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Atellica® Solution Calibration PEP to Go Version 1.25 and Below

PEP to Go is an education resource material designed to support competency mastery on-the-job.

SIEMENS Healthineers SP0010 KA System Samples Inventory Calibration Qc Patient Orders Worklist Maintenance Setup Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMT Calibration Filters Analyzer Assay Analyzer Cal Lot Number Result Date Cal Status Cal Exp Type Reagent Lot - Pack/Well - Flags Accept Assay ¥ FSH 00109 CB68 02/07/2018 3:53:15 PM Invalid 02/21/2018 1:21:15 PM Pack 994 10510 Well 1 Reject Reagent Lot VALT CM00110 7JD021 09/04/2018 3:39:52 PM Valid 01/13/2019 2:29:02 PM Lot 270427 00655 Well 1 Details Reagent Pack ¥ Dig 00109 CB68 11/14/2017 12:30:34 PM Invalid Pack 990 11884:Well 1 No Primary, No Lot M ... Export Date From ¥ Dig 00109 CB68 09/05/2017 1:18:00 PM Invalid - Pack 990 11493 Well 1 Sample Integrity, Can ... MM/DD/YYYY Edit Order Date To v Ca CM00110 128433B 10/12/2018 4:30:24 PM Valid 11/14/2018 3:21:06 PM Lot 270449 00492 Well 1 MM/DD/YYYY Attributes v Ca CM00110 128433B 10/29/2018 11:12:11 AM Valid 11/01/2018 11:03:16 AM Deleto Order Pack 270449 00492 Well 2 Pending Expired v D_HDL CM00113 412577 09/14/2018 1:58:59 PM Valid 11/13/2018 12:48:26 PM Lot 260292 00167:Well 2 Invalid ¥ CEA P1-02 CD86 10/10/2018 10:07:34 AM Valid 10/31/2018 10:07:34 AM Pack 175 01394:Well 1 Rejected Atellica® Solution ¥ CEA 00109 CD94 10/10/2018 9:44:49 AM Valid 11/08/2018 9:44:49 AM Lot 177 01807:Well 1 Extended Valid v ThCG P1-02 1284338 9/28/2018 9:56:57 AM Awaiting Acceptance 10/31/2018 9:47:14 AM Pack 299 00486:Well 1 Cancelled v DLDL CMO0113 412577 09/14/2018 11:11:47 AM Valid 11/01/2018 11:59:59 PM Lot 270531 01670:Well 1 Ordered Calibration PEP to Go Measuring Interval Verification ¥ TSH3UL 1A00104 CH15 09/25/2018 11:47:11 AM Valid 11/10/2018 11:59:59 PM Pack 315 07980 Well 1 Calibration 1 ¥ TSH3UL 1A00104 CH15 09/25/2018 10:15:02 AM Valid 11/10/2018 11:59:59 PM Pack 315 08110:Well 1 Active Template Effective Date: 05/27/2019 | HOOD05162003010284 TSH3UL 1A00104 CH15 09/09/2018 1:40:19 PM Valid 11/10/2018 11:59:59 PM Pack 315 07983 Well 1 Effective Date: 28 -DEC -2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Frequency Healthineers Reagent calibration should be performed according to the following: • Expired assay reagent calibration • New assay reagent lot • Replacement of major system components or service • Troubleshooting quality control results • Government regulations Healthineers TACR SIEMENS G TACR P1 Syva telLico? Laboratory quality control programs and procedures TACR P2 Emit 2000 Siro/Tacro Sample Pretreatment Reagent • IVD Intended Use: For use with the Emt & 2000 5rol mas RxOnly LOT J3 2019-06-07 SIEMENS ------ CE Enit - 2000 Sira/last ------ Weigle Prestation fs The Atellica Solution manages reagent calibration by using both lot calibrations and pack calibrations. The Instructions For Use (IFU) contains the frequency requirements for lot and pack calibrations for each assay. 2 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration: Lot and Pack Calibration Intervals Healthineers The system utilizes both reagent lot and reagent pack calibration intervals to determine when a reagent needs to be calibrated: Lot Calibration Interval • Starts when a reagent pack with a new lot is calibrated within 24 hours after it is loaded on the system for IM reagents, or 24 hours after the well is pierced for CH reagents • The lot calibration will be valid for any pack with the same lot that is loaded on the system until the lot calibration interval expires • A reagent pack that uses a lot calibration to calculate results for the duration of the Pack calibration interval or Lot expiration, whichever comes first Pack Calibration Interval • On the CH analyzer, a pack calibration is actually a well calibration. There are 2 wells in most CH packs, which are treated as separate reagents by the system • The pack/well calibration interval is valid for an individual pack for IM or well for CH, and not used for subsequent packs/wells placed on the system • Useful for labs that perform a low-volume of tests because they can avoid disposing of reagent packs due to QC shifts seen when calibrating aged packs The system tracks lot and pack calibration and displays reminders when calibration or recalibration of an assay reagent pack is due. NOTE: In order for a calibration to qualify as a lot calibration, the calibration must be done within 24 hours after a new IM pack is loaded on the system or 24 hours after a CH well is pierced. If a new pack/well is not 3 calibrated within 24 hours, the calibration will be a pack calibration. Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration: Lot and Pack Calibration Key Benefits Healthineers High Volume Assays: This is the case for a system that is performing a large amount of tests for an assay, and uses the Atellica Solution uses automation, as • entire contents of the first pack for IM, or well for CH, of a lot before the pack calibration interval well as lot and pack calibrations to: expires. • When the first pack/well is replaced with a second pack/well of the same lot, the system uses the • Save labs money original lot calibration established by the first reagent pack/well to calculate test results. • Extend the calibration intervals • Subsequent packs/wells of the same lot do not require calibration when loaded/pierced until the on assays • lot calibration interval expires. Maintain quality control High volume assays use lot calibrations which leads to fewer calibrations for the life of a lot of • Increase efficiency for labs with • reagents. both a high and low volume of tests Low Volume Assays: • This is the case for a system that is performing a smaller amount of tests for an assay and does not use the entire contents for the first pack/well of a lot before the pack calibration interval expires • Recalibration is required to ensure continued use of the pack/well on the system. The system uses the pack/well calibration to calculate patient results. • Low volume assays use pack/well calibrations which lead to more stable QC results as reagents age on the system. 