Atellica® Solution Key Tasks for Basic Operation Job Aid Version 1.25 and Below

SIEMENS Healthineers @ c IM Atellica® Solution ealthineers Atellica Solution PEP to Go Key Tasks for Basic Operation 1 Template Effective Date: 05/27/2019 | HOOD05162003010284 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 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: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Key Tasks for Basic Operation SIEMENS Table of Contents Healthineers Sign Out and Sign In 4 Status Bar Overview 5 PEPconnect 6 Online Help 7 System Alerts 8 Checking System Health 10 Maintenance 11 Loading the Cal-QC Tube Storage Area 19 Checking and Loading Reagents 21 Checking and Loading Supplies 25 Calibration 37 Quality Control 48 Processing Patient Samples 56 Searching for a Sample 64 Remote Assistance 65 Appendix A – Decapper – Emptying Waste 66 Appendix B – Direct Load – Processing Samples 67 Appendix C – Asa 70 Appendix D – Configurations with Multiples of the Same Module 71 3 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Signing out of the System / Signing into the System Healthineers To control the user security level, it is recommended that the operator signs out when walking away from the system, and K System Samples Inventory Caleration OC Pabert Cedens Workdest Maintenance Setup then the next operator signs in with their credentials. Signing out and back in also helps the software to run smoothly by refreshing all the screens. If the software is slow to respond, a first troubleshooting step is to sign out and back in. Healthineers Signing out of the System Operator ID labmanager 1. On the Status bar, select the sign out icon Password Forget Passarce 2. Select Sign Out Restart Shutdown Sign In 3. Select Yes Signing into the System 1. At the Sign In window, enter the Operator ID and password 2. Select Sign In ? PEP zbManager Tuesday, August 07. 2018 8 49:49 AM NOTE: If the operator forgets their password, select the Forgot Password NOTE: If an incorrect password is entered too many times, the account will be link. Then, answer 1 of the 2 security questions to reset the password. The locked. After approximately 10 minutes the account will automatically unlock so security questions are configured in Setup > Accounts > Accounts. the operator can use the account to try again to sign into the system. 4 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Status Bar Healthineers ? PEP connect LabManager SIEMENS A. Online Help - Displays online help A B C D E F G H I J K L M B. PEPconnect - Connects to PEPconnect (Personalized Education Plan) C. Print - Prints the workstation screen D. Quick Find - Searches for a specific result in the Worklist Overview screen E. Keyboard - Displays an on-screen keyboard for text input F. File Manager - Accesses folders containing archives, back-ups, and exports, and manages data transfer to USB G. Sign Out - Locks or signs the operator out of the system H. Atellica Process Manager (APM) - Indicates the system is communicating and sending updates to the APM I. Remote Assistance - Can be used to initiate a remote session with Siemens Technical Support or submit a ticket for assistance J. Laboratory Information System (LIS) - Displays or changes the current status of the LIS connection and performs diagnostics K. Dashboard - Displays a summary of samples, tests, and their status L. Volume - Adjusts the volume of the system alerts M. Watch List - Displays a list of STAT and other samples the operator specifies as the Watch List Placeholder – 5 Please insert Effective Date: 5-JAN-2021 | HOOD05162003156009 text Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS PEPconnect Healthineers The e-learning experience, PEPconnect, enables the operator to access product-specific content for initial K System Samples Inventory Calibration Pabient Orders Maintenance Setup training and ongoing operations. Sample Handler Sample List P-P1-03: Standby Drawer: 4 nne-info.comisniak Accessing PEPconnect in the Atellica Solution software: -:- 000001 PEPconnect^ - Sample Details A 1. On the Status bar, select the PEPconnect icon PEP connect Explive FEZconnect 2. PEPconnect will open in a separate window Querplate My Lescronl ASAP Your serartad connoiition to knowledge in digitalzing PEP Asprated connect 3. To access the Atellica Solution content in ------- SHILS Calibrafor --- DI PEPconnect, either: Complete a Qualificacion . Quit PEPconnect, a personalized education experience wim options to manage an jafitution's woisforce education and performance growth" ---------- None Refrigeration Not Required • Enter search words in the Search Content and Groups field at the top of the screen OR • Navigate to Explore PEPconnect > Laboratory 10 ..... = ..... Diagnostics > Integrated Systems > Atellica 11 Solution ? PEP LabManager 583 Wednesday, June 06, 2018 1:38 PM NOTE: The connection to PEPconnect needs to be setup by your field service engineer during product install. NOTE: This document – Atellica Solution PEP to Go Key Tasks for Customer Operation – can be found on PEPconnect. 6 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Online Help Healthineers The Online Help icon ? A on the Status bar is accessible Help X from every screen. Help Troubleshooting Favorites - B ➢ Provides links to help topics specific to the screen Atellica® Solution Language EN Info ? C Light | Dark currently displayed, and provides access to the table Go back Go forward of contents where the entire Online Help package Your quicklinks 111 Search Library can be accessed Enter your search here .... A. The guide is divided into tabs including Help, Troubleshooting, and Favorites Print Save to favorites Search within page Enter your search here ... B. Search - Enter words, phrases, or questions for Status 11 Contents quick access to information The following information is available for this tab: Daily System Operation Legal Information System Status Intended Use Statements Library - Access to content within the Online Help CH Status IM Status Safety and Symbols Atellica Magline Transport Status Quick Reference C. A Quicklinks list is available to provide access to: SH Status About the System Status Display System D The following information is related: › Status • Saved searches Software Information Logs • Favorite content pages SIEMENS Filter Event Log Close D. Remote Assistance - Can be used to initiate a remote session with Siemens Technical Support or submit a ticket for assistance 7 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS System Alerts Healthineers CI-SH GGCVESSCI-SH The Alert Module displays all active module and System Samples Inwerdory Calibration OC Patient Orders Workkst Maintenance Setup system alerts. The operator accesses the Alert Status Logs CC/DL Operator Diagnostics Operator Diagnostics About Module using the colored tab above the Command System VMM CI-SH CI-CH CHM bar. To filter alerts, select a Module or Category from Stand Standby Standby off the Alert Module. Alert Category Module Time The system alerts are designated as follows: Add Reagent RPC2 Inventory > Reagent Forecast System 27/2016 10:19:10 AM Add Reagent RPC1 Inventory > Reagent Forecast System 10/27/015 10:19:10 AM A. Black tab with a red outline - errors have been Add Reagent RPC4 Inventory > Reagent Forecast System 10/7/2015 019:10 AM acknowledged but error conditions still exist Add Reagent WBA Inventory > Reagent Forecast System 10/27/2015 10:10 10AM Acknowledge System Alerts Maintenance activity Database Backup failed The requested backup was partially completed Some data was not backed Systen 10/27/2015 10:16:13A B. Solid yellow tab - there are one or more up. Refer to the Event Log for details unacknowledged warnings C. Black tab with a yellow outline - warnings have A been acknowledged but warning conditions still exist B D. Solid red tab - there are one or more unacknowledged errors C D 8 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Viewing and Acknowledging System Alerts Healthineers The operator can view the Alert Module to display all SP0010 active module and system alerts. System Filter Alert Summary Setup 2 3 5 Module Al Alert Category Module Time To view and acknowledge system alerts: System Category All The SH has an unrecoverable error. Shut down and then restart the SH. It problem persists, contact the local technical support provider System > Status SPOOLO 03/04/2019 10:45:07 B Check the TCS. Clear all sample tubes from carrier at the station. If 1. Above the Command bar, select the colored tab appropriate, remove the sample tube from the SH robot gripper System > Status SPOOL07 03/04/2019 10:45:07 A UNW ALERT_MSLActivityfaled01. Maintenance > Schedule CM00110 03/04/2019 8:25:16 AM 2. To filter the alert list, select a Module or Category À H Fluid in container AcidLiquidConsumableLocation is below the operator- defined threshold. Replace the specified system fluid soon. Inventory > Supplies Queodew 1400104 02/28/2019 11:21:48 AM 3. To acknowledge individual alerts, select the hand ? symbol to the right of the alert 4. To acknowledge all alerts, select the Acknowledge Alerts button NOTE: Selecting Acknowledge Alerts does not resolve the system alerts. Action must be taken on the system. 5. To suppress an alert, select ? 4 Acknowledge Alerts Close • This suppresses all future notifications of this ? PEP LabManager Monday, March 04, 2019 11 23:07 AM alert. Only suppress alerts that you do not want to be notified of again NOTE: The system response to suppressed alert conditions remains the same and operators must continue to resolve the alert condition. If an alert is suppressed and the system stops new tests from processing, the system does not allow new 9 tests to start until the operator resolves the alert condition, even if the alert is suppressed and does not display. Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Healthineers Checking System Health To check the status of each module: 1 E System Samples Inventory Calibration Patient Orders Workdie Maintenance Setup 1. On the Command bar, select System 2 Status Logs Operator Diagnostics About 2. Select Status System VMM P-P1-05 C-P1-02 P1-02 B 3 3. Review the status for each module Standby Standby Standby Standby Alerts 68 CH Capabilities • Current state Alert Category Time Pretreatment erature : 10 0 ºC • Capabilities Reagent Compartment 1 : 8.1/8.1 ºC ¥ Reagent Compartment 2: 0.0/0.0ºC • Alerts Connected to PCC Dutions ¥ Cuvette Ring Thermal : 37 0 *C Module Stopped / Patient Sample Processing Reagent Loader V System Fluids Front Cover V BIT Consumables Back Cover ? PEP LabManager Monday, July 29. 