Symbia Pro.specta™ Broad Quantification Calibration: Sensitivity Calibration USA

Broad Quantification Calibration: Sensitivity Calibration Symbia Pro.specta™ This job aid will guide the user in performing the Sensitivity Calibration for the accurate quantifi- cation of Broad Quantification studies. Sensitivity Calibration measures the difference between the system’s ability to detect the radioactivity and the true amount of radioactivity using a point source and collimator. Volume sensitivity calibration is needed for Broad Quantification. Details can be found in the Instructions for Use Manual or the Broad Quant Calibration: Volume Sensitiv- ity Calibration job aid. Please Note: Sensitivity calibration for Broad Quantification should be performed every six months or per Regulatory/License requirements (if applicable). What you will need:  Sensitivity Source (respective clinical isotope to be calibrated) yielding a count rate of 5-30 kcts/sec per detector o Amount of activity needed depends on the respective isotope. Here are a few examples: Isotope mCi Tc99m 1-5 mCi In111 1-5 mCi I123 1-5 mCi Lu177 10-30 mCi I131 1-5 mCi  Peaking and calibration sources for the respective clinical isotope to be calibrated Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 SIEMENS Master Template Effective Date: 21 Apr 2023 | HILS 2224 Job Aid Effective Date: 23 Aug 2024 | QR700012090 Healthineers Job Aid | Broad Quantification Calibration: Sensitivity Calibration Effective Date: 23 Aug 2024 | QR700012090 Before starting the procedure, complete the following prerequisites:  Install the applicable collimators  Prepare point source of applicable isotope  Ensure that the system is homed Performing the Broad Quantification Sensitivity Calibration: 1. Move the cursor over the Settings icon and select Clinical Configuration from the menu. meauserv Configuration Panel Administration Portal Administration Portal [EN] Clinical Configuration Check up MI System Check Daily QA Calibration Resume 2. Click the Quality Assurance tab. Technical Configuration O Quality Assurance Clinical Configuration 3. From the navigation tree on the left, select MI Quality Assurance > Quantitative > Broad Quant Sensitivity to display the Broad Quant Sensitivity page with the protocol set to LEHR and source as Tc99m. SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Master Template Effective Date 21 Apr 2023 | HILS 2224 Healthineers Page 2 of 10 Job Aid | Broad Quantification Calibration: Sensitivity Calibration Effective Date: 23 Aug 2024 | QR700012090 MI Quality Assurance Detector Calibrations Extrinsic Flood Head Alignment Intrinsic Flood NMCTFOV Quantitative xSPECT Sensitivity Broad Quant Sensitivity Cross Calibration Broad Quant VSF Calibration Sensitivity Dashboard Source Management 4. Install the collimators and source as instructed in the prerequisites. Instructions will ap- pear on the screen. 1. Install collimators on both detectors 2. Prepare a 5-10 mCi point source of the selected isotope. Attach it to the source holder when prompted 3. Select Dose Calibrator DC1 4. Enter assay dose and time Dose MBq Time 5. Click Start (system motion will occur) SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Master Template Effective Date 21 Apr 2023 | HILS 2224 Healthineers Page 3 of 10 Job Aid | Broad Quantification Calibration: Sensitivity Calibration Effective Date: 23 Aug 2024 | QR700012090 5. If applicable, enter the assay Dose and Time for the dose calibrator. If correcting a regis- tered Dose Calibrator, enter the data using the dropdown menu. The correction can be performed in a single calibration. For example: 3. Select Dose Calibrator DC1 4. Enter assay dose and time Dose mCi 10 Time 04/02/2021 8:00:00 AM 6. Click Start to initiate the Calibration. The system’s prepositioning task is performed. The system motion occurs as the detectors are retracted and the patient pallet raises. 3. Click Start (system motion will occur) Start Cancel Spectrum Save Reset 7. When prompted during the prepositioning step, extend the integrated source holder. In- struction to attach the point source to the holder will be displayed, as well as a video demonstrating the installation procedure. C 0:00:07 1 x SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Master Template Effective Date 21 Apr 2023 | HILS 2224 Healthineers Page 4 of 10 Job Aid | Broad Quantification Calibration: Sensitivity Calibration Effective Date: 23 Aug 2024 | QR700012090 8. Install the prepared point source into the end of the integrated source holder. X 9. From the end of the integrated point source holder, unscrew the source holder cap coun- terclockwise. 10. Screw the precision source clockwise. 11. You will be prompted to click Continue. The system motion will occur. 12. A time display will appear and count down the time remaining for the quality assurance calibration. 