Safety Information

SIEMENS Healthineers Safety Information Job Aid Version 2021.1 Template Effective Date: 10 AUG 2021| HILS 2223 Effective Date 30 AUG 2021 | HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Safety Information – SIEMENS Healthineers Table of Contents General Information 3 Support Tools 4 SIEMENS Heatthineers Pre-Screening of Patients and Workers 5 Patient Safety Checklist 7 MAGNETOM Free Max Emergency and Accidents 8 Magnet Stop Button 9 Quench 10 Magnet Stop Failure 11 System Check 13 Safety-related Messages 14 2 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 General Information SIEMENS Healthineers Please note: The general safety instruction provided in the safety online training material (in the MR Safety training area of PEPconnect) is still valid and needs to be taken into account as valid for this system. Following the safety regulations and pre-screening of workers and patients is essential. PEP PHIL 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 ensure before the MR and non-MR personnel enter the examination room. 3 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Prohibited Objects in the Examination Room SIEMENS Healthineers • Especially in medical emergency scenarios, you need to check the support tools. • Oxygen bottles, defibrillators, surgical tools etc. should not be stored or brought into the examination room. These objects are magnetic and could be attracted to the magnet and hit someone. • Ensure to screen and inform emergency and security personnel (e.g. police, fire fighters, etc.) before they enter the examination room. The strong magnetic field has impact on their equipment (e.g. fire extinguishers, weapons) and it should not be brought into the examination room. 4 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Pre-screening of Patients and Workers – SIEMENS Healthineers Particularity of MR systems with low Magnetic Fields Before any examination, the patient must be screened and informed about the effects and risks (e.g. stimulation, acoustic noise, heating effects, patient table movement) during a MR examination and how to best collaborate. This information exchange must be documented in a patient consent form, which must be signed before the examination. With MR systems with a lower magnetic field such as MAGNETOM Free.Max, ferromagnetic material may induce stronger effects and more severe image artifacts compared to higher fields. This is independent of the body region to be scanned. Therefore, it is important that before starting the examination, all potential ferromagnetic objects that may cause image degradation are removed from the patient. 5 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Pre-screening of Patients and Workers - SIEMENS Healthineers Overview Ferromagnetic Objects Ferromagnetic objects are: bd X • Bras (with and without underwire) U X × X X • Belts 60 • Trousers with zips or buttons × X X × X • Hair pins or hair bobbles • Removable dental braces X X X • Nose and mouth masks with metal stripes × Please note: The behavior with ferromagnetic materials is different from implants where artifacts at low field are minimized. The reason is that implants are made of paramagnetic materials. Take care that the patient always removes these objects before s/he enters the examination room. 6 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Patient Safety Checklist SIEMENS Healthineers Always put patient safety as a priority, while performing an examination. Before starting scanning, please check the following: ⃣ Is the patient wearing sufficient hearing protections? ⃣ Is the alarm bell working? ⃣ Is the patient correctly positioned avoiding skin-to-skin contact between body parts (e.g. touching hands, feet…)? ⃣ Is the patient correctly positioned avoiding contact between 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 that are confused, sedated or - unconscious), decompensated cardiac patients, febrile patients or all patients with potential of developing cardiac arrest, seizures or - claustrophobic reactions. 7 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Emergencies and Accidents – SIEMENS Healthineers How to React O O In case of emergency, prompt reaction is required. • Therefore, use one of the emergency switches which are installed in the operator room, at the workplace, as well as in the examination room. • In case of accidents or injuries to the patient due to table movements: immediately stop the table with any table stop button positioned on the Intercom or at the side of the patient table. • In case of emergency cases like fire, voltage accidents or natural events, it shall be enough to switch off the electric power of the entire system. If the situation requires immediate shut down, you can use the Emergency Shut-down button for immediate interruption of the power supply, , while the magnet will remain at field. In all other cases, to shut-down the system, use the ON/OFF button at the Intercom. 8 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Magnet Stop Button SIEMENS Healthineers In an emergency involving persons that are hit or squeezed in by metal parts attracted by the magnet, or in case of fire in the magnet bore, the magnetic field must be shut down immediately by pressing the Magnet Stop button (quenching the magnet), for the safety, rescue and evacuation of the patient and involved personnel. When the Magnet Stop button has been pressed, an alarm is triggered at the PRESS TO REMOVE FIELD EMERGENCY USE ONLY Intercom. The alarm sound is repeated three times and ends automatically. The alarm indicates that the user has pressed the quench button correctly. 