2019 1 01.56 PM 10 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Daily Maintenance Inspecting CH Wash Probes 1. Enter the system into Diagnostic State: A. Navigate to the CH Status screen: System > Operator Diagnostics > CH icon B. Select Enter Diagnostics > Yes 2. Under Subsystems, select Inspect and Clean 3. Select Inspecting the Washer Probes 4. Select Perform > Yes 5. Wait for the analyzer to prepare for maintenance then lift open the CH back cover 6. Check the outside of each washer probe for residue build up 7. If residue is present, cover the cuvettes with a paper towel 8. Wipe the washer probes with a lint-free tissue dampened with special reagent water if residue is present 9. Remove the paper towel from the cuvettes and close the CH back cover 10. Select Continue > Close NOTE: This is the only manual daily maintenance activity. All other daily maintenance activities are automated. Check the Maintenance > 11. Select Exit Diagnostics > Yes Schedule screen to ensure all automated maintenance activities are 12. Mark Inspecting the Washer Probes as completed in the Maintenance > successfully completed. Schedule screen 11 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution As Needed Maintenance Performing IMT Advanced Clean K 1 The IMT Advanced Clean prevents protein build up in the System Samples lewertory Pabert Orders Workdesd Maintenance Setup Schedule Report Log 2 IMT Data Restore Software Updates Copy Configuration IMT system but it renders the IMT multisensor unusable. CH A reminder displays when replacing IMT supplies if the 3 IMT Clean and Prime MT Detalis IMT Messages IMT Status IMT Calibration completed 1. Select the appropriate IMT function. Prime IMT analyzer processed 2500 IMT samples or the multisensor IMT Dilution Check IMT Calibration 2. Select Prime fluids one at a time by selecting a fluid. IMT Routine Clean was in use for 10 days. This notifies the operator to Last Performed 06/20/2018 9:01:08 PM Next Scheduled 06/21/2018 1:01:08 AM Operation Status 4 IMT Advanced Clean perform the IMT Advanced Clean procedure at the next A-LYTE Multisensor Prime All multisensor change. Date Last Replaced 05/20/2018 1:41:45 PM Tests on Chip Prime Standard A Routine Clean After the CH Analyzer completes the IMT Advanced Prime Standard B Last Performed 06/20/2018 2:05:54 AM Prime Salt Bridge Clean, the operator must discard the old A-LYTE® Advanced Clean Prime IMT Diluent multisensor. Last Performed . Not Performed Days to next clean Maximum Serum or Plasma samples processed Limit 1. At the Command bar, select Maintenance Average Fluid Delta Not Available imum - 0.0 mv Sample Port Drain Time Not Performed Maximum . 1.7 seconds 2. Select the IMT tab Cancel 3. Select IMT Clean and Prime ? PEP =0 LabManager Thursday, June 28, 2018 12:36:26 PM 4. Select IMT Advanced Clean 5. Select OK to acknowledge that multisensor must be replaced after IMT Advanced Clean completes 6. Wait 14 minutes for advanced clean to complete 7. Replace the current A-LYTE multisensor 12 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution As Needed Maintenance Replacing A-LYTE® Multisensor A reminder displays when replacing IMT supplies if the analyzer processed Replace IMT Supplies X 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 The IMT Advanced Clean maintenance procedure is due. change. 1. Ensure the analyzer is in Ready, Processing or Standby state: To begin the Advanced Clean before replacing the A-LYTE mulitsensor, select Perform IMT Advanced Clean. A. On the Command bar, select System > Status B. Review the status of the CH analyzer To replace IMT supplies directly without performing the IMT Advanced Clean, select Replace IMT Supplies. 2. To pause the IMT in preparation to replace the A-LYTE multisensor: To exit, select Cancel. A. Select IMT Supplies on the module display B. If a window displays with options to either perform IMT Advanced Perform IMT Advanced Clean Replace IMT Supplies Cancel Clean or replace IMT supplies (see image on the right), it means that an IMT Advanced Clean is required before the next multisensor replacement. Continue with these steps: 1) Select Perform IMT Advanced Clean and wait for the IMT Advanced Clean to complete Note: Do not perform an IMT Advanced Clean after replacing the A-LYTE multisensor. Performing the IMT Advanced Clean on the current multisensor 2) Select IMT Supplies then Pause IMT and wait for this process renders it unusable. Perform the IMT Advanced Clean on the current to complete multisensor prior to replacement. 3) Select A-LYTE Multisensor *This procedure is continued on the next slide. 13 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution As Needed Maintenance Replacing A-LYTE® Multisensor (continued) 3. Open the IMT fluids lid 4. To scan a new A-LYTE multisensor: • For a Sample Handler configuration, use the module display • For a Direct Load configuration, use the handheld barcode reader 5. Ensure the Lot, Sequence, and Expiration display correctly 6. Remove the A-LYTE multisensor. To release the multisensor, pull down the sensor access latch. 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. Perform 1 of the following, as appropriate: • From the module display (Sample Handler configuration), select OK • From the primary display (Direct Load configuration), select Save 10. The IMT will automatically prime, condition, and calibrate. Wait for the processes to complete 14 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Maintenance Schedule 5 When a maintenance activity fails or is overdue, an alert displays in the Maintenance tab on the Command bar: K 1 2 montery Pabert Orders Workdet Maintenance Belve Schedule Report Log IMT Data Restore Software Updates Copy Configuration • Solid yellow: new overdue activities Filter Y Module: All Frequency Aal Tiere: Nod 24 hours Performed By. A Solid red: new failed activities Modulo All Module Activity Scheduled Sal-10 Sur-11 Mon:12 Ter-13 Wed-14 Thru-15 • 11-000 A Frequency All 1P1-06 Cleaning Te Exterior of the Reagent Probes 1 382058 1:00 Time Next 24 hours P1-060 • Yellow triangle: acknowledged overdue activities 1-01-00 IM Weekly Mairienance 1 36/2018 5 00 Performed By All C-P1.06 CPio 8 Di Weekly Martenance B Search Text Ciilest Pas acavry name Plantar Dass • Red triangle: acknowledged failed activities C-P1.06 C-P1-06 Checking the Lamp Coolant 1 3112018 6 00 0 Schedued by Operator foxVew Database Backup 3/12/2018 0:30 To view maintenance activities: Schedued Automatically SH Autocheck O? Schwedued by Service 1 312/2018 1 00 VMM 1. On the Command bar, select Maintenance C Atelica Magline Transport Autocheck !! 3/12/2018 1:10 Fated P1-050 IM Paly Marterance 8 212001 2:00 X Inprocess CPI06 2. Select Schedule C-P1-06 8 SMT Daly Dleaning 312/2018 2:00 ¥ Completed 18100 IM Adocheck 312/2058 3:50 3. Apply any desired filters: X Not Percemed C-P100 CP10 With Comments CH Daly Maintenance CPIO Vw Acivibes Ienpecting the Winter Probes 312/2018 5:00 A. Filter options: Module, Frequency, Time, Performed By 4 P1-000 1-P1-06 Inspecting and Emptying the IM Diyer 1:1 312/2018 7:00 A B. In the Search Text field, enter any part of the Get Warming maintenance activity title ? PEP. [] LatManager Monday, March 12.2018 11:32 AM C. Filter by who performs the activity and the status *The view includes the status of the maintenance activity for 7 days. The current day 4. To apply the selected filters, select View Activities is highlighted with 3 days before and 3 days after that date. 5. The Filters area can be hidden by selecting the arrow at the top of the screen. If the Filter area is hidden, the view will include an additional column displaying the frequency of 15 the activity Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Maintenance Schedule Activity column Calendar view The Activity column indicates how the maintenance activity is Module Activity Scheduled Mon-04 Tue-05 Wed-06 Thu-07 Fri-08 Sat-09 Sun-10 performed: W-1A2 UIW-1A2 Cleaning the Exterior of Reagent Probes 9/7/2017 1:00 -- -- -- A ➢ Manual activity W-IA2 UIW-IA2 nspecting and Emptying the IM Water Trap 9/7/2017 1:00 -- -- A • Activity is performed by the operator UIW-SH2 UIW-SH2 SH Autocheck = 9/7/2017 1:00 -- -- VMM VMM Atellica Magline Transport Autocheck : 9/7/2017 1:10 -- ➢ Automated activity W-IA2 UIW-IA2 M Autocheck : 9/7/2017 3:30 -- - - A UIW-CC2 • Activity is performed by the system UIW-CC2 CH Daily Maintenance : 9/7/2017 4:00 -- -- UIW-CC2 The calendar view will indicate whether: UIW-CC2 Inspecting Washer Probes :: 9/7/2017 5:00 A A • -- The activity is scheduled to automatically run at a set Database Backup : 9/8/2017 0:30 -- V V day and time Move to Historical 9/8/2017 2:00 -- -- V V UIW-CC2 The activity is not scheduled to automatically run and UIW-CC2 MT Daily Cleaning 9/8/2017 2:00 -- V V must be manually initiated by the operator W-IA UIW-IA2 M Daily Maintenance 9/8/2017 2:00 -- V X Database: Archiving and Deleting : 9/8/2017 3:00 -- -- v v ➢ Service activity Database: Optimizing . 9/8/2017 5:30 -- V V Activity is performed by Service NOTE: To view the meaning of any of the symbols displayed on the screen, select • the symbol and a list describing the meaning of those type of symbols will display. *See the next slide for more information on manual and automated activities 16 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Maintenance Schedule Manual activities: To document the completion of a manual maintenance System Samples Inventory Calibration OC Patient Orders WorkJent Maintenance Setup • Schedule Report Log IMT Data Restore Software Updates Copy Configuration activity, select the activity and then select the Mark as Filter Y Module: All Frequency. All Time: Next 24 hours Performed By: All Completed button Module Al Module Activity Scheduled Fri-09 Sat-10 Sun-11 Mon-12 Tue-13 Wed-14 Thu-15 Frequency Al To document that a manual maintenance activity was not Cleaning the Exterior of the Reagent Probes 1 38/2018 1:00 Mark ans Completed • Time Next 24 hours P1-000 IM Weekly Maintenance { :3/8/2018 5:00 Not Perform performed, select the activity and then select the Not Performed By All C-P1.0 C-P1-06 CH Weekly Maintenance 3/11/2018 4:00 .. - Search Text Enter the activity name C-P1-06 Procedure Details Perform button 00 P1-06 Checking the Lamp Coolant 1 3/11/2018 6:00 EdWWView Scheduled by Operator Database Backup 3/12/2018 0:30 • A popup window will prompt you to enter a required Scheduled Automatically P.P1-03 SH Autocheck = 3/12/2018 1.00 Desete comment to explain why the activity was not performed Q? Scheduled by Service VMM Atellica Magline Transport Autocheck = 3/12/2018 1:10 Failed A Overdue -P1-06 IM Daly Maintenance = 3/12/2018 2:00 Automated activities: Inprocess CP10 P1-06 IMT Daily Cleaning = 3/12/2018 2:00 ¥ Completed 21-080 Pt-0 IM Autocheck de 3/12/2018 3:30 • The operator may choose to manually start automated X Not Performed C-P1.08 00 C-P1-06 CH Daly Maintenance = 3/12/2018 4.00 maintenance activities by selecting the activity and then vs.With Comments V C.P1.08 Inspecting the Washer Probes = 3/12/2018 5.00 V V selecting