PEPconnect

Atellica® Solution Software Version 1.23.1 Updates

This training material is in support of Atellica® Solution Software Version 1.23.1 Release Notes. This is provided as a supplement to the Atellica® Solution Operator's Guide, Quick Guide, and online help.

SIEMENS Healthineers Atellica® Solution New System Behaviors Software Version 1.23.1 HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 1 Reference for Software v1.23.1 Enhancements SIEMENS . Healthineers ... The enclosed information is customer training material in support of Atellica® Solution* Software Version 1.23.1 Release Notes English SMN 11484988 In an ongoing effort to keep our customers informed, Siemens Healthineers is providing this information as a supplement to the Atellica Solution Operator’s Guide, Quick Guide, and Online Help. For the most up-to-date versions, see Accessing Product Information in the Document Library in the Online Help. To obtain the latest revision of Online Help search the Document Library for SMN 11313586. *Product availability varies by country HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 Systems on v1.21.0 SP1 and above will receive customer installable v1.23.1 Upgrade Version software to their system automatically when connected to SRS. There is also an update to the Online Help files to version 1.23. Using the customer-facing Release Notes, a customer can complete this software upgrade without any special training. Systems on software version 1.21.0 or lower will need to schedule a service visit to perform the upgrade. 2 Understanding Atellica Solution Software v1.23.1 SIEMENS . Healthineers ... 1. Introducing Atellica Asa™ Application 2. New features for setup 1. Global Calibration Configuration 2. HIL Donor Configurations 3. More new setup options 3. Changes to system behaviors 1. IM Reagent Loader Troubleshooting 2. CH Cuvette Status Window 3. QC and Calibrator Material Labels 4. More New Behaviors 3. Display changes 4. Miscellaneous Enhancement HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 Siemens is focused on ensuring a positive Atellica Solution experience and strives for continuous improvement. This presentation is provided to help you understand the contents of Atellica Solution software version 1.23.1. 3 1. Introducing SIEMENS. Healthineers ... Atellica Asa™ Application Key Features System Status – provides a graphic of your system configuration along with the color coded status of each component. Current Status – monitors what is currently in process or needing an intervention Atellica Ass SIEMENS Healthingers Day Needs – across 4 categories, displays the supplies the lab will need to run their testing within a-24 hour period based on historical Current Status information established by the lab and analyzed by the software. O Cart List – select reagents, supplies, consumables to create an interactive and mobile list which facilitates collecting supplies. Support Functions – one-click access to troubleshooting, PEPconnect and remote assistance tools HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 Your Atellica Solution tablet can be upgraded to include the Atellica Asa Application as soon as software version 1.23.1 has been installed on your system. The Atellica Asa Application 1.1.0 Release Notes (SMN11482136 EN) and Customer Bulletin Announcing Atellica Asa Application for Atellica Tablet (SMN11536895 EN) available in Document Library, explain more about the software update and new application. This application helps to improve workflow by allowing the operator to walkaway from the system with confidence and easily monitor the system remotely from the operator tablet. Key Features System Status – provides a graphic of your system configuration along with the color coded status of each component Current Status – monitors what is currently in process or needing an intervention Day Needs – across 4 categories, displays the supplies the lab will need to run their testing within a-24 hour period based on historical information established by the lab and analyzed by the software Cart List – select reagents, supplies, consumables to create an interactive and mobile list which facilitates collecting supplies Support Functions – one-click access to troubleshooting, PEPconnect and remote assistance tools For an overview of the Atellica Asa Application and to see how to use it day to day, complete the training module in PEPconnect titled Asa Application Overview Online Training. Contact Siemens Support to schedule your tablet upgrade to Atellica Asa Application as soon as your system has been updated to v1.23.1 ! 