9 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Quench SIEMENS Healthineers Please note: The quench triggered by Magnet Stop button is irreversible and after evacuation you need to call the Siemens Service. For safety reasons, nobody is allowed to enter the examination room until the Siemens Service gives permission after putting the system back in operation again. PRESS TO REMOVE FIELD Use the Magnet Stop button carefully and only in case of harm or death risk: EMERGENCY USE ONLY immediate quench is not needed in other situations such as attraction of a metal object to the magnet without any risk to persons. In these cases, contact the Siemens Service immediately. 10 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Magnet Stop Failure (1/2) SIEMENS Healthineers In case of Magnet Stop failure (e.g. low battery or defective cabling) a safety related alarm will be initiated. The acoustic alarm sound as well as the visual alarm (red flashing LED bars) will sound continuously. The acoustic alarm can be muted. You can mute it by pressing the listen or speak buttons. The visual alarm disappears as soon as the MR system is released by the Siemens Healthineers Customer Service. SIEMENS Healthineers ece 11 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Magnet Stop Failure (2/2) SIEMENS Healthineers When a safety related alarm is initiated, due to Magnet Stop failure a message dialog will appear at both Select&GO display and Host display, Emergency evacuation of the patient is needed. Indications will appear at both at the workplace monitor and the Select&GO display in the examination room. You must evacuate the patient from the scanner. After evacuation, ensure that the examination room cannot be entered and call the 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 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 System Check SIEMENS Healthineers Attention! • For the safety of the patients and personnel, it is always important to behave considering the magnet in operation at the magnetic field and observing the trained safety measures. • Act this way independently of the system status (at field, quench, safety alarm, message indicating × magnet not ready). • From the home screen, the system check icon might be red. • Go to the Administration portal to look for the reason. If the reported reason is only the magnet, System Check shown in red, please check the Message History MR Scanner and Acquisition. If the issue can be solved, a message will inform you when the magnet will be ready again. MR Scanner & Acquisition ? X Message Text Domain Date MRI_MSC [s] 1/25/2021 5:44:03 PM x System not ready for measurement. Magnet will be ready in approx. 98 minutes. 13 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Safety-related Messages SIEMENS Healthineers 1 System Tests required When the test is overdue or not completed an This warning informs you that a functional safety error message will appear and the safety test will test needs to be performed. be forced to be performed. System Tests Required ? X System Test Error ? x For the safe operation of this system, routine tests must be System tests are overdue or have not been successfully carried out at regular intervals. completed. X Scanning cannot be continued until these system tests -- The tests will take approx. 9 min and will delay the have been successfully completed. shutdown procedure. For the safe operation of this system, routine tests must be carried out at regular intervals. If the time point is not suitable, you can postpone execution until the next system startup. The tests will take approx. 9 min. Press OK to start the tests now. These tests can be repeated. If this message appears again, please contact Siemens Tests will start automatically in 49 second(s). Service as soon as possible. The system will shut down automatically when the tests Press OK to start the tests now. are completed. Tests will start automatically in 215 second(s). OK Cancel OK Postpone 14 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021 Safety-related Messages SIEMENS Healthineers 2 System not Enabled 3 Scanning prohibited If the necessary safety checks have not been performed, If the safety monitoring for the patient is the System not Enabled dialog window shows up. deactivated, you see a red symbol flashing in This informs you that scanning might endanger the the User Interface indicating No human patient and Siemens Healthineers cannot accept scanning allowed. For safety reasons, the the responsibility for operating the system. Contact scanning of patients is prohibited. Siemens Healthineers service. To reactivate safety monitoring register the patient again. When the red symbol System not Enabled ? X disappears, you can continue scanning. Scanning patients on the system can endanger the patient. You have not successfully performed all safety-related checks. Contact Siemens Healthineers service immediately. Siemens Healthineers cannot accept responsibility for the clinical operation of this system. Apply Cancel 15 Effective Date: 30 AUG 2021| HOOD05162003218515 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. © Siemens Healthcare GmbH 2021 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens-healthineers.com 16 Effective Date: 30 AUG 2021| HOOD05162003218515 Unrestricted © Siemens Healthineers, 2021