the Perform button 01 000 Inspecting and Emptying the IM Dryer 1 :3/12/2018 7:00 Add Activity Set Warning • If the activity is not scheduled to automatically run, the ? PEP LabManager Monday, March 12, 2018 11:41 AM operator must manually start the activity • When an automated maintenance activity completes NOTE: These tasks can also be performed by left-clicking on a status glyph from the date columns. successfully, the analyzer updates the schedule to display A list of tasks that can be performed on that maintenance activity will display. the next due date or resets the current count • If an automated scheduled maintenance activity fails, a red alert displays and the due date does not update 17 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Maintenance Report The Maintenance Report provides a record of the completion of maintenance activities, displayed one month at a time. The 1 Cyatem Camples Inventory Castration Patient Orders Workkion Maintenance Setup report is grouped by module and frequency. From this screen 2 Schedule Report Log IMT Data Restore Software Updates Copy Configuration the following tasks can be completed: 3 Filter Module: All Frequency: Al Time: All Performed By: Al February 2018 4 Modaly All Module 01 02 03 04 05 05 07 08 09 10 11: 12 13 14 15 15 17 15 19 20 21 22 23 24 25 26 27 28 • Check that all required maintenance for the month is Frequency All P1-060 1-P1-46 completed 5 1 Weekly Activity Search Test Erter the activity nato P1-060 0 Ceaning the Exterior of the Rtengent Probes P1-08C Fated 83 IN Weedy Maintenance • Modify activity status to document that activities were /Ã Overdur P1-060 0Jespecting and Emptying the IM Dryer completed or not performed, and add comments 6 X Not Performed P1-060 ‚ Iopecting and Emptying the IM Water Trap With Comments -P1-46 ; " Daily Activity • Generate maintenance reports ! Items For Approval P1-060 View Actvibes 23 IN Daily Maintenance P1-050 • Appropriate security level approves the displayed month P1-060 -P1-46 Monthly Activity To view the Maintenance Report: P1-000 Ceaning the IM Fan Filter P1-06C Ceaning the Exterior of the Asprate Frobes 1. On the Command bar, select Maintenance P1-060 -P1-40 414 Activity Based on Counts 2. Select Report 7 Hems To approve: 199 Approve Get Batch Actions Use the arrows to select the month that displays ? PEP 3. LabManager Monday, March 12, 2018 12:10 PM 4. If desired, select filter options: Module and Frequency NOTE: The last 3 months of maintenance activities displays, 1 month at a time. The default view If desired, in the Search Text field, enter any part of the is the current month. 5. maintenance activity title 6. If desired, filter by status and then select View Activities 7. To print the Maintenance Report, select the printer icon in 18 Effective Date: 5-JAN-2021 | HOOD05162003156009 the Status bar Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Load the Cal-QC Tube Storage Area 1. At the Command Bar, select Inventory SIEMENS edithingers Atellita TU Soluion Version 1.13.0.268+004 P-P1-03 1 Select the Cal-QC Storage Inventory tab System Samples Inventor Calibration Patient Orders Seap 2. 2 Worldest Maintenance Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Let Comparison Cal-QC Storage Inventory Cal-QC Needs 3. If the Cal-QC storage area is full, unload Cal-QC materials: Capacity Cal-QC Sample Details Assay Details 51 Available Type Material A Lot Sequence Status Vol GIL) Location Expiration Chem Control 1 1 A. Select one or more samples Cal ALP Cal B 6JD058 000006 224 P.P1-03 - Assay Expiration Filter A Chem Control 1 1 14491 000012 OK 1577 P.P1-03 Alb 9/28/2017 2:59: 11 PM B. Select the Unload button Search Gc Chem Control 2 2 14492 000013 OK 1577 P-P1-03 ALT 925/2017 2:59:11 PM Assay Cal 002 Cal B 78178 000007 OK 1443 P.P1-03 10/5/2017 5:48:18 PM AST 9/28/2017 2:59:11 PM 4. If loading a new material, create a definition for the calibrator Status Cal Drug Cal A 78005 000004 OK 800 P.P1-03 Ca #/28/2017 2:59:11 PM or QC material and print the label if appropriate OK 9/28/2017 2:59:11 PM Insufficient volume Cal Drug Cal B 780053 000004 OK 838 -P1-03 CO2_c Expired Cal Drug Cal C 780053 000004 OK 808 P.P1-03 10/3/2017 1:33:37 PM Crea_2 9/28/2017 2:59:11 PM 5. If appropriate, pour the calibrator or QC materials into Partialy Expired Type Cal Drug Cal D 780053 000004 OK 765 P.P1-03 10/3/2017 1:33:37 PM D_HDL 928/2017 2:59:11 PM labeled 12x75-mm round-bottom glass sample containers OC Cal Drug Cal E 780053 00000 OK 797 P.P1-03 10/3/2017:1:33:37 PM GluH_3 928/2017 2:56:11 PM Cal Location LDLP 9/28/2017 2:50:11 PM P-P1-03 6. Load the calibrator or QC material containers in a STAT rack Phot 928/2017 2:59:11 PM for immediate processing and storage TBA 926/2017 2:59:11 PM Theo 9/28/2017 2:50:11 PM ➢ Loading the calibrator or QC materials in a STAT rack B Unload --------. minimizes unrefrigerated time in the SH drawer. Ensure ? PEP LabManager 503 Monday, October 02, 2017 11:16 AM the calibrator or QC material containers are fully seated in NOTE: For information on how to create calibrator or QC definitions, refer to the rack the Calibration or Quality Control topics. To load the material in the Cal-QC *This procedure is continued on the next slide. 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. 19 IM Effective Date: 5-JAN-2021 | HOOD05162003156009 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Load the Cal-QC Tube Storage Area (continued) 7. Load the STAT rack in a sample drawer ➢ The SH robot automatically transfers the container 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. 20 IM Effective Date: 5-JAN-2021 | HOOD05162003156009 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Reviewing Reagent Needs Healthineers Reagent Needs posts a need for a reagent based on the expected tests for that day compared to the current inventory. The reasons for a posted need include the following: *NOTE: The predictive forecast and alert threshold are both configured in the Reagent Requirements Settings screen. • Predictive: Suggested need based on the number of tests per day defined by the operator or system historic assay utilization* • Below Threshold: The reagent inventory level is below the alert threshold* NOTE: The reagent needs for IM diluents and IM/CH wash fluids are posted based only on • Pending Orders: There are existing orders in the Worklist and no reagent is onboard for the the Threshold criteria, not based on the assay prediction. A need is red when the current inventory drops below a threshold defined by the operator on the Reagent Requirements Settings screen or when there are pending orders with no reagent available. To view the Reagent Needs: 1 K System Sample Inventory Calibration QC Patient Orders Worklist Maintenance 1. On the Command bar, select Inventory Reagent Overview Reagent Loader 2 Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibration Needs QC Needs Name 2. Select the Reagent Needs tab 3 Average Tests Tests Remaining Packs to Load Analyzers Reasons aTGDil 0 1 00109,1A00104,00109 Predictive o 3. If desired, sort the data by selecting one of the RPC2 70 70 GGW7_SAM Below Threshold column headings RPC1 70 70 GGW7_SAM Below Threshold RPC4 35 35 GGW7_SAM Below Threshold - 21 *This topic is continued on the next slide. Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Reviewing Reagent Needs Healthineers Reviewing Reagent Needs Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibration Needs QC Needs If a need is determined for a reagent, that reagent will display Name Average Tests Tests Remaining Packs to Load Analyzers Reasons on the screen. The information listed for each reagent includes: MDil13 0 00109,1A00104,00109 Predictive RPC2 70 70 GGW7_SAM Below Threshold • Average Tests: The forecasted need run based on the RPC1 70 70 GGW7_SAM Below Threshold configuration on the Reagent Requirements Settings screen RPC4 35 35 GGW7_SAM Below Threshold • Tests Remaining: System calculates as the difference between the Average Tests (or volume) and the amount performed • Packs to Load: The number of reagent packs to load o System calculates as Tests Remaining ÷ tests per pack • Analyzers: The analyzer(s) where that reagent pack could be loaded ? LabManager Tuesday, July 09, 2019 1:01:56 PM NOTE: The Reagent Needs can be printed by selecting the Print icon in the Status bar. 22 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 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 10. Load the reagent pack onto the analyzer 3 4 Healthineers IND RxOnly For USA RxOnly Fit in vero diagnostic use in the quantitaties T4 te Nelica"" M Aralveel For Professional Che Containe Lito fisacoct 10 0ml: Spat Phase 25 0 ml. ReadyPack" Fw USA SIEMENS T4 Heelthiseers 23 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Loading Reagent Packs Healthineers 1. Ensure the system is in the Ready or Inprocess 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: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Checking Supplies Healthineers The system will alert the operator that supplies need to be replenished or waste is getting full by displaying 1 1A2 E System Samples wwventory Calibration Oc Pabient Orders Workelest Maintenance an alert on the Inventory button in the Command Bar. Reagent Overview Reagent Loader Reagent Needs 2 Supplies Overview Reagent Lor Comparison Cal-QC Storage Inventory Cal-QC Needs 3 0010 To check the status of waste and supplies: System Fluids Volume Status OBS Lot Expiration Lot Sequence Number 1. On the Command bar, select Inventory VIMAcid 10 OK 2447h 2/6/2018 00000 0007 V IM Base 11 OK 24d7h 26/2018 00000 0019 2. Select Supplies Overview IM Cleaner 9 On reserve 5d 16 h 5/8/2018 00000 0020 3. Select the appropriate analyzer icon V IM Wash OK 26 d 16 h 9/23/2018 000028 1215 24 d 4h 9/23/2018 282482 1040 4. Check the status of the supplies and waste Replace System Fluids 5. If appropriate, replace system fluids or supplies or Supplies Status Waste Status 2 Storage Locations Available empty the waste V Tips OK 7 Tip Trays In Storage Cuvette and Tip Waste OK Cuvettes OK Tip Tray Waste OK Open To Tray Waste Drawer V Water OK Liquid Waste OK ? PEP LatManager Wednesday, June 06, 2018 1.30 PM NOTE: All supplies can be replaced while the system is in process, unless otherwise noted for that procedure. NOTE: Ensure all supplies are replenished prior to the weekend or overnight if automatic maintenance is going to run while the system is not attended. 