VersaCell® X3 System Key Tasks for Basic Operation Job Aid

SIEMENS Healthineers VersaCell® X3 System Key Tasks for Basic Operation Job Aid SIEMENS Template Effective Date: 10 Aug 2021| HILS 2223 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 Key Tasks for Basic Operation Job Aid – SIEMENS Healthineers Table of Contents Hardware Overview 3 Software Overview 4 Sample Processing 5 Monitoring Samples and Results 8 Shutdown and Startup 11 As Needed Maintenance 13 Troubleshooting 16 Disabling and Enabling Tests 21 IMMULITE® Systems 22 ADVIA Centaur® XP System 23 ADVIA® 1800 System 24 SIEMENS Dimension® Systems 25 Communication Pathway 37 Connection Summary 38 2 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Hardware Overview A. Robotic Arm • Consists of a gripper with O-rings and a barcode reader B. Priority Drawer Up to 8 sample tubes can be added at one time for prioritized A F • sample delivery C. 4 Standard Drawers B • Can be unlocked by pushing a button beneath them 50 sample tube positions in each drawer C • D. Emergency Stop VersaCell X3 SIEMENS D • When pushed, power is disabled to all moving parts of the system while the system computer remains on E. Panel Covering Computer E F. Interface Wheel • Required to connect the VersaCell® X3 system to an ADVIA® 1800 Chemistry system, ADVIA Centaur® XP Immunoassay system, or Dimension® Integrated Chemistry system 3 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Software Overview Homescreen SIEMENS VerlaCed x1 4.0.5.15 A. Instrument icons and statuses B. Drawer status indicators Centaur - Left VersaCell RxL - Rear RxL - Right • Priority Drawer status indicator displays above the 4 standard drawers only if A priority drawer is enabled D Running Running Running Running • Error: sample tube problem Delayed: connected system problem Delayed In Process @ Complete • • In Process: tube is being processed - 0 Error O Error Error Complete: all tests on the tube have resulted · Error • B Delayed o Delayed Delayed Delayed In Process • Green Checkmark: all samples have aspirated · In Process In Process . in Process o Complete Complete Complete Complete C. Help – opens the Operator’s Guide D. Change User ID / Sign Off ? @: Operator Running 5/6/2013 2:52:44 PM C D E F G H E. VNC • Each button initiates a virtual session for the designated connected system F. Search G. Run / Stop buttons H. Lock / Unlock Doors 4 • To lock or unlock the main doors and the interface wheel doors Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Sample Processing Running Samples in a Standard Drawer Scan Rack Options 1. Unlock a drawer by pressing one of the green drawer buttons under each Drawer 1 Rack ID AA070887 drawer. Start from First Position • The drawer can be opened once the button light is a steady green A B C D E • If it is a flashing light, the drawer is currently in progress and cannot be 1 opened until all tubes are returned to the drawer 2. Load the drawer from positions A1- A10, B1-B10, etc. without leaving spaces. Resume from Last Position 3. Close drawer and allow to lock. The robotic arm reads the rack carrier barcode A B C D E post and displays the Scan Rack Options window. 4. Select Start from First Position to begin sample processing. Include tubes with: Barcode Errors Sample Errors NOTE: When adding samples to a partially filled drawer, where samples have not been Transfer Errors removed, select Resume from Last Position. OK 5 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Sample Processing Running Samples in a Priority Drawer 1. Unlock the priority drawer by pressing the green drawer button to the right of the drawer. • The drawer can be opened once the button light is a steady green 2. Load sample tubes into the drawer. Tubes can be removed or added to any open spot in the priority drawer at any time. 3. Close the drawer and allow it to lock. All 8 positions are re-scanned every time the priority drawer is closed. All 8 positions will also be scanned if you press the green VersaCell x3 button but never open the drawer. 6 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Sample Processing Running with a Sort Drawer If a Sort drawer is configured, that drawer will be labeled SIEMENS VerlaCed x03 4.0.5.15 A “Sort” on the Home screen. The Sort Drawer Icon displays the following indicators: Centaur - Left VersaCell RxL - Rear RxL - Right • Error – turns red when an exception group (sample errors, barcode errors, duplicate samples) is sorted Running Running Running Running • New Work – turns red when a sample has new work Errer @Delayed In Process Complete orders associated with it after it has been selected for D sorting. Tubes with New Work must be returned to Error Error Error Error Delayed Delayed Delayed New Work their original drawer to complete processing In Process 20 In Process In Process Group Warning O O Complete Complete 0 Complete Group Full • Group Warning – turns yellow when a sort group is 75% full ? Operator Running 5/6/2013 3:03:55 PM • Group Full – turns red when a sort group is full 7 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Monitoring Samples and Results Drawer Screen To access the Drawer screen, select either: SIEMENS VerLACed X1 4.0 5.15 • Samples button on the Command Bar • A drawer icon on the Home screen Selected Sample Rack Barcode 20074779 Mutig Tonpty Position HONDHORET There is a tab for each drawer, as well as a tab to view an Overview Farolde Comm Drptr Parkson Started Rescan Resend Requery screen which provides that status of all tubes on the system. waiting Enpty Punition Empty Fautdon Selected Sample Orders Empty Position Empty Parlous Teit Nane - Sulat kesdit Sample status for each position is indicated by color. To obtain Transesitoed 0.00 ag/a. Centaur 39 waiting Depty Punition Dipty Paultion Lingity Partition additional status information for a specific sample, select the Started Empty Paulton tmpty Position sample’s tube position. - Q Starbed writing Empty Passion The buttons on the right of the screen: Tmnpty Fusion - • Rescan – resets that position to an unscanned status (for Empty Parition Empty Punition Empty Parition Refresh example, could use if the operator removes a single tube) ? Operator Running 7/23/2013 1:07:20 PM • Resend – sends tube to connected system • Requery – requeries LIS for orders on the selected tube The Refresh button is only for the Selected Sample Orders list. The colors and sample status update automatically. 8 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Monitoring Samples and Results Test Results Screen The Test Results screen allows you to review the status of test orders SIEMENS VerlaCed x3 :4.0.5.15 go and results. Sthe To access the screen, select the Test Results button on the Command Pre-defined Filters Date Range From TO No Filter Previous 24 Hours 05/05/2013 02:11 PM 05/06/2013 - 02:11 PM Bar. States Rap View Details 1000258 Desring. Michael Rerun The buttons on the right of the screen: M Queue Cestaur - Left PSA Transmitted Costait - Let Clear TSHOLE Transmitted Cestast - Left • View Details – opens Patient Sample Detail screen Transmit 1000257 Stephenson, Cody Requery LIS YSHIR Cestait - Len • Rerun – orders a repeat test 10002:57 5.5 meld • Clear – removes the order and/or result from the Test Results Hardis, Edna LIS Communication Cestait - Let Active Transmitted Centaur - Laft screen 1000054 • Transmit – sends results to LIS for the selected sample Cestaur - Left Refresh • Requery LIS – requeries the LIS for the selected sample ? Lab Manager Running 5/6/2013 2:11:35 PM • Active – pauses and reactivates LIS communication • Refresh – updates the screen 9 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Monitoring Samples and Results SIEMENS VersaCell X3 4. Searching for Sample Tubes Home Samples Instruments Test Results Setup Utilities Events Use the Search screen to locate sample tubes on or off board the Overview VersaCell X3 system. Centaur-Left VersaCell ADVIA1800-Back ADVIA1800-Right Search To search for a tube: Sample ID Contains 100 Search Sample ID Name PID Status Rack Drawer Position Last Scanned Date View In 1. At the Status Bar, select the Search icon 1004 01 pl, pa 1000101 A- 8/5/2013 9:40:20 AM Drawer 1000102 pl, pa 1000102 AA074474 A-Z 8/5/2013 9:40:24 AM Patient Details 2. Select one of the search criterion: Contains, Starts With, or 1000103 pl, pa 1000103 AA074474 A-3 8/5/2013 9:38:39 AM 1000104 ol, pa 1000104 AA074474 A-4 8/5/2013 9:39:24 AM Ends With 1000105 pl, pa 1000105 AA074474 A-5 8/5/2013 9:39:28 AM 1000106 pl, pa 1000106 AA074474 A. 8/5/2013 9:39:48 AM 1000108 pl, pa 1000108 Complete AA074474 2 A-1 8/5/2013 9:44:32 AM 3. Enter one or more of the following data: Sample ID, Patient 1000109 pl, pa 1000109 ฿ Complete AA074474 2 A-2 8/5/2013 9:44:36 AM 1000110 pl, pa 1000110 Complete 44074474 A- 8/5/2013 9:44:41 AM Close name, Patient ID 0 ) In Process 13) In Process 0 In Process 0 In Process 0 ) Complete Complete 16 Complete o Complete 4. Select Search To sort the results, select a column heading. ? Operator Running 8/5/2013 10:10:59 AM To display further information, select the record and select: • Drawer: The Drawer screen displays with the specific sample highlighted • Patient Details: The Patient Sample Detail screen displays 10 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Shutdown and Startup Startup 1. On the Windows desktop, select the Versacell windows account. This automatically launches the VersaCell X3 software. VersaCell Note: Only users with Siemens Personnel access can log into the Siemens Personnel Windows Acccount. 2. At the Login screen: R 1 A. Select one of the User Name options: Operator, Lab Manager, or Siemens GO Personnel. Each user has different privileges. B. Enter the password for the selected User Name. C. Select one of the Startup Mode options: VersaCell, Bypass, or Event Log. The Login default is VersaCell mode, which is normal operating mode. 2 User Name Operator Password D. Select Sign In Startup Mode VersaCell VersaCell 3. To begin processing sample tubes, select the Run icon. If the system is connected Bypass Event Log Exit to an interface wheel, the robotic arm will check all 12 positions on the interface wheel when Run is first selected. 