Atellica® Solution Cal-QC Storage Area Job Aid Version 1.26 and Above

SIEMENS Healthineers Atellica® Solution Cal-QC Storage Area Job Aid 1 Template Effective Date: 10 Aug 2021| HILS 2223 Effective Date: 01-NOV-2021 | HOOD05162003232395 Unrestricted © Siemens Healthineers, 2021 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 or polypropylene 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 manually access the Cal-QC storage area except to perform a reset. This can be due to pick or place errors or in the event of a power failure that prevents the SH robot from removing the materials 2 IM Effective Date: 01-NOV-2021 | HOOD05162003232395 Hardware Overview Unrestricted © Siemens Healthineers, 2021 Atellica® Solution SIEMENS Cal-QC Storage Inventory Healthineers The Cal-QC Storage Inventory screen provides details about QC > Cal-QC Inventory 8 LabManager the individual calibrator and QC tubes in the Cal-QC storage Capacity Filters Status : OK, Type : QC, Calibrators, Location : SH-01 C Assay Details D area of all SH’s within the Atellica® Solution or on the Atellica A Available O O Type Material Lot Sequence Status Vol (uL) Location Expiration Assay Expiration Magline® Transport. 0 QC CHQC19 1 CHQC19 000129 OK ~1524 SH-01 12/1/2021 11:59 PM Acet 8/1/2021 11:59 PM QC CHQC19 1 CHQC19 000080 Expired NA SH-01 3/1/2021 11:59 PM Alb 8/1/2021 11:59 PM The Cal-QC Storage Inventory has 4 areas: B Filters Tx Clear 0 QC IMQC1 1 IMQC1 000012 OK 1400 SH-02 11/1/2021 11:59 PM Amylas 8/1/2021 11:59 PM Q Search Inventory IMQC1 2 IMQC1 000222 OK 1300 SH-02 11/1/2021 11:59 PM C3 8/1/2021 11:59 PM A. Capacity – displays the total number of available and Q Search Assay 0 Qc QCSERPLAS 1 452412 000112 OK 1200 SH-01 4/1/2022 11:59 PM Ca 8/1/2021 11:59 PM unusable Cal-QC storage positions. Unusable positions Status 0 Qc BIOLIQUID 1 45770 000123 OK ~3000 SH-01 1/1/2022 11:59 PM Chol2 8/1/2021 11:59 PM cannot be used for storage due to a hardware-related OK ] Qc BIOLIQUID 2 45770 000124 OK ~3000 SH-01 1/1/2022 11:59 PM CO2 _C 8/1/2021 11:59 PM Insufficient Volume error condition. If the unusable count reaches 6, the Expired 0 Qc BIOLIQUID 3 45770 000125 OK ~3000 SH-01 1/1/2022 11:59 PM Crea_2 8/1/2021 11:59 PM Partially Expired 0 Cal DrugCal A 0433 000001 OK ~1200 SH-01 12/1/2021 11:59 PM GLUH_ 8/1/2021 11:59 PM storage area will need to be reset. If there are no 0 Cal Type DrugCal B 2411 000001 Expired ~1200 SH-01 8/1/2021 11:59 PM IgA_2 8/1/2021 11:59 PM unusable positions, the Unusable field does not display OC Cal DrugCal C 777 000002 OK ~1200 SH-01 12/1/2021 11:59 PM lgG_2 8/1/2021 11:59 PM Calibrators 0 Cal CHEMCAL 1 0433 000001 OK ~1200 SH-02 12/1/2021 11:59 PM IP 8/1/2021 11:59 PM B. Filter – used to filter the list by status, type, or location ocation 0 Cal CHEMCAL 2 2411 000001 Partially Expired -1200 SH- 02 11/1/2021 11:59 PM O SH-01 0 Cal SH-02 CHEMCAL 3 777 000002 OK ~1200 SH-02 12/1/2021 11:59 PM C. Cal-QC Sample Details – displays information for each Cal Unload or QC tube available. To sort the list, select a column Related Callbration Due QC Needs 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: 01-NOV-2021 | HOOD05162003232395 Unrestricted © Siemens Healthineers, 2021 Atellica® Solution SIEMENS Load the Cal-QC