Atellica® Solution Updating from v1.27 to v1.28 Online Training

Continue Continue Untitled Scene ? Master Template HILS2218 | Effective Date: 25 Mar 2022 Atellica® Solution Updating from 1.27 to 1.28 Online Training Overview of changes for your system. Highlights & Install Notes 1 Good to Know 4 Display Changes 3 New Procedures & Features 2 Welcome Welcome to the Atellica Solution Updating from 1.27 to 1.28 Online Training. ? Highlights and Install Notes Windows 10 OS Cumulative Update Migration from Windows 10-1909 Operating System to Windows 10-LTSC Operating System for Atellica Solution Product Security Documentation White Paper - Atellica Solution Product Security Whitepaper and MDs2 Form - 11603734 Bulletin - Rev. A Creating a Secure Laboratory Environment - 11641806 Installation Must be performed by Siemens Service. Please contact Siemens technical support to schedule the installation Note: A five hour window is needed for installation. Highlights and Install Notes The major change with this release is the Windows 10 operating system cumulative update. This includes migration from windows 10-1909 Operating System to Windows 10-LTSC Operating System for Atellica Solution. The security whitepaper has been updated with this current software and we would like to inform you about a new bulletin to help you address questions with your IT group, both can be found in Document Library. This is a mandatory installation which will be performed by service to ensure that you continue to use the Microsoft supported operating system. New Procedures and Features In this new release there are several new procedures on the system. Select the tab arrows on the right to learn more about these: Load Cal/QC Samples - STAT Priority Scanning QC 2D Barcodes Calibration with QC for IM assays Lab Evaluation - Reagent Comparison ? Load Cal/QC Samples - STAT Priority Scanning QC 2D Barcodes Calibration with QC for IM assays Lab Evaluation -Reagent Comparison New Procedures and Features Main Layer Audio: On the system there are four new procedures and features that we will discuss on this slide. Select the tab arrows on the right to learn more about these. Tab One Audio: The Sample Workflow screen includes a new Sample Priority Section for systems which are connected to Automation. The following two settings are available in this section: Load Cal/QC samples with STAT priority and process patient STAT orders with Routine Priority. These two settings have been added to assign carriers to Cal QC samples. For systems which are connected to Automation, a feature is added which facilitates how samples are assigned to carriers within the Atellica Solution. In some cases, the volume of priority samples at the Sample Handler Connect which need to transfer to the Atellica Solution is so high that they block the ability to load Cal/QC samples from the drawers or cold storage of the Sample Handler. This new Sample Workflow screen settings allows labs to modify a priority so that carriers can be assigned, and calibrators and QC can run when requested, with no delay to wait for carriers. Tab Two Audio: Siemens Healthineers Quality Control material will be manufactured with a 2D barcode which can be used to automatically create the QC Definitions. QC Definitions can also be imported using XML files and manually entered. Please refer to the customer bulletin for more information about this and how to utilize and scan these new barcodes. You will begin to see the new 2D barcodes implemented as new lots are manufactured. Tab Three Audio: When enabled for IM assays, Perform QC with Calibration will not only order the QC with the calibration but will also verify QC results are within QC Definition ranges as part of the calibration acceptance criteria. This new configuration provides consistent behavior for calibration with QC between IM and CH analyzers. To enable this feature, the check box for QC results must be within specific ranges in calibration setup. The benefit is that IM assay calibrations can now be automatically accepted when the QC is in range. Before enabling this feature your lab manager should consider how this may impact your overall calibration setup and calibration result acceptance process. Always follow your lab process for setting system configurations. Tab Four Audio: The capability of the Reagent Comparison Lab Evaluation has been expanded to allow reagent comparison of the same lot on the same or different Atellica CH or IM analyzers within the same Atellica Solution. You can now compare reagents with any combination of the variables of analyzer, lot or pack. This provides a way to perform instrument comparison studies. Lab Evaluation - Reagent Comparison Now you can perform analyzer to analyzer reagent comparisons of the same lot. Reagent Comparison Lab Evaluation allows reagent comparison of the same lot on the same or different analyzer. For more information on this topic please refer to the Atellica® Solution Reagent Comparison Job Aid available on PEPconnect. Note: Select the X at the top of the page to return back to the course. Calibration with QC for IM Assays IM assay calibrations can be automatically accepted when QC results are within QC Definition range to save time with calibration results review. When enabled for IM assays, Perform QC with Calibration with calibration but will also verify QC results are