4. You may start the VersaCell X3 system first or start the connected instruments first. To start and initialize the connected instruments, follow the instructions in the 11 Effective Date 02 MAY 2023| HOOD05162003351482 appropriate manual for that system. Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Shutdown and Startup Shutdown 1. Verify that all tubes have been returned to the drawers prior to shut down. Green checkmarks in the upper-left corner of the drawer status indicators on the Home screen indicate that Login all samples have been aspirated and returned. User Name Operator Password 2. Perform the daily shutdown procedures for the connected instruments, as appropriate. See the operator's manuals for the connected instruments to verify the shutdown frequency. Sign In Exit 3. Select the green button beneath the standard drawers or to the right of the 8-position priority drawer to unlock the drawer. When the green button light turns solid green, pull the drawer open and remove the tubes. (? 5/6/2013 2:38:05 PM 4. On the Status Bar, select the log off icon. At the Login screen, select Exit. A message displays: “Are you sure you want to exit the system?”. Select Yes. When shutdown is complete, the Windows desktop displays. 12 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Software Updates SIEMENS 1 VersaCell X3 4.7 go A Remote Update Handling (RUH) Home Samples Instruments Test Results Setup Utilities Events Maintenance Updates 2 RUH helps to push updates to the VersaCell system remotely Package Name Component Name Version Received Status Install Time (min) through Smart Remote Services (SRS). DX_CZ021-80-Z_OSP_VERSA11 Security Update Win10_2021.2 02/25/2022 10:26 AM New 3 30 OX_CZ021-90-Z_OSP_VERSA24 VersaCell X3 Software 4.8 02/24/2022 10:59 AM New 30 The user can install these updates and the installation status is automatically updated on SRS after installation: 1. Select Updates. 2. Select Updates. 3. Select the appropriate software version. 4 4. Select Install. Install ? Lab Manager Locked 2/25/2022 10:33:46 AM 13 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers As Needed Maintenance Replace O-Rings 1. Ensure the robotic arm is facing forward. 2. Select the Stop icon. 3. Select the Unlock Door icon and open the main doors. 4. Replace all four O-rings. There is one O-ring on each of the four “fingers”. a) Carefully cut or pull off each O-ring b) One at a time, stretch one new O-ring over each “finger” 5. Close the main doors and select the Lock Door icon. 6. Select the Run icon to resume normal operation. 14 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers As Needed Maintenance Cleaning the Interface Wheel 1. Ensure the system is in Stop mode and select the Unlock Door icon. 2. Open an accessible interface wheel cover. If connected to an ADVIA® 1800 system, unscrew the pipette cover, if necessary. 3. Unscrew the wheel knob. 4. Lift the interface wheel straight up to clear the shaft and pull it toward you. CAUTION: Tipping the interface wheel can cause spills and can result in bodily harm. 5. At a proper waste disposal area, dispose of any excess liquid waste. Using a clean dry cloth, wipe the interface wheel. Use a general-purpose cleaner or disinfectant if required. 6. Completely dry the interface wheel. 7. Reinstall the interface wheel: a) Align the wheel on the shaft and spin the wheel so that it drops down on O the pin b) Tighten the wheel knob c) Replace the pipette cover if appropriate 8. Close the interface wheel cover. Select the Lock Door icon and then the Run icon. 15 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers As Needed Maintenance Cleaning the Racks To clean the standard drawer racks: 1. Open the drawers and remove the racks. 2. Decontaminate drawers and racks using surface disinfectant and a damp cloth. To clean the priority drawer rack: 1. Open the priority drawer. 2. Loosen the two thumbscrews on the priority drawer rack. 3. Lift the priority drawer rack up to remove it. 4. Decontaminate the priority drawer and rack using surface disinfectant and a damp cloth. 5. Reinstall the priority drawer rack. 6. Tighten the two thumbscrews. 16 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Troubleshooting Assay Errors SIEMENS 1. Identify the cause of the assay error. Costear-Lan VersaCall • At the Command Bar, select Instruments, which is flashing. Review the Instrument Errors Centaur-Left Assay Errors area on the Instruments screen The AnalyzerC instrument could not process se order for sample D 1000115, order ID 17836, and best code PSA, due to a r (slate. At the Lis, rendbre the problem. 