08:05 Time Remaining Start Cancel Spectrum As the check protocol tasks are performed, the task currently running is active. The Status column displays the progress of the task. Tasks Detector Collimator MCounts Date and Time Status Position Point Source N/A Calibration Both LEHR 5 O Running SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Master Template Effective Date 21 Apr 2023 | HILS 2224 Healthineers Page 5 of 10 Job Aid | Broad Quantification Calibration: Sensitivity Calibration Effective Date: 23 Aug 2024 | QR700012090 Upon completion, a green light indicator with a checkmark will appear with the status message OK. 13. If necessary, click Cancel to stop the calibration from running. Detector 1 and Detector 2 growing images display on the right side of the screen, containing the following information: A. Continually updating counts per thousand (kCnts) total displays, along with other calibration information B. Windowing information: • T (top) 100% kCnts • B (bottom) 0% Sensitivity Cross Callwatios ICHis A B Upon completion, the text may change. SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Master Template Effective Date 21 Apr 2023 | HILS 2224 Healthineers Page 6 of 10 Job Aid | Broad Quantification Calibration: Sensitivity Calibration Effective Date: 23 Aug 2024 | QR700012090 The QC results lists the following:  Detector  Measurement  Photopeak  Results (cps/Mbq)  Status Sensitivity (Details) Detector Measurement Photopeak Results (cps/MBq) Status Tc-99m 1 68.45853 OK Tc-99m 1 68.07466 OK The status displays per measurement and overall. Status Description OK Results are in tolerance OK Failed Results are out of tolerance Failed Pending An action must take place before proceeding Pending 14. After reviewing the results, click Close Details to close the results screen and display the acceptance screen. The status along with instructions will be displayed. 15. Click Accept to apply results, or Cancel to keep the previous results, if available. Canceling doesn’t apply new results. Click Accept to apply results. Click Cancel to keep previous results if available. Accept Cancel 16. If the status indicates Failed, then additional instructions will be displayed. Results are out of recommended range. Check source placement. If source placement is incorrect, select CANCEL, adjust the sources, and repeat calibration. If calibration continues to fail, click ACCEPT and call Service. SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Master Template Effective Date 21 Apr 2023 | HILS 2224 Healthineers Page 7 of 10 Job Aid | Broad Quantification Calibration: Sensitivity Calibration Effective Date: 23 Aug 2024 | QR700012090 Sensitivity Dashboard The Sensitivity Dashboard allows you to view the overall results for sensitivity calibrations as shown below: • xSPECT Quant Precision Source System Sensitivity • Cross Calibration Sensitivity • Broad Quant Dose Calibrator Source System Sensitivity To access the Sensitivity Dashboard: 1. Move the cursor over the Settings icon and select Clinical Configuration from the menu. 2. Click the Quality Assurance tab. 3. From the navigation tree on the left, select MI Quality Assurance > Quantitative > Sensi- tivity Dashboard. MI Quality Assurance Detector Calibrations Extrinsic Flood Head Alignment Intrinsic Flood NMCTFOV Quantitative xSPECT Sensitivity Broad Quant Sensitivity Cross Calibration Broad Quant VSF Calibration Sensitivity Dashboard Source Management SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Master Template Effective Date 21 Apr 2023 | HILS 2224 Healthineers Page 8 of 10 Job Aid | Broad Quantification Calibration: Sensitivity Calibration Effective Date: 23 Aug 2024 | QR700012090 4. The results shown on the Sensitivity Dashboard are based on the collimator selected. Use the drop-down menu to change the collimator and display the results. Sensitivity Dashboard LEHR Results xSPECT Quant Precision Source System Sensitivity Collimator Source Preset Date and Time Status LEHR 05-588 Tc99m_Siemens 06/29/2021 12:46 AM To Do LEHR 25-588 Tc99m_Siemens 06/29/2021 12:46 AM To Do Cross Calibration Sensitivity Collimator Source Prese Date and Time Status Broad Quant Dose Calibrator Source System Sensitivity Collimator Source Preset Date and Time Status SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Master Template Effective Date 21 Apr 2023 | HILS 2224 Healthineers Page 9 of 10 Job Aid | Broad Quantification Calibration: Sensitivity Calibration Effective Date: 23 Aug 2024 | QR700012090 Please note this learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or In- structions 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 Opera- tor 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 infor- mation 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 “Functional- ity”) 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 fic- tional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Siemens Healthineers HQ I Siemens Healthi- neers AG Siemensstr. 3 91301 Forchheim Germany Phone: +49 9191 18-0 siemens-healthineers.com SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Master Template Effective Date 21 Apr 2023 | HILS 2224 Healthineers Page 10 of 10