4 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration: High Volume Assay vs Low Volume Assay Example Healthineers Lot Calibration Interval = 180 days Pack Calibration Interval = 9 days If you load a new pack with a new lot and use it to calibrate shortly after it is loaded (within 24 hours), this will be the lot calibration. High Volume Assays: At any point during the 180 days after creation of the lot calibration, if you remove the original pack and load a new pack with the same lot, or pierce the second well of the pack, you do not need to calibrate the new pack/well because the lot calibration does not expire until day 180. If you keep replacing packs within 9 days, you only need to recalibrate every 180 days. Low Volume Assays: 9 days after the start of using the lot calibration, if the pack/well is still being used, it needs to be re-calibrated because the pack/well calibration interval has now expired. The calibration is a pack/well calibration, because a lot calibration must be done within the 180 day lot calibration limit for a newly loaded pack/pierced well. If the pack remains onboard, it will have to be recalibrated every 9 days until it reaches the reagent’s onboard stability. Summary: You don’t need to calibrate until you load a new lot, a pack is in use for more than 9 days or the lot calibration interval expires at 180 days. 5 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Reviewing Calibration Needs Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibration Needs QC Needs The Calibration Needs provides a prediction of the calibrations Calibrator Name Calibrator Lot Onboard Status Comment Assay Calibration Expiration Reagent Lot and Pack Analyzer Storable that need to be performed by the end of that day* based on CALFol CT84 Not Onboard L1,12 Fol Th 0min 284 00100 system settings. CT84 Not Onboard L1,12 Fo Dhomin 284 BA00104 A calibration need is created if one of following applies: • A pack or lot calibration will be ordered (based on the Test Definition settings) before the current day ends • There is a pending calibration order in the Worklist A need will also be created if a lot calibration is required and no fresh packs are available. In this case, the Comment field will display “No valid pack onboard “ . A need is red when the calibration is due to expire within the threshold set on the Alert Settings screen and there is no calibrator material available. Group by Calibrator Material Create Cal *NOTE: The ‘end of day’ can be configured using the Day Setting on the Settings > System Configuration > Reagent Requirements Settings screen . NOTE: If the All checkbox at the bottom of the screen is not checked, only needs for which the calibrator material is not available will display. This is the default setting. This topic is continued on the next slide. 6 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Reviewing Calibration Needs System 1 Samples Inventory Calibration Patient Orders 2 Workles Maintenance Setup To view the Calibration Needs: Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibration Needs QC Needs 1. At the Command Bar, select Inventory Calibrator Name Calibrator Lot Onboard Status Comment Assay 3 Calibration Expiration Reagent Lot and Pack Analyzer Storable CHEM CAL 2988738 2. Select Calibration Needs CHEM CAL 2008738 Onboard L2 - Partially Expired - No valid pack onboard DB4_2 0h 0 mir 190043 CM00113 CALTOXOG C447 3. To sort the data by selecting one of the column CALTONOG C447 Onboard L1,12 TaMO 0h 0 mis 247 00109 headings. The columns with the arrow indicators 6 C447 can be sorted C447 Onboard L1,L2 TaxO_ 247 LA00104 CALRub G C713 4. To view the calibrations for which the calibrator CALRub G C713 Onboard L1,12 Rub_G 213 00109 C713 material is both onboard and not onboard, select All C713 Onboard L1.12 Rib_G 213 LA0010 5. To group calibrator material by Calibrator Name, select CALHCY C8856 CALHCY C8856 Orboard L112 HCY 3h 0 m 185 00109 Group by Calibrator Material C8856 C8856 Onboard HCY 185 6. To consolidate the list, collapse each calibrator name 5 CALFol 4 CTB using the arrow to the left of the calibrator name Group by Calibrator Material B Create Cal Order 7. To create an order: ? PEP LabManager Tuesday, July 09. 2019 1:05:01 PM 8 A. Select the row for that calibration B. Select Create Cal Order C. Select Order 8. To print the Calibrator Needs, select the print icon in 7 the Status bar This topic is continued on the next slide. Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Reviewing Calibration Needs The information displayed for each calibration needed includes: • Onboard status: Whether the calibrator material is onboard or not onboard • If the status is “Onboard”, the material could be in either a Sample Handler drawer or in the Cal-QC storage area (SH configurations only) • Comment: Lists the level(s) of calibrator material needed • Will display “No valid pack onboard “ if a lot calibration is required and no fresh packs are available • Assay: Assays impacted by the calibration need • Calibration Expiration: Expiration date and time of the current calibration interval that requires calibration • If the Calibration Expiration is red, it indicates that the order will be generated within the threshold configured on the Alert Settings screen. The Reagent Overview screen, however, may display a green status for the well/pack in use at this time. • Reagent Lot and Pack: The appropriate reagent pack lot or “Any” if the order does not specify a reagent pack lot • Analyzer: The analyzer(s) associated with the calibration • Storable: Whether the calibrator material is storable onboard (Sample Handler configurations only) Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibration Needs QC Needs Calibrator Name Calibrator Lot Onboard Status Comment Assay Calibration Expiration Reagent Lot and Pack Analyzer Storable CALFol CT84 Not Onboard L1,L2 Fol 0h 0 min 284 00109 IM CT84 Not Onboard L1,L2 Fol 0 h 0 min 284 IA00104 8 Effective Date: 28-DEC-2020 | HOOD05162003154972 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Options for Reviewing Calibration Status ➢ Reagent Overview screen o Displays the calibration status and calibration intervals for reagent packs currently onboard the system (unopened CH wells are not displayed) o Ability to create calibration orders for reagent packs currently onboard the system ➢ Calibration Overview screen o Displays the order status and calibration intervals for reagent packs currently onboard the system o Provides the lot numbers of the calibrator and QC materials needed for the calibration o Ability to print calibrator and QC barcodes and a calibrator and QC material report The following slides have the procedures for each of these options. 9 IM Effective Date: 28-DEC-2020 | HOOD05162003154972 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Review Calibration Status: Reagent Overview Screen SIEMENS Healthineers Atellica® Solution Version 1.14.0.2975003 P-P1-04 To view information for onboard reagents on the Reagent 1 System Samples Inventory Calibration Patient Orders Worklist Maintenance Setup Overview screen: 2 Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs 3 1. On the Command bar, select Inventory All CM00110 00104 Reagents 4 Reagent Details Analyzer Reagent Inventory Onboard Cal Type QC 2. Select the Reagent Overview tab Stability Sequence Calibration Calibration Status Interval In Use Status Lot Cal Eligibility CM00110 Afc_3 182 78 d 22 h 00144 / 00102 OdOh 170007 Lot and Pack 3. If desired, select to view reagent information for all CM00110 ALP 2c 944 86 d 22 h 10030 / 10036 14 d 0h Lot 373121 Lot and Pack connected analyzers or a selected analyzer CM00113 ALP_2c 1188 89 d 21h 10040 / 10035 16 d 22 h Lot 373121 Lot and Pack CM0011 ALP_2c 129 24 d 22 h 10042 / 10038 11 d 22 h Lot 373121 Pack 4. To sort, select a column heading CM00113 ALT 327 27 d 2h 00833 / 01395 27 d 2 h Lot 270426 Pack CM00113 AST 536 86 d 22 h 00571 / 00572 26 d 23 h Lot 270313 Lot and Pack ➢ Calibration Status: to bring reagents that have an CM00110 AST 479 86 d 22 h 00428 / 00218 26 d 22 h Lot 270428 Lot and Pack invalid calibration or have not been calibrated to the CM00113 Acet 55 9 d 22 h 00075 / 00057 0 d 22 h Pack 160160 Pack top of the screen CM00113 Acet 135 4d1h 00079 / 00071 12 d 22 h 160160 Pack CM00113 Acet 89 11 d 2h 00090 / 00056 0 d 22 h Pack 160160 Pack ➢ Calibration Interval: to bring the reagents that have CM00110 Acet 47 11 d 2h 00102 / 00102 0 d 22 h Pack 160161 Pack CM00110 Acet 255 86 d 0 h a calibration that will expire soon to the top of the 00102 / 00102 0 d 22 h Pack 160162 Lot and Pack Group by reagent Disable Reagant Pack Disable Reagent Lot Unload screen ? PEP LabManager Monday, June 04, 2018 1:04:41 PM NOTE: If the Calibration Status is green, it indicates that is the current calibration status for the well/pack in use at this time. The Calibration Needs screen, however, may display a red Calibration Expiration status if an order will be generated within the threshold configured on the Alert Settings screen. * Refer to the Creating Calibration Orders section of this document for 10 information on using the Reagent Overview screen to create calibration orders IM Effective Date: 28-DEC-2020 | HOOD05162003154972 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Review Calibration Status: Calibration Overview Screen SIEMENS Atellica® Solution Version 1.15.0.3080004 P-P1-04 Healthineers 1 To view calibrations: System Samples Inventory Calibration Qc Patient Orders Worklist Maintenance Setup 2 Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMT Calibration 1. On the Command Bar, select Calibration Filters 3 4 Analyzer Assay Analyzer Order Calibration Pack Barcode Calibrator Lot QC Material Extend Calibrition Status Cal Type Interval Reagent Lot 2. Select the Calibrator Overview tab Conf P1-02 Pack 134 00728:Well 1 Undo Extend C3934 Assays Result Details MALT C-P1-05 Lot 270427 3. Use the Filters area to filter by Analyzer, Assays, Expiration Cal-QC Inventory Conf P1-02 Lot odOh 134 C3934 Calibration Expiration, and Order Status Expired Crea_2 C-P1-05 Lot OdOh 260249 135808B 26431,26432 Expires Within Print Material Report Amylas C-P1-05 Pack 0 d 19 h 270434 00011:Well 1 26431,26432 ➢ The Expires Within filter can be used to display only Order Status Print BarCode Amylas C-P1-05 Pack 0d 21 h 270434 00011: Well 2 00 26431,26432 Ordered calibrations that will expire within a time range Processing