4 2. Setup Improvements SIEMENS . Healthineers ... Global Calibration Configuration SIEMENS ealthineers Atellica Solution Version 1.23.1.3778001 SP01482 System Samples Inventory Calibration patient Orders Maintenance Test Definition Settings Accounts General Setup * Regional Connectivity Patient Cal-QC Accounts Maintenance Security Settings Results Review Mode Settings Send Results to QC Statistics System Configuration RiliBAK Feature Mode Review None V QC O Off SH Configuration Hold Results by Analyzer Patient On Module Configuration Analyzer Hold Results QC Mode Settings 1H01226 QC Mode: O By System IS Configuration By Module Type AS Configuration IH01232 IM HO1233 Reports Setup QC Statistics Violation: N IH01235 Patient Test Action | Never Disable Directories QC on Pack Change Disable IM Standard Configuration Material for Automatic QC Order Router Settings 1Level All Levels Alerts Configuration 1. Calibration Settings Automatically Order Calibration By System Lot Calibration Expiration or New Lot IFU Changed Pack Calibration Expiration Perform QC with Calibration Save Clear ? PEP Fax LabManager Thursday , August 13 , 2020 5:45 PM HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 The new Calibration Settings (1) section in the General Setup provides a single location to view the calibration configurations for all the assays. With these new settings you can select how to calibrate all assays with a few clicks on one screen. Automatically Order Calibration field sets how the system will generate Calibration orders. The options are By System and By TDef By System This is useful if you want to do the same calibration actions for all assays. All assays follow the settings configured by the checkboxes below The individual assay TDEF settings for automatic calibration orders will not be used Use TDEF Settings This is useful if you want to have a variety of calibration actions for assays All Automatic Calibration options will be dictated by what is defined in each individual TDef. The ordering options must be configured individually, in each assay TDEF There are additional options to further specify when a calibration order is triggered and if QC should also be ordered if you select to order By System. These are the same options found in each individual TDEF Lot Calibration Expiration or New Lot – the system will generate an order as soon as a New Lot is loaded or if a current lot calibration interval will expire in 24 hours. Pack Calibration Expiration – the system will generate a calibration order if a current pack calibration interval will expire in 1 hour IFU Changed – the system will generate calibration order if the calibrator assigned values are modified in Calibration Definition screen Perform QC with Calibration – when the system generates a calibration order, the order will include QC Note: These settings do not apply to IMT Calibrations 5 2. Setup Improvements SIEMENS Healthineers ... HIL Donor Configuration SIEMENS Atellica Solution Version 1.23.1.3778001 SP00105 Healthineers A System Samples Inventory Calibration Patient Orders Workliet Maintenance Test Definition Settings Accounts Result Monitor ssay List 1.* HIL using Donor CH Test Definition Disable ( Enable 3. Move Up M Test Definition Test Priority Test Name Select as Donor Move Down Ratios, Panels, and Off- System AST 2. est Display Order ALT Open Channel 3 ALTPLC Sort Test Definition ASTPLC HIL Donor Configuration LDLP KK KKK 6 XHILChris XHILStep3 8 XStep5 9 XHILStep6 10 XDonor1 11 XDonors 4. ? PER B & )CSE hursday, August 13, 2020 5:39:55 PM *this setting Impacts throughput HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 You now have more flexibility for HIL testing. Modify how HIL is performed using these settings on the HIL Donor Configuration screen. 