8/5/2013 9:52:04 AM The AnalyzerC imtrent reported a petto error for sample ID 1000815, order D 17886, and best code PSA. The order could not be processed. Caibeste the 8/5/2011 9:53:03 AM • You can also navigate to the Drawer screen, select the tube with the assay Analyzer Status Ready 05/2013 :24:35 AM error and look at the sample orders Running Pipetter Status Wheel Status 2. Resolve the assay error at the connected instrument (for example, add more Assay Errors inventory). PSA Anagent Failure, Rougeat Non Calibrated 3. Select Resolved (if necessary). • The error on the VersaCell X3 system may be cleared automatically. • However, in some cases, you must indicate on the Instruments screen that Wheel Resolved error has been resolved: ? Operator Running 8/5/2013 10:14:00 AM o Select the Resolved checkbox for the test(s) for the error you resolved o Select the Resolved button Once the assay error is resolved, the VersaCell X3 system will automatically transfer sample tubes to the connected instrument to complete processing. 17 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Troubleshooting Sample Errors SIEMENS VersaCell X3 4. Home Samples Instruments Test Results Setup Utilities Events 1. Identify the tube with the sample error. Overview Drawer 1 Drawer 2 Drawer 3 Drawer 4 Priority Scan Rack Options Drawer 3 Rack ID • At the Command Bar, select Samples, which will display a red pl pa pl pa AA071088 Rack Barcode 1000127 1000135 AA071088 Aspirated Aspirated Empty Position Empty Position Start from First Position pl pa triangle error icon 1000136 Aspirated Aspirated Empty Position Empty Position A B C D pi pa Resend 1000170 Requery You can also select the drawer icon with red errors Aspirated Sample Error Empty Position • Empty Position pl pa 1000130 ders Aspirated 1000140 Aspirated Empty Position Empty Position Resume from Last Position Result Instrument 2. Open the drawer and remove the sample tube. Resolve the sample pl pa pipa 1000131 1000141 Sample Error Empty Position Empty Position e Error ADVIA1800-Back pl pa A C D E issue. pl pa 1000132 Aspirated Empty Position Empty Position pl pa pl pa 1000133 1000139 3. Reload the tube in a drawer, using one of these options: Aspirated Sample Error Empty Position Empty Position Include tubes with: pl pa pl pa Barcode Errors 1000134 1000162 Aspirated Aspirated Empty Position Empty Position Sample Errors • Place the tube in its original position. On the Scan Rack Options pl pa pl pa Transfer Errors Aspirated spirated Empty Position Empty Position screen, select Resume from Last Position with the Sample Errors pi pa OK 1000138 Aspirated Empty Position Empty Position Empty Position Empty Position Refresh checkbox selected ? Operator Running 8/5/2013 10:47:57 AM • Place the tube in the next available position in the original drawer. On the Scan Rack Options screen, select Resume from Last Position* • Place the tube in a different drawer. On the Scan Rack Options screen, select Start from First Position* *To clear the error from the original position, open that drawer. On the Drawer 18 screen, select the original position. Select Rescan and close the drawer. Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Troubleshooting Barcode Errors SIEMENS VersaCell X3 4.1 Home Samples Instruments Test Results Setup Utilities Events 1. Identify the tube with the barcode error. Drawer 1 4 Overview Drawer 2 Drawer Drawer 4 Priority Drawer At the Command Bar, select Samples, which will display a red pl pa pl pa • Selected Sample Rack Barcode 1000127 1000135 AA071088 Complete Aspirated Empty Position Empty Position Empty Position 1000126 pl pa triangle error icon. Identify and locate the sample tube with the 1000136 Complete Aspirated Empty Position Empty Position Empty Position pl pa Resend 1000129 Rescan Requery error Aspirated Barcode Error Empty Position Empty Position Empty Position pl pa Selected Sample Orders 1000130 Aspirated 1000140 You can also select the drawer icon with red errors to navigate to Aspirated Empty Position Empty Position Empty Position • Di Da 1000141 Barcode Error Empty Position a barcode error Empty Position Empty Position pl pa pl pa 1000132 Aspirated Empty Position Empty Position Empty Position pi pa 2. Remove the sample tube and reposition or replace the barcode label. 1000133 No Orders Aspirated Barcode Error Empty Position Empty Position mpty Position pl p pl pa 1000134 1000162 3. Reload the tube in a drawer. Aspirated Aspirated Empty Position Empty Position Empty Position pl pa pl pa Aspirated spirated Empty Position Empty Position Empty Position • Return the sample tube to its original position and close the pi pa 1000138 Aspirated Empty Position Empty Position Empty Position Empty Position Refresh drawer. At the Scan Rack Options screen, select Start from First ? Operator Running 8/5/2013 10:49:23 AM Position, or Resume from Last Position with the Barcode Errors checkbox selected • You can also place the sample tube in a new position. It will be processed like a new sample tube 19 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Troubleshooting Transfer Errors