Safety Information (USA)

SIEMENS Healthineers Safety Information Job Aid 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), Template Effective Date: 10 Aug 2021 | HILS 2223 MR Medical Director (MRMD), or Directing Job Aid Effective Date: 9 Jul 2025 | QR700025108 Radiologists. Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers Table of contents General information 3 SIEMENS Healthineers Restricted items in the examination room 4 Emergency switches – location 5 Emergency switches – handling 6 MAGNETOM FLOW Magnet Stop switch 7 Daily MR components functionality checklist 8 Healthiners Pre-screening of patients and workers 9 Patient safety checklist 10 Safety-related messages 11 2 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers General information Ensure that all MR and non-MR personnel entering the examination room are adequately trained on safety instructions and restrictions. -- The following pages provide you with a checklist of important aspects to PEPconnect consider that before the MR and non-MR personnel enter the examination Experience PEPconnect room. SIEMENS .. Healthuneers The general safety instructions provided in the safety online training material in PEPconnect need to be taken into account. MR Safety 3 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers Restricted items in the examination room Especially in medical emergency scenarios, you need to check the support tools. Oxygen bottles, defibrillators, surgical tools, etc. shouldn’t be stored or brought into the examination room. These objects are magnetic and could potentially become a projectile that is injuring personnel. Ensure to screen and inform emergency and security personnel (e.g., police, firefighters, etc.) before they enter the examination room. The strong magnetic field has an impact on their equipment (e.g., fire extinguishers, weapons) and it shouldn’t be brought into the examination room. BOE 4 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers Emergency switches - location A prompt response is required in the event of an emergency. Therefore, use one of the emergency switches installed in (3) the operator room, at the workplace, and in the (3) examination room. P (3) (1) Magnet Stop switch (1) (1) + (2) Emergency Shutdown switch (2) + (2) (3) Table Stop button (2)|4 5 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers Emergency switch - handling O PRESS TO REMOVE FIELD EMERGENCY USE ONLY Magnet Stop switch Emergency Shutdown Table Stop on the patient Table Stop/Shutdown on table the intercom The static magnetic field is shut The electrical power of the Motorized table movement and Motorized table movement and down (quenched). entire MR system is switched the current measurement are the current measurement are off, but the magnet remains at stopped immediately. stopped immediately with field. Table Stop. For example, in the event of For example, in the event of For example, in the event of In all other cases, use the accidents with attracted metal fire. accidents or injury due to table ON/OFF button at the Intercom parts or in the event of fire. movement. to shut the system down. 6 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers Magnet Stop switch Magnet Stop and Emergency Shutdown are two distinct functions. Use them appropriately to avoid confusion and unintended consequences. PRESS TO REMOVE FIELD Use Magnet Stop only in emergency situations where there’s a risk to individuals and the EMERGENCY USE ONLY magnetic field must be switched off immediately. Shutting down the static magnetic field is irreversible and leads to several consequences, including the need for a Siemens Healthineers Service call. Please note: For safety reasons, no one should enter the examination room until cleared by an authorized Siemens Healthineers Service personnel. The magnet can only be put back into operation by a Siemens Healthineers Service personnel. In other situations, for example if a metal object is attracted to the magnet without any risk to persons, please contact Siemens Healthineers Service. 7 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers Daily MR components functionality checklist Before using the MR system, it’s always important to observe the trained safety measures and check the functionality and/or cleanliness of the following parts and areas: ⃣ Check that all warning symbols and signs are present inside and outside the examination room. ⃣ Check the examination, control, and equipment room for liquid spills and puddles on the floor. ⃣ Ensure that no magnetizable materials or objects are present in the examination room. ⃣ Visually inspect the table appearance and cleanliness. ⃣ Check the Intercom functionalities (e.g., LED, sound, patient communication). ⃣ Verify that pressing the squeeze bulb triggers the patient alert. ⃣ Test the Table Stop buttons to ensure they function properly and stop the table immediately (see page 6). ⃣ Check that the patient video monitoring systems transmit images properly. ⃣ Look for the System Check icon on the Home Screen. If it's red, review the Message History - MR Scanner and × Acquisition and contact Siemens Healthineers Service or wait until the system is ready. 