CO2_ C-P1-05 Lot 1d1h 160144 978178 26431,26432 (options from 4 hours up to 72 hours) Intervention Needed UN_c C-P1-05 Pack 2 d 0h 260239 11408:Well 2 135808B 26431,26432 Error AFP P1-02 Lot 2 d 21 h 204 06571 ➢ The Order Status filter can be used to display Ordered, Crea_2 C-P1-05 Pack 3 d 20 h 260249 00047:Well 2 135808B 26431,26432 aHAVM P1-02 Pack 4d5h 171 00338: Well 1 C3924 7030071,7030072 Processing, Intervention Needed, and Error statuses Vanc C-P1-05 Pack 4 d 20 h 170228 00376:Well 1 C335 4. To sort, select a column heading Vanc C-P1-05 Pack 4 d 20 h 170228 00716:Well 1 C335 Group by assay ➢ The Calibrator Lot column displays the lot number of ? PEP LabManager Wednesday, October 03, 2018 1:50 PM the calibrator material needed to run that calibration ➢ The QC Material column displays the lot number(s) of *NOTE: “Perform QC with Calibration” is either selected when the calibration order the QC material(s) that are required to be run with is created on the Create Calibration Orders screen (in the Edit Calibration Order that calibration. If there is nothing listed , the window), or configured for the assay in Setup > Test Definition. “Perform QC with Calibration” has not been selected* 11 * Information on the Calibration Overview screen is continued on the next slide Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Review Calibration Status: Calibration Overview Screen SIEMENS Atellica® Solution Version 1.15.0.3080004 P-P1-04 Healthineers Red and yellow highlights alert the operator to critical and System Samples Inventory Calibration Qc Patient Orders Worklist Maintenance Setup Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMT Calibration impending warning calibration or QC events. Filters Y Analyzer Assay Analyzer Order Calibration A Status Cal Type Interval Reagent Lot Pack Barcode Calibrator Lot QC Material Extend Calibrition Red alert highlight: P1-02 Pack 134 00728:Well 1 Undo Extend C3934 Assays Conf Result Details Calibration or QC material status is Expired or Invalid MALT C-P1-05 Lot 270427 • Expiration Cal-QC Inventory Conf P1-02 Lot odOh 134 C3934 • The master curve for an IM assay is missing Expired Crea_2 C-P1-05 Lot OdOh 260249 135808B 26431,26432 Expires Within Print Material Report Amylas C-P1-05 Pack 0 d 19 h 270434 00011:Well 1 26431,26432 Yellow alert highlight: Order Status Print BarCode C-P1-05 Pack 0d 21 h 270434 00011: Well 2 00 26431,26432 Ordered Amylas Processing co2_ C-P1-05 Lot 1d1h 160144 978178 26431,26432 • Calibration status of Expires Soon Intervention Needed UN_c C-P1-05 Pack 2 d 0h 260239 11408:Well 2 135808B 26431,26432 K Error AFP P1-02 Lot 2 d 21 h 204 06571 • Calibration acceptance data requires operator Crea_2 C-P1-05 Pack 3 d 20 h 260249 00047:Well 2 135808B 26431,26432 intervention to accept or reject the calibration aHAVM P1-02 Pack 4d5h 171 00338: Well 1 C3924 7030071,7030072 Vanc C-P1-05 Pack 4 d 20 h 170228 00376: Well 1 C335 • Calibrator or QC material is not onboard the system Vanc C-P1-05 Pack 4 d 20 h 170228 00716:Well 1 C335 • QC requires operator intervention Group by assay ? PEP LabManager Wednesday, October 03, 2018 1:50 PM * Information on the Calibration Overview screen is continued on the next slide 12 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Review Calibration Status: Calibration Overview Screen SIEMENS Atellica® Solution Version 1.15.0.3080004 P-P1-04 Healthineers The following tasks can be performed: System Samples Inventory Calibration Qc Patient Orders Worklist Maintenance Setup Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMT Calibration A. Extend Calibrations – to extend the calibration beyond the Filters Y A Analyzer Assay Analyzer Order Cal Type Calibration A Extend Calibration Status Interval Reagent Lot Pack Barcode Calibrator Lot QC Material original expiration date. Results will be flagged as Undo Exten B Conf P1-02 Pack 134 00728:Well 1 C3934 Assays Extended. This option is available for lot calibrations but Result Details MALT C-P1-05 Lot 270427 C Expiration Cal-QC Inventory not available for pack calibrations. Available for all CH D Conf P1-02 Lot odOh 134 C3934 Expired assays and certain IM assays as defined by the Test Crea_2 C-P1-05 Lot OdOh 260249 135808B 26431,26432 Expires Within Print Material Report Amylas C-P1-05 Pack 0 d 19 h 270434 00011:Well 1 26431,26432 Definition Order Status Print BarCode Amylas C-P1-05 Pack 0d 21 h 270434 00011: Well 2 00 26431,26432 Ordered ➢ Recalibrate an extended calibration as soon as possible Processing co2_ C-P1-05 Lot 1d1h 160144 978178 26431,26432 Intervention Needed UN_c C-P1-05 Pack 2 d 0h 260239 11408:Well 2 135808B 26431,26432 K B. Undo Extend – returns an extended calibration interval to Error AFP P1-02 Lot 2 d 21 h 204 06571 Crea_2 C-P1-05 Pack 3 d 20 h 260249 00047:Well 2 135808B 26431,26432 the original calibration interval expiration date aHAVM P1-02 Pack 4d5h 171 00338: Well 1 C3924 7030071,7030072 C. Result Details – displays the Calibration Results screen Vanc C-P1-05 Pack 4 d 20 h 170228 00376: Well 1 C335 Vanc C-P1-05 Pack 4 d 20 h 170228 00716:Well 1 C335 D. Cal-QC Inventory – displays the Cal-QC Storage Inventory Group by assay screen ? PEP LabManager Wednesday, October 03, 2018 1:50 PM NOTE: Do not extend a calibration unnecessarily. Extending calibrations may cause erroneous results. The calibration is extended for 180 days. * Information on the Calibration Overview screen is continued on the next slide 13 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers SIEMENS Healthineers Atellica® Solution Version 