the ring with new cuvettes. View Status 12 Incubation Ring Initialize Incubation Ring Move the incubation ring and associated subsystems to their primary positions. Cancel Luminometer 12. Select Incubation Ring under Subsystems Operator Event Log Module Covers 13. Select Empty and Fill Ring System Other Messages Log Reagent Compartment 14. Select Perform > Yes LIS Log Reagent Probes Reagent Loader 15. Select Exit Diagnostics > Yes Assay Troubleshooting Sample Probe Tip Loader 16. To resume the analyzer, select the appropriate IM Analyzer D in the System Status map and then select Turn Mechanics On Enter Diagnostics 16 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS CH As Needed Maintenance Healthineers Performing IMT Advanced Cleaning Filters To Clear < Filters: Frequency : Weeklv. Monthly Counts X June 2021 A reminder displays when replacing IMT supplies if All Activities ? = X View By Day the analyzer processed 2500 IMT samples or the . By Count Filters Tx Clear Filters: Module : CH1-SCI1 X multisensor was in use for 10 days. This notifies 2 Module Module Activity 1 Last Performed View Details 4 CH1-SCI1 CH1-SCI1 CH1-SCI1 Cleaning the Washer Probes Perform the operator to perform the IMT Advanced Clean Activity Type Mark as Completed Sunday Monday Tu All CH1-SCI1 CHI CON Draining and Filling the Reaction Ring Bath at the next multisensor change. 30 31 1 Frequency 3 Procedure Details X All IMT Advanced Cleaning 6/3/2021 X The IMT Advanced Clean prevents protein build up Search CH1-SCI1 6 8 CH1-SCI1 IMT Daily Cleaning 6/2/2021 CH1-SCI1 12:00 AM in the IMT system. After the CH Analyzer CH1-SCI1 IMT Routine Cleaning 13 14 15 CH1-SCI1 t12:00 AM completes the IMT Advanced Clean, the operator CH1-SCI1 Inspecting and Cleaning the CH Probes and Mixer Impellers 5/31/2021 CH1-SCI 12:00 AM 20 27 22 CH1-SCI1 Inspecting and Cleaning the Probe Wash Stations 5/31/2021 must replace the A-LYTE multisensor. CH1-SCI1 [ 12:00 AM 27 28 29 CH1-SCI1 Inspecting the Washer Probes 6/2/2021 CH1-SCI1 1. Navigate to Maintenance > All Activities CH1-SCI1 Refreshing the Water Bath Additive 5 CH1-SCI1 or CH1-SCI1 Replacing Reagent Mixer Impeller at 1:00 AM . 2. Select the appropriate CH Analyzer CH1-SCI1 Frequency CH1-SCI Replacing Sample Mixer Impeller Weekly, Monthly, Counts CH1-SCI at 1:00 AM 3. Select IMT Advanced Cleaning Module CH1-SCI1 Replacing the CH Reaction Ring Cuvette Segments All CH1-SCI1 at 1:00 AM Activity Type CH1-SCI1 Replacing the Dilution Mixer Impeller 4. Select Perform > then OK to acknowledge All at 1:00 AM Close Activity Status at 1:00 AM that multisensor must be replaced after IMT All - SCI1 1841 Cr19 2. .. rinaninathe Cvtariar ofthe Donnant Drahar nun an 6/74/70 71 2+ 1 . nn And Advanced Clean completes 1 Related IDjy Review and Approve Maintenance Log All Activities 5. Wait 14 minutes for advanced clean to complete Note: Do not perform an IMT Advanced Clean after replacing the A-LYTE multisensor. Performing 6. Replace the current A-LYTE® multisensor the IMT Advanced Clean on the current multisensor renders it unusable. Perform the IMT Advanced Clean on the current multisensor prior to replacement. 17 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS CH As Needed Maintenance Healthineers Replacing A-LYTE® Multisensor 1 A reminder displays when replacing IMT supplies if the analyzer CH-01 System Processing SH-01 Connected to PCC CH-02 IM-01 CI-01 processed 2500 IMT samples or the multisensor was in use for 10 days. This notifies the operator to perform the IMT Advanced Clean at the next multisensor change. Patient Sample Processing Unlock Front Cover Unlock Back Cover Service Diagnostics U 1. Ensure the CH Analyzer is in Ready, Processing or Standby state: A. In the System Status area, select the CH Module ? IMT Maintenance is Due ? A X B. Review the status of the CH analyzer The IMT Adfvanced Clean Maintenance procedure is due. 2. To pause the IMT in preparation to replace the A-LYTE multisensor: To begin the IMT Advanced Clean before replacing the A-LYTE Multisensor, select Perform IMT Advanced Clean. ➢ For a Direct Load configuration: To replace IMT Supplies directly without perfoming the IMT Advanced Clean, select Replace A-LYTE Multisensor. To exit select Cancel A. Navigate to Supply Needs > View All Supplies B. Locate the A-LYTE Multisensor on the appropriate CH Analyzer and select Replace Item Perform IMT Advanced Clean Replace A-LYTE Multisensor Cancel C. If an IMT Advanced Clean is required at the next multisensor replacement, a window displays with two options (image to the right): Note: Do not perform an IMT Advanced Clean after replacing the A-LYTE multisensor. 1) To begin the Advanced Clean before replacing the A- Performing the IMT Advanced Clean on the current multisensor renders it unusable. Perform LYTE multisensor, select Perform IMT Advanced Clean the IMT Advanced Clean on the current multisensor prior to replacement. and wait for the IMT Advanced Clean to complete 2) Select Replace A-LYTE Multisensor > Replace, and *This procedure is continued on the next slide. 18 wait for IMT system to pause Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS CH As Needed Maintenance Healthineers Replacing A-LYTE® Multisensor (continued) ? IMT Maintenance is Due ? A X ➢ For a Sample Handler configuration: The IMT Adfvanced Clean Maintenance procedure is due. A. Select IMT Supplies on the module display To begin the IMT Advanced Clean before replacing the A-LYTE Multisensor, select Perform IMT Advanced Clean. B. If a window displays with options to either perform IMT Advanced To replace IMT Supplies directly without perfoming the IMT Advanced Clean, select Replace A-LYTE Multisensor. Clean or replace IMT supplies (see image on the right), it means that an IMT Advanced Clean is required before the next multisensor To exit select Cancel replacement. Continue with these steps: 1) Select Perform IMT Advanced Clean and wait for the IMT Advanced Clean to complete Perform IMT Advanced Clean Replace A-LYTE Multisensor Cancel 2) Select IMT Supplies > Pause IMT and wait for this process to complete 3) Select A-LYTE Multisensor 3. Open the IMT fluids lid 4. To scan a new A-LYTE multisensor*: ➢ For a Sample Handler configuration, either the module display barcode reader or the handheld barcode reader can be used ➢ For a Direct Load configuration, use the handheld barcode reader *Note: If the barcode reader is not functioning, the information can be manually entered in the software. 19 *This procedure is continued on the next slide. Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS CH As Needed Maintenance Healthineers Replacing A-LYTE® Multisensor (continued) 5. Ensure the Lot, Sequence, and Expiration display correctly 6. To release the multisensor, pull down the sensor access latch. Remove the A-LYTE multisensor, discard per laboratory protocol 7. Insert a new multisensor with label facing forward 8. Push up the latch and close the IMT fluids lid 9. Select Save 10. Wait for the IMT restart to complete 20 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Reagent Needs Healthineers The Reagent Needs provides information about current inventory that fall below the operator configured threshold*. Reagent Needs When a reagent need exists, an alert displays in the Reagent Needs tile on the Dashboard: • Red: At least 1 reagent is below the operator configured threshold 5 • Green: No reagents are below the operator configured threshold The tile body displays: • The total number of reagent needs If the tile is red, select it to display the Reagent Needs screen (see next slide). Reagent Needs *NOTE: The alert threshold is configured in the Reagent Thresholds screen. O NOTE: Refer to the Instructions For Use (IFU ) for instructions on preparation, storage, and handling of reagents. For additional information on handling reagents, refer to these Job Aids on PEPconnect: Handling Reagent Packs on the Atellica® CH Analyzer Job Aid Handling Reagent Packs on the Atellica® IM Analyzer Job Aid 21 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Reagent Needs Healthineers C The Reagent Needs screen is intended to be the Reagent > Reagent Needs 6 LabManager primary screen used to determine what reagents need Reagent Needs A to be loaded on the system. Reagent Packs to Load Module Inventory Reason Add To Cart DMX 1 CH-01 0 No Available Reagent To view the reagent needs: EHIV IM-01 0 No Available Reagent aHCV 1 IM-01 No Available Reagent O 1. Navigate to Reagent Needs TSH 1 IM-01 O No Available Reagent • The number of packs to load, module, current TSH IM-02 Below Threshold ( <10 ) - inventory, and reason for the need are listed • The Below Threshold status indicates the reagent is below the operator defined threshold* 2. The Cart List feature can be used to create a list for retrieving the reagents from the storage location. B To add a reagent to the Cart List: Add All To Cart A. Select the Add to Cart button B. To add all of the reagents on the screen to the *NOTE: Select the Gear icon in the upper right corner to access the Reagent Thresholds screen. Cart, select Add All to Cart NOTE: The Reagent Needs screen is updated within 5 minutes if an analyzer is rebooted or if an C. To view the Cart List, select the cart button in assay status changes. the Access bar at the top of the screen 22 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Manually Mixing IM Primary Reagent Healthineers Primary reagents must be manually mixed before being loaded on the system: 6. Return the pack to a horizontal position 1. If the reagent pack is pierced, gently press on the self-sealing laboratory 7. Repeat steps 2–5 a minimum of 20 times or until: film that covers the pierced film area, while mixing, to prevent leakage ➢ Any clumps are broken up and no longer visible on the 2. With the film side up, loosely hold the reagent pack at each end bottom of the pack 3. Raise one end of the pack 90◦ to its vertical position ➢ No large aggregates are visible floating inside the pack 4. Return the pack to a horizontal position 8. Mix 5–10 times more to ensure complete mixing 5. Raise the other end of the pack 90◦ again to its vertical position 9. If the reagent pack is pierced, remove the self-sealing NOTE: If foam appears inside the pack, use a slower mixing speed. laboratory film NOTE: Be sure to wear gloves, especially when handling pierced reagent packs. 