SIEMENS VersaCell X3 4.1 Home Samples Instruments Test Results Setup Utilities Events 1. Recognize indications of a Transfer Error: Overview An error report with the message “A robotic arm error occurred Centaur-Left VersaCell ADVIA1800-Back ADVIA1800-Right • VersaCell Error Report when moving a tube from the drawer” will display on the screen Code Date and Time Source Event 102015 8/5/2013 11:00 AM VersaCell A robotic arm error occurred when moving a tube from the drawer. Remove the tube, or gently 2. Select the Unlock Door icon and open the main doors. pull the gripper toward you if no tube is present. Load the tube. D Running Running 3. Deflect the gripper. • If there is a tube in the gripper, grasp the sample tube and lift up. There will be a loud release of air as the gripper releases the Error Sound On Close sample tube o Delayed Hayed 12 In Process 0 In Process o In Process o In Process If there is not a tube in the gripper, the operator should still 0 Complete 21 Complete 16 Complete o ) Complete • deflect the gripper and hear the air release. Check the VersaCell ? Operator Error Paused 8/5/2013 11:00:33 AM X3 system, interface wheel, and connected systems to locate the tube 4. Close the main doors and select the Lock Door icon. 5. Investigate what created the jam and correct the cause. 6. Select the Run icon to resume normal operation. 20 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Troubleshooting Recovering from E-Stop 1. Pull out the E-Stop button. • After the operator hits the E-Stop button, wait at least one minute before pulling out the E-Stop button to recover the VersaCell X3 system 2. Select the Run icon. • Select the Run icon to allow the robotic arm to home itself. When the homing is complete, the system will be in Stop mode 3. Select the Run icon again. • Select the Run icon a second time to put the system into Run mode and continue processing tubes 21 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Disabling and Enabling Tests There is an option in the software that allows SIEMENS 1 VersaCell X3 4.1 you to temporarily disable a test. % Home Samples Instruments Test Results Setup Utilities Events VersaCel Instrumen LIS Drawers Panels Sorting Test Routing rest Enable 2 Enable / Disable Tests To enable or disable a test: Test Code Centaur-Left ADVIA1800-Back ADVIA1800 - Right ALB ALPAMP 1. Select the Setup icon from the top Command Bar. ALT AMYLAS 3 BNP 2. Select the Test Enable tab. CA 2 CHOL_ CKNAC 3. Select the checkbox for any test you want to CL Co2_ enable. Deselect the checkbox for any test you want to CREA CRP D-HD disable. DLOL KK K KK KK KK ECRE_2 KK KK KK KK KK FER V 4. Select Save. 4 Save Cancel ? Siemens Locked 8/5/2013 8:21:11 AM - Any user can enable or disable a test. The system must be in Stop mode. 22 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers IMMULITE® Systems Startup • On the IMMULITE system screen, a “Received Reinitialize 1” message indicates that communication has been established with the VersaCell X3 system • On the VersaCell X3 system screen, the IMMULITE system status remains “Not Connected” until the IMMULITE software is initialized and the prompt to delete the worklist is answered Reflexive Tests • The VersaCell X3 system receives the reflexive test orders, retrieves the sample tube and resends it to the instrument. The test orders and results appear on the VersaCell X3 screens Tests Manually Ordered on the IMMULITE Systems: • The VersaCell X3 system receives the reflexive test orders, retrieves the sample tube and resends it to the instrument. The test orders and results appear on the VersaCell X3 screens 23 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers ADVIA Centaur® XP System Startup • When the first sample is sent from the VersaCell X3 system to the interface wheel, the ADVIA Centaur XP system will automatically do a prime before the first sample is pipetted • On the VersaCell X3 system software, the ADVIA Centaur XP system status will be “Running” if the system is ready to start processing Reflexive Tests • The VersaCell X3 system automatically resends sample tubes to an ADVIA Centaur XP system when the instrument generates a repeat or reflex test order • After the VersaCell X3 system resends the sample tube to the instrument, a system-generated order is created with Resend as the test code to indicate a pending resend request. This order is automatically cleared once the resend request has been honored • Once the test has completed, the results for the repeat/reflex tests will be displayed. The Test Results screen does not display interim information for the sample after it has been resent and before it results Tests Manually Ordered on the IMMULITE Systems: • If the tube is placed on the VersaCell X3 system, the Resend button on the Drawer screen must be used to send the tube to the connected instrument. The test orders do not display on the VersaCell X3 system software until the test results • Calibrators and quality