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Atellica® Data Manager QC Graph Overview Job Aid

This job aid provides an overview of the QC Graph tab and instructions on how to add QC populations to the QC Graph tab.

Atellica® Data Manager QC Graph Overview The Atellica Data Manager (DM) QC Graph functionality enables the operator to plot and compare individual or multiple QC populations on the same graph for troubleshooting purposes to make it easier to identify the root cause of QC failures. Key enhancements were introduced in the Atellica DM software update version 1.2 making it easier to plot and compare QC populations having multiple QC lots, levels, instruments and even assays on the same chart. This may be helpful to quickly understand if the QC issue is specific to an individual QC material, reagent, lot or specific to an individual instrument. The following information is included within this job aid: • Overview of the QC Graph tab • Adding a single QC population to the QC Graph tab • Adding multiple QC populations to the QC Graph tab • Adding QC populations for instrument groups to the QC Graph tab QC Graph Tab Overview 1. QC Populations Panel • : indicates if the QC population or group should be shown on the graph • : enables and disables the display of a trend line on the graph for the QC RK population or group • : enables operators to edit the QC population or group × • : removes the QC population or group • Color: the QC population color border matches the color of the line on the graph colthinkers Atellica & Data Manager ADMDemo EN EO Home Sample Query Browser Review and Edit Archive Utilities Results Alerts Graph QC Population Status QC Populations Levey-Jennings Graph Use Global Range +4 SD 319.00- From 05/01/2018 00:00 To 05/31/2018 : 00:00 Apply x Test Chol 2 Lot 26431 Level 1 Instrument Atellicat_CH930_1 4 X +3 SD 301.50- From 05/01/2018 6 00:00 To 05/31/2018 00:00 N Mean SD Target value 249.0 Current 23 254.96 GV 7% 22.87 8.97 +2 SD 284.00- Target deviation 17.5 Cumulative 0 LO Data range 23 254.96 8.97 +1 SD 266.50 249.00- -1 SD 231.50- O -2 SD 214.00 O -3 SD 196.50 -4 SD 179.00 05/01/2018 05/05/2018 5/09/2018 05/13/2018 05/17/2018 05/21/2018 05/25/2018 05/29/2018 Add Add Group Draw Graph N: 23 Mean: 254.96 SD: 22.87 CV % : 8.97 ? sysman, Systemmanager Friday, June 19, 2020 - 13:15 Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 SIEMENS Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Job Aid Effective Date: 23-Jul-2020 | HOOD05162003112060 Healthineers Job Aid | QC Graph Overview Effective Date: 23-Jul-2020 | HOOD05162003112060 2. Levey-Jennings Graph a. Time line slider: enables operators to narrow the date range b. Statistics: dynamically reflect the data the graph displays c. Legend: indicates which population operators are viewing d. Color-coordinated graph area • Green band: lies between +/- 2 standard deviation (SD) of the reference value • Yellow band: lies between 2 to 3 SD and -2 to -3 SD of the reference value • Red band: lies above 3 or below -3 SD of the reference value e. Color-coordinated plotting characters to reflect severity • Green: results with a severity of zero • Red: results with a severity not equal to zero • White cross marks: omitted values • White circles with a dot: results with associated comments f. : restores the graph to the default magnification g. : displays horizontal and vertical lines to indicate the exact coordinates of the mouse h. : displays or hides the dots for all QC results Atellica ® Data Manager VM-TST-ADM 3 X EO. LEE Sample Query Browser Review and Edit Archive Traceability Utilities Results Alerts Graph QC Population Status QC Populations Levey-Jennings Graph Use Global Range +4 SD 1.66 From 35/01/2018 00:00 To 05/31/2018 00:00 Apply O Test PHIN Lot 40881 Instrument AdviaCentaur_1 / X +3 SD 1.54- From 05/01/2018 00:00 To 05/31/2018 00:00 Mean SD +2 SD 1.42- Target value 1,18 Current 461 1:24 0.56 44.72 Target deviation 0.12 Cumulative 0 +1 SD 1.30 Data range 35 1.18 0 16 13.74 T 1.18 d 1 SD 1.06- 2SD 0.94- e 3SD 0.82- 05/03/2017 08/03/2017 13/03/2017 17/03/201 21/03/2017 25/03/2017 23/03/2017 h a Add Add Group Draw Graph N: 35 Mean: 1:18 SD: 0.16 CV%: 13.74 b f ? sysman, Systemmanager Tuesday, January 1, 2019 - 17:20 C g SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Healthineers Page 2 of 10 Job Aid | QC Graph Overview Effective Date: 23-Jul-2020 | HOOD05162003112060 Add a Single QC Population to the QC Graph Tab 1. From the Command bar, select QC 2. Select the Graph tab 3. Select Add Atellica ® Data Manager 1 ADMDemo -9 x EO Home Sample Query Brows 2 view and Edit Archive raceability Utilities Results Alerts Graph QC Population Status QC Populations Levey-Jennings Graph Use Global Range From 06/12/2020 3 00: To 06/20/2020 00:00 Apply 3 Add Add Group Draw Graph N: 0 Mean: - SD: - CV%: . ? sysman, Systemmanager Friday, June 19, 2020 - 13:11 4. Select the appropriate QC population 5. Select Select SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Healthineers Page 3 of 10 Job Aid | QC Graph Overview Effective Date: 23-Jul-2020 | HOOD05162003112060 QC Populations selection Y QC Populations Method Instrument Method Test QC Lo Species Cur N Advia1800_1 AST 61620 34 Advia1800_1 AST 61635 4 Advia1800_1 AST 61645 2 Advia2120_1 RBC 0000 5 Advia2120_1 RBC Human 6 Advia2120_1 WBC 0000 ? 5 Advia2120_1 WBC ? Human 10 Atellica1 _CH930_1 AMY 26431 23 Atellica1 _CH930_1 AMY 26432 23 Atellica1_CH930_1 CA 26431 23 Atellica1 _CH930_1 CA 26432 61 4 Atellica1_CH930_1 Chol_2 26431 23 Atellica1_CH930_1 Chol_2 26432 23 Atellica1_CH930_1 Crea_2 26431 23 Atellica1 _CH930_1 Crea_2 26432 23 Atellica1_CH930_1 UN 26431 23 Atellica1_CH930_1 UN 26432 23 5 Select Cancel 1 selected › › 6. Select Draw Graph Healthineers Atellica ® Data Manager ADMDemo -9 x EO Home Sample Query Browser Review and Edit Qc Archive Traceability Utilities ... Results Alerts Graph QC Population Status QC Populations Levey-Jennings Graph Use Global Range +4 SD 319.00 From 05/01/2018 00:00 To 05/31/2018 FREE 00:00 Apply Test Chol 2 Lot 26431 Level 1 Instrument Atellica1_CH930_1 0 X +3 SD 301.50 From 05/01/2018 0 00:00 To 05/31/2018 00:00 Mean SD CV% Target value 249.0 Current 23 254.96 22.87 8.97 +2 SD 284.00- Target deviation 17.5 Cumulative 0 Data range 23 254.96 22.87 3.97 +1 SD 266.50- -O 249.00 -1 SD 231.50 O -2 SD 214.00- O -3 SD 196.50 -4 SD 179.00 05/01/2018 05/05/2018 05/09/2018 05/13/2018 05/17/2018 05/21/2018 05/25/2018 05/29/2018 6 -... - Add Add Group Draw Graph N: 23 Mean: 254.96 SD: 22.87 CV%: 8.97 ? B sysman, Systemmanager Friday , June 19 , 2020 - 13:15 SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Healthineers Page 4 of 10 Job Aid | QC Graph Overview Effective Date: 23-Jul-2020 | HOOD05162003112060 Add Multiple QC Populations to the QC Graph Tab 1. From the Command bar, select QC 2. Select the Graph tab 3. Select Add Healthines Atellica ® Data Manager 1 ADMDemo - PX P. EO. Home Sample Query Brows 2 view and Edit QC Archive Traceability Utilities ... Results Alerts Graph QC Population Status QC Populations Levey-Jennings Graph Use Global Range From 06/12/2020 00:00 To 06/20/2020 00:00 Apply 3 Add Add Group Draw Graph N: 0 Mean: - SD: CV%: CD ? CO sysman, Systemmanager Friday, June 19, 2020 - 13:11 4. Select the QC Populations filter icon 5. Specify the criteria to identify the QC populations to be evaluated SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Healthineers Page 5 of 10 Job Aid | QC Graph Overview Effective Date: 23-Jul-2020 | HOOD05162003112060 QC Populations selection 4 7| QC Populations i iii Method Instrument Method Test QC Lot Species Cur N - Advia1800_1 AST 61620 ? 34 Advia1800_1 AST 61635 4 Advia1800_1 AST 61645 N Advia2120_1 RBC 0000 ? 5 Advia2120_1 QC population query Advia2120_1 Test Chol 2 Advia2120_1 Instrument group : ? Atellica1_CH930 Instrument: ? Atellica1_CH930 5 Type: Any Atellica1_CH930 QC Lot: 26431 Atellica1_CH930 Species: ? MISPL Filter: ? Atellica1_CH930 Atellica1_CH930 OK Cancel Atellica1_CH930_1 Crea_2 26431 ? 