10. Load the reagent pack onto the analyzer 3 4 NOTE: There are assays that require special reagent preparation. Refer to the Instructions for Use (IFU) to check the preparation requirements for each ND RxOnly RxOnly For USA T4 reagent. re Far in vitro daghosts use in he quartiato the AteBida " IM Analyzer For Protestonal Lise Contains: Lhe Raagert 10 0 +i. Sand Phase 25 0mg. ReadyPack" Far USA T4 23 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Loading Reagent Packs Healthineers 1. Ensure the system is in the Ready or Processing state 2. Open the CH reagent tray lid or the IM reagent drawer 3. Insert reagent packs into the tray/drawer ➢ Any combination of primary or ancillary reagent packs may be loaded in the IM reagent drawer ➢ Ensure the top barcode is on the right side of the drawer and the pack is well-seated in the slot 4. Close the CH reagent tray lid or the IM reagent drawer CH Reagent Tray ➢ When the reagent tray lid closes, the gripper scans the packs and automatically loads valid packs 5. Review the Reagent Loader screen and resolve any loading issues that may occur NOTE: Some reagent packs must be manually prepared and mixed before loading them on the CH analyzer. IM primary reagents must be manually mixed before being loaded on the system. IM Reagent Drawer 24 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Supply Needs Healthineers The Supply Needs provides information about the status of onboard supplies. When a supply need exists, an alert displays in the Supply Needs tile on the Supply Needs Dashboard: • Red: The supply level is below the operator configured alert threshold. The 2 waste level is above the operator configured alert threshold* • Green: No supply is below the operator configured alert threshold The tile body displays: • The number of required supplies Supply Needs If the tile is red, select it to display the Supply Needs screen (see next slide). *NOTE: These alert levels are configured in Supplies Alert Threshold Configuration screen. The thresholds for the fluid bottles are set based on the percentage that the bottles are full, not including the reservoirs. 25 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Supply Needs Healthineers Supplies > Supply Needs 6 LabManager To view the supply and waste needs: 2 View All Supplies C 1. Select Supply Needs Module Alert Time Supply Position Status V . CH-01 The name, lot, and status for supplies that need 1:28 PM CH Conditioner 6 Empty Replace Item A • . IM-01 to be loaded are listed 12:37 PM IM Was 8 5% Remaining Replace Item 2. To view detailed information for all supplies, select View All Supplies 3. To return to the view of only the needs, select View Alerts Only View Alerts Only 3 Expand All Collapse All CH1-SCI1 V 4. The Cart List feature can be used to create a list for -SCI1 retrieving the supplies from the storage location. System Fluids # Volume Onboard Stability Lot Expiration Lot To add a supply to the Cart List: IM Base 17 100 % 21 d 3 h 5/22/202 987654 Replace Item IM Acid 10 100 % 21 d 3 h 4/21/2022 123456 Replace Item IM Cleaner 100 %6 od 3h 20/2022 123456 Replace Item A. Select the Add to Cart button Replace Item B IM Wash 8 (Left) 100 % 21 d 3 h 3/20/2022 123456 Add All to Cart 8 (Right) 100 % 21 d 3 h 4/21/2022 198765 Replace Item B. To add all of the supplies on the screen to the Other Supplies Status Waste Status Cart, select Add All to Cart Tips Empty Packs Available for Loading : 5 O Tip Trays In Storage Cuvette and Tip Waste OK Water Reserve empty Tip Tray Waste OF Open Tip Tray Waste Drawer C. To view the Cart List, select the cart button in cuvettes Empty Liquid Waste Humidity Pack Insufficient the Access bar at the top of the screen NOTE: The Supply Needs screen is updated within 5 minutes if an analyzer is rebooted or if an assay status changes. 26 NOTE: Select the Gear icon in the upper right corner to access the Supplies Alert Threshold Configuration screen. Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Replacing System Fluids Healthineers 1. Open the system fluids drawer ➢ The System Fluids screen will display on the module display MISIEMENS System Fluids 8 IM Wash 2. Locate and tighten the cap of the system fluid container to be removed. Select the container location After tightening the lid, remove the appropriate system fluid container and turn the container upside down so it doesn't leak on the floor ? OK WWW Wash 3. Discard the system fluid container according to laboratory protocol SIEMENS IM Wash Using the module display or the handheld barcode scanner, scan the 2017-09-23 282482 11098501 4. new fluid container using the barcode on the front label To scan using the module display, hold the container 150 mm (6 OO • inches) at a 45 ◦ angle under the module display barcode reader 5. Ensure the module display shows the correct Lot and Lot Expiration under the appropriate fluid. If the Lot and Lot Expiration are incorrect, enter the Lot and Lot Expiration listed on the container manually into the system software by selecting Manual Entry 6. Select OK *This procedure is continued on the next slide. NOTE: If replacing the IM Wash the operator will have to select the container location (right or left position) after scanning the fluid container. NOTE: Do not load the same system fluids container multiple times. Removing and reloading a system fluid container can cause the punctured membrane to leak. Load only new and unused containers on the analyzer. 27 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Replacing System Fluids Healthineers 6. Holding the new system container vertically with the septum facing down, firmly insert the container straight down into the drawer with the label away from the analyzer NOTE: The fluid containers are keyed to fit only in the designated drawer position. NOTE: The container only delivers fluid when the operator fully seats it into the designated location. Refer to the fluid chart within the drawer for correct container placement. To securely seat the container, do not insert container at an angle. 7. Ensure the container is seated securely with the tabs on both sides of the container even with the drawer surface 8. To prevent a vacuum from forming inside the container that could cause the analyzer to stop processing, vent the container. To vent the container, squeeze the cap at the arrows and twist the cap slightly more than a 1/4 counterclockwise turn past the first stop (see figure 1 below). Then release and twist the cap counterclockwise until the arrows on the cap match figure 2 below 9. Close the system fluid drawer 1 2 28 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Replacing IM Cuvettes Healthineers 1. Open the cuvette bin lid 2. To open the cuvette packaging, use scissors to ensure that plastic bag NOTE: Do not push down the cuvettes, remove the plastic divider, push fragments do not drop into the cuvette bin that could cause jams cuvettes to the right side of the bin, or overfill the bin enough to prevent the 3. Pour cuvettes into the cuvette bin up to the brim in the left side of the cuvette lid from fully closing. Performing any of these can cause a cuvette jam. cuvette bin 4. Close the cuvette bin lid and ensure the lid completely closes Plastic Divider Left Side of Right Side of Cuvette Bin Cuvette Bin 29 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Replacing IM Sample Tips Healthineers NOTE: Wear new, uncontaminated gloves when handling sample 4. Slide the tip tray bundle down on to the 4 tip tray hooks tips to prevent cross contamination. 5. Twist then pull the tab down and out to release the strap from 1. Open the sample tip loading lid the trays 2. Remove the protective cover from the sample tip tray bundle 6. Pull the strap out to remove it from the bundle. Note: Leave and inspect the bottom tray for damage or defects the top on the upper trip tray 3. Install the sample tip trays ensuring that the tab is facing the 7. After the analyzer lowers the bundle into the tip tray storage opening on the right and the rounded notches in the trays are area, close the sample tip loading lid facing the back of the system 2 3 5 30 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Emptying the IM Sample Tip Tray Waste Healthineers 1. Navigate to Supply Needs 2. Select Open Tip Tray Waste Drawer 3. Open the solid waste door 3 *This procedure is continued on the next slide. Supplies > Supply Needs 7 LabManager View All Supplies Module Alert Time Supply Position Status . CH-01 1:28 PM CH Conditioner 6 Empty Replace Item 1:10 PM A-LYTE Multisensor OBS Expired Replace Item IM-01 10:50 AM Tip Tray Waste Full 2 Open Tip Tray Waste Drawer Add All to Cart 31 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Emptying the IM Sample Tip Tray Waste Healthineers 3. Pull open the sample tip tray waste drawer 5. Close the sample tip tray waste drawer 4. Remove the empty sample tip trays 6. Confirm the tip tray waste is empty by responding to the software prompt 3 4 O 32 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Emptying the IM Solid Waste – Cuvettes and Sample Tips Healthineers 1. Open the solid waste door 4. Return the bins to the solid waste drawer 2. Pull out the solid waste drawer and remove the solid 5. Push the drawer in and close the door waste bins. To facilitate solid waste bin removal, grasp 6. the bin with both hands and shake slightly Confirm the cuvette and tip waste bins are empty by responding to the software prompt 3. Empty the contents of the solid waste bins into a laboratory-approved container for biohazardous waste 2 33 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Replacing IMT Fluids Healthineers Be sure to follow the screen prompts and perform the steps in the correct order when replacing the IMT consumables. SIEMENS Healthineers ... CH-01 abManager 1. Ensure the analyzer is in Ready, Processing, or Standby state by 1 Ready reviewing the Module State on the module display Module State System Fluids Other Supplies Reagent Loader 2. Open the IMT fluids lid 3 3. Select IMT Supplies on the module display MT Supplies Pretreatment 4. Select Pause IMT on the module display -00 5. Locate and remove the appropriate IMT fluid container 6. Discard the IMT fluid container per laboratory protocol IMT Supplies LabManager NOTE: Do not refill an IMT fluid container. Refilling a container can cause contamination. Ready IMT Fluids Lid Closed Remove the bottle from the IMT fluids area and install a new container. To replace A-LYTE multisensor or IMT fluids, at the module display, select Pause IMT. Scan or manually enter the A-LYTE Multisensor or IMT fluid barcode. NOTE: Do not load the same IMT fluids container multiple times. Removing and reloading an IMT fluid container can cause the punctured membrane to leak. Load only Na K CI 2 3 A-LYTE Multisensor IMT Std B + Salt Bridge IMT Standard A IMT Diluent new and unused containers on the analyzer. 4 Pause IMT ? *This procedure is continued on the next slide. 