www.siemens.com/healthcare MAGNETOM Skyrafit Operator Manual – MR System syngo MR E11 Answers for life.
MAGNETOM Skyrafit Operator Manual – MR System syngo MR E11
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 Used for references and for table or figure titles Used to identi
Legend WARNING Indicates a hazardous situation which, if not avoided, could result in death or serious injury. :$51,1* WARNING consists of the following elements: ◾ Information about the nature of a hazardous situation ◾ Consequences of not avoiding a hazardous situation ◾ Methods of avoiding a hazardous situation MAGNETOM Skyrafit | syngo MR E11 Print No. M6-04401.621.02.02.
Legend 6 MR System | Operator Manual Print No. M6-04401.621.02.02.
Table of contents 1 Introduction MAGNETOM Skyrafit | syngo MR E11 Print No. M6-04401.621.02.02.02 11 1.1 Layout of the operator manual 11 1.2 The current operator manual 11 1.3 Intended use 12 1.4 Authorized operating personnel 1.4.1 Definitions of different persons 13 13 2 Safety 15 2.1 Preface about safety 2.1.1 Hazards and risks 2.1.2 Common causes of accidents 2.1.3 Responsibility 2.1.4 Configuration of hazard hints 15 15 15 15 16 2.2 Common/permanently existing hazards 2.2.
Table of contents 3 MR system components 47 3.1 Overview MR system 3.1.1 About function 3.1.2 Super-conducting magnet 3.1.3 Electronics cabinets 3.1.4 RF coils 47 47 47 47 49 3.2 syngo Acquisition Workplace 3.2.1 Host 3.2.2 Data recording 3.2.3 Monitor 3.2.4 Keyboard 3.2.5 Mouse 3.2.6 syngo MR Workplace (optional) 49 50 50 50 51 52 53 3.3 System control 3.3.1 Description 3.3.2 Operating the Dot display 53 53 57 3.4 Patient table 3.4.1 Description 3.4.2 Operating the patient table 57 57 59 3.
Table of contents 4 Physiological imaging 4.1 Triggering methods 4.1.1 Prospective triggering 4.1.2 Retrospective gating 83 83 84 4.2 Physiological Measurement Unit (PMU) 4.2.1 Description 4.2.2 Preparing the measurement 84 84 89 4.3 ECG triggering 4.3.1 Description 4.3.2 Performing 91 91 92 4.4 Pulse triggering 4.4.1 Description 4.4.2 Performing 95 95 95 4.5 Respiratory triggering 4.5.1 Description 4.5.2 Performing 96 96 96 4.6 External triggering 4.6.1 Input for external trigger signal 4.
Table of contents 5.6 Starting/Stopping the measurement 5.6.1 Starting the measurement 5.6.2 Stopping the measurement 6 Maintenance 117 6.1 Cleaning 6.1.1 Cleaning the LCD monitor/video display 6.1.2 Cleaning the camera lens 6.1.3 Cleaning the data carrier 6.1.4 Cleaning the plugs and connectors 6.1.5 Cleaning the patient table and the straps 6.1.6 Cleaning and disinfecting the receptors 6.1.7 Disinfecting system components 6.1.8 Care and cleaning of floors 117 117 118 118 118 118 118 119 119 6.
Introduction 1 1 Introduction In order to operate the MR system accurately and safely, the operating personnel must have the necessary expertise as well as knowledge of the complete operator manual. The operator manual must be read carefully prior to using the MR system. 1.1 Layout of the operator manual Your complete operator manual is split up into several volumes to improve readability. Each of these individual operator manuals covers a specific topic: ◾ Hardware components (system, coils, etc.
1 Introduction The graphics, figures, and medical images used in this operator manual are examples only. The actual display and design of these may be slightly different on your system. Male and female patients are referred to as “the patient” for the sake of simplicity. 1.
Introduction 1 1.4 Authorized operating personnel The MAGNETOM MR system must be operated according to the intended use and only by qualified persons with the necessary knowledge in accordance with country-specific regulations, e.g. physicians, trained radiological technicians or technologists, subsequent to the necessary user training. This user training must include basics in MR technology as well as safe handling of MR systems.