1.15.0.3080004 P-P1-04 Review Calibration Status: Calibration Overview Screen 160 System Samples Inventory Calibration Qc Patient Orders Worklist Maintenance Setup Calibration Overview Create Calibration Orders Calibration Results To print a calibrator and QC materials report: Calibrator Definitions IMT Calibration Filters Select the desired calibration(s) Analyzer Assay Analyzer Order Cal Type Calibration Interval Reagent Lot Pack Barcode Calibrator Lot QC Material Extend Calibration 1. Status Assays Conf P1-02 Pack 134 00728:Well 1 C3934 Undo Extend 2. Select the Print Material Report button Result Details MALT ;-P1-05 Lot 270427 Expiration A Conf P1-02 A Lot 134 C3934 Cal-QC Inventory OdOh 3. The Print Calibrator or QC Material window opens. Expired Crea_2 C-P1-05 Lot OdOh 260249 135808B 26431,26432 Expires Within 2 Print Material Report This provides a list of the calibrator and QC materials Amylas C-P1-05 Pack 0 d 19 h 270434 00011:Well 1 00 26431,26432 Order Status Print BarCode C-P1-05 0d 21h 270434 00011:Well 2 26431,26432 needed for the selected calibrations. Includes the Ordered Amylas Pack X Processing CO2_c C-P1-05 Lot 1d 1h 160144 978178 26431,26432 material name, lot, and level. To sort the list, select a Intervention Needed UN_C C-P1-05 Pack 2d0h 260239 11408:Well 2 135808B 26431,26432 K column heading 3 Print Calibrator or QC Material 1 X 06571 A 135808B 26431,26432 A. The Storable column indicates if that material is Type Material Lot Level Status Expiration Assays Storable C3924 7030071,7030072 defined to be stored in Cal-QC storage. If the Cal Chem Cal 1358088 OK 9/30/2019 11:59 Alb,Ca,Chol_2,Crea_2,GluH_3,IP,Iron_2,Mg, PM TBil_2,TP,Trig, UN_c V C335 Alb,ALP_2c,ALT,Amylas,Ca,Chol_2,CO2_c,Cr material is storable, check the Cal-QC Inventory QC 26431 26431 OK 2/29/2020 11:59 PM ea_2,GluH_3,IP,Iron_2,TBil_2,TP,UN_c.NA.K. C335 CL Alb,ALP_2c,ALT,Amylas,Ca,Chol_2,CO2_c,Cr screen to determine if the material is currently QC 26432 26432 2 OK 2/29/2020 11:59 PM ea_2,GluH_3,IP,Iron_2,TBil_2,TP,UN_c.N.A.K. V CL onboard Wednesday, October 03, 2018 1:50 PM 4. Select the Print button to print the materials report * Information on the Calibration Overview screen is continued on the next slide ? 4 Print Cancel 14 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers SIEMENS P-P1-04 Healthineers Atellica® Solution Version 1.15.0.3080004 Review Calibration Status: Calibration Overview Screen 160 System Samples Inventory Calibration Qc Patient Orders Worklist Maintenance Setup Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMT Calibration To print calibrator and QC barcodes: Filters Analyzer Assay Analyzer Order Cal Type Calibration Interval Pack Barcode Calibrator Lot QC Material Extend Calibration 1. Select the desired calibration(s) Status Reagent Lot Undo Extend Assays Conf P1-02 Pack 134 00728:Well 1 C3934 Result Details Select the Print BarCode button MALT ;-P1-05 Lot 270427 2. Expiration Cal-QC Inventory Conf P1-02 A Lot OdOh 134 C3934 3. The Print Calibrator or QC Barcode window opens. Expired Crea_2 C-P1-05 Lot OdOh 260249 135808B 26431,26432 Expires Within Print Material Report This provides a list of the calibrator and QC materials Amylas C-P1-05 Pack 0 d 19 h 270434 00011:Well 1 00 26431,26432 2 Order Status Print BarCode Amylas C-P1-05 Pack 0d 21h 270434 00011:Well 2 26431,26432 needed for the selected calibrations. To sort the list, Ordered Processing CO2_c C-P1-05 Lot 1d 1h 160144 978178 26431,26432 select a column heading 1 Intervention Neede UN_C C-P1-05 Pack 2d0h 260239 11408:Well 2 135808B 26431,26432 K 3 Print Calibrator or QC Barcode X 06571 4. Select the Print button to print barcodes for all the 135808B 26431,26432 Type Material Lot Expiration materials listed C3924 7030071,7030072 Cal Chem Cal 1358088 9/30/2019 11:59 PM C335 QC 26431 26431 2/29/2020 11:59 PM C335 QC 26432 26432 2/29/2020 11:59 PM Wednesday, October 03, 2018 1:50 PM ? 4 Print Cancel 15 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers SIEMENS. Healthineers Atellica® Solution Version 1.14.0.2951003 P-P1-03 Installing New Calibrator Definitions 1 System Samples Inventory Calibration Oc Patient Orders Worklist Maintenance Setup Calibrator definitions must be installed when a new lot of calibrator Calibration Overview Create Calibration Orders Calibration Re 2 Calibrator Definitions IMT Calibration will be used. To install a new calibrator definition: Filters Assays Material Name Lot ID Material ID Expiration Date Assays Add New A1c 7CD070 70 5/1/2019 11:59 PM A1c_3, tHb Edit 1. On the Command Bar, select Calibration Status Expired ENZ1 7CD069 69 3/1/2018 11:59 PM LDLP, GGT Derote 2. Select the Calibrator Definitions tab Active Add Calibrator Definition 4 HDULDL 412577 77 3/1/2018 11:59 PM D_HDL, DLDL Print Barcode 5 X Calibrator Material Assay Type Material Name Material ID Lot ID Expiration Date Revision 3. Scan the barcode(s) from the calibrator lot-specific value sheet Measuring Interval Verification Material CH Tox Ca TO 729099 5/31/2018 Active Store Onboard using the barcode reader (the value sheet can be found in the Search box with the calibrator material) Select Tests Assigned Values 6AM A1c_3 AAG Cal Code Assay Level1 Level 2 Units AAT Acet Alb 102 Ace 9.2 mg/dL X O ➢ IM assays: all the linear barcodes on the value sheet must AlbP ALP_20 ALT be scanned ALTPLC Amm Amp 1K ➢ Amp300 Amp500 Amylas CH assays: the 2D barcode on the value sheet is scanned APO A1 APO B ASO_2 Confirm the scanned information on the Add Calibrator AST ASTPLC B2M 4. BLUE Bnz200 Bnz300 Definition window Brb200 