34 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Replacing IMT Fluids Healthineers 7. Using the module display or handheld barcode scanner, scan the new IMT IMT Sunnliac lah Manan fluid container 3 IMT Diluent RE X ed Lot 8. Ensure the module displays the correct Lot, Sequence, and Expiration under 1234567894-22332 Instructions for Scanning the appropriate fluid. If the Lot and Lot Expiration are incorrect, enter the Lot Lot Expiry 11/26/2021 11:59 PM and Lot Expiration listed on the container manually into the system software OBS L 10d 10 h by selecting Manual Entry Status Empty (0 % Remaining) 9. Holding the new IMT fluid container vertically with the septum facing down, insert the new container into position ? Manual Entry Cancel 10. To replace each additional IMT fluid, repeat steps 5-9 11. Close the IMT fluids lid 12. Select the button in the software to save and complete the procedure NOTE: Do not touch the cannulas in the keyed areas at the bottom of the system fluids drawer. The cannulas can puncture skin. NOTE: The system and IMT fluid containers only fit in the designated position when SIFMENS A the cannulas puncture the septum. 35 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Replacing the Pretreatment Pack Healthineers NOTE: Do not handle pretreatment 1. Stop the CH analyzer and unlock the front cover: solution without wearing protective equipment, including A. At the module display, select Module State gloves, laboratory coat, and safety B. Select the Stop icon glasses or a protective face shield. Pretreatment solution can cause C. Select the icon to unlock the CH front cover skin irritation. 2. Lift open the CH front cover 3. Grasp the pretreatment pack and pull up and out. Discard the pretreatment pack per laboratory protocol 4. On the module display, select Pretreatment 5. The pretreatment screen will display. If needed, select Instructions for Scanning for guidance on how to hold the pretreatment pack while scanning SIEMENS .... Healthineers CH-01 LabManager 6. Using the module display, scan the new pretreatment pack Ready Module State System Fluids Other Supplies Reagent Loader 7. Confirm that the module display shows the correct Lot and Expiration. If the Lot 1 and Lot Expiration are incorrect, enter the Lot and Lot Expiration listed on the container manually into the system software by selecting Manual Entry IMT Supplies Pretreatment 8. Insert the new pretreatment pack into the CH analyzer. Remove cap and discard -00 4 9. Close the CH front cover 10. Resume the CH analyzer by selecting the Resume icon on the Module State screen 36 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Maintaining Cal-QC Storage Healthineers 1. Navigate to the Cal-QC Storage Inventory screen QC > Cal-QC Inventory 8 LabManager 2. If the Cal-QC storage area is full, unload Cal-QC materials: Capacity Filters Status : OK, Type : QC, Calibrators, Location : SH-01 Assay Details Available O [ Type Material Lot Sequence Status Vol (uL) Location Expiration Assay Expiration A. Select one or more samples 0 Qc CHQC19 1 CHQC19 000129 OK ~1524 SH-01 12/1/2021 11:59 PM Acet 8/1/2021 11:59 PM A CHQC19 1 CHQC19 000080 Expired NA SH-01 3/1/2021 11:59 PM Alb 8/1/2021 11:59 PM B. Select the Unload button. Ensure there is a rack Filters Tx Clear 0 QC IMQC1 1 IMQC1 000012 OK 1400 SH-02 11/1/2021 11:59 PM Amylas 8/1/2021 11:59 PM loaded to receive the samples Q Search Inventory IMQC1 2 IMQC1 000222 OK 1300 SH-02 11/1/2021 11:59 PM C3 8/1/2021 11:59 PM Q Search Assay 0 Qc QCSERPLAS 1 452412 000112 OK 1200 SH-01 4/1/2022 11:59 PM Ca 8/1/2021 11:59 PM 3. If loading a new material, create a definition for the Status 0 Qc BIOLIQUID 1 45770 000123 OK ~3000 SH-01 1/1/2022 11:59 PM Chol2 8/1/2021 11:59 PM calibrator or QC material OK ] Qc BIOLIQUID 2 45770 000124 OK ~3000 SH-01 1/1/2022 11:59 PM CO2 _C 8/1/2021 11:59 PM Insufficient Volume Expired 0 Qc BIOLIQUID 3 45770 000125 OK ~3000 SH-01 1/1/2022 11:59 PM Crea_2 8/1/2021 11:59 PM 4. If appropriate, pour the calibrator or QC materials into Partially Expired 0 Cal DrugCal A 0433 000001 OK ~1200 SH-01 12/1/2021 11:59 PM GLUH_ 8/1/2021 11:59 PM labeled 12x75-mm round-bottom glass or polypropylene 0 Cal Type DrugCal B 2411 000001 Expired ~1200 SH-01 8/1/2021 11:59 PM IgA_2 8/1/2021 11:59 PM OC sample containers Cal DrugCal C 777 000002 OK ~1200 SH-01 12/1/2021 11:59 PM lgG_2 8/1/2021 11:59 PM Calibrators 0 Cal CHEMCAL 1 0433 000001 OK ~1200 SH-02 12/1/2021 11:59 PM IP 8/1/2021 11:59 PM 5. Load the calibrator or QC material containers in a STAT ocation 0 Cal CHEMCAL 2 2411 000001 Partially Expired -1200 SH-02 11/1/2021 11:59 PM O SH-01 rack for immediate processing and storage 0 Cal SH-02 CHEMCAL 3 777 000002 OK ~1200 SH-02 12/1/2021 11:59 PM B Unload ➢ Loading the calibrator or QC materials in a STAT rack Related Callbration Due QC Needs minimizes unrefrigerated time in the SH drawer. Ensure the calibrator or QC material containers are NOTE: For information on how to create calibrator or QC definitions, refer to fully seated in the rack the Calibration or Quality Control topics. To load the material in the Cal-QC storage area, select Store Onboard in the definition. NOTE: The system processes calibrator and QC materials in other size sample containers (including tube top cups) but does not store them in the Cal-QC storage area. Only 12x75-mm round-bottom sample containers are stored in the Cal-QC storage area. 37 37 *This procedure is continued on the next slide. IM Effective Date: 16-FEB-2022 | HOOD05162003255836 Hardware Overview Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Maintaining Cal-QC Storage Healthineers 6. Load the STAT rack in a sample drawer ➢ The SH robot automatically transfers the container(s) to the Atellica Magline® Transport. After the Tube Characterization Station identifies the sample as a calibrator or QC material, the system transports the container to the appropriate analyzer if it has open orders ➢ After the system returns the container to the SH, the system performs 1 of the following actions: • If the material requires onboard storage, the SH robot loads the container into the Cal-QC storage area • If the material does not require onboard storage, the SH robot loads the container into an available position in a routine output rack NOTE: If the system does not store the calibrator or QC material in the Cal-QC storage area, ensure a routine output rack with empty positions is available in a sample drawer. If the material does not require onboard storage and the operator configures a Cal-QC sort area, the SH robot places the container into an available position in the designated sorting rack. 38 38 IM Effective Date: 16-FEB-2022 | HOOD05162003255836 Hardware Overview Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Calibrations Due Healthineers Calibrations Due Red Tile Banner: Calibration Due • If there are calibrations that require operator intervention, and it is within 1 hour* before the schedule time, the system generates a warning alert by turning the Calibration Due tile 6 Lo banner red • The operator must resolve the needs (such of missing calibrator definition, QC material, calibrator material, etc) so the automatic orders can start running when they are generated Green Tile Banner: Calibration Due • If there are no calibrations that require operator intervention within the next 1 hour*, the Calibration Due tile banner will be green 5 L℮ Tile Count: • The tile count is the number of calibrations due today** Select the tile to display the Calibration Due screen. *NOTE: The 1 hour is the Calibrations Due Warning Example: It is currently 4:00 am, there are 5 calibrations that require intervention today, and the threshold. This can be configured in the Calibration Setup screen. calibration schedule time is 8:00 am. In this case, the Calibration Due tile will be green with the number 5 displayed as the count. The tile will be green since it is more than 1 hour until the **NOTE: Today is the period before midnight of the calibration schedule time. If there are no longer any calibrations required for today, the count current day. will change to zero. 39 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Calibrations Due Healthineers The Calibration Due screen lists the calibration orders the < Calibration > Calibrations Due 8 LabManager system is planning to place for onboard reagents when Timeframe Calibrations required for New Packs (4) V the calibration schedule time arrives. Today and Tomorrow i Calibration Order Settings Automatic Schedule 05:00 AM Calibration Warning 1 hours Analyzer Assay Reagent Lot Calibrations Required With Needs (4) A Tests CH Amp1K 111100 The items on the schedule may change as reagent Analyzer Assay Reagent Lot - Pack ID Remaining Pack OB Order Status Order Time Material Status Calibration • Expiration CH MALT 111100 O CH ALT 111100-55605:Well 1 421 50 d 0 h Place Order Now Need Cal Def 0 hours Order inventory changes. For example, if a calibration is due CH Amp500 111100 CH GluH_ 111100-95205:Well 1 22 d 0 h Place Order Now Need Cal Def 0 hours Schedule 777 Print Barcode CH Amp300 111100 O for a reagent and the reagent is removed from the CH ALT 111100-55605:Well 2 419 50 d 0 h Place Order NOW Need Cal Def 0 hours Ignore system, the calibration will no longer be listed on the CH GluH_3 111100-95205:Well 2 774 22 d 0 h Place Order Now Need Cal Def 0 hours 0 0 Extend screen Calibrations Required without Needs (1) • The system determines if a pack or lot calibration is O Tests Analyzer Assay Remaining Pack OBS Order Status Order Time Status Calibration Reagent Lot Pack/Well Materia Expiration needed at the time the order is created O CH-02 Amylas 452158-7521481:Well 2 60 20 d 0 h Scheduled Order 3:00 AM Onboard 22 hr Ignore Extend • The system verifies what is needed to perform the calibrations (calibrator definitions, calibrator material, QC material, etc) • The screen divides the calibrations into 2 categories: Related Calibrator Needs Calibration Results Cal-QC Inventory Calibrator Definitions QC Definitions QC Needs Reagent Overview ➢ Calibrations that ready to run (bottom) ➢ Calibrations that need user intervention (top) NOTE: The Calibration Results screen displays the details for the orders, including calibration type (pack or lot). • Once the calibration starts processing, the calibration NOTE: The section at the bottom (Calibration Required without Needs) will not display if there are no calibrations will be removed from the list in this category. NOTE: For more information on monitoring calibrations due, refer to the Checking Calibrations Due on the Atellica® Solution Job Aid on PEPconnect. 