1 Introduction Term used Explanation Siemens Service/service personnel Group of specially trained persons who are authorized by Siemens to perform certain maintenance activities References to “Siemens Service” include service personnel authorized by Siemens. 14 MR System | Operator Manual Print No. M6-04401.621.02.02.
Safety 2 2 Safety 2.1 Preface about safety 2.1.1 Hazards and risks An MR system may present various hazards. Some occur only during the examination, while others exist permanently and thus are also relevant to non-users (e.g. cleaning personnel). The various hazards and the corresponding safety instructions are explained in the safety chapter of this operator manual. 2.1.2 Common causes of accidents Despite safety instructions, some hazards lead to accidents time and again.
2 Safety 2.1.4 Configuration of hazard hints All hazard hints are identified in a special way. The following keywords signal the level of hazard involved: WARNING Warning regarding risks that may result in death or serious physical injury. CAUTION Warning regarding risks that may result in minor physical injury or material damage. Example: WARNING Source of danger! Consequences ◆ Countermeasure. 2.
Safety Fields Most serious hazards Static magnetic field Movement by implants and prostheses in the body 2 Attraction, alignment, and projectile-like acceleration of magnetizable objects ( Page 18 Safety instructions on the static magnetic field) Gradient fields Peripheral nerve stimulation ( Page 20 Safety instructions on RF and gradient fields) RF fields Warming of body tissue ( Page 20 Safety instructions on RF and gradient fields) All persons (e.g.
2 Safety RF fields lead to warming of the body tissue. In this context, an important value per body weight is the specific absorption rate or SAR. ( Page 108 Physiological effects) Side effects 2.2.2 Possible undesirable side effects for MR are dizziness, heating, claustrophobia and nerve stimulation. Safety instructions on the static magnetic field The list of objects in this chapter is not exhaustive.
Safety 2 WARNING Movement and/or alignment of implants and prostheses in the body, as well as attraction, alignment, and projectile-like acceleration of magnetizable objects may result in very serious hazards! Injury to patient and operating personnel ◆ Do not use resuscitation devices - for example, defibrillators or oxygen bottles - in the examination room. ◆ Do not use transport trolleys, movable beds, stretchers, etc. that consist of magnetizable parts.
2 Safety For China only: In 3-T systems medical supervision is required for all patients according to IEC 60601-2-33 (2nd edition). Dizziness during exposure When persons (e.g. MR workers or patients) are exposed to the static magnetic field, possible effects are dizziness, light-headedness, or metallic taste, especially in 3-Tesla magnetic fields. 1 Ask the patient to lie still during the measurement. 2 Keep a sufficient distance to the magnet and avoid rapid movements of the head.
Safety 2 Ensure to prevent potential current loops as shown in the red labeled illustration. Ensure the patient is positioned with proper distance (5 mm) to magnet tunnel as well as proper distance between parts of the body as shown in the green labeled illustration. ◆ To lower the effects of gradient fields or RF fields, keep a sufficient distance from the RF coils and the magnet tunnel (gradient coils), and reduce the time of exposure during measurements. MAGNETOM Skyrafit | syngo MR E11 Print No.
2 Safety CAUTION The patient is wearing electrically conductive material! Incorrect patient positioning! Formation of electric current loops Peripheral nerve stimulation of the patient ◆ Ensure that the patient does not wear clothing that is wet or dampened by perspiration. ◆ Ensure that the patient is free of metallic rings, chains, or electrically conductive materials worked into items of clothing (for example, brassiere support wires, metallic appliqués or woven metallic yarns).
Safety 2 CAUTION Heating up of RF blankets or shields used to avoid aliasing artifacts! Patient burns ◆ Never use RF blankets or other conductive sheets within the MR system. 2.2.4 Contraindications This chapter contains very important information about MR safety: In principle, a qualified physician must evaluate the risk/ benefit ratio of the MR examination for every patient.
