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Atellica® Solution Cal-QC Storage Area Job Aid Version 1.25 and Below

This job aid provides instructions on how to use the Cal-QC storage area on the Atellica® Solution.

SIEMENS Healthineers Atellica® Solution Cal-QC Storage Area Job Aid Template Effective Date: 05/27/2019 | HOOD05162003010284 Effective Date: 8/18/2019 | HOOD05162003029644 Unrestricted © Siemens Healthcare GmbH, 2019 Atellica® Solution Cal-QC Storage Area Overview of Cal-QC Storage Area • A refrigerated space that allows for prolonged storage for up to 60 sample containers containing calibrator or QC material • Calibrator and QC materials can be stored for the maximum time listed on the material Instructions for Use (IFU). For Siemens materials, this is typically up to 7 days • The following types of tubes can be stored in the Cal-QC storage area:  Calibrator or QC materials in 12 x 75-mm round-bottom glass sample containers  QC materials in sample containers provided by Bio-Rad Laboratories, Inc. • The operator loads calibrator and QC materials in the sample drawers of the Atellica® Sample Handler (SH) in the same manner as patient sample containers  If the material is configured for on-board storage, and there are no open work orders for the material, the container will be placed in the Cal-QC storage area  After the SH stores the calibrator or QC material, the robot retrieves the appropriate calibrator or QC material from the Cal-QC storage area when the system requires it • Operators do not access the Cal-QC tube storage area except in the event of a system failure or power outage that prevents the SH robot from removing the materials 2 IM Effective Date: 8/18/2019 | HOOD05162003029644 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2019 Atellica® Solution SIEMENS Cal-QC Storage Inventory Healthineers The Cal-QC Storage Inventory tab provides details about the HEMENS Alellea U Solution Version 1.13.0.2684004 P-P1-03 individual calibrator and QC tubes in the Cal-QC storage area 1 Inventory Calibration Pahent Orders 2 Workint Maintenuinge Setup of all SHs or on the Atellica Magline® Transport. Reagent Overview Reagent Loader Reagent Needis Supplies Overview Reagent Lot Comparison Cal OC Storage Inventory Cal-OC Needs Capacity A Cal-QC Sample Details C Assay Details D To access the Cal-QC Storage Inventory tab: 51 Ava abile Typo Material a Lot Sequence Stalin Vol OuLD : Location Expiration Chem Control 1 1 Cal ALP Cal a 00000 224 P.P1-03 ASSEY Expiration 1. At the Command Bar, select Inventory Filter B QC Chem Control 1 1 14491 000012 OK 1577 Ab $282017 2 56:11 PM Search 2. Select the Cal-QC Storage Inventory tab Chom Control 2 2 14492 000013 OK 1577 P.PIO ALT 9:25-2017 2:50: 11 PM Assay Cal 002 Cal B. 978178 000007 OK 1443. P-P1-O 10/5/2017 5:48: 18 PM AST 9/28/2017 2:59:11 PM The Cal-QC Storage Inventory has 4 areas: Status Cal Drug CalA 780053 000004 OK P1-03 Ca #28/2017 2:59:11 PM OK Insufficient volume [Cal Drug Cal B 78005 000004 OK 83.8 PPI-0 928 2017 2:59 11 PM A. Capacity – displays the total number of available and Expired Cal Drug Cal C 78005 000004 OK +808 P.P1-03 10/3/2017 1:33:37 PM Crea_2 928/2017 2 59:11 PM Partialy Expired unusable Cal-QC storage positions. Unusable positions Type Cal Drug Cal D 780053 000004 OK 765 P.P1-03 10/3/2017 1:33:37 PM DIHDL @28/2017 2:59:11 PM cannot be used for storage due to a hardware-related Cal Drug Cal E. 78005 000000 OK 797 P.P1-03 100/2017 1:33:37 PM GluH 3 D28/2017 2:59:11 PM Cal Location TOLP 926 /2017 2:50 11 PM error condition. If there are no unusable positions, the P-P1-03 Phnb $26 /2017 2 56 11 PM Unusable field does not display 928-2017 2:50:11 PM Theo 9/28/2017 2 50:11 PM B. Filter – used to filter the list by status, type, or location Union C. Cal-QC Sample Details – displays information for each Cal ? PEP LabManager Monday, October 02. 