40 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Calibrator Needs Healthineers C The Calibrator Needs screen displays a list of the ‹ Â Calibration > Callbrator Needs 6 LabManager (LM) calibrator material that needs to be loaded. Calibrators to be Loaded (7) 2 A To view the Calibrator Needs: 0 Callbrator Material Level Lot Assay Store Onboard Reason Add To Cart Emit Ca N2 (Expired) Amp300, Bnz300 Yes Scheduled at 8:00 AM Print Barcode O 1. Navigate to Calibrator Needs 0 Emit Cal N3 mp300 Yes Scheduled at 8:00 AM O Emit Ca 2 N4 Amp300, Bnz300 Yes Scheduled at 8:00 AM 2. The reason for the need is listed Emit Ca 3 N5 Amp300, Bnz300 Yes Scheduled at 8:00 AM Emit Cal 4 N6 Bnz300 Yes Scheduled at 8:00 AM O • In this example, the reason is that these Emit Cal 5 Bnz300 Yes Scheduled at 8:00 AM 3 O calibrations are scheduled to be run before the Chem Ca 1,2 H123053 Iron_2, TP Yes Scheduled at 8:00 AM O end of the current day and the calibrator material needs to be loaded 3. The Cart List feature can be used to create a list for retrieving calibrator materials from the storage location. To add calibrator material to the Cart List: Add All To Cart A. To add a calibrator material to the Cart, select the Related Callbration Results Cal-QC Inventory Callbrator Definition Callbration Due B Add to Cart button B. To add all calibrator materials on the screen to the Cart, select Add All to Cart C. To view the Cart list, select the cart button in the Access bar at the top of the screen 41 41 IM Effective Date: 16-FEB-2022 | HOOD05162003255836 Hardware Overview Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Creating Calibration Orders Healthineers Options for Creating Calibration Orders ➢ Configure the system to automatically create calibration orders ➢ Create calibration orders manually using the Order button on the Calibrations Due screen ➢ Create calibration orders manually using the active calibration lot for reagent packs currently onboard the system using the Reagent Overview screen ➢ Create calibration orders manually using the Create Calibration Orders screen. This method is useful in the following cases: • To use a calibrator lot other than the active lot • To order for multiple assays or analyzers at once NOTE: Refer to the vendor IFU for instructions on preparation, storage, and handling of calibrator materials. 42 IM Effective Date: 16-FEB-2022 | HOOD05162003255836 Hardware Overview Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Reviewing Calibration Results Healthineers Options for Reviewing Calibration Results • To view the status of test orders and results for calibration, QC, and patient orders, navigate to the Worklist screen • To export or print a detailed calibration report, and to troubleshoot calibration results, navigate to the Calibration Results screen ➢ Multiple calibration results can be selected for printing or exporting in batches • To view detailed information for a calibration result, access the Calibration Results Details. This screen can be accessed from either the Worklist or the Calibration Results screen ➢ See the following slides for more information on Calibration Results Details NOTE: The system can be configured to automatically print calibration results reports (navigate to the Reports Setup screen and select the Automatic Reports tab). 43 43 IM Effective Date: 16-FEB-2022 | HOOD05162003255836 Hardware Overview Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Reviewing Calibration Results – Details Screen Healthineers The Calibration Results Details can be accessed from either the X Worklist or the Calibration Results screen. Calibration Results Details for Mg on CH1 Information A Data B Comments A. Information – summary of the calibration order information Activity Assay 1 (L) 2 (H) Reagent Lot Calibration Mg Replicate Include Analyte Signal Flag Include Analyte Signal Flag Units Calculation Type mg/dl Linear Replicate 1 -208664910499855.00 ... 542.82 mAU -208664910499855.00 ... 542.82 mAU B. Data – calibration data for each replicate Ordered Date Completed Date Edit 10/27/2021 3:56:12 PM 10/27/2021 4:06:03 PM Replicate 2 V -64606693336667.50 m ... 546.06 mAU -64606693336667.50 m ... 546.06 mAU Accepted By Analyzer Name CH1 Replicate 3 V 273271603836522.00 m ... 553.66 mAU 273271603836522.00 m ... 553.66 mAU ➢ If applicable, the Include checkboxes can be used to Graph Analyzer Serial Number Reagent Lot Mean 0.00 547.51 Mean 0.00 547.51 CH1 110000 555- exclude or include replicate results Pack/Well Ancillary 1 12921338667333.50 546.06 Median -12921338667333.50 546.06 11114:Well 1 Median Ancillary 1 Lot/Pack Ancillary 2 SD 247378696699206.00 5.56 SD 247378696699206.00 5.56 C. QC Performed with Calibration – provides a summary of QC Ancillary 2 Lot/Pack Calibrator Name Observed %CV 1.02 Observed %CV 1.02 CALC System Response results, when the system automatically performed QC with C Calibrator Lot Calibration Status QC Performed with Calibration D Acceptance Criteria CALC Awaiting Acceptance 540 Acceptance Criteria Acceptance Mode QC QC Limit New Observed Old Observed Criteria Result Value Expected Observed Expected Concentration calibration Failed Automatic No auto-excluded rigger Mode Cal Expiration replicates Pass 0.00 -0.5- 0.5 -0.5 - 0.5 Operator Initiated 04/25/2022 3:56:25 PM Curve Shape No flags or Pass 0.00 -0.5 - 0.5 -0.5 - 0.5 comments 42,1 0.00 D. Acceptance Criteria – displays the criteria to evaluate the Delta System Fail 0.00 mAU 121.0 - 690.0 Coefficients 121.0 - 690.0 Response 42,1 0.00 42,1/42,1 -.- calibration, and indicates whether each criteria failed or Co Statistic 547.51 Slope 0.00 C1 Intercept 0.00 passed for the selected calibration 0.00 Corr. Coefficient 0.00 C2 C5 Enlarge ➢ The system automatically accepts calibration results if the Print Accept Reject Close acceptance criteria passes * See the next slide for more information on this screen NOTE: In order to exclude a replicate, the minimum number of replicates the system requires for a valid calibration must remain after the exclusion of the replicate. After excluding an outlier replicate result, the system recalculates the calibration data and rechecks the calibration criteria. The Atellica® IM Analyzer can be configured to automatically exclude outlier calibration replicates. 44 44 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Reviewing Calibration Results – Details Screen Healthineers E. Comments – displays any comments entered by the operator for this result Calibration Results Details for Mg on CH1 X Comments E Information Data ➢ To enter a new comment, select the Edit button Activity Assay 1 (L) 2 (H) Reagent Lot Calibration Mg Replicate Include Analyte Signal Flag Include Analyte Signal Flag Units Calculation Type mg/dl Linear 542.82 mAU -208664910499855.00 ... F. Graph* – displays a graph of the results as Expected Replicate 1 -208664910499855.00 ... 542.82 mAU Ordered Date Completed Date Edit 10/27/2021 3:56:12 PM 10/27/2021 4:06:03 PM Replicate 2 -64606693336667.50 m ... 546.06 mAU -64606693336667.50 m ... 546.06 mAU Concentration/System Response Accepted By Analyzer Name CH1 Replicate 3 V 273271603836522.00 m ... 553.66 mAU 273271603836522.00 m ... 553.66 mAU Graph F Analyzer Serial Number Reagent Lot 547.51 Mean 0.00 547.51 CH1 110000 Mean 0.00 555- ➢ To display a larger view of the graph, select the Pack/Well Ancillary 1 Median -12921338667333.50 546.06 Median -12921338667333.50 546.06 11114:Well 1 ,552 Enlarge button Ancillary 1 Lot/Pack Ancillary 2 SD 247378696699206.00 5.56 SD 247378696699206.00 5.56 5.49 Ancillary 2 Lot/Pack Calibrator Name Observed %CV 1.02 Observed %CV 1.02 CALC System Response G. Select Accept or Reject for calibrations with a Cal Status Calibrator Lot Calibration Status QC Performed with Calibration Acceptance Criteria CALC Awaiting Acceptance 540 Acceptance Criteria Acceptance Mode QC QC Limits New Observed Old Observed Criteria Result Value Expected Observed Expected Concentration of “Awaiting Acceptance” Failed Automatic No auto-excluded rigger Mode Cal Expiration replicates Pass 0.00 -0.5-0.5 -0.5 - 0.5 Operator Initiated 04/25/2022 3:56:25 PM Curve Shape No flags or 0.00 -0.5- 0.5 -0.5 - 0.5 ➢ “Awaiting Acceptance” indicates the results do not comments Pass 42,1 0.00 Delta System 121.0 - 690.0 Coefficients 0.00 mAU 121.0 - 690.0 42,1 0.00 Response Fail 42,1/42,1 -.- meet the acceptance criteria for 1 or more expected Co Statistic 547.51 18 Slope 0.00 Intercept 0.00 calibration values and the following conditions apply: C1 0.00 Corr. Coefficient 0.00 C5 G Enlarge 10 o Automatic Acceptance is disabled in the test Print Accept Reject Close definition ➢ The operator must select to accept or reject the *NOTE: The Graph is only displayed for CH calibration results. calibration NOTE: The “Awaiting Acceptance” status will also occur if the Order QC with Calibration and QC Results Must Be Within Ranges settings are enabled and the calibration passes but the QC is out of range. 45 45 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Calibration - Scanning IM Master Curve and Assay Test Definition Barcodes Healthineers • Each IM assay reagent kit includes a Master Curve and Test Definition (MC TDEF) 2D barcode Setup > Test Definition > IM Test Definition 6 LabManager • The MC TDEF insert can have 1 or more 2D barcodes Select Tests Assay Identification Advanced • The MC TDEF barcode(s) must be scanned when a Definition Test Name / ID Display Name * Replicates Acceptable CV % new lot of reagent is loaded on the system Calculation Test Type Print Name Patient O Calibration Test Version LIS Code * Control To scan the MC TDEF barcode(s): O Reagents IM CI IM Status O Lots Overdilution Point Enter Slope 1. All connected IM analyzers must be in one of the following 1.0 1.1 CI Status O Ranges Specimen Type Enter Intercept LOINC states: Delta Check Compatibility Code Add Result Ready, Standby, Stopped, Startup, or Warming up Repeat Minimum SW Version SMT O General IM Region Recalibrate After Update 2. Navigate to IM Test Definition Result Review Mode CI Region Manual Dilution 3. Select Scan Data Reuse Result for Ratio Centerfuge Before Repeating Range Window Result Time Limit (hours) Control-Bracketed Test 4. Scan the first 2D barcode using the Handheld Barcode Scanner Analyte Stability (minutes) Bracket Timeout (h ... Reminder (hours) 5. Scan the remaining 2D barcodes in consecutive order 3 6 • The barcode scanner audio confirms successful Import Export Scan Data Restore Defaults Save Cancel scans 6. Select Save NOTE: Do not scan the linear barcode on the bottom of the MC TDEF insert, if present. The linear barcode is for manufacturer use only. 46 46 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Installing New Calibrator Definitions Healthineers Calibration > Calibrator Definitions 8 Calibrator definitions must be installed when a new lot of calibrator will be used. To install a new calibrator definition: Filter x Clear Filter: Material Name : All X Status : Ac 2 Material Name Add New Scan Barcodes All 1. Navigate to Calibrator Definitions Status Material Name Active Lot ID Material ID Expiration Date Assays O Assay Type All CALTBil2 T4343 K5 09/16/2021 11:59:59 PM TBil 2 O 2. Select Scan Barcodes Q Search CalCa56 C3456 CA 09/16/2021 11:59:59 PM Ca O CALAFP123 123456 09/16/2021 11:59:59 PM AFP BLUE CLN10 O 3. Scan the barcode(s) from the calibrator lot-specific value sheet CLN20 PLR100 CALHBSII HB62 09/16/2021 11:59:59 PM HBsIl O using the barcode reader (the value sheet can be found in the box with the calibrator material) B A. IM assays: all the linear barcodes on the value sheet must CHEM CAL be scanned B. CH assays: the 2D barcode on the value sheet is scanned SIEMENS CHEM CAL = CHEMICAL UL ....... --- A 47 47 * This procedure is continued on the next slide Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Installing New Calibrator Definitions Scan Calibrator Definition X Healthineers i scan the 20 barcode from the lot-specific value sheet using the barcode scanner Calibrator Scanned Material Name 4. Confirm the scanned information on the Scan Calibrator laterial ID Lot ID Definition window and then select OK 5. If storing the calibrator in the Cal-QC storage area, select the Store Onboard checkbox (only applies to Sample Handler 4 configurations) OK Cancel ➢ Certain assay calibrators are not compatible with onboard View or Edit ? = X storage in the Cal-QC area. The operator cannot select the Calibrator Details Material Name . 