controls must be loaded directly on the ADVIA Centaur XP system 24 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers ADVIA® 1800 System Startup • On the VersaCell X3 system Home screen, the ADVIA 1800 system status remains “Not Connected” until the software is started and the Outside Analyze Start option is selected Reflexive Tests • The ADVIA 1800 Chemistry system will run repeat and reflex testing on the original aliquot for all samples except for electrolytes • Electrolyte samples are pipetted exclusively from primary tubes. If a repeat or reflex test is ordered for an electrolyte on a tube on the VersaCell X3 system, the operator can use the Resend button on the Drawer screen to have the robotic arm has to bring the tube back to the interface wheel • Once the test has completed, the results for the repeat/reflex tests will be sent to the VersaCell X3 system. The Test Results screen does not display interim information for the sample before it results. The VersaCell X3 system sends the results to the LIS Tests Manually Ordered on the IMMULITE Systems: • If the tube is placed on the VersaCell X3 system, the Resend button on the Drawer screen must be used to send the tube to the connected instrument. The test orders do not display on the VersaCell X3 software until the test results • Calibrators and quality controls must be loaded directly on the ADVIA 1800 system 25 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems Startup • The Dimension system instrument status on the VersaCell X3 system should display “Running”, unless there is an error • It is not required to shutdown the Dimension systems as part of the VersaCell X3 system shutdown procedure, but an error message DMW/HOST Communication Problem will display. When the VersaCell X3 system is back online, press Reset to clear the message on the Dimension systems Reflexive Tests • If samples are loaded by the STM, with automatic reflex testing defined in the Dimension system, the reflex test will run from the aliquot sample • If the sample is loaded manually on the Dimension system, the reflex test will be run from the tube or cup • The Dimension system will never request the sample tube from the VersaCell X3 system • The reflex test orders generated by the Dimension system will only display on the VersaCell X3 system after the test orders result and the results are sent to the VersaCell X3 system • Errors generated by the Dimension system for reflex tests will not be indicated on the VersaCell X3 system as this information is not sent to the VersaCell X3 system from the Dimension system 26 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems Panic Repeats Ordered on the Dimension Systems • Automatic Repeat for Panics is defined in the Dimension system software • When the first panic result is completed, the repeated result will be performed from the aliquot sample if the tube was delivered to the Dimension by the STM probe • A result is not sent to the VersaCell X3 system until the repeat test is finished. The LIS screen displays both results To Order Re-Runs or Add a Test to the Dimension Systems • Ordering Re-runs or Adding a Test cannot be done from the aliquot. It is not allowed. The message says Cannot EDIT/RERUN STM aliquoted samples • In order to rerun or add a test, the tube must be removed from the VersaCell X3 system drawer and manually loaded on the Dimension system • If a new test is added through the LIS or Middleware, the VersaCell X3 system will send the tube back for testing as long as it is still in the Input/Output drawer and the barcode is rescanned. To rescan the tube, open and then close the drawer and select Start from First Position or load the tube into a different drawer • To most efficiently order the re-run, display the Enter Data screen on the Dimension system and change the Sample Container Mode to Bar Code Tube. Then type or scan the barcode number and order the repeat test(s). Load the tube and press RUN on the Dimension system 27 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems Tests Manually Ordered on the Dimension Systems • Patient Samples: the tube must be manually loaded on the Dimension system. The tube cannot be loaded on the VersaCell X3 system. Results will be sent when they are complete • Calibrators and Quality Controls: all calibrations and quality controls are ordered and loaded on the Dimension system. For instruments with QCC PowerPak software, barcoded tubes assigned to QC Panels are loaded directly onto an instrument segment 28 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems STM Processing Status The current processing status of the STM appears in the instrument status area of the Dimension system screen. Instrument Status Area STM Standby 2 IMT STM Status 5 Dimension Photometric Date and Processing Sampler Time STM Status Meaning STM Standby The STM is available to receive STM work STM Processing The STM is currently transferring samples STM Needs The Dimension system will not