8 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers Pre-screening of patients and workers Before any MR examination, screen and inform the patient about the effects and risks (e.g., stimulation, acoustic noise, heating effects, patient table movement). Additionally, educate the patient on how to collaborate. Document this information exchange in a Patient consent form, which must be signed before the examination. Ensure that patients always remove ferromagnetic objects before entering the examination room. Ferromagnetic objects are: • Bras (with clasps, underwire) U X X X ×00 • Belts X • Trousers with zippers or buttons 60 Hair pins, barrettes, or hair clips X X × × • • Removable dental braces • Nose and mouth masks with metal strips X X × 9 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers Patient safety checklist Always prioritize patient and staff safety while performing an examination. Before starting scanning, please check the following: ⃣ Does the patient have any implants, are they pregnant or are they wearing any (permanent) make-up? ⃣ Is there a possibility of embedded metal splinters (e.g., due to military activities)? ⃣ Is the patient wearing sufficient hearing protection? ⃣ Is the patient correctly positioned to avoid skin-to-skin contact between body parts (e.g., touching hands, feet, etc.)? ⃣ Is the patient correctly positioned to avoid contact between the body parts and the scanner bore? ⃣ Does the patient need active and extra medical supervision during the exam? This is required for the following patient groups:  Patients not capable of communicating autonomously (infants, children, patients who are confused, sedated, or unconscious)  Decompensated cardiac patients, febrile patients, or all patients with potential of developing cardiac arrest, seizures, or claustrophobic reactions. Please note: The same pre-screening steps apply for MR workers to avoid accidents and establish safety measures. 10 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers Safety-related messages System Tests Required ? X System Test Error ? X System not Enabled ? X For the safe operation of this system, routine tests must be carried out at regular intervals. X System tests are overdue or have not been successfully completed. Scanning patients on the system can endanger the patient. You have not successfully performed all safety-related checks. -- The tests will take approx. 9 min and will delay the Scanning cannot be continued until these system tests shutdown procedure. have been successfully completed. Contact Siemens Healthineers service immediately. If the time point is not suitable, you can postpone For the safe operation of this system, routine tests must be Siemens Healthineers cannot accept responsibility for the clinical execution until the next system startup. carried out at regular intervals. operation of this system. The tests will take approx. 9 min. Press OK to start the tests now. These tests can be repeated. Tests will start automatically in 49 second(s). If this message appears again, please contact Siemens The system will shut down automatically when the tests Service as soon as possible. are completed. Press OK to start the tests now. Tests will start automatically in 215 second(s). X OK Postpone OK Cancel Apply Cancel Perform the security-relevant latent error test as part of the shutdown before the deadline When the test is overdue or not completed, an If the required safety checks haven’t been expires. This test ensures that the system's error message will appear. This error message performed, further measurements are monitoring functions continue to work will prompt you to perform the safety test. prevented by the dialog box. Please contact correctly. Siemens Healthineers Service. 11 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Safety Information SIEMENS Healthineers Safety-related messages Scanning prohibited Emergency run down unit (ERDU) battery If the safety monitoring for the patient is deactivated, you’ll In the event of a low ERDU battery, a safety alarm will be see a red symbol flashing in the user. For safety reasons, initiated. Indications will appear at both at the the scanning of patients is prohibited. workplace monitor and the Select&GO display in the To reactivate safety monitoring, register the patient again. examination room. Evacuate the patient from the When the red symbol disappears, you can continue scanner, ensure that the examination room can’t be scanning. entered, and call Siemens Healthineers Service. MR scanner AF X Magnet Supervision: ERDU Battery voltage is below alarm threshold. X Stop scanning and bring the patient outside magnet room. Please contact Siemens Service. OK 12 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 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 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. Siemens Healthineers HQ I Siemens Healthineers AG Siemensstr. 3 91301 Forchheim Germany Phone: +49 9191 18-0 siemens-healthineers.com 13 Job Aid Effective Date: xx Jan 2025 | QR7000xxxxx Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024