MR Safety Information

SIEMENS Healthineers MR Safety Information Version 2020.03 USA HRT Approved - Effective Date 5.1.2021 | HOOD05162003145893 Template Effective Date: 27 MAY 2019 | HOOD05162003010284 Effective Date: 10 SEP 2020 | HOOD05162003091800 © Siemens Healthineers, 2020 Safety Information – SIEMENS Healthineers Table of Contents General Information 3 SAR Management 4 Precautions when using the ECG Sensor 6 Creating a Savelog 8 ECG I ECG 67/min RR-I: 890 ms ECG II mrm E ECG III USA HRT Approved - Effective Date 5.1.2021 | HOOD05162003145893 Effective Date: 10 SEP 2020 | HOOD05162003091800 © Siemens Healthineers, 2020 General Information SIEMENS Healthineers • All Safety Relevant Information is given in the User Manuals and is covered by the scanner training. Please make sure that every user operating the scanner is aware of the safety information and received appropriate training. • This document serves as supplementary information only. USA HRT Approved - Effective Date 5.1.2021 | HOOD05162003145893 Effective Date: 10 SEP 2020 | HOOD05162003091800 © Siemens Healthineers, 2020 SAR Management SIEMENS Healthineers • Any exposure to Radiofrequency Waves is limited according to the Specific Absorption Rate (SAR) for the respective region of the body that is exposed (Head, Torso, or Extremities). • SAR Limits: In accordance with the IEC 60601-2-33 standard and National regulations, our systems are limited to: SAR Aspect Limits in Normal Limits in First Level Operating Mode Operating Mode [W/kg] [W/kg] Whole Body 2.0 4.0 Exposed Body 2.0 - 10.0 2.0 – 10.0 Head 3.2 3.2 • For more information, please have a look at the Operator Manual - Scanning of your system. USA HRT Approved - Effective Date 5.1.2021 | HOOD05162003145893 Effective Date: 10 SEP 2020 | HOOD05162003091800 © Siemens Healthineers, 2020 SAR Management SIEMENS Healthineers • Limits for the SAR emitted during acquisition are calculated at an ambient temperature of 25°C and are a function of: • Strength of B0 magnetic field • Flip angle α • Patient’s weight • Patient’s position in relation to the magnet (head or feet first) USA HRT Approved - Effective Date 5.1.2021 | HOOD05162003145893 Effective Date: 10 SEP 2020 | HOOD05162003091800 © Siemens Healthineers, 2020 Precautions when using ECG Sensor – SIEMENS Healthineers Use of ECG Sensor in MRI, Patient Preparation • Use of ECG Sensor in MRI • ECG synchronization is used to eliminate artifacts caused by heart movement, especially during heart examinations. • Aim of the Siemens Sensor is to obtain the best possible signal while taking into account the interference produced by the switching of the RA gradients, as well as the magnetohydrodynamic effect causing a disturbance in the ECG signal. • "Physiological ECG Respiratory Unit" (PERU) is provided for this purpose. LL LA • Patient Preparation Skin is cleaned and shaved using an abrasive gel such as NuPrep©. RL • • Electrodes are arranged as shown in the illustration. • Siemens Healthineers recommends using Conmed ClearTrace© electrodes (reference 2700). USA HRT Approved - Effective Date 5.1.2021 | HOOD05162003145893 Effective Date: 10 SEP 2020 | HOOD05162003091800 © Siemens Healthineers, 2020 Precautions when using ECG Sensor – SIEMENS Healthineers Signal Learning Phase and Recommendations, Precautions • Signal Learning Phase and Recommendations • Use foam pad provided for the PERU • Examination Table must be located less than 30 cm from "Home" position • ECG Learning Phase lasts approximately 10 heartbeats • During this time the patient must remain motionless • No interaction (e.g. coil placement, movement of the New patient registered table, etc.). ECG I ECG 67/min RR-I: 890 ms • Check on screen that ECG alignment is correct once patient is positioned in center of magnet ECG II • Activation of at least three elements out of five on two different branches is recommended. Start examination only if the ECG signal is satisfactory. ECG III • • Precautions • Don’t use alcohol to clean skin. • PERU cannot be used to monitor patient's vital signs. • Ensure a minimum distance of 10 cm is maintained between PERU and the inside of the bore to avoid damage to PERU. USA HRT Approved - Effective Date 5.1.2021 | HOOD05162003145893 Effective Date: 10 SEP 2020 | HOOD05162003091800 © Siemens Healthineers, 2020 Creating a Savelog – SIEMENS Healthineers Definition and Role • Definition • Savelog (memory system log file) • File containing all events in the system • Must be created within a time interval close to the appearance of an error, and before the system shuts down. • Role • File makes it possible to reconstruct and understand the system’s activity at all times before its creation, and is necessary for the precise diagnosis of errors and in order to resolve them in as effectively as possible and prevent their recurrence. • Please Note • Don’t hesitate to contact the Customer Care Center (CCC) to allow follow-up of any system errors. • US Customer Care Center (CCC) [1-800-888-7436] USA HRT Approved - Effective Date 5.1.2021 | HOOD05162003145893 Effective Date: 10 SEP 2020 | HOOD05162003091800 © Siemens Healthineers, 2020 Create a Savelog – SIEMENS Healthineers Implementation • Move Mouse to Top Right (Left • Enter Name and Description of • Message notifies you when Screen in case of dual screen Problem Savelog procedure is complete configuration) • Click OK • Select Cog Wheel icon • Option given to add a • Choose SaveLog screenshot to Savelog. • No actions are possible on acquisition console when creating Savelog. Create SaveLog Create SaveLog Your name Configuration Panel Time of observation 3/27/2020 11:27:03 AM SaveLog created successfully Description ofme Administration Portal error or of your observation The created SaveLog was saved to C:\store\SaveLog The created process dumps were saved to Remote Access C:\store\SaveLog Remote Assistance ency Register ent Patient Screenshots Screenshots may contain patient data. Screenshots help our service in analyzing problems faster and more efficiently. Screenshots will only be used for this purpose and will be handled confidentially. DaveLoy Attach screenshots OK Cancel OK USA HRT Approved - Effective Date 5.1.2021 | HOOD05162003145893 Effective Date: 10 SEP 2020 | HOOD05162003091800 © Siemens Healthineers, 2020 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's Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. 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. Copyright © Siemens Healthcare GmbH 2020 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens.com/healthineers USA HRT Approved - Effective Date 5.1.2021 | HOOD05162003145893 10 Effective Date: 10 SEP 2020 | HOOD05162003091800 © Siemens Healthineers, 2020