2 Safety WARNING Electronic and/or electrically conductive implants and magnetizable inclusions in static and low-frequency magnetic fields and RF fields! Risk of patient death/patient injury ◆ Ask the patient about implants and inclusions. ◆ Do not perform MR examinations on patients with electronic or electrically conductive implants and magnetizable inclusions. ◆ Ensure that patients wearing such implants and/or inclusions remain outside the exclusion zone (0.5 mT line).
Safety 2 CAUTION Eddy currents induced by low-frequency magnetic fields! Patient burns ◆ Do not examine patients with electrically conducting implants or prostheses. CAUTION Electrically conducting objects! Injury to patient due to warming Incorrect diagnosis due to artifacts ◆ Request that the patient removes all electrically conducting objects, e.g. necklaces, rings, braces, rubber bands for long hair, piercings as well as jewelry.
2 Safety CAUTION Accidental patient table movement! Injury to the patient ◆ If you plan an intervention outside the magnet, activate the Table Lock function at the Dot display with the control unit to avoid accidental patient table movement, or injury to the patient. After completing the intervention, the table can be unlocked.
Safety 2 CAUTION Vertical and horizontal movement of the patient table! Injury to patient and other persons Damage to the patient table ◆ Ensure that there are no obstacles (e.g. extending or overhanging body parts, hair, clothing, straps) between table and the magnet, or that the additional equipment (e.g. IV tube, respirator or ECG) does not get caught and remains in and on the patient when moving the tabletop.
2 Safety WARNING Improper patient transport with the dockable patient table, improper use of the side rails! Injury to the patient Damage to the patient table ◆ Carefully transport the patient on the dockable patient table. Secure the patient if necessary. ◆ Do not pull/push the tabletop or use the emergency release to avoid any unintended horizontal movement. ◆ Use the side rails as intended (as an arm rest or in the vertical position e.g. for securing the patient).
Safety 2 Auxiliary equipment, which has not been specifically tested and approved for use in the environment of the MR equipment, may result in burns or other injuries to the patient. If the MR system is combined with other systems or components, it must be ensured that the planned combination and cable routing do not affect the safety of patients, personnel, or the environment. Ensure that the devices used in the examination room are compatible with the field strength of the MR system.
2 Safety MR Conditional An item that has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Field conditions that define the specified MR environment include field strength, spatial gradient, dB/dt (time rate of change of the magnetic field), RF fields, and SAR. Additional conditions, including specific configurations of the item, may be required. MR Conditional devices (for example, RF communications equipment) may present hazards as well.
Safety 2 2 Ensure that the door to the examination room opens and closes correctly. 2.3.3 Noise development By switching the currents in the gradient coils for imaging purposes, the mechanical forces lead to noise development (humming, knocking noises) during the MR examination which can exceed 99 dB(A) in the bore.
2 Safety ◾ For appropriate sound attenuation, the proper use of hearing protection is important. All personnel should be trained to correctly apply the hearing protection. ◾ Special attention and training of the operator is required for proper positioning of the hearing protection for neonates and infants. In addition this applies to any other condition where an alternative form of hearing protection might be necessary. ◾ For MR examinations of infants special hearing protection may be required.
Safety Patient monitoring 2 Patients may be acoustically as well as visually and physiologically monitored in the MR system. ◾ The viewing window or a video system is used for visual monitoring. ◾ The intercom can be used to acoustically contact the patient. ( Page 74 Description) ◾ Medical supervision: MR Conditional monitoring devices are used to monitor the patient's vital parameters, provided the conditions for safe operation are observed.
2 Safety Causes: Artifacts and imaging errors are listed according to their source for error: ◾ System-related artifacts/imaging errors ◾ Patient-related artifacts/imaging errors ◾ User-related artifacts/imaging errors, see: Software operator manual User-related and patient-related artifacts/imaging errors can be largely avoided through patient instructions and proper conduct of patient and personnel.