1. By default, Enable is selected for the feature HIL using Donor. The system will use the default assays as HIL donor assays, integrating HIL testing when the assays listed are performed. Set HIL using Donor to Disable if you want to run HIL in its own cuvette where sample and system water are added to the cuvette for HIL analysis. NOTE: Selecting Disable for HIL using Donor configures HIL test to run in it’s own cuvette. This configuration may impact throughput depending on volume of testing. The more donor assays in use, the less likely it is to impact throughput. 2. Specify donor assays to be used by the system using a check in the box under “Select as Donor” 3. The priority of donor assay selection can be changed by highlighting the test and selecting the “Move Up” or “Move Down” buttons 4. Save changes 6 SIEMENS 2. Setup Improvements Healthineers ... HIL Open Channel Configuration Healthineers Atellica Solution Version 1.23.1.3778001 SP00105 SIEMENS System K eborders Worklist Samples Maintenance Setup Inventory Test Definition Settings Accounts Result Monitor The laboratory is responsible for validating any modifications they make to the instructions, systems, reagents, or software provided by Siemens Healthineers Available Channels 0 Assay List i) Assay CH Test Definition Definition Sample/Reagent Calculatio Calibratic Mitigation Ranges Calculation High-dose Hook Effect HIL Calculations Repeat Conditions M Test Definition 1. Reflex Group Setup Ratios, Panels, and Off- Use as HIL Donor System HIL Scalars Result Setting est Display Order Intercept H Slope Open Channel I Intercept I Slope L Slope Sort Test Definition . Intercept Alternate HIL Factors HIL Donor Configuration Factor A Factor AU actor B actor BO Factor C Factor CO Factor D Factor E Factor Create New Copy Create HIL Modify Existing Delete Assay Discard Changes Save Changes ? PER 5 8 Thursday, August 13, 2020 5:41:20 PM HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 An additional new features allows you to set an Open Channel test to use as a donor assay for HIL. Any Open Channel test marked Use as HIL Donor (1) will also show in the HIL Donor Configuration screen. Please refer to the 1.23.1 Release Notes for the step by step instructions to configure this screen. 7 2. Setup Improvements SIEMENS More New Setup Options Healthineers ... In response to your requests, we have incorporated other new configuration options and improvements: 1. Patient Exceptions List updated 2. Pack calibration intervals for CH can be modified 3. Privilege to disable CH well can be set by operator HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 1. Patient Exceptions List is found in General Setup – Settings – Patient. It provides the ability to hold patient results by all flags generated for results in worklist. The list has been updated with all available result flags for more effective auto- validation from Atellica Solution system. 2. Pack calibration intervals for CH can be modified. In the Test Definition – Calibration screen, you can adjust the pack calibration interval to be more frequent but not less frequent. For instance, you could change the Mg pack calibration interval from 3 days to 2 days but you cannot change it to 4 days. This aligns with the same capability already available for IM pack calibration intervals. 3. Privilege to disable CH well by operator – Lab Manager login level can designate which operators can disable a CH well. 8 3. Behavior Improvements SIEMENS Healthineers ... IM Reagent Loader Troubleshooting The system offers more communication to the operator about resolving reagent loader issues. This helps you resolve the issues and return to patient testing faster. SIEMENS Healthineers Reagent Loader Siemensinternal Off Reagent Drawer 2 Unlock Drawer 3 Clear All 4 Manual Entry 1. Resume Work 5 ? HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 The system offers more communication to the operator about resolving IM Reagent Loader issues. This helps you resolve the issues and return to patient testing faster. For the IM Reagent Loader: • The button previously called Error Resolved is renamed Resume Work (1) and it has different messaging. This button initializes the latch and tray mechanism and is used to bring the latch back online. • The messaging and controls for resuming the Reagent Loader are accessible on the module console right at the analyzer so that you can see the loader respond to your commands without walking back and forth to the main UI screen. • We have added automatic recovery routines that will bring the IM Reagent Loader back online, without interrupting the solution. NOTE: Always clear any visible obstructions before using the Resume Work button. If Resume Work is used before clearing any visible blockage, such as a dropped pack, the latch or tray could run into the obstruction during initialization and the retry will not be successful. 