accept any STM work until STM needs are resolved STM Pausing The STM will complete the current sample transfer and will pause when the carriage returns to home position STM Paused The Dimension system will not accept any STM work STM Error The Dimension system will not accept any STM work until the STM error is resolved 29 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems Segment Status Area k 1 a 2 3 d 4 b 5 A 6 • An STM segment appears with a lower-case letter • STM segment status boxes can appear in three background colors: red, green and yellow o Red and green have the same meaning as primary sample tube/sample cup segments o Yellow indicates that the STM segment has unused aliquot positions available on it. Do not remove STM segments that are red or yellow 30 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems Aliquot Segments Screen Help Standby Sampler Idle IMT OK STM Standby 06/28/10 13:30 jFbACE • The Aliquot segments screen displays the status of the aliquot Run OFF segments currently on the sample wheel and the count or status Home of the STM components ALIQUOT SEGMENTS STM State: READY Backlog: STM Aliquota: 126 Pipette tips: 234 Tips to Waste Full: 1148 Navigate to the Aliquot Segments screen from the Operating STAT Status 1 • Menu by pressing F8: Segment Status or from any screen by Sample Alert 2 pressing Alt/S. The F2: function key will alternate between SEE Supplies 3 STM and SEE ONBOARD QC Alert • The information on this screen includes: Calib Alert 5 o STM State o STM backlog time Exit 6 o The number of unused aliquot positions available Enter o The number of pipette tips available o The number of pipette tips remaining until the tip waste F1: F2: SEE ONBOARD F3: DELETE SEG F4: container is full F5: F6: F7: F8: DEL. RECORDS o The current status of each aliquot position 31 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems Loading Aliquot Segments The aliquot segment can be replaced when the segment status box is green indicating that all positions have been used. 1. Press the Pause key on the system keyboard to stop the movement of the sample wheel and wait for the Photometric Sampler Status to display the “Samplers Off” status. After this the sample wheel can be moved manually to remove aliquot segments. WARNING: never remove an aliquot segment that has a red segment status box on the screen. This segment is currently being used to process a sample. Removing this aliquot segment may result in erroneous patient results. 2. Remove the used aliquot segment from its base (leave the segment base in place on the sample wheel). Place a lid on the used aliquot segment to keep fluids from splashing out of the segment and then discard the aliquot segment. 3. Place a new, unused aliquot segment on the base. Ensure that the aliquot segment is fully seated in the segment base. WARNING: never place a previously used or partially used aliquot segment onto the sample wheel. This will cause erroneous patient results. 4. Repeat Step 2 and Step 3 to replace other segments as required. 5. When all aliquot segments are replaced, press the Pause key. 6. Press the Run key and the following steps will automatically occur: a) The system will scan the sample wheel b) The Aliquot Segment screen and Segment Status box on the screen will update c) The replaced aliquot segments will appear with green + symbols in all positions 32 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems Loading Pipette Tips The tip feeder must be loaded when the Pipette Tips field on the Aliquot Segments screen is zero, as the STM will stop transferring samples and the “STM Needs” message appears. 1. Raise the tip feeder cover and wait for the tip tray to move the tip racks to the front of the feeder. 2. Remove empty pipette tip racks and dispose with other laboratory hazardous waste. 3. Place the new rack(s) onto the tip tray and close the tip feeder cover. 4. The system automatically inventories the number of tips in both racks of the tip tray. The total number of inventoried tips appears in the Pipette Tips field at the top of the Aliquot Segments screen. The total number includes the tips in the trays plus one on the STM probe. 33 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems Emptying the Tip Waste Container The tip waste container must be emptied when the Tips to Waste Full field on the Aliquot Segment screen is zero, as the STM stops transferring samples and the “STM Needs” message appears. This container, however, can be emptied at any time. Removing the waste container automatically pauses the system. 1. Open the STM cabinet door and remove and empty the tip waste container. 2. Place a biohazard bag liner inside the empty container and place the container back in the cabinet and close the STM cabinet door. 3. Navigate to F4: System Prep and then press F6: Sys Counters to access the System Counters screen. Move the cursor to the STM Tip Waste field. 4. Press the Enter key to change the NO to a YES and then press F1: Store Changes. 