Reviewing Calibration Results on the Atellica® Solution Video Version 1.25 and Below

The work list overview screen can be used to view the status of calibration test orders and results. To view the work list overview screen at the Command Bar, Select work list. The first tab is the Worklist overview tab. The filter area of the screen is used to filter the orders that are displayed under sample type. Calibrater can be selected. The main area of the screen displays the result time for inprogress test orders. For orders with results, an indication of whether the result is valid or invalid will display. To view details on calibration results, select either the ID or test name for that order or select the order and then select the edit slash view button. The calibration results details window displays for the selected calibration result. The information area of the results details window provides a summary of the information for the calibration result. The data area of the screen displays the measurements from each calibrater replicant and the average and SD for each calibration level, if applicable. The include checkboxes can be used to manually exclude or include replicant results in order to exclude a replicant. The minimum number of replicates the system requires for a valid calibration must remain after the exclusion of the replicant. After excluding an outlier replicant results, the system recalculates the calibration data an rechecks the calibration criteria. If a replicant is excluded, enter the reasons for excluding the replicant in the comments area by selecting the edit button. The QC performed with calibration area of the screen provides a summary of QC results for any QC tests that were automatically performed with the calibration. The acceptance criteria area of the screen displays the criteria used by the system to evaluate the calibration and indicates whether each criteria failed or passed. The graph area of the screen displays a graph of the calibration results to display a larger view of the graph, select the enlarge button. There are options to accept or reject the calibration with awaiting acceptance status. The system will prompt you to enter a comment to document the reason for accepting or rejecting the calibration. Select the print button to print the detailed information for the selected calibration. This feature provides the option to print to a printer or to save a file with the detailed information. Select the close button to return to the work list overview screen. Another way to access calibration result information is using the calibration results screen to access this screen at the command bar, select calibration. Then select calibration results. The calibration results screen can be used to export or print a detailed calibration report an to troubleshoot calibration results, the filters area of the screen can be used to filter the results displayed based on analyzer assay, reagent lot or pack date range an attributes. The calibration results area displays information including calibration lot number, calibration status, calibration expiration and reagent lot. The data can be sorted by selecting one of the column headings. For calibration results within awaiting acceptance status, the operator can accept or reject the result on this screen or on the calibration results details screen. To view the calibration results details screen for a selected result, select the details button. This is the same screen that can also be accessed from the Worklist overview screen. Select the export button on the calibration result screen to export a file with the calibration data for selected calibration results. This screen also provides options to edit or delete calibration orders that have not yet resulted. This completes our overview of reviewing calibration results.

SIEMENS . Atellicae Solution Version 1.16.0.3124001 Atellicas Solution Version 1.16.0.3124001 SIEMENS Atellica' Solution Version 1.16.0.3124001 spoon Healthineers HeoLtnineers Calibration Results Details for CEA on SIEMENS Calibration Results Details for DBil 2 on c-P1-06 c-P1-cs Healthineers Information Comments Information Calibration Expibrmation Commficients Comments Ovserview Observied Overview Ovderview Create Orders Create Calibration Orders Monitoring Calibration Results Calibrator Definitions 'MT calibration Pack Calibration Information Cal Expiration Activity Re."ent Lot Reagent Lot Assay CEA Assay Units units Include Ana Me Signal Flag Flags units Order Date Time Filters Filter Sam* Type Sam* Type Sam* Tests 7 By Calculation Ty Linear Repucate Rephcate Repuicate Include Analyte Analyzer Analyter Signal Flag Flags Calculation Ty Ty Sample AM Analyzer Assay In the Cal Status column, red indicates the calibration is expired, rejected, or Reagent Lot 3185 Order Status 10204 PM 10:58 AM 101502 AM PM AM Accept Acceptance Acceptance Acceptance C In the Assay column, a check mark indicates that the system is using the active calibration to calculate patient results. In the Assay column, a check mark indicates that the system is using the active calibration to calculate patient results Assay Analyzer Result Date cal status Cal Status cal Exp Reagent Reagent Lot pack/WeIl Reagent Pack Flags ordered order orderved Replicate 2 Replicate 3 Replicate I 000 mg'dL 392 mg,'dL O, 00 mg'dL 0.00 mg,'dL 000 mg'dL_ mg'dL mg'dL_ 393 -57 35 Date 4r9,201g 22825 PM 4/9/2012 22825 PM 4r9,201g 228:25 PM the calibration acceptance criteria exceeds limitations and the cahbration is To be able to select to view the other attributes, you must first select an analyzer. basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. Assay PI .02 Replicate 1 Replicate I 10530.00 2970 Accepted By Acceptance Acceptance C Acceptance Acceptance Ce Automatically ac Automatically accepted FSH 02/07/2018 3:53: 15 PM Vnvalid. Invalid. 