5 Material ID Store Onboard checkbox and save a calibrator definition Lot ID . CALTBil2 K5 Global ID T4343 Store Onboard Revision ID Per Level Expiration Date . 9/16/2021 Active that includes an assay that is incompatible with onboard 6 storage Select Assays Assigned Values Assay Type Assay Level 1 Level 2 Units Chemistry Cal Code To enable the calibrator material for calibration, select the Q Search 207 TBil 2 N/A 4.52 mg/dL 6. X H Active checkbox L 6AM A1c_3 AAG ➢ More than 1 calibrator definition may exist on the system AAT ACE for an assay. To ensure the system uses the calibrator Acet Alb Albp Aldo definition as the primary calibrator, deselect the Active ALP_2c ALT checkbox for additional calibrator definitions associated ALTPLC Amik Amm AMY_2 with the assay* Amylas APO A1 7 7. Select Save Add Assay by Cal Code Save Cancel *NOTE: It is important that only one calibrator definition for each assay is set to Active. The calibration ordering process in Calibrations Due will use the Active calibrator lot with the shortest expiration date. NOTE: If the barcode reader is not available, the calibrator definition can be manually added by 48 48 selecting the Add New button on the Calibrator Definitions screen. Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Calibration – Drugs of Abuse Calibrator Definitions on the CH Analyzer Healthineers • The ID Per Level option allows individual lot and expiration dates to be assigned to each calibrator level • With this option, levels are also grouped together under one Parent Lot, to allow for traceability Add Calibrator Definition Calibrator Details Material Name : Material ID Lot ID + Emit Cal O Global ID 45678 Store Onboard Revision O ID Per Level Active Select Assays Assigned Values Assay Type All Cal Code Assay Level 0 Level 1 Level 2 Level 3 Q Search Lot ID = Lot ID Lo ID Lot ID N2 N4 NS Expiration Date . Expiration Date - Expiration Date . Expiration Date - Ampik Amp300 331/2022 3/31/2022 331/2022 3/31/2022 Amp500 Bnz200 137 Amp500 300 500 1000 Bnr300 Brb200 140 Amp300 0 300 500 1000 NOTE: For more information, refer to the Drugs of Abuse Calibration Workflow on the Atellica® CH Analyzer Job Aid on PEPconnect. 49 49 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Calibration – C0 Adjust Pack Calibrations on the CH Analyzer Healthineers C0 Adjust Pack Calibrations The CH Analyzer supports 2 types of pack calibrations: ➢ Full – multiple calibrator levels are used ➢ C0 Adjust – only a low level calibrator is used o For Siemens assays that use C0 Adjust pack calibrations, CH Diluent is used as the calibrator o For open channel assays that use C0 Adjust pack calibrations, either a zero level calibrator or CH Diluent is used as the calibrator The CH assay test definition specifies the type of pack calibration an assay requires. Only certain assays use C0 Adjust pack calibrations. For assays that use C0 Adjust pack calibrations: ➢ When the system alerts that a pack calibration is needed because the previous pack calibration has expired, and the operator orders a pack calibration, the system will perform a C0 Adjust pack calibration. For Siemens assays, the operator does not need to load calibrator samples in this case because the system automatically uses CH Diluent ➢ When the system alerts that a pack calibration is needed because the previous lot calibration has expired, and the operator orders a pack calibration, the system will perform a full pack calibration. The operator must load the appropriate calibrator level samples 50 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Calibration – IMT Calibrations on the CH Analyzer Healthineers IMT Calibrations ➢ The CH Analyzer uses a 2-point calibration to automatically calibrate the IMT subsystem in the following situations: • 4-hour intervals • After 250 tests have been completed since the last calibration • A-LYTE® multisensor temperature changes outside of specifications • Ion drift or unstable errors • Standard air or liquid detect error • System startup • Reset for a paused or stopped state • Routine cleaning procedure • Exiting diagnostics • IMT successful error recovery • A-LYTE multisensor, Standard A, or Standard B replacement ➢ The operator can also manually calibrate the IMT subsystem if needed during troubleshooting ➢ The materials used for IMT calibration are the IMT fluids (Standard A and Standard B) ➢ During IMT calibrations, the system does not process IMT tests 51 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking QC Needs Healthineers The QC Needs tiles provides a list of the QC materials the system requires for the operator-defined day based on the QC schedule. QC Needs When a QC need exists, an alert displays in the QC Needs tile on the Dashboard: 10 • Red: A QC order exists and the QC material is either not onboard, low, or expired • Green: No analyzer has an immediate need for QC material The tile body displays: • The number of required QC materials. QC material is required if it is low, expired, or not onboard AND one of following applies: QC Needs o The QC scheduler is set up to create an order before the end of the operator- defined day* 5 o There is a pending QC order in the Worklist *NOTE: Refer to the Configuring Automatic QC Scheduling topic for more information on the QC Scheduler. NOTE: There will be a green tile with a number in the case where the only QC that needs to be loaded is for scheduled QC and not pending orders. *This topic is continued on the next slide. 52 IM Effective Date: 16-FEB-2022 | HOOD05162003255836 Hardware Overview Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking QC Needs Healthineers C To view the QC Needs: QC > QC Needs 6 LabManager 1. Navigate to QC Needs QC Needs 2 A QC Name Level The reason for the need is listed QC Lot Control ID Assays Store Onboard Reason Add To Cart 2. AFP Control 1 152637 1253 AFP No Scheduled at 11:00 AM In this example, the reason is that the QC AFP Control 2 152637 1248 AFP No Scheduled at 11:00 AM • ENZQual 1 193421 1264 Ca, AlbP Yes Scheduled at 3:00 PM scheduler is set up to create an order before the ENZQual 2 193421 1235 Ca, AlbP Yes Scheduled at 3:00 PM end of the operator-defined day and the QC CHEMQUAL 1 173612 1238 ALB, ETOH Yes Scheduled at 5:00 PM material is required if it is low, expired, or not onboard 3. The Cart List feature can be used to create a list for retrieving the supplies from the storage location. To add a supply to the Cart List: A. To add a QC material to the Cart, select the Add to Cart button B Add All To Cart B. To add all of the QC materials on the screen to the Cart, select Add All to Cart C. To view the Cart list, select the cart button in the Access bar at the top of the screen 53 IM Effective Date: 16-FEB-2022 | HOOD05162003255836 Hardware Overview Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Creating QC Orders Healthineers Options for Creating QC Orders • Create QC orders manually using the Create QC Orders screen • Configure the system to automatically create QC Orders using the QC Scheduler: ➢ By Day and Time ➢ By Test Count ➢ By Control 54 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 SIEMENS Healthineers Atellica® Solution QC Preparation The following are approved tube types for storing quality control material: 12x75 round bottom polypropylene or glass tubes • Water Quality Testing Pre-labeled plastic tubes from Bio-Rad ine Quaily Testing • CHIO-RAD 12009950 Immunoassay Plus Control InteliQ Assayed BIO RAD Multiqual Control 120095-49 CE LA00 IntellQ Immunnossay Plus Control LOT 458211 CE- 12008257 InteliQ Assayed CHIO PLAD Multiqual Control 12009948 InteÑO CE V 458221 Immunoassay Plus Control 120082:58 InteliQ Assayed CE- Multiqual Control CE LOT 458237 55 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 NOTE: Refer to the vendor IFU for instructions on preparation, storage, and handling of quality control materials. Atellica® Solution SIEMENS Review QC Test Orders and Results Healthineers The Worklist screen can be used to view the status of test orders and results for calibration, QC, and patient orders. Results > Worklist 6 LabManager Search T. Otar Filters Sample Type : Control X To view test orders and results: Order Time Q Search Workliegt Sample Type" Order Time Sample Statut Analyzer 6 Control 4 #/1012021 12:39:13 PM #NPCongol Completed CH-01 1. Navigate to Worklist Edit I' View View By Test Status Interpretationi Flags 5 Add Test to Order EINE Completed 46 g/L 4 2. The Filter area of the screen is used to filter the orders Samples Tests Move to Historical Result : 1.4 mmol/l. Repeat displayed. Under Sample Type, Control can be selected Filters High 3.8 . 4,7 mmol/L Accept Advanced Low 2.3 - 3.0 mmol /L Tranpm 3. The main area of the screen displays the result time Cancel Order Tima All Delete for in process test orders, and the result value and 2 Control Print Barcode units for resulted test orders All Priority 4. If the View is by Samples, select the arrow to the left of an order to view the individual tests orders for that sample 5. Selecting one of the Flags symbols will display a list of what the symbols mean. The low and high limits that are defined in the QC Definition screen for that control are listed, not related to the settings in the QC Statistics screens 6. Select a QC result and select Edit/View to open QC Statistics 56 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Monitoring QC Results – QC Statistics Screens Healthineers The QC Statistics screen provides real-time and long-term 2 Review Analysis Messages Tools Setup evaluation of system and assay performance. A Show by O Control O Test Analyzer Type Analyzer Name Show Results Unreviewed Out of Control Warning Other B C The Review screen displays current QC results. Panel A Severity Date Qualitative System Analyzer SN Analyzer Na ... Test Control Level Lot QC Violation Result Unit Z Review / EHIV-NEG031 312201 1/4/2022 5:24 ... SH1-SCI1 IM1-SCI1 SCIT EHIV EHIV -... 