9 3. Behavior Improvements SIEMENS. Healthineers ... IM Reagent Loader Troubleshooting Event Code Event Message Confirmation Please confirm that the error (physical obstruction, dropped pack) were resolved Screen for and the instrument is ready to resume. To resume work, select Yes. If the errors are Resume Work not resolved, select No and resolve the errors. 03 600 07 40 Reagent Compartment is not verified. Rescan the Reagent Compartment. 03 600 00 30 Reagent Drawer latch failed to lock or unlock. Open and close the drawer. 03 999 00 64 The reagent drawer on the IM Analyzer has no slots available. Verify that Reagent Compartment is scanned and verified. Open and close drawer. 03 999 00 65 The reagent compartment on the IM Analyzer has no slots available. Rescan Reagent Compartment. HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 These are the new events with instructions for corrective action that you will see to help troubleshoot the IM Reagent Autoloader tray, latch and drawer. 10 3. Behavior Improvements SIEMENS Healthineers ... CH Cuvette Status Window Cuvette Status X P00105 Reaction Cuvettes Dilution Cuvettes Segment A Usable 11 Usable Jsable sable Usable Usable Jsable Jsable Usable Usable Jsable Jsable Usable Jsable Jsable 16 Usable Usable Segment B 18 23 25 26 27 34 Jsable Usable Usable Jsable Usable Usable sable Usable Usable Usable Usable Usable Usable sable Usable Usable Usable Segment 35 36 37 38 43 46 47 49 50 51 Usable Usable Jsable Jsable Usable Usable sable Usable Usable Jsable isable Usable Usable Isable Usable Usable Usable 52 54 55 56 Segment D Usable 60 61 63 64 66 68 Usable Usable Usable Usable Usable Jsable Usable Usable Usable Isable Usable Usable Usable Usable Usable Usable 69 Usable 74 76 80 81 83 84 85 Segment E Usable Usable Usable Isable Usable sable sable Usable Usable sable Usable Usable Jsable Usable Usable Usable Segment 86 94 100 101 102 Usable Usable Usable Usable Jsable Usable sable Usable Usable Usable Jsable Jsable Usable sable Usable Usable Usable 103 104 105 106 109 110 113 114 115 117 118 119 Segment G Usable Usable Usable Usable Usable Usable Jsable Usable Usable Usable Jsable Usable Usable Isable Usable Usable Usable 120 124 126 127 130 134 Segment H 121 122 123 125 128 129 132 135 Usable Usable Usable Usable Usable Usable Jsable Jsable Usable Usable sable Usable Usable Isable Usable Usable Need R 137 138 139 140 142 144 146 148 149 153 Segment Usable Usable Usable Usable Usable 145 Usable sable Usable Usable Usable Jsable Usable Usable Isable Usable Usable Usable 154 155 156 157 158 159 160 161 162 163 165 168 169 170 Segment Usable Usable Usable Usable Jsable Usable sable Usable Usable 164 166 167 Usable sable Usable Usable sable Usable Usable Usable 172 173 175 176 178 179 180 182 183 184 185 186 187 Segment K Usable Usable Usable Usable Usable Usable Usable Usable Usable Usable Jsable Usable Usable Usable Usable Usable Usable 188 189 190 192 193 194 195 196 197 198 199 200 201 202 203 204 Segment L Usable Usable Usable Usable Usable Usable Usable Usable Usable Jsable Usable Usable Jsable Usable Usable Usable 205 206 207 208 209 Isable 210 211 212 213 214 215 216 217 218 219 220 221 egment M Usable Usable Usable Usable Usable Usable Usable Usable sable Usable Usable sable Usable Usable Usable ? 1. Cuvette State Information Close ? CSE ES Thursday , August 13 , 2020 5 : 44 :24 PM HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 The CH cuvette cleaning activity is part of the Daily Maintenance, Weekly Maintenance and it can also be performed as a separate activity. The cuvette cleaning procedure has been modified by adding an air blank photometer reading from the cuvette after drying. This procedure change has not added more than 10 seconds and the cuvette cleaning activity still runs in under 30 minutes. The results of the photometer readings are incorporated into the cuvette quality checks which are now available for you to review in Inventory/Supplies/Cuvette Status by clicking on the Cuvette State Information button (1). 