Safety Variations in brightness 2 CAUTION Local variation in the sensitivity of local coils! Continuous fluctuations in MR image brightness ◆ Whenever possible, use a local coil with transmit characteristics that are more suitable for the field of view desired. ◆ Use the normalization filter.
2 Safety Distortions/signal obliteration along the edges CAUTION Spatial non-linearity of the gradient field and inhomogeneity of the static magnetic field! Pin-cushion and barrel-shaped distortions and/or loss of signal in the margins of the MR image ◆ Go through a distortion correction. ◆ Position the region to be examined as close to the magnet isocenter as possible. ◆ Use phantoms for the control measurements.
Safety DIXON swapping 2 WARNING When using the DIXON method, water and fat swaps might occur! Incorrect diagnosis ◆ Diagnosis should be confirmed by a second contrast and/or a different orientation. Patient-related artifacts/ imaging errors CAUTION Poor image quality! Wrong image position! Incorrect diagnosis ◆ Prior to the examination, inform patients about movements and their negative effects on the measurement. ◆ Ensure that the patient does not move during the measurement.
2 Safety 2.3.6 Maintenance/repair WARNING High voltage and currents inside the electronics cabinets! Risk of death by electrocution ◆ Electronics cabinets should only be opened by Siemens Service. Daily checks Safety-relevant accessories Windows, doors, and emergency flaps must not be blocked.
Safety Potential injury to persons Risk of injury Risk of breaking Maximum load side rails 2 Laser radiation Laser (for the US only) Laser Refilling with liquid nitrogen and helium Prohibition signs MAGNETOM Skyrafit | syngo MR E11 Print No. M6-04401.621.02.02.
2 Safety Implants susceptible to electromagnetic effects Open flames, no smoking Metallic implants and other metallic objects inside the body Fire extinguishers with magnetizable metal housing Metal parts, e.g. tools Electronic data carriers Unauthorized access Mechanical watches and electronic data carriers Implants susceptible to electromagnetic effects Further symbols Sign requiring mandatory hearing protection 40 Non-ionizing radiation MR System | Operator Manual Print No. M6-04401.621.
Safety Protective class symbol B for application parts 2.3.8 2 Protective class symbol BF for application parts System owner-related advices Some safety instructions address the system owner. They are included as “Safety information” in a separate operator manual, see: System owner manual. This manual also contains the technical description of the system. 2.3.
2 Safety Switch Effect Emergency Emergency Shutdown Electric power of the entire MR system is switched off, but magnet remains at field E.g. in case of fire Table Stop Motorized table movement is stopped In case of accidents or injury due to table movement In case of emergency, the relevant switch should be pressed.
Safety 2 After the Magnet Stop switch has been pressed, an alarm is triggered at the alarm box. The WARNING LED will light up and an alarm signal will sound. As a rule, Siemens Service must be called following a quench. The magnet must only be put back into operation by Siemens Service personnel. WARNING Formation of droplets due to condensation during quenching! Personal injury Risk of fire ◆ Do not touch the exhaust line. ◆ Do not stand under the exhaust line.
2 Safety Emergency Shut-down switch Typically there are two Emergency Shut-down switches installed: one near the alarmbox and another one in the examination room. The switch is used to switch off the electric power of the entire MR system. WARNING Fire or electrical accidents! Personal injury ◆ Press the Emergency Shut-down switch immediately. ◆ Contact your fire department. Table Stop button 2.4.2 It is located on the intercom and on the patient table.
Safety 2 CAUTION Squeeze bulb is defective! Risk of injury to patient because emergencies cannot be communicated ◆ Check the functionality of the squeeze bulb daily. 2.4.3 First aid in case of shortness of breath Coolant accidents During a quench, a person might become unconscious due to severe shortness of breath: 1 Remove unconscious persons immediately from the examination room. 2 Start adequate first aid measures and contact a physician immediately.
2 Safety 2.4.4 Fire/Fire fighting The following devices/materials may be used for fire fighting: ◾ Non-magnetic CO2 extinguisher ◾ Self-contained, anti-magnetic compressed-air breathing apparatus (or hose connection) ◾ Airtight chemical protective suit 46 MR System | Operator Manual Print No. M6-04401.621.02.02.