2017 11 :10 AM or QC tube available. To sort the list, select a column header. To unload a selected tube from the Cal-QC Storage area, select Unload at the bottom of the screen D. Assay Details – displays a list of the assays that use the selected Cal-QC material and expiration information for the assay 3 Effective Date: 8/18/2019 | HOOD05162003029644 Unrestricted © Siemens Healthcare GmbH, 2019 Atellica® Solution SIEMENS Load the Cal-QC Storage Area Healthineers 1. At the Command Bar, select Inventory HEMINS Atollcau Solution Version 1.13.0.2684004 P-P1-03 1 2. Select the Cal-QC Storage Inventory tab Samples Inventor Calteration Pahent Ordors 2 Setup Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Cal-OC Nonds 3. If the Cal-QC storage area is full, unload Cal-QC materials: Capacity Cal-QC Sample Details Assay Details 51 Available Type Material Lot :Sequence Statuns Vol Cut) : Location Expiration Chem Control 1 1 A. Select one or more samples Cal ALP Cal B 6JD058 00000 224 P.P1-03 - Assay Expiration Filter A / oc Chem Control 1 1 14491 000012 OK 1577 Ab 928/2017 2:59:11 PM B. Select the Unload button Search oc Chom Control 2 2 14492 000013 OK 1577 P-P1-03 ALT 9282017 2:50: 11 PM Assay Cal 002 Cal B 278178 000007 OK 1443 -P1-03 10/5/2017 5:48:18 PM AST 9/26/2017 2:59:11 PM 4. If loading a new material, create a definition for the calibrator Status Cal Drug Cal A 780053 000004 OK 890 P-P1-03 #28/2017 2:59:11 PM or QC material OK Insufficient volume Cal Drug Cal B 000004 OK 838 9/28/2017 2:59:11 PM Expired Cal Drug Cal G 780053 000004 OK 808 PP1-03 10/3/2017 1:33:37 PM Crea_2 928/2017 2 59:11 PM 5. If appropriate, pour the calibrator or QC materials into Partially Expired Type Cal Drug Cal D 780053. 000004 OK 765 10/3/2017 1:33:37 PM DIHDL 28/2017 2:59:11 PM labeled 12x75-mm round-bottom glass sample containers Cal Drug Cal E 780053 00000 OK 797 P.P1-03 10/3/2017 1:33:37 PM GH_3 0:28/2017 2 59:11 PM Cal Location LDLP 26/2017 2:50:11 PM 6. Load the calibrator or QC material containers in a STAT rack P-P1-03 Phot 926/2017 2:59 11 PM for immediate processing and storage TB4 2 928/2017 2:50:11 PM Theo 9/28/2017 2:59:11 PM  Loading the calibrator or QC materials in a STAT rack B Unload -------- minimizes unrefrigerated time in the SH drawer. Ensure ? PEP ={)LabManager Monday, October 07. 2017 11:16 AM the calibrator or QC material containers are fully seated in the rack NOTE: For information on how to create calibrator or QC definitions, refer to the Calibration or Quality Control topics. To load the material in the Cal-QC *This procedure is continued on the next slide. storage area, select Store Onboard in the definition. NOTE: The system processes calibrator and QC materials in other size sample containers (including tube top cups) but does not store them in the Cal-QC storage area. Only 12x75-mm round-bottom sample containers are stored in the Cal-QC storage area. 4 IM Effective Date: 8/18/2019 | HOOD05162003029644 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2019 Atellica® Solution SIEMENS Load the Cal-QC Storage Area (continued) Healthineers 7. Load the STAT rack in a sample drawer  The SH robot automatically transfers the container to the Atellica Magline® Transport. After the Tube Characterization Station identifies the sample as a calibrator or QC material the system transports the container to the appropriate analyzer if it has open orders  After the system returns the container to the SH, the system performs 1 of the following actions: • If the material requires onboard storage, the SH robot loads the container into the Cal-QC storage area • If the material does not require onboard storage, the SH robot loads the container into an available position in a routine output rack NOTE: If the system does not store the calibrator or QC material in the Cal-QC storage area, ensure a routine output rack with empty positions is available in a sample drawer. If the material does not require onboard storage and the operator configures a Cal-QC sort area, the SH robot places the container into an available position in the designated sorting rack. 5 IM Effective Date: 8/18/2019 | HOOD05162003029644 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2019 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 2019 Global Siemens Healthineers Headquarters Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84 0 siemens.com/healthineers 6 Effective Date: 8/18/2019 | HOOD05162003029644 Unrestricted © Siemens Healthcare GmbH, 2019