11 3. Behavior Improvements SIEMENS Healthineers ... CH Cuvette Status Window Cuvette Status SP00105 X Reaction Cuvettes Dilution Cuvettes Segment A 5 10 12 13 15 16 17 Usable Usable Sable Usable Usable Usable Usable Usable Usable Usable Usable Usable Usable Usable Usable Usable Usable Segment 18 20 22 23 24 25 Usable 26 27 33 34 Usable Usable Psable Usable Usable 29 30 Usable Usable Usable Usable Usable Usable Usable Usable Usable Usable Usable Segment C 35 36 38 39 40 42 43 44 45 46 47 48 49 50 Usable Usable sable Usable Usable Usable Usable Cuvette State Information × 66 egment D 52 54 65 68 Usable Usable sable able Usable sable Usable Segment E 82 83 84 Usable Usable Osable Usable Wash is complete. The cuvette is ready for use. able Usable Jsable Usable Segment F 99 101 Usable 102 Isable Isable able sable Jsable Usable 117 Segment G 103 104 105 peed Usable sable Cannot use the cuvette. Cuvette QC, washing and cleaning failed too often. Replace the cuvette 116 118 119 sable Replacement able Usable Usable Usable 120 121 133 134 135 egment 122 Usable Isable sable able Usable Usable Need R .. 137 138 139 Disabled Cannot use the cuvette. The cuvette was disabled by service in Diagnostics. 150 151 152 153 Segment Usable Usable usable able Usable Usable Usable 154 155 156 167 168 169 170 Segment . Usable Usable bable Waiting for _ Cannot use until the cuvette is washed and checked again. The cuvette failed the last Cuvette QC able Usable Usable Usable acceptable QC check. 171 184 Segment K 186 187 Usable Usable Usable able Usable Close sable 188 189 201 203 204 Segment L 202 Usable Usable sable able Jsable sable Usable 205 218 221 Segment M Usable 207 sable Usable Usable 210 able 211 Isable 212 Usable 213 215 able 214 sable Usable Isable 217 sable Usable Usable able Usable ? Cuvette State Information Close ? PER 5 8 )CSE Thursday, August 13, 2020 5:43:21 PM HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 Cuvette State Information Air blank reads are tested against an absorbance threshold and if any reading fails to meet the threshold then the cuvette will be marked as “Waiting For Acceptable QC”. A cuvette marked as Waiting for Acceptable QC will be omitted from available cuvettes and will need to pass additional reads before the state is cleared and it is reinstated as an available cuvette. If it continues to fail to meet the threshold, the status will change to Need Replacement. The quality check does not occur when the cuvette is cleaned following every reaction and does not apply to dilution cuvettes as there is no photometer to read dilution cuvettes. This change does not impact the current requirement to perform 300 replicates of CO2 when reaction ring cuvettes are replaced. The benefit of this additional check is to identify individual bad cuvettes and remove them from use. 12 3. Behavior Improvements SIEMENS. Healthineers ... CH Cuvette Status Window As the cuvette status changes , the system monitors impact on throughput. A new event notifies the operator that reaction ring cuvettes may need to be replaced in an effort to maintain the best possible throughput. Event Code 04 801 95 11 The CH Analyzer has 36 or more unusable reaction cuvettes. Replace all reaction ring cuvette segments to maintain throughput Possible Causes Corrective Action The reaction ring cuvettes failed Cuvette QC Replace all reaction ring cuvettes. too often. Time (minutes): 30 HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 As the cuvette status changes , the system monitors impact on throughput. A new event notifies the operator that, when 36 or more cuvettes are unusable, reaction ring cuvettes may need to be replaced in an effort to maintain the best possible throughput. 