Brb300 Bupn C3 C4 Ca 5. To enable the calibrator material for calibration, select the Caff Carb Che Active checkbox ? Add Assay by Cal Code Print Save Cancel ➢ More than 1 calibrator definition may exist on the system for an assay. To ensure the system uses the calibrator definition as the primary calibrator when calibrating a reagent directly from Inventory > Reagent Overview, * This procedure is continued on the next slide deselect the Active checkbox for additional calibrator 16 definitions associated with the assay Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers SIEMENS. Healthineers Atellica® Solution Version 1.14.0.2951003 P-P1-03 Installing New Calibrator Definitions (continued) System Samples Inventory Calibration Oc Patient Orders Worklist Maintenance Setup 6. If storing the calibrator in the Cal-QC storage area, select the Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMT Calibration Filters Store Onboard checkbox (only applies to Sample Handler Assays Material Name Lot ID Material ID Expiration Date Assays Add New A1c 7CD070 70 5/1/2019 11:59 PM A1c_3, tHb Edit configurations) Status ENZ1 7CD069 69 3/1/2018 11:59 PM LDLP, GGT Expired ➢ Certain assay calibrators are not compatible with onboard Active HDU/LDL 412577 77 3/1/2018 11:59 PM D_HDL, DLDL Print Barcode Add Calibrator Definition 6 X storage in the Cal-QC area. The operator cannot select the Calibrator Material Assay Type Material Name Material ID Lot ID Expiration Date Revision CH Tox Ca TO 729099 5/31/2018 Active Store Onboard Store Onboard checkbox and save a calibrator definition Measuring Interval Verification Material that includes an assay that is incompatible with onboard Search Select Tests Assigned Values storage 6AM Cal A1c_3 AAG Assay Level1 Level 2 Code Units AAT X Acet Alb 102 Ace 9.2 mg/dL O 7. Select Save AlbP ALP_20 ALT ALTPLC Amm Amp 1K Amp300 Amp500 Amylas APO A1 APO B ASO_2 AST ASTPLC B2M BLUE Bnz200 Bnz300 Brb200 Brb300 Bupn C3 C4 Ca Caff Carb Che 7 ? Add Assay by Cal Code Print Save Cancel NOTE: If the barcode reader is not available, the calibrator definition can be manually added by selecting the Add New button on the Calibrator Definitions screen. 17 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Editing Calibrator Definitions Healthineers Atellica Solution Version 1.14.0.2951003 SIEMENS P-P1-03 1 A 999 System Samples Inventory Calibration Qc Patient Orders Worklist Maintenance Setup To edit a calibrator definition: Calibration Overview Create Calibration Orders Calibration Res 2 Calibrator Definitions IMT Calibration 1. On the Command Bar, select Calibration Filters 3 Assays Material Name Lot ID Material ID Expiration Date Assays Add New 4 3/1/2018 11:59 PM LDLP, GGT 7 ENZ1 7CD069 69 Edit 2. Select the Calibrator Definitions tab Status Expired HOULDL 412577 77 3/1/2018 11:59 PM D_HDL, DLDL Delete 5 6 Active Tox Cal 7290999 TO 5/31/2018 11:59 PM Acet Print Barcode 3. To remove existing filters, select from the Filters area Inactive Drug Cal 780053 53 9/1/2019 11:59 PM Theo X OOO CALUL C1022 4/4/2018 11:59 PM Tnl_UL 4. To view a calibrator definition for an assay, select from the Assays dropdown menu in the Filters area Add Calibrator Definition 8 × Calibrator Material Assay Type Material Name Material ID Lot ID Expiration Date Revision O Measuring Interval Verification Material CH Tox Cal TO 7290999 5/31/2018 1 Active Store Onboard 5. To view calibrations with a specific status, select a Status filter Search Select Tests Assigned Values 6. Select a calibrator definition Cal 6AM A1c_3 AAG Code Assay Level 1 Level 2 Units AAT Acet Alb 102 Acet 0 9.2 mg/dl X 7. Select Edit AlbP ALP_2c ALT ALTPLC Amm Amp1K 8. The following edit options are available: Amp300 Amp500 Amylas ? PEP. APO A1 APO B ASO 2 Add an assay AST ASTPLC B2M – BLUE Bnz200 Bnz300 Delete an assay Brb200 Brb300 Bupn – C3 C4 Ca Modify the level values from the calibrator value sheet Caff Carb Che – 9 Correct the expiration date ? Add Assay by Cal Code Print Save Cancel – Activate or deactivate the calibrator – Enable Store Onboard – 18 9. Select Save Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Print Calibrator Barcodes – Calibrator Definitions screen SIEMENS Healthineers Atellica Solution Version 1.16.0.3124001 1 SP00107 Calibrator barcodes must be printed using the Atellica System Samples Inventory 2 Calibration Qc Patient Orders Worklist Maintenance Setup Solution software to ensure that each barcode has the correct Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMT Calibration sequence number. Filters 3 Assays Material Name Lot ID Material ID Expiration Date Assays Add New CALC CC53 01/04/2019 11:59:59 PM VB12, Fer Edit To print calibrator barcodes from the Calibrator Definitions Status O CALRub G C703 12/14/2018 11:59:59 PM Deleto Expired Rub_G screen: Active TOX Cal 72909627 TO 02/28/2019 11:59:59 PM Acet, Sal 5 Print Barcode O Inactive Audit Chem 06580 AC 01/05/2019 11:59:59 PM Alb, ALT, DBil_2, Crea_2, TP, GluH_3 1. On the Command Bar, select Calibration Audit IM Print Calibrator Barcode X 2. Select the Calibrator Definitions tab A1c_3 CAL Material Name Lot ID Material ID Expiration Date CALaHAVM 3. To limit the number of Calibrator Definitions that display, CALD CALA CA98 01/15/2019 11:59:59 PM V 4 use the filters in the Filters area of the screen V CALA CALD CD94 10/16/2019 11:59:59 PM Audit TDM TOX Cal 72909627 TO 02/28/2019 11:59:59 PM 4. Select the material name for 1 or more calibrator CALHBSII DRUG CAL definitions LSP CAL 5. Select the Print Barcode button Audit 1.14.2 ➢ The system displays all selected calibration definition ? PEP Labl barcode labels in the Print Calibrator Barcode screen 6. Select Print ➢ Barcodes print on the system barcode label printer ? 