5. Answer the prompt that appears by typing a “y”. The Cycles column changes to zero and the Last Replaced column changes to the current date and time. 34 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems Resolving STM Error Messages • If an error message appears on the Dimension screen, press the Alt/M key combination to see specified information about the error • If Alt/M does not display troubleshooting help for the STM error message, refer to the Dimension system STM Operator’s Guide • For information regarding messages not included in the Operator’s Guide, contact the Remote Services Center (RSC) 35 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems STM Sample Aspiration Problem • These error messages appear because pressure data that is monitored during and after aspiration detected an abnormal condition. This can be caused by the STM aspirated air or the STM tip is leaking or plugged • When the STM posts these errors, the tube is returned to the VersaCell X3 system and is marked as a sample error • Investigate and resolve the cause of the problem Error Message Probable Causes STM Aspirated Air (782) • Crimped tubing • Bubbles or foam on top of sample STM Tip Leaking (780) • Misalignment of STM pipette tip to tip tray • Leak in tubing • STM Air Pump syringe tip defective • Defective pipette tip STM Tip Plugged (781) • Poor quality sample (clot) • Crimped tubing • Pipette tip entered the gel or separator area of sample (insufficient sample) • Pipette tip aspirated a clot or fibrin from tube (poor sample quality) • Defective pipette tip 36 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Dimension® Systems STM Probe Found No Sample During Level Sense (788) • This error message appears when the STM probe does not detect fluid in the sample tube within the full vertical travel of the probe. The sample tube is returned to the VersaCell® X3 system and will display a sample error Possible Cause To Resolve the Error: Press reset Insufficient sample in • If the error does not reappear on the next sample, the most likely cause was the tube the tube had an insufficient volume of sample • Retrieve the sample. If more sample is available, add more sample and reload on the VersaCell X3 system. If no more sample is available, load directly on to the Dimension system in a sample cup Faulty level sense • The error appears on the next sample and there is sufficient sample • Access the STM Fluidics system from the back of the STM and check all air tubing connections on the STM air pump, pressure PCB, board and the STM carriage/probe • Ensure the P30 connector is secure on the level detect PCB (near the STM pump) • If all tubing and cable connections are secure and the error reappears, call RSC No sample tube present • Observe transfer of samples from the VersaCell X3 system to the Dimension system and STM aspiration • If no sample tube is present when the STM probe aspirates, call RSC 37 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Communication Pathway 1. Sample tube is scanned on VersaCell X3 system. 2. VersaCell X3 system queries the LIS for test orders. 3. Test orders are received by VersaCell X3 system and displayed on the Test Results screen. 4. Test orders are sent to the connected instrument. 5. The sample tube is sent to the connected instrument and is pipetted. 6. The same tube is returned to the VersaCell X3 system. 7. When the test completes, the result is sent to the VersaCell X3 system. 8. The VersaCell X3 system sends the result to the LIS. 38 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 VersaCell® X3 System – SIEMENS Healthineers Connection Summary IMMULITE® DIMENSION® ADVIA CENTAUR® XP ADVIA® 1800 Reflex Tests / AutoDilutions / Panic Repeats ordered by Yes – VersaCell X3 system sends connected system tube Run on aliquot Yes – VersaCell X3 system sends tube Run on DTT Re-runs or manual tests ordered by operator on Yes – VersaCell X3 system sends Front-Load instrument tube RESEND button RESEND button LIS add-on or reflex test YES – YES – YES – YES – Must rescan Must rescan Must rescan Must rescan Special Tests Front load whole blood methods HIV tests – must have open Front load whole blood methods and urine drugs of abuse bracket to process and urine drugs of abuse Calibrators / QC / Microsamples Recommend Recommend Recommend Recommend Front-Load Front-Load Front-Load Front-Load 39 Effective Date 02 MAY 2023| HOOD05162003351482 Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers Please note this learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. ADVIA, Centaur, VersaCell, IMMULITE and Dimension are trademarks of Siemens Healthineers. All other trademarks and brands are the property of their respective owners. © Siemens Healthcare GmbH 2023 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany 40 Telephone: +49 9131 84-0 Effective Date 02 MAY 2023| HOOD05162003351482 siemens-healthineers.com Unrestricted © Siemens Healthineers, 2023