13 3. Behavior Improvements SIEMENS . Healthineers ... QC and Calibrator Material Labels The serial number of the Sample Handler Prime or Direct Load and the date on which the label is generated have been added to the calibrator and QC barcode labels Before After :%CECD968000011 CAL D :%CECD968000006 CAL D CD96 2 CD96 2 000006 000011 QQSWSH3 30.04.2020 :%CECD96A000006 :%CECD96A000011 CAL D CAL D CD96 1 CD96 1 000006 000011 QGSWSH3 30.04.2020 HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 The Sample handler or Direct Load serial number and the current date which the system printed the barcode have been added to the calibrator and QC bar code labels at the bottom. NOTE: make sure barcode printer paper is properly aligned in the barcode printer 14 3. Behavior Improvements SIEMENS Healthineers ... More New Behaviors In response to your requests, we have incorporated other new behavior: 1. Autocalibration Order Timing 2. Expanded Sorting Functions 3. QC Sample Volumes for IM 4. Deleting Open Channel Assays 5. Onboard Stability Extension for CH Fluids HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 1. Autocalibration Order Timing: For assays where the OBS of the well and the Pack Calibration Interval are within one hour, the system will no longer trigger an automatic pack calibration order. If the reagent lot for CH is set to expire within 24 hours of the next lot calibration trigger a lot calibration will not be triggered. This eliminates needless pack calibrations on packs that are about to expire. 2. Expanded Sorting Functions: Samples will sort to a rack location based on Reflex test orders. If a sample has been placed in an output rack after aspiration, if the subsequent result triggers a reflex order to sort, the sample will be moved to the sort location. This allows easier retrieval of samples based on their results. For example, Reactive HCV can be configured to reflex order a Sort Test Code and the tube will be moved to the assigned sort location. 3. QC Sample Volumes for IM: The stored QC samples for testing on IM Analyzer have improved volume measurements and will give accurate volumes in the Cal/QC Inventory display instead of NA. This improves the monitoring of your QC Needs. 4. Deleting Open Channel Assays: When an Open Channel Assay is no longer in use, the data can be cleared so the channel can be reused. Deleting an open channel will archive and delete calibration results, and delete Calibrator Definitions associated with the open channel. Prior to attempting to delete an Open Channel assay, perform the following steps: a. Confirm that all results for the assay have been moved to the Historical database b. Remove the appropriate assay from Calibrator Definition and QC Definition c. Remove the appropriate assay from Ratios and Panels d. Remove all appropriate packs from the analyzer 5. The onboard stability for these CH Fluids are extended from 30 to 90 days: CH Diluent, CH Conditioner, CH Wash, CH Cleaner, IMT Diluent, RPC1, RPC2. Please refer to Customer Bulletin Atellica CH Systems Fluids and A-LYTE IMT Diluent Stability 11536854, Rev. A for all of the details. 15 4. Display Changes SIEMENS Healthineers ... CH Reaction Curve Healthineers Atellica Solution Version 1.23.0.3716007 SP0108 Reaction Curve - SID: 1453 Assay: AST X Reaction Data Reagent Lot 201119 R1Pack 20111910012721030 500 112431 R2Pack 20111920012721030 750 106153 Concentration 264.481545963602 ABS 650 Primary Wavelength 340 600 Blank Wavelength 410 550 Wavelengths 500 340 nm 450- 410 nm 451 nm 400 Absorbance 478 nm 350- 505 nm 300 545 nm 250 571 nm 200 596 nm 150 658 nm 100- 694 nm 50- 805 nm 20 40 60 80 100 120 140 160 180 200 220 240 260 280 300 320 340 360 380 400 420 440 460 480 500 520 540 560 Time(in Seconds) ? Close Export ? PEP B + CSE Thursday, August 13, 2020 6:07 PM HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 The Reaction Curve view, accessed from Test Details window by pressing the Curves… button, has been enhanced to be pre-filtered for only the wavelengths applicable to the reaction. This makes it easier to view the applicable reaction points when troubleshooting test results. Additional wavelengths can still be added. 