23 6. Select the appropriate QC populations to be graphed 7. Select Select QC Populations selection QC Populations, for test Chol_2, on lot 26431 6 iii Method Instrument Method Test QC Lot Species Cur N Atellica1_CH930_1 Chol_2 26431 2 23 V Atellica1_CH930_2 Chol_2 26431 23 Atellica2_CH930_1 Chol_2 26431 21 V Atellica2_CH930_2 Chol_2 26431 24 7 Select Cancel 4 selected SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Healthineers Page 6 of 10 Job Aid | QC Graph Overview Effective Date: 23-Jul-2020 | HOOD05162003112060 8. The Use Global Range fields can then be utilized to set the date range to be reviewed for all displayed populations and select Apply 9. Select Draw Graph Atellica ® Data Manager ADMDemo -X Home A EO Sample Query Browser Review and Edit Archive Traceability Utilities ... Results Alerts Graph QC Population Status QC Populations Levey-Jennings Graph 8 Use Global Range From 05/01/2018 00:00 To 05/31/2018 00:00 Apply +4 SD- Test Chol 2 Lot 26431 Level 1 Instrument Atellica2_CH930_1 3 SD- From 05/01/2018 00:00 To 05/31/2018 00:00 Mean 80 SD CV% Z Target value 249.0 Current 21 255.33 18.00 7.05 +2 SD- Target deviation 17.5 Cumulative 0 Data range 21 255.35 18.00 7.05 +1 SD Test Chol_2 Lot 26431 Level Instrument Atellica2_CH930_2 88 8 From 05/01/2018 00:00 To 05/31/2018 00:00 1 SD - N Mean SD CV% 2 SD- Target value 249.0 Current 24 257.71 Target deviation 17.5 23.14 8.98 O Cumulative 0 Data range 24 257.71 23.14 8.98 3 SD- V X Test Chol 2 Lot 26431 Level 1 Instrument Atellica1_CH930_1 @ X From 05/01/2018 E 00:00 To 05/31/2018 00:00 ISD Mean 05/01/2018 05/05/2018 05/09/2018 05/13/2018 05/17/2018 05/21/2018 05/25/2018 05/29/2018 Target value 249.0 Current 23 254.90 22.87 8.97 Target deviation 17.5 Cumulative 0 Data range 23 254,96 22.87 8.97 9 - Add Add Group Draw Graph N: 0 Mean: SD: CV%: - ? sysman, Systemmanager Friday, June 19, 2020 - 13:31 SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Healthineers Page 7 of 10 Job Aid | QC Graph Overview Effective Date: 23-Jul-2020 | HOOD05162003112060 Add QC Population Groups to the QC Graph Tab 1. From the Command bar, select QC 2. Select the Graph tab 3. Select Add Group Healthineers Atellica ® Data Manager 1 ADMDemo 9 x EO QC Archive LEE Home Sample Query Browse 2 ew and Edit Traceability Utilities ... Results Alerts Graph QC Population Status QC Populations Levey-Jennings Graph Use Global Range From 06/12/2020 00:00 To 06/20/2020 00:00 Apply 3 Add Add Group Draw Graph N: 0 Mean: - SD: CV% : - ? sysman, Systemmanager Friday, June 19, 2020 - 13:11 4. Enter or double click to select a value for the Test field • Additionally, values can be entered for the Lot and/or Species fields 5. Filter the Instruments list by entering or selecting a value for Instrument Group OR by entering an instrument name in Search and pressing Enter on your keyboard, if applicable 6. Select one or more instruments • To display only the selected instruments, select Show Selected Only 7. Select Select SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Healthineers Page 8 of 10 Job Aid | QC Graph Overview Effective Date: 23-Jul-2020 | HOOD05162003112060 C Group Selection QC Test Instruments (4 Selected) 4 est Chol_2 Instrument Group ... 5 Lot Search Species Show Selected Only Atellica1_CH930_1 Atellica1_CH930_2 Atellica2_CH930_1 6 Atellica2_CH930_2 7 Select Cance 8. Select Draw Graph SIEMENS Atellica ® Data Manager ADMDemo EO. Home Sample Query Browser Review and Edit ac Traceability Utilities ... Results Alerts Graph QC Population Status QC Populations Levey-Jennings Graph Use Global Range From 05/01/2018 00:00 To 05/31/2018 00:00 Apply Test Chol_2 Instruments Atellica1 CH930 1, Atellica1 CH930 2, 0 X Atellica2 CH930 1, Atellica2 CH930 2 +3 SD - From 05/01/2018 00:00 To 05/31/2018 00:00 N Mean SD Target value Current 185 181.95 '5.13 41.29 +2 SD- Target deviation Cumulative 0 Data range 185 75.13 41.29 +1 SD -1 SD 2 SD- -3 SD- 0 800 SP2018 05/05/2018 05/09/2018 05/13/2018 05/17/2018 05/21/2018 05/25/2018 05/29/2018 8 Add Add Group Draw Graph N: 185 Mean: 181.95 SD: 75.13 CV%: 41.29 ? sysman, Systemmanager Friday, June 19, 2020 - 13:40 SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Healthineers Page 9 of 10 Job Aid | QC Graph Overview Effective Date: 23-Jul-2020 | HOOD05162003112060 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 c ountry 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 auth ority. 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 regulato ry requirements. Please contact your local representative for availability. Copyright © Siemens Healthcare GmbH 2020 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0 siemens-healthineers.com SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Master Template Effective Date: 3/5/2020 | HOOD05162003074494 Healthineers Page 10 of 10

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