6 Print Cancel 19 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Options for Creating Calibration Orders ➢ Create calibration orders manually using the active calibration lot for reagent packs currently onboard the system using the Reagent Overview screen ➢ Create calibration orders manually using the Create Calibration Orders screen. This method is useful in the following cases: • To use a calibrator lot other than the active lot • To add QC to the calibration order (if the option to automatically Perform QC with Calibration setting in Setup is turned off) • To order for multiple assays or analyzers at once ➢ Configure the system to automatically create calibration orders The following slides have the procedures for each of these options. 20 IM Effective Date: 28-DEC-2020 | HOOD05162003154972 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Configuring Automatic Calibration Ordering 1. Select Setup on the Command Bar SIEMENS Healthineers Atellico" Solution Version 1.14.0.2974006 P-P1-03 2. Select the Test Definition tab 1 System Samples Inventory Calbration OC Patient Orders Worldest Maintenance Setup 2 Test Definition Settings Accounts 3. Select either IM Test Definition or CH Test Definition Assay List Fzer Ranges 4. Select the assay 5 CH Test Definition Assay Definition Calculation Calibration 4 Reflex Group Setup General Acceptance Measuring Interval Verification 3 IM Test Definition 6AM (8053) Acceptance 5. Select the Calibration tab Alc_3 (705) Automatically Order Calibrations 6 Calibration Interval Repeat Conditions Ratios, Panels, and Off- System (60LL) DY Lot Calibration Expiration (Days) Lot Calibration Interval (Days) 52 Restore Defaults 6. Select the Automatically Order Calibrations checkbox Test Display Order AAT (1110) V Pack Calibration Expiration (Hours) Acet (102) Pack Calibration Interval (Days) Open Channel Alb (1106) New Lot 7 7. Select the criteria to trigger the system to Calibrator Onboard Stability (Hours) Sort Test Definition NbP (148) IFU Changed automatically order a calibration: ALP_2c (1108) Refrigerated 72 Perform QC with Calibration ALT (1105) Unrefrigerated 168 • Lot Calibration Expiration – set the number of days ALTPLO (4035) Amen (116) prior to the expiration of a lot calibration • Pack Calibration Expiration – set the number of hours prior to the expiration of a pack calibration • New Lot • IFU Changed 21 IM Effective Date: 28-DEC-2020 | HOOD05162003154972 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Creating Calibration Orders Manually – Reagent Overview SIEMENS Healthineers Atellica Solution Version 1.14.0.2975003 P-P1-04 Screen 1 System Samples Inventory Calibration Patient Orders Worklist Maintenance Setup On the Command Bar, select Inventory 2 Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs 1. 3 CM00110 4 All CM00113 00104 2. Select the Reagent Overview tab Reagents Reagent Details Reagent Inventory Onboard Stability Sequence Calibration Calibration Cal Type In QC Interval Use Status Lot Cal Eligibility 00266 00922 Status 3. Select the analyzer Name Amylas AST 476 86 d 22 h 00428 / 00218 26 d 22 h Lot 270428 Lot and Pack Lot ID 270433 Acet 44 11 d 2 h 00102 / 00102 0 d 22 h Pack 160161 Pack Pack Location CH Reagent Compartment 1 4. To sort, select a column heading Position 43 Acet 255 86 d 0 00102 / 00102 0 d 22 h Pack 160162 Lot and Pack Status Idle Sequence Number 00266 ➢ Calibration Status: to bring reagents that have an Alb 1700 86 d 22 h 00060 58 d 16 h Lot 260227 Lot and Pack Paired Pack 00922 Alb 1698 86 d 22 h 00187 57 d 3 h Lot 260227 Lot and Pack Count Remaining 338 invalid calibration or have not been calibrated to Onboard Stability 8/22/2018 1:36:31 PM Alb 0 63 d 22 h 00220 47 d 23 h 260227 Lot Expiration 9/1/2018 11:59:59 PM the top of the screen Calibration Expiration 5/31/2018 10:29:05 AM 5 Amylas 338 79 d 0 h 00266 / 00922 OdOh 270433 Lot and Pack Well 1 K CO2_c 469 21 d 22 h 01230 0d 22 h Lot 841088 Pack Test Count 163 Ready ➢ Calibration Interval: to bring reagents with a Time Punctured 5/24/2018 1:38:04 PM Ca 851 50 d 20 h 00301 / 00252 2 d 22h Pack 270449 Lot and Pack Calibra Calibrate Pack calibration that will expire soon to the top of the Well 2 Chol_2 386 13 d 21 h 00657 1 d 23 h Pack 270467 Pack Test Count 175 Sealed screen Crea_2 910 84 d 21 h 00061 / 00045 0 d 21 h Lot 260249 Lot and Pack Calibrate Lot Calibrate Pack DLDL 53 12 d 2h 00292 / 00290 12 d 2 h Lot 444445 Pack Submi 5. Select the desired reagent pack Group by reagent Disable Reagent Pack Disable Reagent Lot Unload ? PEP LabManager Monday, June 04, 2018 1:06:14 PM * This procedure is continued on the next slide Calibration Status Glyphs: Green – Valid calibration exists Yellow – The pack supports more than one assay and not all assays are calibrated Red – Invalid calibration or the pack does not have a calibration 22 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Creating Calibration Orders Manually – Reagent Overview SIEMENS Healthineers Atellica Solution Version 1.14.0.2975003 P-P1-04 Screen (continued) System Samples Inventory Calibration Patient Orders Worklist Maintenance Setup In the Reagent Details area of the screen, select the Reagent Overview Reagent Loader Reagent Needs Supplies Overview 6. Reagent Lot Comparison Cal-QC Storage Inventory Cal-QC Needs CM00110 appropriate button to order either a pack calibration or All CM00113 00104 Reagents