within QC ranges as part of calibration acceptance criteria. This provides consistent behavior for Calibrations with QC between IM and CH assays. Note: To enable this feature, select the check box for QC Results must be within ranges in Calibration Setup. Let’s Discuss Lab Manager and team when implementing this configuration should discuss both the benefits and impacts. Follow your lab process for system configuration. Note: Select the X at the top of the page to return back to the course. Scanning QC 2D Barcodes Navigate to QC Definitions Select Scan Barcodes Scan the QC 2D barcode Note: If the barcode reader is not available, manually add the QC definition To save the new QC Definitions, select the appropriate check box for Test Name Confirm the information Select Save For more information on this topic please refer to the Customer Bulletin. Note: Select the X at the top of the page to return back to the course. Load Cal/QC – STAT Priority Section For systems which are connected to Automation, a feature is added which facilitates how Cal/QC samples are assigned to carriers within the Atellica Solution. The new Sample Workflow screen settings allows labs to modify a priority so that carriers are more easily assigned, and Cal/QC samples can run when requested, with no delay to wait for carriers. All automation samples will be processed with Routine priority and Cal/QC will process with STAT priority. Note: This setting affects the turnaround time of STAT samples Load Cal/QC samples with STAT Priority When enabled, the system loads all Cal/QC samples from the SH (drawers or storage area) with a STAT priority to the Atellica Magline. Process patient STAT orders with Routine Priority This is automatically enabled if Load Cal/QC samples with STAT priority is enabled. The system processes all automation samples with Routine priority, regardless of the priority in the order. Let’s Discuss The SH must be in the Stopped state to make changes and only the Lab Manager Account can modify these settings. Note: Select the X at the top of the page to return back to the course. New Procedures and Features In this new release there are several new procedures on the system. Select the tab arrows on the right to learn more about these: Loading Reagents at Module Console Test Definitions IM Measuring Interval Limits Test Definition Setup_A1C_E and A1C_H ? IM Measuring Interval Limits Test Definition Setup_A1C_E and A1C_H Loading Reagents at Module Console Test Definitions More New Procedures and Features Main Layer Audio: On the system there are more new procedures and features that we will discuss on this slide. Select the tab arrows on the right to learn more about these. Tab One Audio: For operator defined assays empty reagent packs can be assigned using the module console and the primary user interface. Tab Two Audio: Test definitions have been reviewed and enhanced for version 1.28 improving the consistency of results. Please download and review the CH test definition enhancements from document library for more information. Tab Three Audio: IM Measuring Interval limits from the Master curve now display in IM Test Definitions as shown on this slide. Tab Four Audio: You can now modify both the A1c and tHb component measuring intervals when you are in the screens for the tests shown on this slide in the Test Definition Setup. Please note: Extending the measuring interval beyond the IFU claims requires assay validation for off-label usage. Test Definition Setup_A1C_E and A1C_H A new setting is added in Test Definition which allows you to extend the Atellica A1c_E and A1c_H component measuring intervals beyond the manufacturer’s limits in the Instructions For Use. Note: Extending the measuring interval beyond the IFU claims requires assay validation for off-label usage. Note: Select the X at the top of the page to return back to the course. IM Measuring Interval Limits IM Measuring Interval limits from the Master Curve are now displayed in IM Test Definitions. The fields can be modified here to extend the reportable range for an IM assay. To restrict the reportable range continue to use the procedure for using the Linearity fields in Test Definition Ranges (Existing values entered in Linearity are not impacted by this software update). Please refer to the assay Instructions for Use and follow your lab procedures when making changes to the assay test definition. *Note: Extending the measuring interval beyond the IFU claims requires assay validation for off-label usage. Table with 2 columns and 3 rows I want to Settings Restrict the range of the assay inside the IFU claims Test Definition – Ranges - Linearity Extend the range of the assay outside the IFU claim* (see note) Test Definition – Advanced Note: Select the X at the top of the page to return back to the course. Test Definitions CH Test Definition Enhancements Please download and review the latest version: Name: CH Test Definition Enhancements Document # 11472896 Location: Document Library Note: Select the X at the top of the page to return back to the course. Loading Reagents at Module Console For Operator Defined assays empty reagent packs can be assigned using the module console and the primary user interface. Note: Select the X at the top of the page to return back to the course. ? Display Changes Sample Flagging: Samples that are waiting for HIL do not display