021211201B PM 02/21/2013 PM Type Rejected Reject Analyzer Replicate I Replicate 3 000 mg'dL_ 0.00 mg'dL_ 0.00 mg,'dL -041 391 mgIdL 391 mg/dL 0.00 mg,'dL 392 mg,'dL 000 mg'dL mg'dL_ 3,91 3,93 Analyzer Name Analyzer Serial Analyzer Namber TOX Cal Reagent Lot Rea gent Lot Reagent Pack Analyzer Serial Analyzer Name Analyzer Serial Number ALT 09.'04,2018 PM 09.'04,'2018 PM 09.04/2013 PM 01/13/2019 PM 09/14/2018 PM 01/13/2019 22902 PM 102s/2018 AM 01/14/2018 PM 01/130019 22902 PM 11/14/2018 PM Details 170112 Replicate I Replicate 2 Replicate 3 -0.43 392 393 392 mg,'dL -5702 -57027 -5714 Expibration Information Ccalibration Lot 0.00 mg,'dL_ 0.00 mg,'dL 392 mg,'dL 000 mgIdL 0.00 mg,'dL -56.74 10:58 AM 1058 AM PM AM P04017-01394:we 1 Pack'Well Pack-well 40941 T, 40942T4D943T Reagent Pack Dig 11/14/2017 PM 11/14/2018 PM 11884Well 1 11084Well 1 1104Well 1 081104Well 1 11884well 1 11ga4well 1 08110:Well 1 No Primary, No Lot M. LOW Ancillary I Ancillary 2 Export The Atellica• 1M Analyzer can be configured to automatically exclude outlier calibration replicates. Ancillary 2 LOVPaCk Ancillary I LoÜPack Ancillary I LotPack Ancillary I Lot'Pack Graph The Grapn is only displayed for CH calibration results. Date From TOX Cal System Error IAC0104 00109 11493:VVell 1 11493:WVell 1 11493:Well 1 11884Well 1 Sample Integrity, Can.. Sample Integrity, Can... Sample Integrity. Can.. Sample Integrity. Can... Ancillary 1 Ancillary 2 -57027 -57.17 -57.14 -57357 -56.174 M WD DIV" Ancillary 2 LoÜPack Ancillary I LoÜPack ess C374 -0941 CM00110 PM Calibrator Name Calibrator Lot Chem cal Order Status cal status -57 u -57.17 -5702 [3 10:58 AM htervention Needed Needed Nee&ed Calibrator Lot Calibration 807936c C] Ordered CM00110 102s/2018 AM 1029/2018 AM 11/01/2018 1103:16AM 11/01/2018 11/0102018 1103:16AM Pack Attributes Cal Status cal status Valid 001 -041 0.01 0178 Cal Com Coefficient Acceptance 0K Completed Acceptance Ce Acceptance Acceptance C Pending Acceptable CV Acceptance CV Acceptance Mode D_HDL o_HDL D-HDL CM00110 CM00113 412577 11/14/2018 PM 09,'14/2018 PM 11/102018 PM Lot 00167:We112 00167:we2 001394:Wve111 Cal n Mode Observed %CV -358 026 EXPIred Expired EXPired Calibration Pack Calibration Cal Expiration The option to automatically perform QC with calibration can be enabled in the Test Definition configurations or selected as part ot a calibration order. Trigger Mode OCkrator Initiated Oßkrator Initiated list 11/182018 10:04$4AM 10:58 AM AM PM Invald invalid. Invalid Valid 01394:vve111 1001/2018 11/102018 p 1.02 10:04:54 AM 10:58 AM 01394:inæ111 01394:ink111 01394:Bnæ111 Calibration Cal Expiration calibration 'MT calibration Calibrator Lot Pack Calibration Cal QC Performed With Calibration Acceptance Criteria Load List List A Error Rejected Relected t ed QC Performed with Calibration Acceptance Criteria Acceptance Ce 26431,26432 CEA 974449 AM Observied Ovserview Ovserview Watch List QC Limits Result Expected Observied Ovserview Observed Observed %CV orderved Overview Observied Observed %CV Awaiting Commficients 9347: 14 AM 11:47:11 AM PI .02 ThCG Pl.02 p I .02 95657 10'31,'2018 AM v. Accepted By A status of "Awaiting Acceptance" indicates the calibration results do not meet the acceptance 0375 - 4.625 - 4625 0.211 0.32 0.211 0381 0.32 NO replicates Level Level 1: 26431 NO Cancelled co -0.43 1.43 10.43 -043 -0.41 -041 11400:VVell 1 Close CM00110 CM00113 412577 09.'14,'2018 AM Invald Invabid. Valid Invalid Invalid. 270531 Invabd vabd 4522 - 19.278 Copyright O Siemens Healthcare GmbH 2018 • Automatic Acceptance is disabled in the CH assay test definition 1.43 -0.43 10.43 NO Level 0978 - 1.61 0.978. 1.61 1.61 • Accept Cal is enabled in the 1M assay test definition TSH3UL MM 04 Z) 104 M} 104 A) 104 A00104 Ml 104 IAC0104 A} 104 Al 104 M) 104 CH15 11:47:11 AM AM PM Measuring Interval VerifcatOn Measuring Interval Verification Measuring Interval Verificaton Measuring Interval VerificatOon Allowed Lcnv Level Deviation pass Refresh Counters Delta response 56.74 rnALJ 56.74 rnAIJ 56.74 rnAuJ rnAIJ System response 23.0 23.0 122.0 230 122.0 response Calibration Cal Expiration 'MT calibration Calibrator Lot Ccalibration Pack Henkestr. 127 rsH3UL ACM 04 A00104 A} 104 IA00104 Al 104 M} 104 A) 104 ACM104 09,'2st2018 AM 1029/2018 AM 101502 AM 10:58 AM 10204 PM Invalid 11/102018 PM 11/102018 11/101/2018 01/13/2019 PM 09/14/2018 PM 10/12/2018 08110:Well 1 Enlarge criteria that are used for Immunoassay and Chemistry assays. Close A00104 IA00104 PM AM Query US- Query workhst Print Lab" anager LabManager Monday, 29, 201B Monday, 29, 201830942 Monday, October 29, 201830942 PM Monday, 29, 2018 Monday, 29, Monday, October 29, 201830942 Monday, 29, 201830942 PM