25 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Replacing System Fluids Healthineers 1. Open the system fluids drawer ➢ The System Fluids screen will display on the module display HealthMENS System Fluids 2. Locate and tighten the cap of the system fluid container to be 3. IM Wash Select the container location removed Let Right 3. Remove the appropriate system fluid container ? OK Cancel IM Wash 4. Discard the system fluid container according to laboratory protocol SIEMENS TD 3.0 L IM Wash 2017-09-23 282482 11098501 5. Using the module display, scan the new fluid container using the barcode on the front label. To scan the new fluid container: A. Hold the container 150 mm (6 inches) at a 45 ◦ angle under the module display barcode reader B. Ensure the module display shows the correct Lot and Lot Expiration under the appropriate fluid 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 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. 26 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Replacing System Fluids Healthineers 7. 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. 8. Ensure the container is seated securely with the tabs on both sides of the container even with the drawer surface 9. 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 10. Close the system fluid drawer 1 2 27 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Replacing IM Cuvettes Healthineers 1. Open the cuvette bin lid 2. Pour cuvettes into the cuvette bin 3. Close the cuvette bin lid NOTE: The maximum capacity of the cuvette bin is 1500 cuvettes. Overloading cuvettes can put too much pressure on the elevator which can contribute to cuvette jams. 28 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Replacing IM Sample Tips Healthineers NOTE: Wear new, uncontaminated gloves when handling sample 4. Twist then pull the tab down and out to release the strap from tips to prevent cross contamination. the trays 1. Open the sample tip loading lid 5. Pull the strap out to remove it from the bundle. Note: Leave 2. Remove the protective cover from the sample tip tray bundle the top on the upper trip tray 3. Install the sample tip trays ensuring that the tab is facing the 6. 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 4 29 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Emptying the IM Sample Tip Tray Waste Healthineers 1. On the module display, select Open Tip Tray Waste Drawer > Yes 2. Open the solid waste door *This procedure is continued on the next slide. 2 SIEMENS Waste ¿ LabManager Off Cuvette and Tip Waste V Ok Tip Tray Waste V Ok 1 Open Tip Tray Waste Drawer Liquid Waste V Ok ? 30 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 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. Select Yes to the message "Did you empty the Sample Tip Tray waste area?“ 3 4 O 31 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 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 6. To confirm the cuvette and sample tip waste is empty, 3. Empty the contents of the solid waste bins into a select Yes to “Did you empty the Sample Tip Tray waste laboratory-approved container for biohazardous waste area?” 2 32 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Replacing IMT Fluids Healthineers 1. Ensure the analyzer is in Ready, Processing, or Standby state by navigating to System > Status and checking the status of the Replace IMT Supplies X appropriate module 2. Open the IMT fluids lid The IMT Advanced Clean maintenance procedure is due. 3. Select IMT Supplies on the module display To begin the Advanced Clean before replacing the A-LYTE mulitsensor, select Perform IMT Advanced Clean. 4. If an IMT Advanced Clean is required at the next multisensor replacement, a window displays with options to either perform IMT Advanced Clean or replace IMT supplies (see image on the right) To replace IMT supplies directly without performing the IMT Advanced Clean, select Replace IMT Supplies. • If you are only replacing the IMT fluids and are not replacing the A- LYTE multisensor, select Replace IMT Supplies and wait for the To exit, select Cancel. analyzer to pause 5. Locate and remove the appropriate IMT fluid container Perform IMT Advanced Clean Replace IMT Supplies Cancel 6. Discard the IMT fluid container per laboratory protocol NOTE: Do not refill an IMT fluid container. Refilling a container can cause contamination. Remove the bottle from the IMT fluids area and install a new container. *This procedure is continued on the next slide. 33 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Replacing IMT Fluids Healthineers 7. Using the module display, scan the new IMT fluid container 8. Ensure the module displays the correct Lot, Sequence, and Expiration under the appropriate fluid 9. Holding the new IMT fluid container vertically with the septum facing down, insert the new container into position 10. To replace each additional IMT fluid, repeat steps 5-9 GIFMENS A 11. Close the IMT fluids lid 12. Select OK SIEMENS IMT Supplies LabManager Standby NOTE: Do not touch the cannulas in the keyed areas at the bottom of the system fluids drawer. The cannulas can puncture skin. To replace IMT Sensor and IMT Fluids, pause the IMT system by opening the IMT i Supplies lid, and then scan or manually enter the IMT Sensor or IMT Fluid barcode. NOTE: The system and IMT fluid containers only fit in the designated position when the cannulas puncture the septum. TD-LYTE O 1 0 2 3 IMT Sensor IMT Std B + Salt Bridge IMT Standard A IMT Diluent Pause IMT ? 34 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Replacing the Pretreatment Pack Healthineers 1. Stop the CH analyzer and unlock the front cover: A. At the module display, select Module State B. Select the Pause button C. Select the button to unlock the CH front cover 2. Lift open the CH front cover 3. Grasp the pretreatment pack and pull up and out. Discard the pretreatment pack SIEMENS CI-CH SIEMENS Supplies 4. On the module display, select Supplies LabManager Standby LabManager Standby 5. The pretreatment screen will display. If 4 Pretreatment needed, select Instructions for scanning for 0 Lot --- 5 guidance on how to hold the pretreatment Lot Expiration pack while scanning Module State System Fluids Supplies IMT Supplies OBS --- Instructions for Status scanning 6. Using the module display, scan the new pretreatment pack Manual Entry Reagent Loader ? *This procedure is continued on the next slide. 35 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Replacing the Pretreatment Pack Healthineers 7. Confirm that the module display shows the correct Lot and Expiration Pretreatment Scanned X × 8. Insert the new pack into the CH analyzer. Remove cap and discard Pretreatment 7 Lot 1222222222 Expiration 2/25/2017 12:00:00 AM 9. Select OK 10. Close the CH front cover 11. Lock the CH front cover by selecting the appropriate button on the Module State screen on the module display Place Pretreatment in the holder, close the front cover, and start the 12. Start the CH analyzer by selecting the Resume icon on the Module analyzer. State screen on the module display ? 9 OK Cancel 36 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Reviewing Calibration Needs Healthineers The Calibration Needs provides a list of the calibrations that Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibration Needs QC Needs need to be performed. Calibrator Name Calibrator Lot Onboard Status Comment Assay Calibration Expiration Reagent Lot and Pack Analyzer Storable A calibration need is created if one of following applies: CALFol CT84 Not Onboard L1,12 Fol Oh0min 284 00109 • A pack or lot calibration will be needed before the current CT84 Not Onboard L1,12 Fo Dhomin 284 BA00104 day ends • There is a pending calibration order in the Worklist A need will also be created if a lot calibration is required and no fresh packs are available. In this case, the Comment field will display “No valid pack onboard“. A need is red when the calibration is due to expire within the threshold set on the Alert Settings screen and there is no calibrator material available. Group by Calibrator Material Create Cal NOTE: If the All checkbox at the bottom of the screen is not checked, only needs for which the calibrator material is not onboard will display. This is the default setting. *This topic is continued on the next slide. 37 37 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Reviewing Calibration Needs Healthineers 1 A To review the Calibration Needs: System Samples Inventory Calibration *OC Patient Orders 2 Workkest Maintenance Setup Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibration Needs QC Needs 1. At the Command Bar, select Inventory Calibrator Name Calibrator Lot Onboard Status Comment Assay 3 Calibration Expiration Reagent Lot and Pack Analyzer Storable 2. Select Calibration Needs CHEM CAL 2988738 CHEM CAL 2008738 Onboard L2 - Partially Expired - No valid pack ontard DB4_2 1h1 0 min 190043 CMO0113 V 3. To sort the data by selecting one of the column CALTOXOG C447 headings. Columns with the arrow indicators can be CAL TONOG C447 Onboard L1,12 TaNO_G 247 00109 6 C447 sorted C447 Onboard L1,L2 Taxo_G 247 A00104 4. To view the calibrations with calibrator material not CALRub G C713 CALRub G C713 Onboard L1,12 Rub_G 213 00109 onboard, ensure the All checkbox is not selected C713 C713 Onboard L1,12 5. To group calibrator material by Calibrator Name, select Rib_G 213 LA00104 CALHCY C8856 the Group by Calibrator Material checkbox CALHCY C8856 Orboard L112 HCY 185 00109 C8856 6. To consolidate the list, collapse each calibrator name C8856 Onboard L1,12 HCY 185 using the arrow to the left of the calibrator name 5 4 CALFol CT& 7. To create an order for a selected calibration*, select Group by Calibrator Material 7 Create Cal Order Create Cal Order > Order ? PEP LabManager OS Tuesday, July 09. 2019-1:05:01 PM 8 8. To print the Calibrator Needs, select the print icon in the Status bar *NOTE: It is recommended to load the calibrator material on the system before an order is created for that calibrator material. 9. Load calibrator material on the system for any needs that are in red and do not have usable calibrator NOTE: No need displays for C0 adjustments. material currently onboard 38 38 *This topic is continued on the next slide. Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Creating Calibration Orders Healthineers Options for Creating Calibration Orders • Create calibration orders manually using the active calibration lot for reagent packs currently onboard the system using the Inventory > Reagent Overview screen • Create calibration orders manually using the Calibration > Create Calibration Orders screen. This method is useful in the following cases: ➢ To use a calibrator lot other than the active lot ➢ To add QC to the calibration order (if the option to automatically Perform QC with Calibration setting in Setup is turned off) ➢ To order for multiple assays or analyzers at once • Create calibration orders when checking for calibration needs using the Inventory > Calibration Needs screen • Configure the system to automatically create calibration orders 39 39 IM Effective Date: 5-JAN-2021 | HOOD05162003156009 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2021 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, access the Worklist > Worklist Overview screen • To export or print a detailed calibration report, and to troubleshoot calibration results, access the Calibration > 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 Overview 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 (Setup > Settings > Reports Setup > Automatic Reports). 