1 312201 < 0.05 Index To access the QC Review screen: EHIV-POS032 312202 U 1/4/2022 4:34 ... SH1-SCI1 IM1-SCI1 -SCI1 EHIV EHIV -... 1 312201 <0.05 Index Comment - EHIV-POS033 312203 1/4/2022 2:18 ... SH1-SCI1 CH1-SCI1 CH1-SC11 ALT OCTAL 1 12366 <7.00 U/L Analyze O 1. Navigate to QC Statistics EHIV-POS034 312204 # O QCPAF 66689 2. Select the Review tab - V QCTAL 12366 Areas of the screen: Test Severity A Level Lot System + V ALT A. Control file selection – contains options for selecting VEHIV the control files to be viewed AFP B. Filters – used to filter the types of files displayed C. Functions: • Review: to designate an out of range and warning result as “Reviewed” D Select Expand Al Auto-select Issues Select 3 results, 1 selected • Comment: to add a comment to a data point Refresh Reports Customize Close • Analyze: to view graphs and statistics for the data D. Close button – select to close QC Statistics and return NOTE: This screen defaults to QC data that is unreviewed, to the main software. When you select Close, a blank out of control, has a warning or another error. QC Statistics screen will display. To relaunch QC Statistics, navigate back to the Home screen 57 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Creating New QC Definitions Healthineers To manually create a QC definition: QC > QC Definitions 6 LabManager 1. Navigate to QC Definitions Filters Yx Clear Filters: Material Name: All 2 Add New Import Material Name 2. Select the Add New button All Material Name Levels Lot Lot Expiration Usage Specimen Type Store Usage O QC_K_N 1,2,3,4,5,6 122 05/09/2020 Primary Serum/Plasma Edit/View Parallel 3. Enter the following information: Control Name, Parent Lot, Specimen, Control Type, Usage, Level(s) Add QC Definition ? X Parent Lot - Lot for the control material, including all Control Details levels. Additional, individual control lot numbers are 3 Control Name * Specimen . Serum/Plasma Usage * Parallel Store Onboard Parent Lot * Control Type * assigned for each level Routine Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7 Level 8 Level Specimen - Select the Specimen type associated with the Select Tests Level Details Assay Type tests that the control supports Control ID * Control Lot * Control Lot Expiration * Q Search Test Name Units SD Low High Mean +/- Range Result OBS Days OBS Hours ➢ The operator must select Serum/Plasma specimen type AAG AAT Amp300 Amp100 for controls associated with tests for Serum, Plasma, or AST ALT both. This specimen type applies to QC samples only ALTPLC AFP Amylas Acet QC Type - The following options are available: Brb200 Brb300 Bnz200 Bnz300 ➢ Routine – independent from the reagent kits and do Ca-2 Chol_2 Crea_2 Clear All Ranges Observed Ranges not require a checksum Save Cancel ➢ Kit – require a checksum and may be lot-locked or control bracketed NOTE: There is also an option to import QC definitions. For more information, refer to the Exporting and Importing QC Definitions on the Atellica® Solution Job Aid on PEPconnect. *This procedure is continued on the next slide 58 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Creating New QC Definitions Healthineers 3. continued: Add QC Definition ? X Usage - The following options are available: Control Details 4 ➢ Primary – Selected by the system when a lot is not Control Name . Usage * ChemistryQC Specimen Serum/Plasma Primary Store Onboard specified. Primary controls that produce QC results Parent Lot . Control Type * Routine Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7 Level 8 Level 9 that determine patient QC flagging in QC statistics Select Tests Level Details ➢ Parallel* – Parallel control results generate Assay Type All Level 1 observed ranges, but do not generate violations or Q Search Control ID Control Lot * Control Lot Expiration * AAG AAT flags for test evaluations Test Name Units SD Low High Mean +/- Range Result OBS Days OBS Hours Amp300 Amp1000 ➢ Alternate – The operator performs alternate AST ALT ALTPLC AFP control lots for additional QC flagging and Amylas Acet statistical data Brb200 Brb300 nz200 Bnz300 ➢ Not in Use – The control lot is no longer active, C3 Ca-2 such as when it is expired Chol_2 Crea_2 Clear All Ranges Observed Ranges If the QC material will be stored onboard, select the Save Cancel 4. Store in Onboard checkbox. (Only available in Sample Handler configurations) *NOTE: The Parallel usage type works together with the Lab Evaluation > QC Parallel study. ➢ When running QC with onboard controls, the system deploys the QC material once the order is generated 59 *This procedure is continued on the next slide Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Creating New QC Definitions Healthineers 5. Select the appropriate test(s). The Assay Type drop down can be used to filter the list Add QC Definition ? X 6. For each level: Control Details Control Name * ChemistryQC Serum/Plasma Primary Store Onboard A. Enter the Control ID, Control Lot, Control Lot Parent Lot Control Type * 122 Routine Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7 Level 8 Level 9 Expiration 6 Select Tests Level Details B. Enter the SD (Standard Deviation) for each assay* 5 Assay Type All Level 2 Level 3 A C. Enter the target values for each assay by entering Q Search Control Lot Control Lot Expiration * 1221 01/31/2022 D AAT either the Low and High limits OR the mean and AAG Test Name Units Low +/- Range Result OBS Days OBS Hours Amp300 Amp 1000 +/- Range * AST ALT AST mmol/L D. Enter the Onboard Stability Days or the Onboard ALTPLC AFP ALT mmol/L Stability Hours Amylas Acet AFP mmol/L Brb200 Brb300 E. Select the Save button Bnz200 Bnz300 B C C3 Ca-2 Chol_2 Crea_2 Clear All Ranges Observed Ranges E Save Cancel *NOTE: There is an option to enter “N/A” for SD and to not enter target values, which would allow the controls to run without entering ranges. There is also an option to enter “QUAL” for SD. 60 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Sample Status - STATs Healthineers The STATs tile displays summary information about STAT samples on the system: A. Status Color: Green – no STAT samples require intervention A STATS Red – at least 1 STAT sample requires intervention B. Number of STAT samples requiring intervention 1 1 B C. Count: • STAT samples that require intervention • STAT samples in progress C 1 Inprocess 1 Intervention Needed Select the STATs tile to open the STATs Only screen and view details on the STAT samples. *This topic is continued on the next slide. 61 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Sample Status - STATs Healthineers The STAT Samples screen provides data not directly viewable on the Worklist screen, such as the time a sample went into an ‹ Â Samples > STAT Samples 8 SH1-SCI LabManager error status and how long a sample has been on the STAT Samples Needing Intervention (1) instrument. This allows for monitoring turn around times. > Time of Error Sample ID 2 Description Impacted Tests Time On System Location 3 3:05 pm SID1512635 Multiple Errors AFP, CKMB, CL, K 5 min SH-01 1 Drawer 4 \ Front 4 Ignore To review STAT samples: Mo Primary AFP, CKMB, CL . Hemolysis Error K 1. Select the STATs tile 2. To sort the information, select a column heading 3. To expand a row, select the appropriate row in the table 4. To remove the STAT needing attention from the window: • Address the issue. Rerun the sample if needed • If desired to remove an item from the screen without fixing the issue, select Ignore STAT Samples Inprocess (1) 5 Related Worklist o If selected, the button changes to Undo Reagent Needs Supply Needs o If it is a sample that you truly cannot fix, you can NOTE: The Related links at the bottom of the screen provide a direct link to other commonly move it to historical from the Worklist screen used screens. Selecting Worklist opens the Worklist screen pre-filtered for STATs. 5. There are separate windows for STAT Samples Needing NOTE: If all STAT samples needing intervention are resolved or ignored, the STATs tile will Intervention and STAT Samples in Process. In this example, turn from red to green. the STAT Samples Needing Intervention are displayed. To display the In Process samples, select that heading 62 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Sample Status - Routine Samples Needing Intervention Healthineers The Sample Interventions tile displays summary information about patient, calibration, and QC samples on the system that require intervention. This is filtering the data from the entire worklist so you can focus on the samples that need attention such as failed calibrations, QC that failed to run and is needed to complete an entire order, or patient samples that need to be repeated but the A Sample Interventions tube is not onboard. A. Status Color: Green – no samples require intervention B 1 WU Red – at least 1 patient, calibration, or QC sample requires intervention B. Number of routine samples requiring intervention C. Count: C 0 Calibration 0 QC Displays the total number of calibration, QC and routine patient samples that require intervention 1 Patient (non-STAT) Select the Sample Interventions tile to open the Sample Interventions screen and view details on these samples. NOTE: If the Sample Intervention tile number seems very high, is increasing rapidly or is for all one test, check your Supply and Reagent Needs tiles first. *This topic is continued on the next slide. 63 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Checking Sample Status - Routine Samples Needing Intervention Healthineers The Sample Interventions screen provides data not directly viewable on the Worklist screen, such as the time a sample Samples > Sample Interventions 8 SH1-SCI1 abManager went into an error status and how long a sample has been on 4 Calibrations Needing Intervention (0) V the instrument. This allows for monitoring turn around times. QC Needing Intervention (0) Samples Needing Intervention (1) > To review routine samples: > Time of Error Sample ID Description 2 Impacted Tests Time On System Location 3 V 2:48 pm SID1512635 Multiple Errors Carb, DHDL, DMX, FSH 15 min SH-01 1 Drawer 4 1 Front 1. Select the Sample Interventions tile . No Primary Carb , DMX . Hemolysis Error DHDL, FSH 2. To sort the information, select a column heading 3. To expand a row, select the appropriate row in the table 4. There are separate windows for: • Samples Needing Intervention • Calibrations Needing Intervention • QC Needing Intervention Related Worklls Reagent Needs Supply Needs Callbration Results QC Statistics Cal-QC Inventory To display each of these windows, select the appropriate heading. NOTE: The Related links at the bottom of the screen provide a direct link to other commonly used screens. Selecting Worklist opens the Worklist screen pre-filtered for STATs. NOTE: Samples are removed from this screen as issues are resolved or when samples are reordered. Exception to this: Invalid calibrations would be listed in Calibrations Needing Intervention, however, reordering the calibration and obtaining a valid/active calibration would not clear this entry from this screen since each order is considered a separate entity. Invalid calibrations are cleared from this screen at midnight. 