Storage Area Healthineers 1. Access the Cal-QC Storage Inventory screen QC > Cal-QC Inventory 8 LabManager 2. If the Cal-QC storage area is full, unload Cal-QC materials: Capacity Filters Status : OK, Type : QC, Calibrators, Location : SH-01 Assay Details Available O [ Type Material Lot Sequence Status Vol (uL) Location Expiration Assay Expiration A. Select one or more samples 0 Qc CHQC19 1 CHQC19 000129 OK ~1524 SH-01 12/1/2021 11:59 PM Acet 8/1/2021 11:59 PM A CHQC19 1 CHQC19 000080 Expired NA SH-01 3/1/2021 11:59 PM Alb 8/1/2021 11:59 PM B. Select the Unload button. Ensure there is a rack Filters Tx Clear 0 QC IMQC1 1 IMQC1 000012 OK 1400 SH-02 11/1/2021 11:59 PM Amylas 8/1/2021 11:59 PM loaded to receive the samples Q Search Inventory IMQC1 2 IMQC1 000222 OK 1300 SH-02 11/1/2021 11:59 PM C3 8/1/2021 11:59 PM Q Search Assay 0 Qc QCSERPLAS 1 452412 000112 OK 1200 SH-01 4/1/2022 11:59 PM Ca 8/1/2021 11:59 PM 3. If loading a new material, create a definition for the Status 0 Qc BIOLIQUID 1 45770 000123 OK ~3000 SH-01 1/1/2022 11:59 PM Chol2 8/1/2021 11:59 PM calibrator or QC material OK ] Qc BIOLIQUID 2 45770 000124 OK ~3000 SH-01 1/1/2022 11:59 PM CO2 _C 8/1/2021 11:59 PM Insufficient Volume Expired 0 Qc BIOLIQUID 3 45770 000125 OK ~3000 SH-01 1/1/2022 11:59 PM Crea_2 8/1/2021 11:59 PM 4. If appropriate, pour the calibrator or QC materials into Partially Expired 0 Cal DrugCal A 0433 000001 OK ~1200 SH-01 12/1/2021 11:59 PM GLUH_ 8/1/2021 11:59 PM labeled 12x75-mm round-bottom glass or polypropylene 0 Cal Type DrugCal B 2411 000001 Expired ~1200 SH-01 8/1/2021 11:59 PM IgA_2 8/1/2021 11:59 PM OC sample containers Cal DrugCal C 777 000002 OK ~1200 SH-01 12/1/2021 11:59 PM lgG_2 8/1/2021 11:59 PM Calibrators 0 Cal CHEMCAL 1 0433 000001 OK ~1200 SH-02 12/1/2021 11:59 PM IP 8/1/2021 11:59 PM 5. Load the calibrator or QC material containers in a STAT ocation 0 Cal CHEMCAL 2 2411 000001 Partially Expired -1200 SH-02 11/1/2021 11:59 PM O SH-01 rack for immediate processing and storage 0 Cal SH-02 CHEMCAL 3 777 000002 OK ~1200 SH-02 12/1/2021 11:59 PM B Unload ➢ Loading the calibrator or QC materials in a STAT rack Related Callbration Due QC Needs minimizes unrefrigerated time in the SH drawer. Ensure the calibrator or QC material containers are NOTE: For information on how to create calibrator or QC definitions, refer to fully seated in the rack 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 sample 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: 01-NOV-2021 | HOOD05162003232395 Hardware Overview Unrestricted © Siemens Healthineers, 2021 Atellica® Solution SIEMENS Load the Cal-QC Storage Area (continued) Healthineers 6. Load the STAT rack in a sample drawer ➢ The SH robot automatically transfers the container(s) 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: 01-NOV-2021 | HOOD05162003232395 Hardware Overview Unrestricted © Siemens Healthineers, 2021 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 Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please 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. © Siemens Healthcare GmbH 2021 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens-healthineers.com 6 Effective Date: 01-NOV-2021 | HOOD05162003232395 Unrestricted © Siemens Healthineers, 2021