myExam Implant Suite | MR Conditional implants: Safety and permitted coils - USA

SIEMENS Healthineers MR Conditional implants: Safety and permitted coils Template Effective Date: 10 Aug 2021 | HILS 2223 Effective Date 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 Safety and permitted coils – SIEMENS Healthineers Table of contents What this job aid is about 3 Scanning patients with MR Conditional implants 4 Warnings 6 Permitted coils and interfaces 8 Responsibilities of the implant manufacturer 9 Responsibilities of the MR operator 10 Disclaimer 11 USA DISCLAIMER: Siemens Healthineers MAGNETOM MR systems are not labeled for use with implantable medical devices. FDA has not evaluated the safety and effectiveness of these systems for use with implantable medical devices. Siemens Healthineers does not assume any responsibility or liability for the operation of a MAGNETOM MR System with any implantable device. Please direct any safety-related questions to your facility’s MR Safety Officer (MRSO), MR Medical Director (MRMD), or Directing Radiologists. 2 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 What this job aid is about SIEMENS Healthineers Provides relevant safety information… • …for scanning patients with MR Conditional implants using myExam Implant Suite. • …on permitted coils. MR In addition, you will find information regarding the responsibilities for the implant manufacturer, Siemens Healthineers, and you as the MR operator. Disclaimer: Siemens Healthineers MAGNETOM MR systems are not labeled for use with implantable medical devices. FDA has not evaluated the safety and effectiveness of these systems for use with implantable medical devices. Siemens Healthineers does not assume any responsibility or liability for the operation of a MAGNETOM MR System with any implantable device. Please direct any safety related questions to your facility’s MR Safety Officer (MRSO), MR Medical Director (MRMD), or Directing Radiologists. 3 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 Scanning patients with MR Conditional implants SIEMENS Healthineers Procedure: Implant Scanning • Select MR Conditional during patient registration. MR Conditional • Enter the correct implant-specific RF limits of the Program Selection MR Conditional implant after registration. SIEMENS >> I-spine » library » SAR adaptive VLoad Program to Queue RF Transmit Mode Any Polarization Body Part and Laterality L-Spine Unpaired Patient Orientation IT Select Exam 4 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 Scanning patients with MR Conditional implants SIEMENS Healthineers Please note: Limits for MR Conditional Implants ? > • The user-defined RF limits need to be lower than the SAR 1 2 3 limits in Normal Operating Mode. RF Limits General Confirmation • The limits defined may require measures such as longer RF Limits acquisition times or modified parameters. In special cases, B1+ rms Head SAR 2.0 W/kg the limits might make it impossible to acquire certain SAR Whole Body SAR 1.2 W/kg protocols. Normal Operating Mode • When you enable myExam Implant Suite and scan in Normal RF Transmit Mode Operating Mode, an additional safety component will be Any Polarization activated. This may result in the Normal Operating Mode limit being exceeded earlier than if the non-implant mode is selected. Back Next Cancel 5 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 Warning SIEMENS Healthineers Warning: Patient injury due to implant failure or local burns! • Only use permitted coils. • Do not use non-volume transmit (Tx) coils to scan patients with implants. • Use only receive (Rx) coils if you use non-volume coils (non-closed coils like a flex coil). • Select MR Conditional and enter correct limits. Please note: Observe the general safety information and especially the contraindications in the Operator Manual MR Systems and Coils. Refer to the permitted coils and interfaces list as well. 6 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 Warning SIEMENS Healthineers Warning: Patient injury due to non-connected coils! • All coils to be used must be connected prior to the examination. • Do not leave any unconnected coils on the table. Please note: Observe the general safety information, especially the contraindications in the Operator Manual MR Systems and Coils. Refer to the permitted coils and interfaces list as well. 7 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 Permitted coils and interfaces SIEMENS Healthineers List of permitted coils and interfaces for myExam Implant Suite • Body Coil • Body 6 long (revision level ≥ 06)* • Breast 18 Head/Neck 20 (revision level ≥ 11)* Body 30/Body 60 (revision level ≥ 01)* • • • 4 Ch BI Breast • BM Head/Neck 20 • Contour 24/Contour 48 • 16 Ch AI Breast • Head/Neck 16 • Peripheral Angio 16 • 2-/4-/8-Channel Sentinelle Breast Coil • Spine 32 • Peripheral Angio 36 • 2-/10-/16-Channel Sentinelle Breast Coil • BM Spine 32 • Special Purpose 4 • Breast BI 7 • Spine 24 • Flex Small/Large 4 • Pediatric 16 • BM Spine 24 • UltraFlex Small/Large 18 • Tim Coil Interface • Nexaris Spine 36 • Flex Loop Large • Flex Coil Interface • BM Spine 48 • Loop 4/7/11 • Multi-Channel Interface • BM Body 12 • Shoulder 16 Small/Large • Body 18 • Shoulder Shape 16 • Body 18 long • Hand/Wrist 16 • BM Body 18 • Foot/Ankle 16 • Body 6 (revision level ≥ 06)* • Tx/Rx Knee 18 * Requires the stated Revision Level. The Revision Level is indicated together with the coil information on a sticker on the individual coil. (ES Erzeugnis Stand, RV Revision Level) 8 For further information, please contact your local Siemens Healthineers Service representative. Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 Responsibilities of the implant manufacturer SIEMENS Healthineers It is the responsibility of the implant manufacturer to declare an implantable medical device as MR Conditional if appropriate and to define the conditions (constraints) for safe MR scanning. Siemens Healthineers does not accept any liability for these definitions. These definitions are the sole responsibility of the implant manufacturer. 9 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 Responsibilities of the MR operator SIEMENS Healthineers Always adhere to the operator manuals. You must be aware of any implant manufacturer conditions for MR scanning. You must decide whether the implant information is sufficiently clear or whether it is necessary to contact the manufacturer. If you scan patients with MR Conditional implants, ensure to select MR Conditional during patient registration. It is your obligation to assure that these conditions are strictly adhered to. To obtain these specific conditions, refer to the labeling of the implantable medical device or contact the device manufacturer. It is your responsibility to acquire and enter the limits in the myExam Implant Suite user interface correctly before starting an examination. 10 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 Disclaimer SIEMENS Healthineers Siemens Healthineers is not responsible for controlling technical parameters of the MRI system other than those defined by the normal operating mode, the first-level controlled operating mode, or the parameters set by the user in MR Conditional implant scanning mode (SAR or B1+rms), and the data provided in the system owner manual, e.g., spatial gradient field plots. Siemens Healthineers does not assume any further responsibility or liability for the operation of the MR system with an implantable medical device. 11 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 SIEMENS Healthineers 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 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 are 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. © Siemens Healthineers AG 2024 Siemens Healthineers Headquarters Siemens Healthineers AG Siemensstr. 3 91301 Forchheim, Germany Telephone: +49 9191 18-0 siemens-healthineers.com 12 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024 SIEMENS Healthineers The MRI restrictions (if any) of the metal implant must be considered prior to patient undergoing MRI exam. MR imaging of patients with metallic implants brings specific risks. However, certain implants are approved by the governing regulatory bodies to be MR conditionally safe. Please contact the implant manufacturer for the specific conditional information. It is the responsibility of the implant manufacturer, not of Siemens Healthineers, to label an implant as MR Safe or MR Conditional and to define the specific MRI limits if applicable. 13 Effective Date: 19 Feb 2024 | QR700005547 Unrestricted I Published by Siemens Healthineers AG I © Siemens Healthineers, 2024