64 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Monitoring Sample Tube Status Healthineers Samples 1 The Samples Overview screen displays the status of samples that are currently in the Sample Handler drawers. To view sample status via the Samples Overview screen: 2 1. Locate the Samples area of the Home screen ➢ If there is more than one Sample Handler in your Atellica Solution configuration, select the tabs at the bottom to view the samples for each Sample Handler ➢ The shape and color of the glyph describes the status of the sample: o A round glyph identifies a patient sample container o A square glyph identifies a calibrator or QC container 2. To view more information, select one of the racks SH-01 SH-02 NOTE: Refer to Online Help for a list of the meaning of the sample container position glyph colors and symbols. 65 65 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Loading Samples on the SH Healthineers 1. Place sample containers in the appropriate type of rack using an adaptor if needed. Ensure all sample containers are fully seated to the bottom of the rack. Containers with tube top sample cups can be loaded in a routine rack* Rack sizes: Rack Types: ⚫ 55 position ⚫ Routine rack ⚫ 15 position ⚫ STAT rack – pink label ⚫ Special False-Bottom Tube rack – blue label ⚫ Special STAT rack – magenta and blue label STAT 15 position rack Routine 55 position rack Special False-Bottom Tube NOTE: Do not fill sample containers past the maximum recommended level of 1 container 55 position rack diameter below the top of the container. Overfilling may cause splashing while the container moves in the SH or on the Atellica Magline® Transport. For example: The maximum fluid height for a 16 mm diameter container is 16 mm from the top of the container. *NOTE: Refer to the Atellica Solution Small Sample Management Job Aid on PEPconnect for information on running tube top sample cups and capillary tubes. *This procedure is continued on the next slide NOTE: Refer to the Atellica Solution Online Help for information on the placement of sample barcode labels 66 66 and determining minimum sample volumes, as well as a complete list of the supported sample containers. Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Loading Samples on the SH Healthineers 2. Locate the appropriate sample drawer that will be used to load the samples. Load the rack in the appropriate sample drawer position. Load 1 or more empty routine racks in an appropriate output area or sort area in a sample drawer. The LED indicator above the drawer indicates if the drawer is locked: • If the LED is off, the drawer is unlocked • If the LED is on, the robotic arm is currently accessing tubes from the drawer and the drawer is locked. To access the drawer, either: 2 ➢ Wait until the LED indicator turns back to off OR ➢ Press the button above the drawer. The LED above the drawer will start blinking, indicating that as soon as it is able to, the system will unlock the drawer. When the LED light stops blinking and remains off, the drawer will be unlocked and can be opened 3. Open the unlocked sample drawer by grasping the drawer handle and pulling open the drawer. Ensure the sample drawer is pulled fully open. If NOTE: Do not position pacemakers or other implanted medical the drawer is not fully open, the system may not properly scan the racks devices closer than 7.5 cm (3 inches) from the base of a carrier on the when the drawer is closed Atellica Magline® Transport. Magnets in the carrier base generate magnetic fields that can interfere with cardiac medical implants. 4. If there are any old racks in the sample drawer, remove the racks by lifting the racks from the sample drawer 67 67 IM *This procedure is continued on the next slide Effective Date: 16-FEB-2022 | HOOD05162003255836 Hardware Overview Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Loading Samples on the SH Healthineers 5. Load the rack in the appropriate sample drawer position. Load 1 or more empty routine racks in an appropriate output area • Each drawer has a front slot and a back slot for loading racks. Each slot can accommodate either three 15 position racks or one 55 position rack • When loading the rack into the drawer, observe the arrow (as highlighted on the image to the right) on the rack. The arrow should be pointed in, towards the SH • Seat the rack so it clicks securely into the guides in the desired location within the drawer. Ensure the rack is fully seated in the drawer. If a rack is not fully seated in the drawer, the drawer may not close. Do not force the drawer closed 6. Close the drawer • The system will scan the racks as they are loaded into the system, and then the robotic arm will start processing the sample containers NOTE: Do not open or close the sample drawer too quickly. NOTE: Do not load false-bottom sample containers in any rack other than a Opening or closing the sample drawer too quickly or forcefully specifically designated special rack for false-bottom sample container use. Placing can damage the drawer self-closing mechanism or cause the sample containers in a rack other than the special rack may result in damage to splashing of the samples. the system if the probe impacts the sample container bottom. 68 68 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Creating Patient Orders Healthineers Options for Creating Patient Orders • Create Patient orders manually by navigating to the Patient Orders screen ➢ Under System Test Options, use the Edit System Test Options button to make any edits to the test ordered, replicates or analyzer the tests will be run on • Create orders for a group of samples of the same specimen type undergoing the same tests by navigating to the Batch Orders screen and selecting to order by Sample ID • Create orders for samples loaded in specific racks undergoing the same tests by navigating to the Batch Orders screen and selecting to order by Rack ID 69 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Worklist Healthineers Worklist Results > Worklist 8 SH1-SCI1 abManager This screen can be used to view the status of all samples A B Search Ty Clear Filters:|Order Time : 24 Hours X Sort By Order Time processed by the system (including ordered, in-process, Q Search Worklist C > SID Sample Type Order Time Name Sample Status Analyzer and completed tests). 000125 Calibrator 10/271/2021 12:55:12 PM CHEM CAL Completed CH-01 Edit / View View By 000126 Calibrator 10/27//2021 12:55:12 PM CHEM CAL Completed CH-01 10/27//2021 12:52:12 PM Add Test to Order V > SID123456789122 Patient Frank Nardi Ordered CH-01, IM-01 Areas of the screen: Samples Tests > 82345678901234567 Patient 10/271/2021 12:45:12 PM Cecelia Yu Ordered IM-01 Move to Historical > SID123456789555 Patient 10/27//2021 12:43:12 PM Micheal Jackson Inprocess ( 5 mins Remaining ) IM-01 Repeat A. Search and Filters – can be displayed or hidden by Filters 95355678901234567 Patient 10/271/2021 12:36:12 PM Benjamin Franklyn Transmitted CH-01,IM-01 Accept V Basic Advanced > SID000077844 Patient 10/27//2021 12:58:12 PM Josefina Perkins Ordered CH-01 Transmit selecting the arrow at the top of the screen SID000077845 Patient 10/27//2021 12:55:12 PM Jesus Casey Ordered CH-01 Cancel Order Time SID000077846 Patient 10/27//2021 12:52:12 PM Mario Houston Inprocess ( 4 mins Remaining ) IM-01 24 Hours > * SID8554735 Patient 10/27//2021 12:49:12 PM Roman Mason Intervention Needed IM-01 Delete *** + *** ... B. Orders – displays the status and result(s) for each Sample Type All * SID1512635 Patient 10/27//2021 12:46:12 PM Donnie Boyd Intervention Needed CH-0 Print Barcode order Analyzer > SID1772666 Patient 10/27//2021 12:46:12 PM Doris Marshall Intervention Needed CH-01,IM-01 All > 51221121 Control 10/27//2021 12:16:12 PM MULTIQUAL Inprocess ( 3 mins Remaining ) CH-01 Priority All 74121 Control 10/27//2021 12:16:12 PM DrugQual nprocess ( 6 mins Remaining ) CH-02 ➢ If the test is in process, the remaining time to 0 0 000 Test All result will display ➢ When a test order results, the result and any applicable result flags will display 1 2 3 > Total Samples : 34 C. Sample and Test functions – used to perform various D Query LIS Import Worklist Statistics Export functions on selected orders D. General functions – used to print patient barcodes, query the LIS, import a worklist, generate a statistics report, and export test results 70 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Worklist Healthineers A Search Tx Clear D The search and filter area of the Worklist screen is used to select the orders that are displayed: A. Search: to search for a sample or test order Q Search Worklist • The handheld barcode scanner can be used to input sample IDs B. View By: to list the data by either Samples or Tests B View By • Samples: each line is a different sample ID Samples Tests • Tests: each line is a different test order C Filters C. Filters: to filter the display based on various criteria Basic Advanced • The advanced option allows for a more detailed filter to be set up and saved D. The Search and Filters information can be hidden using the arrow at the top right, to allow for Order Time 24 Hours additional columns of data to be displayed Sample Type All Analyzer All Priority All Tests All Status All 71 71 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Searching for a Sample Healthineers To search for a specific sample: 1. On the Tool bar, select the Search icon Q System Search ? = X Search Navigator 2. Enter or scan the sample ID, patient ID, patient name, or rack ID 3 4 Q SID123456789 2 Include Historical Results Search 3. Select whether to include historical results Search Results 4. Select Search A Worklist (5) Patient Name Patient ID Sample I Date 5. Under Search Results: Multiple entries found matching SID123456789 Navigate to Worklist A. Select Worklist to access links to the Worklist screen for Tom Thumb PID1234567 SID123456789 311112021 10:11 AM Navigate to Worklist that sample Frank Nard PID124124124 SID123456789122 311 112021 9:41 AM Navigate to Worklist Jessica Wong PID1621466 SID123456789123 311112021 8:17 AM Navigate to Worklist B. Select Location to view the Rack ID for that sample, and Micheal Jackson BAD1214343 SID123456789555 311 112021 7:22 AM Navigate to Worklist access links to the Samples Overview or Archive Racks B Location (4) C Errors / Events (6) C. Select Errors/Events to view a description of any errors associated with that sample, and access links to the Operator Event Log 72 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Service