as Intervention Needed. Samples flagged for auto-repeat do not display in Intervention Needed if the sample is onboard and ready to process. Improvements to Intervention Tile Date and Number Format Consistently display on all screens. The screen for Calibrations Due no longer displays Load Cal for C0 adjust assays when perform QC with Calibration is enabled. Calibrations Due Screen Display Changes On this slide we will discuss display changes. Improvements have been made to the Intervention Tile. The following sample flagging items have been added. First, samples that are waiting for HIL do not display as Intervention Needed. Also, samples flagged for auto-repeat do not display in this tile if the sample is onboard and ready to process. A change has been made to the date and number format, and now they consistently display on all screens in this new software version. Finally, the Calibration Due screen has been updated, it will no longer display Load Calibrations for CO adjust assays when you perform QC on your system, and you have calibration enabled. ? Display Changes Calibrations Definition Screen View / edit Calibration Definition screen shows N/A instead of 0 as bottle value for Calibration levels that use onboard fluid. Sample ID not populating The system consistently populates the Sample ID when the operator scans a sample barcode. For Patient DOB received from the LIS, the system displays the correct patient date of birth. Patient Date of Birth Calibrations Due excludes orders for reagents with onboard storage or lot expiration within 24 hours of the configured time. For Patient DOB received from the LIS, the system displays the correct patient date of birth. Patient Date of Birth Calibration Due Exclusions More Display Changes On this slide we will discuss more display changes. In this latest software version, the system will automatically populate the Sample ID when you scan a sample barcode. The Calibration Due screen has been updated. if QC with Calibration is enabled for C 0 adjust calibrations and the required QC is not onboard, the screen will not request you to load the calibrator. For a C 0 adjustment calibration no calibrator is needed, but if QC with Calibration is enabled for these assays, the QC will still need to be loaded when the calibration is ordered. Now patient orders from the LIS display the correct patient date of birth. Calibrations Due will no longer ask you to calibrate reagents on your system that are going to expire within the same day. ? Good to Know These items are good to know but do not impact your operator instructions. Select the tab arrows on the right to learn more about these items: IM Reagent Mixing Lab Evaluation Changes IM Cleaner Onboard Stability Calibration Calculations IM Reagent Mixing Lab Evaluation Changes IM Cleaner Onboard Stability Calibration Calculations Good to Know Base Audio: These items are good to know but do not impact operator instructions. Select the tab arrows on the right to learn more about these items. Tab One Audio: The latest version of the system software has helped with instances when your analyzer maybe going from maintenance to a ready state and your reagents were mixing during those states. This increased reagent mixing duration helps to minimize failures in automatic QC scheduling and prevents less manual mixing. Tab Two Audio: The system does not automatically add HIL tests to orders created for Lab Evaluations. When the assay print name was different than the test name, the system did not order QC parallel evaluations. Now in this version so the system consistently creates these evaluations. Tab Three Audio: IM Cleaner onboard stability has increased from seven to fourteen days in this new release. Tab Four Audio: Atellica Solution Calibrator definitions can be defined with a mixed number of levels without seeing calibration failures. Calibration Calculations AS Calibrator definitions can be defined with mixed number of levels without seeing calibration failures. The calibration failed due to the bottle values were not found for the calculations. For example: AMP300 uses L0,1,2,3,4 while COC300 uses L0,2,3,4,5, and these can now be in the same definition and the bottle values will be identified for the calculations. Another example: is ASO and the Liquid Specific Protein calibrator. Note: Select the X at the top of the page to return back to the course. IM Cleaner Onboard Stability IM Cleaner onboard stability has increased from 7 to 14 days Note: Select the X at the top of the page to return back to the course. Lab Evaluation Changes All Orders The system does not automatically add HIL tests to orders created for Lab Evaluations. QC Parallel Orders The system consistently creates QC Parallel Evaluations. Note: Select the X at the top of the page to return back to the course. IM Reagent Mixing The IM will mix reagents during system status changes, such as transitioning out of maintenance, making the reagent packs prepared for testing sooner. With the current design, reagent mixing is not being done while the system transitions to a different state such as from Maintenance state to Ready state. When the transitions take a long time or there are multiple transitions done consecutively, the reagent packs could require mixing time before any tests can be aspirated. This may cause delays in test processing. Tests that attempt to