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Legend Indicates a hint Provides information on how to avoid operating errors or information emphasizing important details Indicates the solution to a problem Provides troubleshooting information or answers to frequently asked questions Indicates a list item Indicates a prerequisite A condition that has to be fulfilled before starting a particular operation Indicates a single-step operation Indicates steps within operating sequences Italic...
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Legend WARNING Indicates a hazardous situation which, if not avoided, could result in death or serious injury. WARNING consists of the following elements: ◾ Information about the nature of a hazardous situation ◾ Consequences of not avoiding a hazardous situation ◾...
Table of contents 1 Introduction Information about branding 1.1.1 Siemens Healthineers 2 Safety information General Handling of hardware components Compatibility 2.3.1 Labeling 3 Description Hardware components 3.1.1 Trigger converter box 3.1.2 Active driver 3.1.3 Passive driver 3.1.4 Additional components Software application 3.2.1...
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Table of contents 9 Appendix: regulatory information Medical devices of other manufacturers MR Elastography | Operator Manual Print No. MR-06020G.640.08.04.02...
MR-PET system. This manual may include descriptions covering standard as well as optional hardware and software. Contact your Siemens Sales Organization with respect to the hardware and software available for your system. The description of an option does not infer a legal requirement to provide it.
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Introduction While we have adopted this new brand name, the legal name of our company and the name of the Legal Manufacturer do not change. This change also does not impact any legal obligations. This new brand name is reflected on newly created product labeling (for example, user and technical manuals).
Safety information Safety information General All safety information of the valid operator manuals must be adhered to without fail. It is merely supplemented by the notes contained herein. All personnel should be instructed in the proper connection, use and handling of the system.
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Safety information CAUTION Active driver is not properly configured! Wrong diagnosis ◆ Ensure that the active driver is configured correctly as described in the configuration setup (see chapter configuration). CAUTION Use of unapproved accessories or cables! Electromagnetic interference may lead to incorrect operation of the equipment ◆...
Installation and configuration of the trigger converter box must only be performed by Siemens Service. Compatibility For the MR Elastography components, the following classifications apply: MAGNETOM Family, Biograph mMR | syngo MR D11, syngo MR D13, syngo MR B19, syngo MR B20P, syngo MR E11 Print No.
Safety information Trigger converter Active driver Passive driver Labeling 2.3.1 ASTM International developed a new classification system for implants and ancillary clinical devices. The following definitions apply: MR Safe An item that poses no known hazards in all MR environments. MR Safe items include nonconducting, nonmagnetic items such as a plastic petri dish.
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If in any doubt contact the vendor and do not place the component inside the magnetic field. Contact Siemens for a complete list of MR Safe Siemens products. MAGNETOM Family, Biograph mMR | syngo MR D11, syngo MR D13, syngo MR B19, syngo MR B20P, syngo MR E11 Print No.
Trigger converter box The trigger converter box is located next to the active driver in the equipment room. It is configured by Siemens Service. It receives input from the scanner electronics and triggers the active driver. The trigger converter box is MR Unsafe.
Description Active driver 3.1.2 The active driver is located in the equipment room. The active driver is triggered by the trigger converter box and creates pressure waves. The pressure waves are transferred to the passive driver via plastic tubing. If the active driver is on, but not triggered by the trigger ...
modifications to the components directly connected to the scanner (for example, trigger converter box) must be approved by Siemens. Software application The software application of the MR Elastography option monitors the propagation of the pressure waves in the human tissue.
Configuration Configuration Before the first usage you need to configure the active driver. Therefore a web interface is available at the active driver. This web interface can be addressed via Internet browser from any laptop, but not from the syngo Acquisition Workplace. Prior to starting the configuration, ensure that the following prerequisites are fulfilled: ✓...
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Configuration In the Select a Unit area, select the active driver ID. Click on the Launch Webpage button. The Resoundant web page is displayed. On the Resoundant web page, select Profile 0 from the Select Profile list, as this profile is not password-protected. Click the Edit button.
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Configuration Select the values to be changed and enter the new values described below. The values for frequency and duration are mandatory. The value for the amplitude is set to this value as a trade-off between optimal wave propagation and patient comfort. You have to change the following values: ◾...
Preparation Preparation ✓ Trigger converter box is connected and configured. ✓ Active driver is connected and plastic tubing is positioned correctly. ✓ Spine coil is positioned on the patient table. Place the belt for securing the passive driver directly on the patient table in the approximate position of the liver.
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Preparation Secure the tubing and the coil cable with straps to avoid bending when moving the table. Align the laser-light localizer with the center marking of the Body MR Elastography | Operator Manual Print No. MR-06020G.640.08.04.02...
Examination Examination Scope The target region for MR Elastography product is liver. Performing the measurement ✓ The active driver box is switched on. ✓ The Power LED (green) and the Awake LED (blue) on the front panel of the active driver are illuminated. If the Awake light is not illuminated, you must power cycle the active driver or receive input over the Ethernet channel.
Examination Viewing the results Four of the resulting image types are automatically loaded in the viewer: Magnitude Image This is the standard MRI magnitude image. Relative stiffness Map (Elastogram) This image contains the magnitude of the complex shear modulus. The displacement field is to be converted to a relative stiffness map by solv...
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Examination Image scale Numerical values on a linear scale of 0 to 8 kilopascals (kPa) are repre sented by a color scale ranging from violet to red, when using the default window/level of the relative stiffness image. The scale defines estimated tissue stiffness: very soft tissues in the 0-2 kPa range are shown with a color range of violet to blue, whereas stiffer tissues above 4 kPa are depicted with colors ranging from green through yellow to...
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Examination Phase Difference Image This image is generated by subtracting the phase values from images acquired with positive and negative cyclic motion encoding. The image is scaled so that a phase accumulation of minus pi is mapped to 0 and a phase accumulation of plus pi is mapped to 4095.
Maintenance of hardware components Maintenance of hardware components Cleaning Unplug the components from AC before attempting to clean. Clean the components with a damp cloth moistened with a mixture of mild soap and water. The cloth should not have any excess water in it that could run off onto the components during cleaning.
Technical data Technical data Technical data of the Resoundant components Device classification Class I equipment, IPX-0, Type B Applied Part Electrical ratings 120/240 Volts AC, 60/50 Hz and 250 VA Operating temperature range 10.0 to 33.3 °C (50 to 92 °F) Operating and nonoperating 10% to 85% RH, noncondensing humidity range...
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Please note that this manual may also contain information about medical devices that are NOT legally manufactured by Siemens. These medical devices are either only distributed by Siemens, or only mentioned for additional information. In the following table you will find information about the medical device, the corresponding legal manufacturer and, if applicable, the authorized representative.
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Appendix: regulatory information This page has been intentionally left blank. MR Elastography | Operator Manual Print No. MR-06020G.640.08.04.02...
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Appendix: regulatory information This page has been intentionally left blank. MAGNETOM Family, Biograph mMR | syngo MR D11, syngo MR D13, syngo MR B19, syngo MR B20P, syngo MR E11 Print No. MR-06020G.640.08.04.02...
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Appendix: regulatory information This page has been intentionally left blank. MR Elastography | Operator Manual Print No. MR-06020G.640.08.04.02...
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Please note: For products that are not legally manufactured This device bears a CE mark in accordance with the by Siemens but distributed, please refer to the Appendix of provisions of Council Directive 93/42/EEC of June 14, 1993 this manual!