Support Request Healthineers The Service Support Request feature can be utilized by Troubleshooting 8 SH1-SCI1 abManager selecting the Troubleshooting button on the Home screen, ? Service Support Request and then selecting Service Support Request. Online Help Create a Service Support Request Previous Ticket This feature allows the operator to contact the local technical Operator If inaccurate patient results or a hazardous condition to the operator, patient, or environment is a result of a system error or malfunction, call for immediate assistance at: Service person name @ 1234567. Do not use Service Support Request to submit a job ticket. Diagnostics Module Short Description * support provider to ask a question, request information, or Free text to describe the problem. Service Support Service Request Request troubleshoot issues Problem Description * Callback Preference Free text to describe the problem. Free text to describe the problem. Free text to describe the problem. See also - Service Ticket #1535413545 • The local technical support provider will call the operator Operator Event O Phone Log Remote session with Chat by phone or text chat within a pre-configured minimum Name System Preferred Time Messages Log 01 : 16:04 PM Tablet-Photo-01 x time or at a requested time Contact Information Tablet-Photo-02 × LIS Log Name * Tablet-Photo-03 x The Service Support Request feature can be utilized on either Phone Number * Assay Troubleshooting the primary user interface or the operator tablet: • On the primary user interface: ability to chat and desktop- share Add Flle Submit • On the operator tablet: ability to video-share, desktop- share, and use the tablet camera to send photos and video NOTE: For more information on how to create a service support request, refer to Online Help or the "Submitting Service Support Requests Video" on PEPconnect. with each service support request 73 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution Key Tasks for Basic Operation – Appendix A SIEMENS Atellica Asa™ Workflow Healthineers Asa Workflow ASA 0 × SIEMENS > Atellica ASA ASA PCC 12/30/2021 Healthineers 9:50 AM Here is a proposed checklist of how to approach the tablet at the beginning of your day: ✓ STAT Samples – are there STAT samples that need Troubleshooting System intervention? X-SH X-SH Decapper- K-CC X-CC2 X-CC3 X-CC4 Decapper X-IA X-1A2 X-1A3 Decapper 1 2 3 ✓ System Health – do any issues need resolution? Current Status Day Needs ✓ Needs – how are my supplies? STAT Samples Sample Interventions Supply Needs Reagent Needs ✓ Cart List – after you have gathered and loaded all of 3 0 your needs, is all operating as anticipated? 4 pm 2 Inprocess Intervention Needed ✓ STAT Samples – check again, are there STAT samples 3 Intervention Needed 0 Calibration o QC that need intervention? 2 Patients ✓ Routine Samples – are there routine samples that need Maintenance Calibrator Needs QC Needs intervention? ✓ Maintenance – if the system health and samples are ok, 2 a 1 DE Next Automated Activity are there any maintenance activities that need to be Daily Cleaning Next Manual Activity performed? Clean Exterior Covers NOTE: For more information on using the Asa software, refer to Online Help or the “Atellica Asa™ Application Overview Online Training” on PEPconnect. 74 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution Key Tasks for Basic Operation – Appendix B SIEMENS Considerations for Configurations with Multiples of the Same Module Healthineers The unique qualities of working with an Atellica Solution with multiple same modules (for example, multiple SHs, multiple IMs, multiple CHs) are around targeting the view A 2 or action to the desired module. System SH-01 SH-02 CH-01 CH-02 IM-01 CI-01 The software includes various options for selecting the module that is displayed: A. System Status map ‹ n Results > Worklist • Select the appropriate module to view alerts Search Yx Clear • Track if all analyzers are in patient processing Q Search Worklist B. On several screens, a filter can be used to select the analyzer or module. These screens include: View By Worklist – ability to view analyzer for orders Samples Tests • • Calibration Results Filters • Reagent Overview Basic Advanced • Reagent Loading • Maintenance Order Time 24 Hours • Maintenance > Review and Approve Sample Type AII • Operator Diagnostics B Analyzer All Priority All Tests All Status All 75 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution Key Tasks for Basic Operation – Appendix B SIEMENS Considerations for Configurations with Multiples of the Same Module Healthineers Atellica is designed to optimize the performance of tasks, but in Setup > System Configuration > Assay List A SH1-SCI1 LabManager certain circumstances, you also have the option to target which CH Assays IM Assays analyzer performs the task. Filters Yx Clear Assay System CH-01 CH-02 CH-03 CI-01 Examples of tasks that allow you to target a desired module: System Enabled Only > AAG Plasma, Serum Plasma, Serum Plasma, Serum Plasma, Serum Q Search > Alb V /Plasma, Serum / Plasma, Serum Plasma, Serum / Plasma, Serum • Performing Operator Diagnostics AAG Alb > ALT Plasma, Serum / Plasma, Serum /Plasma, Serum / Plasma, Serum ALT AlbP › AlbP / Plasma, Serum Plasma, Serum Plasma, Serum Plasma, Serum • Performing maintenance tasks Orders > Patient Orders • Creating a QC Panel and QC Schedule The system will route tests to whichever analyzer can most efficiently Sample Information Add Tests complete the test. However, you can designate to run a test on a Order By O Sample ID Rack ID selected analyzer: X Test Dilution Replicates System Test Options Sample ID* 123 + X Chol2 x1 (Undiluted) Replicates Edit System Test Options B - A. Navigate to Assay List to check that the appropriate Park In assays/specimen type are enabled for the analyzer ‹ Â Orders > QC Orders B. Specify the analyzer on the Patient Orders screen by selecting C the option to edit the test Select By O Assay C. Specify the analyzer on the QC Orders and Calibration Orders O Material screens by filtering to the appropriate analyzer O QC Panel Select Analyzer + 76 CH-01 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution Key Tasks for Basic Operation – Appendix B SIEMENS Considerations for Configurations with Multiples of the Same Module Healthineers Additionally, it is helpful to be aware of some system behaviors for configurations with multiples of the same modules: • Cal-QC Storage Area • It is possible that the system may not store Cal-QC tubes in the same SH that they were originally loaded into • Archiving • There must be a holding area rack and an archive rack in the same SH • If you have 2 SHs and the archive area is full in one of them, the system will not move tubes from that SH’s holding area to the other SH archive rack. The overflow will stay in the holding area until you empty the archive rack in that SH • The system will use an input rack as alternative storage if a holding area rack is not available • SH Rack Configurations • If you are using Input only and Output only drawers, it is recommended to have both input and output drawers on each SH 77 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution Key Tasks for Basic Operation – Appendix C SIEMENS Emptying Decapper Waste Healthineers 1. Pull the cap waste drawer away from the system ➢ When the cap waste drawer is opened, the Decapper goes into Stop mode 2. Remove the biohazard bag and discard according to laboratory protocol 3. Insert a new biohazard bag into the cap waste bin, tucking the bag over the bin and under the flange ➢ To allow the caps to drop freely into the cap waste bin, the new biohazard bag must be fully opened and fit snugly in the bin GRASAHOJE 4. Ensure the cap waste drawer is out for more than 10 seconds to automatically reset the waste counter ➢ If the drawer is opened for less than 10 seconds for a quick check, the system will assume that the waste has not been emptied and the waste counter will not be reset 4. Manually remove any caps dropped in the chassis before closing the drawer 5. Push the drawer until firmly against the back wall to ensure that it is in the correct position NOTE: The cap waste bin has a sensor that will alert the operator if the waste is close to full. 78 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution Key Tasks for Basic Operation – Appendix D SIEMENS Direct Load Sample Processing Healthineers Direct Load Sample Racks • Each sample rack has 6 tube positions • The racks are available in a variety of colors o In the default configuration, the system does not distinguish between different rack colors. The lab can use the colors to organize tubes as desired . . P0020086 o There is a configuration option available to assign a specific tube size to a rack color. If this configuration is used, the system will disregard the tube characteristic data from the vision cameras • The default tube size is 16 x 100mm. Adaptors are used to support shorter and smaller diameter tubes NOTE: Sample containers with caps are not supported. • Tube-top sample cups (TTSC) are automatically detected when placed on top of supported tubes. Before using the TTSC feature, the local technical support provider must configure the TTSC NOTE: Refer to the Atellica Solution Operator Guide for a complete list option and alignment of the supported sample containers. • The system supports both barcoded and non-barcoded tubes 79 Effective Date: 16-FEB-2022 | HOOD05162003255836 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution Key Tasks for Basic Operation – Appendix D SIEMENS Direct Load Sample Processing Healthineers Load Samples on the Direct Load 1. Place sample tubes in the appropriate sample rack 1 and position 2. Load the sample rack in the entry queue • Place STAT racks in the front of the entry queue • When racks are placed on the entry queue, the system will automatically move the racks forward for processing. When processing is 2 complete, the racks will automatically be sent to the exit queue 3. Remove the sample racks as the racks enter the exit queue • Do not allow more than 9 racks in the exit queue. More than 9 racks will obstruct the exit queue. Remove sample racks as the racks are processed 3 80 IM Effective Date: 16-FEB-2022 | HOOD05162003255836 Hardware Overview Unrestricted © Siemens Healthineers, 2022 SIEMENS Healthineers Please note that the learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Atellica, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability varies by country and is subject to varying regulatory requirements. Please contact your local representative for availability. © Siemens Healthcare GmbH 2022 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany 81 Telephone: +49 9131 84-0 Effective Date: 16-FEB-2022 | HOOD05162003255836 siemens-healthineers.com Unrestricted © Siemens Healthineers, 2022