be processed when reagent packs need to be mixed are cancelled by the system. This update in the software allows reagent mixing for as long as possible during state transitions which enables ready packs to be available for testing as soon as possible. Note: Select the X at the top of the page to return back to the course. ? Good to Know These items are good to know but do not impact your operator instructions. Select the tab arrows on the right to learn more about these items: Report Enhancements Report Enhancements More Good to Know Base Audio: These items are good to know but do not impact operator instructions. Select the tab arrows on the right to learn more about these items. Tab Two Audio: In this version we have several report enhancements that are good to know. The lab results report displays all information regardless of when the assay is calibrated. The patient summary automatic report generates a pdf file after processing the samples. The automatic lab results report displays all information regardless of when the assay is calibrated, and finally the automatic calibration report file names printed to file including the test name. Report Enhancements Lab Result Report in Different Languages Lab Results Report generates in all languages. Patient Summary Automatic Report Patient summary automatic report pdf file is now generated after processing the samples Automatic Lab Results Report The Automatic Lab Results Report displays all information regardless of when the assay is calibrated. Test ID in Automatic Report The automatic Calibration Report file names printed to file include the test name. Note: Select the X at the top of the page to return back to the course. Disclaimer Please note that the learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. © Siemens Healthcare GmbH 2023 Siemens Healthineers Headquarters\Siemens Healthcare GmbH\Henkestr. 127\ 91052 Erlangen, Germany\Telephone: +49 9131 84-0\siemens-healthineers.com ? Disclaimer Assessment This assessment will test your retention of the presented content. A passing score of 80% or higher is required to complete the course and earn your certificate. You may repeat the assessment as many times as needed. Start ? Assessment Select the best answer. Question 1 of 5 You can now load __________ directly from your module console operator defined reagents calibrators QC ? Multiple Choice Incorrect You cannot load QC directly from your module console. Incorrect You cannot load calibrators directly from your module console. Correct Select the best answer. Question 2 of 5 Which of the following is TRUE regarding the enhancement to Reagent Comparison studies? Allows reagent comparison of the same lot on the same or different analyzer Increased reagent mixing duration during system status minimizes automatic QC scheduling failures ? Multiple Choice Incorrect Increased reagent mixing duration does not enhance reagent comparison Correct Select the best answer. ? 2D barcodes Question 3 of 5 What is the new way you will be able to define Siemens Healthineers QC? By XML File Import By Manual Entry Multiple Choice Incorrect Incorrect You cannot define Siemens Healthineers QC by manual entry. Incorrect You cannot define Siemens Healthineers QC by XML File Import. Select the best answer. Question 4 of 5 IM Cleaner onboard stability has increased from: 7 to 14 days 7 to 12 days 7 to 10 days ? Multiple Choice Incorrect The onboard stability of the IM cleaner has not increased from 7 to 10 days. Incorrect The onboard stability of the IM cleaner has not increased from 7 to 12 days. Correct Select the best answer. Question 5 of 5 The Automatic Lab Results Report _____ all information regardless of when the assay is calibrated. displays checks off empties ? Multiple Choice Incorrect The Automatic Lab Results Report does not empty all information when the assay is calibrated. Incorrect The Automatic Lab Results Report does not check off all information when the assay is calibrated. Correct Review Review Retry Assessment Results %Results.ScorePercent%% %Results.PassPercent%% Continue YOUR SCORE: PASSING SCORE: Assessment Results You did not pass the course. Take time to review the assessment then select Retry to continue. Congratulations. You passed the course. Exit ? You have completed the Atellica Solution Updating from 1.27 to 1.28 Online Training. Completion Navigation Help Select the icon above to open the table of contents. Click Next to continue. Next Welcome Slide The timeline displays the slide progression. Slide the orange bar backwards to rewind the timeline. Click Next to continue. Next Timeline Select the CC icon to display closed captioning (subtitles). Click Next to continue. Next Caption Icon add subtitles Select the buttons to learn more about a topic. Be sure to review all topics before navigating to the next slide. Click Next to continue. Next Tab Arrow Slide Select the X to close the pop-up. Click Next to continue. Next Layer Slide Select Submit to record your response. Click the X in the upper right corner to exit the navigation help. Assessment Slide Question Bank 1 HOOD05162003360294 | Effective Date: 20 JUN 2023 1.1 Welcome 1.2 Highlights and Install Notes 1.3 New Procedures and Features 1.4 More New Procedures and Features 1.5 Display Changes 1.6 More Display Changes 1.7 Good to Know 1.8 More Good to Know 1.9 Disclaimer 1.10 Assessment