16 SIEMENS 4. Display Changes Healthineers ... CH Reagent On Board Stability SIEMENS Healthineers Atellica Solution Version 1.23.0.3716007 SP0108 Inv bry K Worklist System Samples Calibration Patient Orders Maintenance Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibration Needs QC Needs CM01173 CM0 1173 1H01027 Reagents Reagent Details Reagent nventory Onboard Sequence cantus Calibration Cal Type In QC Statu Lot Cal Eligibility Stability ALP_2 691 28 d 16 h 10090 / 02624 5 d 16 h Lo 201099 Lot and Pack ALI 28 d 19 h 7547 / 07299 201117 Pack ALT 850 1. - 21502 / 06475 77 d 20 h Lot 201117 Lot and Pack AST 171 28 d 21 h 12431 / 06153 28 d 21 h Lot 201119 Pack AST 850 29 d 16 h 00930 / 00565 29 d 16 h Lot 291129 Lot and Pack Alb 925 59 d 20 h 01720 23 d 15 h Lot 291014 Lot and Pack CA_2 333 53 d 18 h 02547 53 d 18 h Lot 201106 Pack CA 2 2046 61 d 16 h 03305 61 d 16 h Lot 201106 Lot and Pack CO2_C 1782 26 d 15 h 0333 5 d 15 Lot 100079 Lot and Pack 356 17 d 17 h 100079 CO2_c 5 d 20 h Pack Ca 431 29 d 19 h 01378 / 06282 2 d 19 h Lot 290995 Lot and Pack Ca 549 26 d 17 h 01740 / 03339 0doh 290995 Pack Group by reagen Disable Reagent Pack Disable Reagent Lot Unload ? PER- 9 CSE Friday, August 14, 2020 4:57 PM HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 In Reagent Overview for CH reagents, onboard stability will not be displayed until the first well is punctured. Once the well is punctured onboard stability will display as the "opened" onboard stability for the well. Previously, the longest expiration for the pack or well was displayed, which is 90 days when unpunctured. 17 4. Display Changes SIEMENS Healthineers ... CH Reagent On Board Stability Onboard stability will not be displayed until the first well is punctured Scenario Well 1 Well 2 Previous OBS data New OBS data (below v1.23.1) (v1.23.1 and above) 1 Unpierced Unpierced 90 days “ ---” 2 Open Unpierced 90 days Well 1 OBS expiration 3 Open Open Well 2 OBS expiration Longest OBS expiration HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 The table displays the 3 possible scenarios for CH reagent packs onboard the CH Analyzer and compares the OBS data changes. In 1.23.1 and above software versions, no OBS will be displayed until the first well is pierced, the column will show the dashes. When well 1 is pierced, the OBS column will decrement the expiration for well 1 from 90 days, as shown in scenario 2. When well 2 is pierced, the OBS column will again display 90 days to reflect the OBS of Well 2 as shown in scenario 3. 18 5. Miscellaneous Enhancements SIEMENS . Healthineers ... 1. Some reports have been enhanced: » Automatic Measuring Interval Verification Report (CH Analyzer only) » Automatic Calibration Reports (IM Analyzer only) » Results Statistics Report 2. Bio-Rad files XML import files enhanced 3. Atellica IM auto-recovery routine for cuvette hopper implemented 4. Sample Handling situations rendering the Cal-QC Storage inaccessible have been resolved HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 This software version offers enhancements for a group of existing features. 1. Some reports have been enhanced: Statistics display correctly for Automatic Measuring Interval Verification Report (CH Analyzer only) Automatic Calibration Reports displaying Mean RLUs for replicates (IM Analyzer only) Results Statistics Report is usable for any regional setting 2. Bio-Rad files XML import without error for duplicate test codes for Troponin I and CRP assays 3. Atellica IM auto-recovery routine for cuvette hopper implemented. This will attempt to resolve a potential jam automatically before taking the cuvette loader offline. If no cuvette is detected at the drop chute the analyzer will move the hopper chain back and forth. If no cuvette is detected even following this routine, the cuvette loader will go offline. 4. Sample Handling situations where samples were requested to be retrieved but the primary destination was not available, rendered the CCS inaccessible. A recovery procedure has been implemented to ensure the CCS remains accessible. 19 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 varies by country and is subject to varying regulatory requirements. Please contact your local representative for availability. Copyright © Siemens Healthcare GmbH 2020 Global Siemens Healthineers Headquarters Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84 0 siemens.com/healthineers HOOD05162003124042 Effective Date: 2-SEP-2020 Unrestricted © Siemens Healthcare Diagnostics, Inc., 2020 20