40 40 IM Effective Date: 5-JAN-2021 | HOOD05162003156009 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Reviewing Calibration Results – Details Screen Healthineers The Calibration Results Details can be accessed from either the Worklist Overview or the Calibration Results screen. Calibration Results Details for Ca on ( C-P1-05 × B Information Data Comments A. Information – summary of the calibration order information Activity Reagent Lot Calibration A Assay Ca 1 (L) 2 (H) Units mg/dl Data – calibration data for each replicate Calculation Type Linear Replicate nclude Analyte Signal Flag Include Analyte Signal Flag B. Ordered Date 9/28/2018 9:45:36 AM Completed Date 9/28/2018 9:56:57 AM Replicate 1 V 0.10 mg/dL 136.42 mAU V 10.94 mg/dL 590.18 mAU Accepted By CSE : G2 ➢ If applicable, the Include checkboxes can be used to Analyzer Name C-P1-05 Replicate 2 -0.01 mg/dL 131.90 mAU VM 11.14 mg/dL 598.79 mAU Analyzer Serial Number C-P1-05 Reagent Lot 270449 Replicate 3 V -0.08 mg/dl 128.92 mAU 11.22 mg/dl 602.03 mAU exclude or include replicate results Pack/Well 270449-00486:Well 1 Edit K Ancillary 1 Ancillary 1 Lot/Pack Graph Ancillary 2 Mean 0.00 132.41 11.10 597.00 C. QC Performed with Calibration – provides a summary of QC Ancillary 2 Lot/Pack Calibrator Name Chem Cal Median -0.01 131.90 11.14 598.79 Calibrator Lot 135808B results, when the system automatically performed QC with Cal Status Valid SD 0.09 3.78 0.14 6.12 Acceptance Criteria OK calibration (enabled in the Test Definition or selected as part Acceptance Mode Manual Observed %CV 2722.13 2.85 1.30 1.03 Trigger Mode Lot Calibration Expired System Response Cal Expiration 10/31/2018 9:47:14 AM of the calibration order) QC Performed with Calibration C Acceptance Criteria D QC QC Limits New Observed Old Observed Criteria Result Value Expected Observed Curve Shape D. Acceptance Criteria – displays the criteria used by the Coefficients 42,1 404.58 Level 1: 26431 8.12 - 9.7 8.89 9.49 No auto-excluded replicates Pass 0.00 -0.5 - 0.5 0.5 - 0.5 42,1: 484.58 42.1/42.1 1.00 CO 132.41 Statistics system to evaluate the calibration, and indicates whether C1 209.27 Level 2: 26432 11.5 - 13.3 12.28 12.92 No flags or comments Pass 0.00 -0.5 - 0.5 -0.5 - 0.5 Slope Intercept Delta system response Pass 464.58 mAU 169.0 - 1121.0 169.0 - 1121.0 Corr. Coefficient each criteria failed or passed for the selected calibration Enlarge ? Print Accept Reject Close ➢ The system automatically accepts calibration results if the 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. 41 41 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 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 Ca on C-P1-05 X Information Data Comments E ➢ To enter a new comment, select the Edit button Activity Reagent Lot Calibration Assay 1 (L) 2 (H) Ca Units mg/dl Calculation Type Linear Replicate Include Analyte Signal Flag Include Analyte Signal Flag F. Graph* – displays a graph of the results as Expected Ordered Date 9/28/2018 9:45:36 AM Completed Date 9/28/2018 9:56:57 AM Replicate 1 V 0.10 mg/dL 136.42 mAU V 10.94 mg/dl 590.18 mAU Concentration/System Response Accepted By CSE : G2 Analyzer Name C-P1-05 Replicate 2 -0.01 mg/dL 131.90 mAU V 11.14 mg/dL 598.79 mAU Analyzer Serial Number C-P1-05 Reagent Lot 270449 Replicate 3 V -0.08 mg/dl 128.92 mAU V 11.22 mg/dl 602.03 mAU ➢ To display a larger view of the graph, select the Edit Pack/Well 270449-00486:Well 1 Ancillary 1 Enlarge button Ancillary 1 Lot/Pack Graph Ancillary 2 Mean 0.00 132.41 11.10 597.00 F Ancillary 2 Lot/Pack Calibrator Name Chem Cal Median -0.01 131.90 11.14 598.79 G. Print – prints the calibration result details Calibrator Lot 135808B Cal Status Valid SD 0.09 3.78 0.14 6.12 Acceptance Criteria OK Acceptance Mode Manual Observed %CV 2722.13 2.85 1.30 1.03 Trigger Mode Lot Calibration Expired System Response Cal Expiration 10/31/2018 9:47:14 AM QC Performed with Calibration Acceptance Criteria QC QC Limits New Old Observed Observed Criteria Result Value Expected Observed Curve Shape Coefficients 42,1: 404.58 Level 1: 26431 8.12 - 9.7 8.89 9.49 No auto-excluded replicates Pass 0.00 -0.5 - 0.5 -0.5 - 0.5 42,1 484.58 02.1142.1 1.00 CO 132.41 C1 209.27 Level 2: 26432 11.5 - 13.3 12.28 12.92 No flags or comments Pass 0.00 -0.5 - 0.5 -0.5 - 0.5 Statistics Slope Delta system response Pass 464.58 mAU 169.0 - 1121.0 169.0 - 1121.0 Corr . Coefficient Enlarge ? G Print Accept Reject Close *NOTE: The Graph is only displayed for CH calibration results. 42 42 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 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 • The MC TDEF insert can have 1 or more 2D barcodes • The MC TDEF barcode(s) must be scanned when a new lot of reagent is loaded on the system 2 System Samples Ervertory Calibration Patient Orders Workbest Maintenance Setup To scan the MC TDEF barcode(s): 3 Test Definition Setting Accounts Assay List Faer 1. Ensure the analyzer is in one of the following states: Lots. CH Test Definition Test - Definition Calculation Calibration Ranges Ready, Standby, Stopped, Startup, or Warming up 4 Test Identification Advanced IM Test Definition AFP Test NameID AFP Replicates Acceptable CV % AHAVM Patient 0.00 Reflex Group Setup 2. At the Command Bar, select Setup Ratios, Panels, and Off- System Test Type Standard SHBCM Control 0.00 Repeat Conditions Test Display Order BNP Test Version : 1.1 Reset Defaults Display Name AFP Overdilution Point 15 3. Select the Test Definition tab CA125 Open Channel CA19 9 Print Name AFP Specimen Type Serum Amniotic Fluid Sort Test Definition CEA LIS Code AFP Compatibility Code :1 4. Select IM Test Definition Conf LOINC Minimum SW Version 1 Dig Status Released 5. Select Scan Barcodes EHI Fe Anonymous General 6. Scan the first 2D barcode FSH FT3 Resul Review Mode None Centrifuge before Repeating FT4 Reuse Rest for Ratio 7. Scan the remaining 2D barcodes in consecutive order Control-bracketed Test HBs Result Time Limit hours Levels 4 . Bracket Timeout (rlouers) |24 - Rerander Gburg) 0 - Rg1A2 Analyte Stability minutes • The barcode scanner audio confirms successful scans 5 8 Scan Barcodes Sme Cance 8. Select Save ? PEP LabManager Tuesday , April 17, 2018 2:16 PM Back 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. 43 43 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Installing New Calibrator Definitions Healthineers Calibrator definitions must be installed when a new lot of calibrator 1 System Samples Inventory Calibration Patient Orders Workdent Maintenance Setup will be used. To install a new calibrator definition: Calibration Overview Create Calibration Orders Calibration Resu 2 Calibrator Definitions IMT Calibration Filters 1. On the Command Bar, select Calibration Assays Material Name Lot ID Material ID Expiration Date Assays Add New TCDOZO TO Status 5/1/02019 11:59 PM Afc_3; THb 2. Select the Calibrator Definitions tab Expired ENZI 3/1/2018 11:59 PM LOUP. OGT Active HDULOL 412577 77 3/1/2018 11.59 PM D_HDL DLDL OO 3. Scan the barcode(s) from the calibrator lot-specific value sheet Add Calibrator Definition 4 5 X using the barcode reader (the value sheet can be found in the Calibrator Material Assay Type Material Name Material ID Lot ID Expiration Date Revision Measuring Interval Verification Material CH Tox Ca TO 729099 5/31/2018 Active Store Onboard box with the calibrator material) Search ➢ IM assays: all the linear barcodes on the value sheet must Select Tests Assigned Values 6AM A1c_3 AAG Cal Code Assay Level Level 2 Units be scanned AAT Acet Alb 102 Ace 9.2 mg/dL X O AlbP ALP_20 ALT ➢ CH assays: the 2D barcode on the value sheet is scanned ALTPLC Amm Amp 1K Amp300 Amp500 Amylas 4. Confirm the scanned information on the Add Calibrator APO A1 APO B ASO_2 Definition window AST ASTPLC B2M BLUE Bnz200 Bnz300 5. To enable the calibrator material for calibration, select the Brb200 Brb300 Bupn Active checkbox C3 C4 Ca Caff Carb Che ➢ More than 1 calibrator definition may exist on the system ? Add Assay by Cal Code Print Save Cancel for an assay. To ensure the system uses the calibrator definition as the primary calibrator when calibrating a reagent directly from Inventory > Reagent Overview, deselect the Active checkbox for additional calibrator definitions associated with the assay *This procedure is continued on the next slide 44 44 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Installing New Calibrator Definitions Healthineers 6. If storing the calibrator in the Cal-QC storage area, select the System Samples Inventory Calibration Patient Orders Working Maintenance Setup Store Onboard checkbox (only applies to Sample Handler Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMAT Calibration configurations) Filters Assays Material Name Lot ID Material ID Expiration Date Assays Add New TCDOTO 5/1/02019 11:59 PM Afc_3; 1Hb ➢ Certain assay calibrators are not compatible with onboard Status Expired ENZI TODO69 3/1/2018 11:59 PM LOUP. OGT storage in the Cal-QC area. The operator cannot select the Active HDULOL 412577 77 3/12018 11.59 PM D_HDL DLDL OO Store Onboard checkbox and save a calibrator definition Add Calibrator Definition 6 X that includes an assay that is incompatible with onboard Calibrator Material Assay Type Material Name Material ID Lot ID Expiration Date Revision Measuring Interval Verification Material CH Tox Ca TO 729099 5/31/2018 Active Store Onboard storage Search Select Tests Assigned Values 7. Select Save 6AM A1c_3 AAG Cal Code Assay Level Level 2 Units AAT Acet Alb 102 Ace 9.2 mg/dL X O AlbP ALP_20 ALT ALTPLC Amm Amp 1K Amp300 Amp500 Amylas APO A1 APO B ASO_2 AST ASTPLC B2M BLUE Bnz200 Bnz300 Brb200 Brb300 Bupn C3 C4 Ca Caff Carb Che 7 ? Add Assay by Cal Code Print Save Cancel NOTE: If the barcode reader is not available, the calibrator definition can be manually added by selecting the Add New button on the Calibrator Definitions screen. 45 45 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 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 46 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 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: • System startup • After a reset from a paused or stopped state • 4-hour intervals • After 250 tests have been completed since the last calibration • A-LYTE® multisensor temperature changes outside of specifications • IMT successful error recovery • IMT cleaning procedure • 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 47 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Reviewing QC Needs Healthineers The QC Needs provides a list of the QC materials the A System Samples Inventory Calibration LOC Patient Orders Worldist Maintenance Setup system requires. Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibrator Needs QC Needs A QC need is created if one of following applies: Name Control ID Control Lot Level Onboard Status Scheduled Usable Volume Needed (HL) Assay Storable 12345 1234 1 Not Onboard 30 Acet • The QC scheduler* is set up to create an order 12345 1234 1 Not Onboard 30 ALT before the end of the current day 12345 1234 Not Onboard 30 Amm 12345 1234 1 Not Onboard 30 AST • There is a pending QC order in the Worklist 12345 12345 12345 123 12345678912 60 12345 12345 12345 123 12345678912 1234567891 2 Not Onboard 30 ALT A need is red when there are pending QC orders in the 12345678912 1234567891 2 Not Onboard 30 C3 Worklist with no QC available. New Control NewControl 90 New Control NewContro NEWCONTROL 2 Not Onboard 30 C3 NewContro NEWCONTROL 2 Not Onboard 30 Ca NewContro NEWCONTROL 2 Not Onboard 30 Carb QC Material One Controlld 57 QC Material One Controild LOTNUMBER 2 Not Onboard 28 ALT V Controild LOTNUMBER 2 Not Onboard 29 Amm V Group by QC Material All QC Order ? PEP LabManager Tuesday, July 09, 2019 1:09:37 PM *NOTE: Refer to the Configuring Automatic QC Scheduling topic for more information. NOTE: If the All checkbox at the bottom of the screen is not checked, only needs for which the QC material is not available will display. This is the default setting. *This topic is continued on the next slide. 48 IM Effective Date: 5-JAN-2021 | HOOD05162003156009 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Reviewing QC Needs Healthineers To review the QC Needs: 1 A System Samples Inventory Calibration Patient Orders Worldist Maintenance Setup 1. At the Command Bar, select Inventory Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibrator Need 2 QC Needs Select QC Needs Name Control ID Control Lot Level Onboard Status Scheduled Usable Volume Needed (pt) Assay Storable 2. 12345 1234 1 Not Onboard 30 Acet 3. To view control material that is both onboard and not 12345 1234 Not Onboard 30 ALT onboard, select All 12345 1234 Not Onboard 30 Amm 12345 1234 Not Onboard 30 AST - 4. To group control material by control name, select 5 12345 12345 12345 123 12345678912 60 Group by QC Material 12345 12345 12345 123 12345678912 1234567891 2 Not Onboard 30 ALT 12345678912 1234567891 2 Not Onboard 30 C3 5. To consolidate the list, collapse each control name New Control NewControl 90 using the arrow to the left of the control name New Control NewContro NEWCONTROL 2 Not Onboard 30 C3 NewContro NEWCONTROL 2 Not Onboard 30 Ca 6. To print the QC Needs, select the print icon in the NewContro NEWCONTROL 2 Not Onboard 30 Carb Status bar QC Material One Controlld 57 QC Material One Controll LOTNUMBER 2 Not Onboard 28 ALT 7. To create QC orders, select QC Order 4 Controil 3 LOTNUMBER 2 Not Onboard 29 Amm V Group by QC Material All 7 QC Order 8. Load QC material on the system for any needs that ? PEP LabManager Tuesday, July 09, 2019 1:09:37 PM are in red and do not have usable QC material currently onboard 6 49 IM Effective Date: 5-JAN-2021 | HOOD05162003156009 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Creating QC Orders Healthineers Options for Creating QC Orders • Create QC orders manually using the QC > Create QC Orders screen ➢ Option to create orders using a panel • Create QC orders when checking QC needs using the Inventory > QC Needs screen • Configure the system to automatically create QC orders: ➢ By Day and Time ➢ By Test Count ➢ By Control 50 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Review QC Test Orders and Results Healthineers The Worklist Overview screen can be used to view the status of test orders and results for calibration, QC, and patient E 1 System Samples Caleration Pabient Orders Working Maintenance Setup orders. 2 Worklist Overview Monitoring Lab Metrics 4 Filter Sample Type: Control , Time: 24 Hours Sort By Name Tests Count 58 To view test orders and results: lample Order Date 24 Hours SIR Nonmit Test Interpretation Flags 3 Sample Type Control 45201 biorad Chol:2 1. At the Command Bar, select Worklist Ast Teil t Dem 45701 biorad US Analyzer 45201 biorad 0 Stat Watching 2. Select the Worklist Overview tab Sample Teit Custom 45701 blorad Saved Filters 45791 biorad No Filter 3. The Filter area of the screen is used to filter the orders 45701 biorad Vane Advanced Filters 45702 Blorad 2 Chol 2 displayed. Under Sample Type, QC can be selected 45.702 biorad 2 5 45202 biorad 2 4. The Orders area of the screen displays the result time for 45702 biorad 2 VanG Result 572 mg/dl Test 45.292 biorad 2 Chol 2 Hepele inprocess test orders, and the result value and units for 45702 biorad 2 LA Low Acbipl Biorad resulted test orders LA Citical High Common Biorad3 ChoLa Critical Low 5. Selecting one of the Flags symbols will display a list of what Biorad > Measuring Interval Biorada Cancel the symbols mean. Scroll down to the bottom of the list to Query US Import workant Export view the low and high limits that are defined in the QC ? PEP B & LabManager Thursday, May 31. 2018 2:41 PM Definition screen for that control 51 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Monitoring QC Results – QC Statistics Screens Healthineers The QC Statistics screen provides real-time and long-term evaluation of system and assay performance. 160 System Samples nvertory Calibration 1 Oc Patient Orders Workdiest Maintenance Setup 2 Create QC Orders Control Bracketing QC Statistics Patient QC Flagging QC Definitions QC Panels QC Scheduler The Review screen displays current QC results. 3 Review Tools B C To access the QC Review screen: Show by @ Control Test Show Results Unreviewed Out of Control Warning 2 Other A V. Sysen Analyour Name Tet Control Level Qc violation Result Target . 250 Comment Dochoded CEA 11/29/2017 3:45PM4 5900007 09109 TOUIL LA PLUS? 12.887 WWIL -4,1 19.5333- 31.2. Comment 1. At the Command Bar, select QC TSNJUL 1 47341 fscl wwwL. 1.8 3.4833. 5.4167 - LA PLUS 2 14.35 2 14-2647 - 18.7 Analyze 2. Select the QC Statistics tab 11/29/2017 3:46 PM4 3900107 09109 LA PLUS ! wUmL .2.9 0.2353 - 0.5207 ThCG 11/29/2417 1:45PM 1000107 A PLUS 9 48343 -- Dit 11/29/2017 3:45PM - 3000507 CEA TM PLUS 16.06 3. Select the Review tab 00109 2. 49341 [25] 85.5 ASc_3 11/29/20173:44PM4 $900107 00100 LA PLUS ! T 43341 14.9 -3-16-2233 - 21.5 .. aHAVM 11/29/20171:46PM: 3000987 TM PLUS3 54633 [25] 249.4 -2,1 251.1333- 308. Areas of the screen: Chem co- :264.33 14.8 -2.5 15.4187 - 23.0_ Chem co 2 25432 [25] 2.4 15.8187- 23.0 A. Control file selection – contains options for selecting the AST control files to be viewed Da B. Filters – used to filter the types of files displayed Cres 2 C. Functions: Select Expand All V] Auto-select Iss Select If results, 1 selected Reports Customize Review: to designate an out of range and warning ? PEP LabManager Thursday, May 31. 2018 2:41 PM • result as “Reviewed” NOTE: For more information on using QC Statistics to view data and graphs, refer to Online • Comment: to add a comment to a data point Help or the “Viewing QC Statistics Video“ on PEPconnect. • Analyze: to view graphs and statistics for the data 52 IM Effective Date: 5-JAN-2021 | HOOD05162003156009 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Creating New QC Definitions Healthineers To manually create a QC definition: 1 1. At the Command Bar, select QC System Samples Inventory Calibration Oc + Patient Orders Worklet Maintenance 2 Setup 2. Select the QC Definitions tab Create QC Orders Control Bracketing Qc Statistics Pallent CC Flagain OC Definitions QC Panels OC Sobeduler Add New QC Definition x Control Details 3. Select the Add QC Definition button Control Name Control Lot Specimen Serum Plasma 4 Control ID Control Lot Expiration 10/17/2018 15 Control Type: Routine 4. Enter the following information: Control Name, Control Level Usage Primary Lot, Specimen, Control ID, Control Lot Expiration, Control Store Onboard Perform QC with Calibration Perform QC on Pack Change Tests Type, Level, Usage Test Name Unes - Low - Mean 2. Result Open Stability Open Stability Clear All Ranges Rang Days Hours L CL Specimen - Select the Specimen type associated with the tests that the control supports AAG AAT WP ➢ The operator must select Serum/Plasma specimen type SHAWVM Alt ABP ALP 3€ for controls associated with tests for Serum, Plasma, or ALT ALTPLE both. This specimen type applies to QC samples only Amk AMY 2 Control Type - The following options are available: ? Cancel 3 And QD Definvoor ➢ Routine controls – independent from the reagent kits ? PEP LabManager 500 Tuesday, November 27. 201# 10:01 AM and do not require a checksum Kit controls – require a checksum and may be lot- NOTE: QC definitions can also be imported into the software using the Import button on ➢ the QC > QC Definitions screen. The QC definition xml file that is needed for importing locked or control bracketed can be obtained from the QC supplier, or it can be exported from an Atellica Solution system. *This procedure is continued on the next slide 53 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Creating New QC Definitions Healthineers Usage - The following options are available: Add New QC Definition x ➢ Primary – Primary controls that produce QC results Control Details Control Name LYPH CHL1 Control Lot 14491 that determine patient QC flagging in QC statistics Specimen Serum/Plasma Control ID 14491 Control Lot Expiration 12/31/2019 15 Control Type Routine ➢ Parallel – The operator can perform new control lots in Level Usage Primary parallel with primary control lots for QC statistics. 5 Store Onboard Perform QC with Calibration Perform QC on Pack Change Parallel control results generate observed ranges, but Tests do not generate violations or flags for test evaluations H Test Name Units SD - Low +/- Result / - Open Stability Ope Open Stability Clear All Ranges High 2 Mean? Range Days Hours - L CL Alb g/dl 3.8 14.34 4.07 0.27 Observed Ranges ➢ Alternate – The operator performs alternate control K NA lots for additional QC flagging and statistical data AAG AAT Acet AFP ➢ Not in Use – The control lot is expired aHAVM Alb 5. If the QC material will be stored onboard, select the Store AlbP ALP_2c Onboard checkbox. (Only available in Sample Handler ALT ALTPLC configurations) Amik AMY_2 ➢ When running QC with onboard controls, the system ? Save Cancel retrieves the control sample automatically as part of the QC order *This procedure is continued on the next slide 54 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Creating New QC Definitions Healthineers 6. To enable the QC lot to be configured to run automatically Add New QC Definition X with calibrations, select the Perform QC with Calibration Control Details Control Name YPH CHL1 Control Lot 14491 Specimen Serum/Plasma checkbox Control ID 14491 Control Lot Expiration 12/31/2019 15 Control Type Routine ➢ To complete the setup of performing QC with calibration, Level Usage Primary navigate to Setup > Test Definition and select the Store Onboard 6 Perform QC with Calibration 7 Perform QC on Pack Change Tests Perform QC with Calibration checkbox for the desired 8 H Test Name Units 9 SD Low High Mean ? Open Stability Open Stability Clear All Ranges test definition Range Result Days Hours L CL Alb g/dl 3 . 