Reagent Details a lot calibration Reagent Inventory Onboard Stability Sequence Calibration Calibration Cal Type In QC Status Interval Use Status Lot Cal Eligibility 00266 00922 Name Amylas AST 476 86 d 22 h 00428 / 00218 26 d 22 h Lot 270428 Lot and Pack ➢ If there are multiple wells in the pack, there will be Lot ID 270433 Acet 44 11 d 2 h 00102 / 00102 0 d 22 h Pack 160161 Pack Pack Location CH Reagent Compartment 1 Position separate options to calibrate each well 43 Acet 255 86 d 0 00102 / 00102 0 d 22 h Pack 160162 Lot and Pack Status Idle 86 d 22 h 00060 58 d 16 h Lot 260227 Lot and Pack Sequence Number 00266 Alb 1700 ➢ The options available will depend on what type of Paired Pack 00922 Alb 1698 86 d 22 h 00187 57 d 3 h Lot 260227 Lot and Pack Count Remaining 338 Onboard Stability 8/22/2018 1:36:31 PM calibration the pack is eligible for (pack/lot) Alb 0 63 d 22 h 00220 47 d 23 h 260227 Lot Expiration 9/1/2018 11:59:59 PM Calibration Expiration 5/31/2018 10:29:05 AM Amylas 338 79 d 0 h 00266 / 00922 OdOh 270433 Lot and Pack Well 1 7. If the reagent includes multiple assays, the system will CO2_c Test Count 163 469 21 d 22 h 01230 Ready 0d 22 h Lot 841088 Pack Time Punctured 5/24/2018 1:38:04 PM display a menu listing the analytes. Select the Ca 851 50 d 20 h 00301 / 00252 2 d 22h Pack 270449 Lot and Pack 6 Calibra Calibrate Pack Well 2 appropriate assay name in the displayed list Chol_2 386 13 d 21 h 00657 1 d 23 h Pack 270467 Pack Test Count 175 Sealed Crea_2 910 84 d 21 h 00061 / 00045 0 d 21 h Lot 260249 Lot and Pack Calibrate Lot ➢ Calibrate Pack For example, if the operator selects HBsII the DLDL 53 12 d 2h 00292 / 00290 12 d 2 h Lot 444445 Pack Submit displayed menu includes HBsII and CONF. The Group by reagent Disable Reagent Pack Disable Reagent Lot Unload operator selects HBsII or CONF as appropriate ? PEP LabManager Monday, June 04, 2018 1:06:14 PM 8. Select Yes in the confirmation window NOTE: When calibrating reagent packs or wells directly from Reagent Overview, the system requires 1 active calibrator definition. If more than 1 calibrator definition exists on the system for a reagent, the system defaults to using the oldest calibrator material and definition to calibrate the reagent. 23 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Calibration Healthineers Creating Calibration Orders Manually – Create Calibration SIEMENS Healthingers Atellica Solution Version 1.14.0.2974006 P-P1-05 Orders Screen 1 System 2 Samples mentory Calibration Patient Orders Worklist Maintenance Setup On the Command Bar, select Calibration Calibration Overview Create Calibration Orders Calibration Results 1. Calibrator Definitions Select Assays Calibrator Material 2. Select the Create Calibration Orders tab Select Analyzer LA-01 IM Cal Name Cal ID Cal Lot Cal Lot Exp Assays 3 Search + CALD CD82 2018-Apr-04 AFP. CEA 4 3. Select the tests to be ordered AFF aHBcM CEA CPLR100 PrimeAl PrimeAB_A 4. If the selected test has multiple calibrator materials Primet-20 Primet20_A PrimeAP defined for it, the calibrator materials will appear in the PrimeRP2 PrimeRP'S PrimeWt Calibrator Materials area of the screen PrimeW1_A APIWWash RPZWWash Orders 5 RPJWWash ThCG TSHJUL X Cal Name Reagent Lot Tests Remaining | Analyzer identifier Assay Cal Lot Pack ID Edit Cal Order ➢ Select one or more materials to include in the xABFish xABFish1 *CAPILR x + CALHBEM 160 IA-01 : (IA) HBM C5760 6 Edu Cal Order order xCAPISP xCAPI *CAPZUR x + CAB ThCG C867 Edt Cal Cider XCAP2SP XCAP3LR *CAPJSP ➢ Once selected, the calibrator test orders will appear xSMH2001 «SMH2002 xSMH2003 in the Orders area of the screen XSMT 110 Calibration Results 1 (L) Assay AFP Units ng/ml Replicate Include Analyte Signal Flag Calculation Type Linear Include Analyte + Signal + Flag Select a calibration Ordered Date 9/30/2018 9:33:55 AM 2. 6593.00 RLU 147.81 ng/ml 102297.00 RLU Completed Date 10/1/2018 9:45:36 AM Replicate 1 3.15 ng/ml Accepted By Replicate 2 3.15 ng/ml 6592.00 RLU V Analyzer Name P1-02 146.22 ng/ml 101333.00 RLU 3. Select Details Analyzer Serial Number I-P1-02 Reagent Lot 204 Edit Pack/Well P04120-02583:Well 1 Ancillary 1 4. Select Print Ancillary 1 Lot/Pack Ancillary 2 Mean 3.15 6592.5 147.02 101815.00 Ancillary 2 Lot/Pack To view the data, select Preview… Calibrator Name CALD CALD Concentration 5.18 231.00 5. Calibrator Lot CD86 CD86 Cal Status Valid Observed %CV 0.00 0.01 0.76 0.67 Acceptance Criteria OK 6. To print, select OK Acceptance Mode Automatic Acceptable CV 0.00 12.00 0.00 6.30 Trigger Mode Pack Calibration Expired Cal Expiration 10/29/2018 9:45:36 AM QC Performed with Calibration Acceptance Criteria 7. To print to a file: QC QC Limits New Observed Old Observed Criteria Result Value Expected Observed A. Select Print to file Signal slope Pass 1.49 0.375 - 4.625 Signal ratio Pass 14.44 7.174 - 35.026 B. Browse to select file name and location Allowed Low Level Deviation Pass -0.12 1.27 - 0.47 C. Select OK ? Print Accept Reject Close 33 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020 SIEMENS Healthineers Please note that the learning material is for training purposes only! For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator's Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Atellica, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability. Copyright © Siemens Healthcare GmbH 2020 Global Siemens Healthineers Headquarters Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84 0 siemens.com/healthineers 34 Effective Date: 28-DEC-2020 | HOOD05162003154972 Unrestricted © Siemens Healthcare GmbH, 2020