3.8 4.34 4.07 0.27 7 Observed Ranges 7. To enable the QC to be run automatically with a reagent K NA 10 11 pack change, select the Perform QC on Pack Change AAG AAT checkbox Acet AFP aHAVM Alb ➢ To complete the setup of performing QC with pack AIbP ALP_2c change, navigate to Setup > Settings > General Setup ALT ALTPLC and select the appropriate QC on Pack Change setting Amik AMY_2 under QC Mode Settings ? 13 Save Cancel 8. Select a test *NOTE: There is an option to enter “N/A” for SD and to not enter target values, which 9. Enter the SD (Standard Deviation)* would allow the controls to run without entering ranges. There is also an option to enter 10. Enter the target values by entering either the Low and High “QUAL” for SD. limits OR the mean and +/- Range * **NOTE: The Open Stability fields are only applicable to Sample Handler configurations. 11. Enter the Open Stability Days and the Open Stability Hours** 12. Add additional tests as needed 55 13. Select the Save button Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Loading Samples on the SH Healthineers 1. Place sample containers in the appropriate type of rack. STAT samples in a STAT rack for immediate processing. Routine samples in a routine rack. False bottom tubes in a special false bottom tube rack. Ensure all sample containers are fully seated to the bottom of the rack Rack sizes: Rack Types: ⚫ 55 position ⚫ Standard rack ⚫ 15 position ⚫ STAT rack – pink label ⚫ Special False-Bottom Tube rack – blue label STAT 15 position rack Routine 55 position rack NOTE: Do not fill sample containers past the maximum recommended level of 1 container 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 *This procedure is continued on the next slide the top of the container. NOTE: Do not position pacemakers or other implanted medical devices closer than 7.5 cm (3 inches) from the base of a carrier on the Atellica Magline® Transport. Magnets in the carrier base generate magnetic fields that can interfere with cardiac medical implants. NOTE: Refer to the Atellica Solution Online Help for a complete list of the supported sample containers. 56 56 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 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 the drawer is not fully open, the system may not properly scan the racks *This procedure is continued on the next slide when the drawer is closed 4. If there are any old racks in the sample drawer, remove the racks by lifting the racks from the sample drawer 57 57 IM Effective Date: 5-JAN-2021 | HOOD05162003156009 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2021 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 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. 58 58 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Monitoring Sample Tube Status – Sample Handler Tab Healthineers The Sample Handler tab displays the status of samples that are currently in the Sample Handler drawers. 1 System Samples Inventory Calibration Patient Orders Workinst Maintenance Setup To view sample status via the Sample Handler tab: 2 Sample Handler Sample List P-P1-04: Standby Drawer: 3 Rack: Front 1. At the Command Bar, select Samples 002016 3 4 C Racks Sample Details 2. Select the Sample Handler tab Complete 3. Under the Racks tab on the right side of the screen, select KA a rack position ➢ On the left side of the screen, the Sample ID and - sample status will display for each sample in that rack --- ➢ The shape and color of the glyph describes the status of the sample: - Complete 10 ICHA 334 SCIA-213 - o A round glyph identifies a patient sample container 11 ICIA-300 o A square glyph identifies a calibrator or QC container ? PEP LabManager 500 Thursday, May 10. 2018 8:30 AM 4. To view information for a sample, select the sample on the left side of the screen NOTE: Refer to the Operator’s Guide for a list of the meaning of the sample container position glyph colors and symbols. ➢ The Sample Details tab (on the right side of the screen) will display status information for that sample *This procedure is continued on the next slide 59 59 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Monitoring Sample Tube Status – Sample Handler Tab Healthineers 5. To view the status of the tests ordered on the sample, select the Details button in the Sample Details tab E System Samples Inventory Calibration Patient Orders Workin Maintenance Setup ➢ The Patient Sample Details screen displays. There are 2 Sample Handler Sample List tabs: P-P1-04: Standby Drawer. 3 Rack: Front 002095 C Racks Sangle Details A. Patient Test Data – displays the status of the tests ordered on the sample* SCIA-237 5 Detalis SOA IN Priority Routine B. Sample and Patient Information – displays detailed Status Insufficient sample Sample Type Patient - Serum sample information on the sample (sample ID, specimen Location C11 type, priority, etc) === Sample Attributes None = Error List -- Insufficient sample Sample Aspirate Error Patient Sample Details One or more tests faled to process 10 Sample Integrity Enor A Patient Test Data B Sample and Patient information Sample ID SCIA-237 Test R PEP - | LabManager Thursday, May 10.2018 8:30 AM Rack ID Specimen Serum ALT A *Additional information on the Patient Test Data tab is on the next slide 60 60 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Creating Patient Orders Healthineers Options for Creating Patient Orders • Create Patient orders manually using the Patient Orders > Create Patient Orders screen ➢ In the Orders section of the screen, use the Edit 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 using the Patient Orders > Create Batch Orders by SID screen • Create orders for samples loaded in specific racks undergoing the same tests using the Patient Orders > Create Batch Orders by Rack ID screen ➢ To process the batch orders by Rack ID, the operator must select Activate Batch on the Patient Orders > View Batch Orders screen 61 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Worklist Overview Healthineers This screen can be used to view the status of all samples SIEMENS Atellica Solution processed by the system (including ordered, in-process, and 1 Palioil O don Marderange completed tests). 2 Workist Overview Monitoring Lab Metrics A Sample Type: Potent : Bene: 24 Hours To access the Worklist Overview screen: B Dot Dy Sample Order Date 24 HORS Beagent Los Test Resul Inborpreciton At the Command Bar, select Worklist Sample Type Patient SCIAG-151 160.44 1. 224 mEat C SCHAG-151 Crea 2 Analy.2xl 260249 260292 2. Select the Worklist Overview tab Sampe Test Custom 990 Investigational Saved Filters SONO-151 200230 GUH 3 Areas of the screen: SCAG 151 260242 LOLE Adranced Filters 293 06 millint $3A0-151 160 38 A. Filters – can be displayed or hidden by selecting the arrow at SCIAO-151 260257 12 the top of the screen (more information on the next slide) SCA0-151 303 Test SCAAG-151 200239 ₹ UN'C SCIAG 367 3:24 PM B. Orders – displays the status and result(s) for each order 322 PM STAG 3? AST 3:23 PM ➢ If the test is in process, the result time will display SCIAG-367 3:20 DM SCIAO-5207 3:16 PM 3:21 PM ➢ When a test order results, the result and any applicable Cale 121 DM 1000000000 Statistics Export result flags will display D Print Patient Barcodes Query US. Import workhet ? PER LabManager Thursday, May 30, 2098:8:30 AM C. Sample and Test functions – the functions under the Sample heading can be performed on selected samples, and the functions under the Test heading can be performed on selected tests D. General functions – used to print patient barcodes, query the LIS, import a worklist, generate a statistics report, and 62 62 export test results Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Worklist Overview Healthineers Worklist Overview Monitoring The Filter area of the screen is used to filter the orders that are displayed: Filter 1. Select an option from each of the dropdown filters: A Order Date 24 Hours A. Time – select the underlined time filter title to select which time criteria to use: Order Date, Scanned Date and Time, or Result Date and Time B Sample Type Patient ➢ For each of the time filter criteria, the dropdown options include various timeframes from C Analyzer All 15 minutes to 24 hours 2 Sample Test Custom 0 Ordered B. Sample Type – All, Patient, Control, Calibrator Inprocess O C. Analyzer – the analyzers connected to the Atellica Solution A 0 Intervention Needed 2. Select the Sample, Test, or Custom tab 0 Completed ➢ The Sample and Test tabs display a count of the number of samples or tests that are currently 0 in various states: Transmitted V 0 Load List • The symbols shown for each state correspond to the symbols displayed for each test order in the Orders area of the screen 0 Watch List o The Sample tab includes options for filtering a Load List (samples that should be loaded immediately for pending orders) and the Watch List • There are checkboxes to select which sample or test states will be displayed Refresh Counters View Samples • At the bottom of the screen, select the View Samples or View Tests button to display the selected sample or test states in the Orders area of the screen 63 63 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Searching for a Sample Healthineers 1. On the Status bar, select the Quick Find icon System Samples Inventory Calibration Patient Orders Workfest Maintenance Setup 2. Choose a search Type from the dropdown menu (SID, PID, Rack, or Name) Status Logs Operator Diagnostics About System VMM ATELLICA CH ATELLICA 3. Enter a Value corresponding to the search type For the SID Type, a sample barcode can be scanned using the handheld Off Off Off • Find Patient/QC Results × Time barcode scanner 2 Type SID • The Calibrator ID is the Material ID found in the Calibrator Definition. T The Calibrator Lot is the Lot ID found in the Calibrator Definition 3 Value REG-96| Acknowledge System Alerts Example: SID001 4. Select a Database from the drop down menu (Active or Historical) 4 Database Historical 5. Select OK 5 OK Cancel 6. The Worklist Overview screen will display the test orders for samples matching the search criteria 1 7. To find the last known location of the sample: ? PEP LabManager Tuesday, August 07, 2018 8:49:49 AM A. On the Worklist Overview screen, select a checkbox for the SID B. Select Edit/View C. Select the Sample and Patient Information tab D. The Last Known Rack ID will display (rack ID and location of the sample within the rack) 64 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution SIEMENS Remote Assistance Healthineers The Remote Assistance feature can be utilized by selecting SIEMENS in the Status bar. System Samples arwentory Calibration Patient Orders Workist Maintenance Setup Status Loga Operator Diagnostics About • Allows the operator to contact the local technical support System Service Support Request x provider to ask a question, request information, or troubleshoot issues What do you want to do? Create a Service Support Request • The local technical support provider will call the operator by phone or text chat within a pre-configured minimum Start a Remote Session See All Service Support Requests Created on the System time or at a requested time Remote Assistance can be utilized on either the primary user A Warning: If inaccurate patient results or a hazardous condition to the operator, patient, or environment is's result of a system error or malfunction, call for immediate assistance at: Siemens Support Center @ 18885551212. Do not use Service Support Request to submit a job ticket. interface or the operator tablet: • On the primary user interface: ability to chat and desktop- share Next • On the operator tablet: ability to video-share, desktop- ? PEP. LabManager DS Tuesday, September 04. 2018 3:50 PM ofa share, and use the tablet camera to send photos and video with each service support request 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. 65 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Key Tasks for Basic Operation – Appendix A 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 GRASAHOJE bag must be fully opened and fit snugly in the bin 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. 66 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Key Tasks for Basic Operation – Appendix B 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 o There is a configuration option available to assign a specific . . P0020086 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 • Tube top cups are automatically detected when placed on top of supported tubes NOTE: Sample containers with caps are not supported. • The system supports both barcoded and non-barcoded tubes NOTE: Refer to the Atellica Solution Operator Guide for a complete list of the supported sample containers. 67 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Key Tasks for Basic Operation – Appendix B SIEMENS Direct Load Sample Processing Healthineers Load Samples on the Direct Load 1. Place sample tubes in the appropriate sample rack and 1 position. Ensure that the tube is placed all the way down in the rack 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 2 for processing. When processing is 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 68 IM Effective Date: 5-JAN-2021 | HOOD05162003156009 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Key Tasks for Basic Operation – Appendix B SIEMENS Direct Load Sample Processing Healthineers Monitor Sample Tube Status – Sample List tab SIEMENS Healthineers Atellica IM Solution Version 1.11.1.2768003 P-P1-04 1 The Sample List tab displays the sample status for all samples System Samples Inventory Calibration Qc Patient Orders Worklist Maintenance Setup 2 Sample List loaded on and read by the system. Filters A Y Samples B Sample Details Search Sample ID Status Scanned Time Load Type GluH-P1W1-E-7 To access the Sample List tab: Sample ID Name C Failed Barcode Read Invalid Barcode 12/13/2017 3:04:18 PM AK030658 - 2 Priority Routine Load Type Test Status Complete 1. At the Command Bar, select Samples Automation System %15128433BB000001 Dec 17ChemCal 2 Complete 12/13/2017 3:01:34 PM AK030658 - 6 Source Rack Address: BZ040000 - 1 Rack Scanned Time 12/14/2017 12:31:37 PM B123 Intervention Needed 12/13/2017 2:57:15 PM AK030658 - 1 Unloaded Time 12/14/2017 12:36:22 PM 2. Select the Sample List tab Sample Type Patient GluH-P1W1-E-4 Assay error 12/13/2017 2:54:36 PM AK030658 - 1 Aspirated Time 12/14/2017 12:34:48 PM Qc Sample Container Type Primary Tube False Bottom Tube Cal GluH-P1W1-E-3 No Orders 12/13/2017 2:51:12 PM AK030658 - 1 Sample Fluid Type Serum The Sample List has 3 areas: Problems Associated None Sample Priority Failed Barcode Read Invalid Barcode 12/13/2017 2:49:04 PM AK030658 - 6 Routine A. Filters – used to filter the sample list by load type, sample STAT GluH-P1W1-E-9 Intervention Needed 12/13/2017 2:42:15 PM AK030658 - 1 Sample Issues 0903 Complete 12/12/2017 8:31:13 AM AK030658 -4 type, sample priority, sample issues, or sample test status GluH-P1W1-E-7 Complete 12/14/2017 3:03:50 PM AK030658 - 3 Sample Test Status B. Samples – displays information for each sample. Waiting 0958 Complete 12/12/2017 8:31:11 AM AK030658 - 2 Started 0283 Complete 12/12/2017 8:31:09 AM AK030658 - 1 3 To sort the list, select a column header Aspirated Complete 0903 No Orders 12/12/2017 8:13:52 AM AK030658 - 4 Colored circles are used to identify sample issues: 320001001 No Orders 12/12/2017 8:13:51 AM AK030658 - 3 Dismiss Problem Samples Alert Print Results • Yellow circles – samples with warnings ? PEP LabManager OS Wednesday, October 18, 2017 3:08:01 PM • Red circles – samples with errors C. Sample Details – displays further details for a sample selected from the Samples area of the screen. There are task buttons at the bottom of this screen: • Print – prints the screen currently displayed • Results – displays the Patient Sample Details screen, which includes a list of the tests ordered on the sample with status and results 69 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Key Tasks for Basic Operation – Appendix C SIEMENS Atellica Asa™ Workflow Healthineers Asa Workflow ASA x SIEMENS 6/27/2020 Healthineers Atellica ASA ASA PCC 2:22 PM = Here is a proposed checklist of how to approach the tablet at the beginning of your work day: ✓ 2 STAT Samples – are there STAT samples that need Troubleshooting System X-SH X-SH X-SH2 Decapper- X-CC X-CC2 X-CC3 <-CC4 Decapper X-IA1 X-1A2 X-IA3 Decapper intervention? 1. 2 3 ✓ System Health – do any issues need resolution? Current Status Day Needs ✓ Needs – how are my supplies? STAT Samples Routine Samples Supply Needs Reagent Needs ✓ Cart List – after you have gathered and loaded all of 3 0 2 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 0 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, 1 ia Next Automated Activity N 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. 70 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Key Tasks for Basic Operation – Appendix D 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 System Sargles or action to the desired module. Logs Operator Diagnostics System VMM P-P1-05 C-P1-02 P1-02 The software includes various options for selecting the module that is displayed: A Standby Standby Standby Standby A. System Status screen Worklist Overview Monitoring • Select the appropriate module to view alerts Filter • Track if all analyzers are in patient processing Order Date 24 Hour Sample Type Patient B. On several screens, a filter can be used to select the analyzer or module. These B Analyzer All Sample Test Custom screens include: 0 Ordered Inproces • Worklist Overview – ability to view analyzer for orders o 14 Intervention Needed • Calibration Overview 0 Completed OOOO • Calibration Results 0 Transmitted 0 • Maintenance Schedule Load List Watch List o • Maintenance Report C. On several screens, the display can be filtered to a single module. These screens Refresh Counters View Samples include: • Supplies Overview Reagent Overview Inventory Castration Patient Orders Manterance • Reagent Loader Reagent Needs Supples Overview Reagent Let Comparison Cal-QC Storage Inventory Cal-QC Needs • Operator Diagnostics C • 00154 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Key Tasks for Basic Operation – Appendix D SIEMENS Considerations for Configurations with Multiples of the Same Module Healthineers Atellica is designed to optimize the performance of tasks, but in certain A System Samples Inventory Calibration OC Patient Orders Worklist Setup circumstances, you also have the option to target which analyzer performs Test Definition Settings Accounts Assay List CH the task. CH Test Definition Enable Assays and Specimen Type Usage Filters GGCCEP GGCCEPO8 IM Test Definition Assay System GGCCEP22 VSystem Enabled Only Ratios, Panels, and Off- Amp1K Urine Lvurine urine Examples of tasks that allow you to target a desired module: System Assay Amp300 Urine urine urine Test Display Order Amp500 Murine Mune Murin Open Channel K K Performing Operator Diagnostics Enabled AMY2 [/plasma, Serum, Urine | plasma, Serum, Urine VI plasma, Serum, Urine • Sort Test Definition O Troubleshooting Specimen Type GGCCEP22 GGCCEP GGCCEPOS Disabled Plasma Enabled Enabled Enabled Performing maintenance tasks Specimen Types Serum Enabled Enabled Enabled • Urine Enabled Enabled Enabled • Creating a QC Panel and QC Schedule K System Samples Inventory Calibration Qc Patient Orders Create Batch Order by Rack The system will route tests to whichever analyzer can most efficiently Create Patient Orders * ID Create Batch Orders by SID Edit Multiple Orders View Batch Orders complete the test. However, you can designate to run a test on a selected Sample Information Test Selections Enter test names, separated by commas. Sample ID 12345 Module Type Select Tests analyzer: Rack ID Orders Specimen Serum X Test Dilution Replicates System Test Options/ A. Navigate to Setup > Test Definition > Assay List to check that the Manual Dilution + X CEA x1(Undiluted) Edit Test Options appropriate assays/specimen type are enabled for the analyzer B System Test Options x Test Name CEA B. Specify the analyzer on the Create Patient Orders / Create Calibration Analyzer Order / Create QC Order screen by selecting the option to edit the test Lot Primary Pack Ancillary 1 Pack Ancillary 2 Pack Diluent Pack ? Clear All OK Cancel Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 Atellica® Solution Key Tasks for Basic Operation – Appendix D 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 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 • 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 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021 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's Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. 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 may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability. Copyright © Siemens Healthcare GmbH 2021 Global Siemens Healthineers Headquarters Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84 0 siemens.com/healthineers 74 Effective Date: 5-JAN-2021 | HOOD05162003156009 Unrestricted © Siemens Healthcare GmbH, 2021