MR system components 3 3 MR system components 3.1 Overview MR system 3.1.1 About function A detailed specification of the systems hardware and software is available in the Info dialog box (main menu Help > Info). 3.1.2 Magnetic field Cooling system Shielding Gradient system Super-conducting magnet The super-conducting magnet generates a strong homogeneous magnetic field with a field strength of 3 T. The magnet is filled with liquid helium as a coolant.
3 MR system components (1) Gradient cabinet (2) Control cabinet (3) System separator Gradient cabinet Control cabinet The gradient cabinet contains the power electronics for generating the magnetic field gradients. The control cabinet includes different electronics components to operate the MR system. The control cabinet includes a sequence-programmable, optical trigger signal output which can be made externally accessible by Siemens Service via installation of a fiber optic cable.
MR system components 3 Please note that Siemens provides customers with the optical trigger signal output for research purposes only. No devices connected to this output have been tested by Siemens. Before connecting devices to the MR suite using the optical trigger signal output, they must be tested for safety by trained personnel. Before using devices in the proximity of the magnet, their nonmagnetic properties and clinical operation in the magnetic field have to be confirmed.
3 MR system components 3.2.1 Host Among other things, the host processor includes the following functions: ◾ Patient management ◾ Image selection and storage ◾ Measurement sequence management 3.2.2 Measured MR images may be transferred to other systems or computers via the network connection (e.g. PACS or RIS systems). MR images from other systems or computers can be received via the network as well. Information about network connections is displayed in the Info... dialog window.
MR system components 3 All other adjustments are blocked since the monitor is already optimally configured by Siemens Service. Do not touch the surface of the screen using sharp, pointed objects. Do not position containers holding fluids, e.g. cups or glasses, on top of the monitor. In addition, general cleaning instructions must be observed. The monitor may only be opened by authorized Siemens Service personnel. 3.2.
3 MR system components Function Original Siemens key Windows key 5/4 Page forth/back in the series / Page forth/back image by image 2/1 / Open patient registration Ins Selecting the Patient Browser Del Copy to film sheet Enter Highlight 3 Send to node 1 + If the computer system is connected to a clinic-wide processor network (HIS/RIS), use the Examination task card to send images to other network addresses via node 1. 3.2.5 Mouse The system is equipped with a wheel mouse.
MR system components 3 ◾ Left mouse button: – Selecting or moving objects – Starting applications – Executing commands ◾ Center mouse button/wheel: – Changing the window values of patient images – Scrolling (for example, through the Patient list) ◾ Right mouse button: – Opening the context menu (depending on the position of the mouse pointer) 3.2.
3 MR system components Control units The control units are located at the right and the left side of the patient table at the front of the magnet cover. Optionally, additional control units are located at the back of the magnet. Each control unit consists of a jogwheel and several additional buttons.
MR system components 3 Depending on the situation, the small jogwheel can have different functions: ◾ Rotate: e.g. for navigating through the display menu or for changing settings of, for example, ventilation ◾ Push: e.g. for resetting the patient alert or for starting a measurement Alternatively, use the intercom to reset the patient alert or to change the volume settings of the headphones and loudspeakers.
3 MR system components ◾ Guidance for attaching ECG electrodes, docking the table and emergency evacuation ◾ General patient information submitted from the software ◾ Information concerning troubleshooting Tool bar You can navigate between the depicted icons by using the small jogwheel. The selected icon is highlighted.
MR system components 3.3.2 3 Operating the Dot display To operate the Dot display, use the jogwheel of the smaller control unit. ( Page 54 Control units) 1 Turn the jogwheel to navigate through the icons. 2 Press the jogwheel to confirm the selection. 3 If necessary, adjust your settings by turning and pressing the jogwheel. 3.4 Patient table 3.4.1 Description The patient table is used for positioning the patient and the coils. The table comprises several sockets and connections.
3 MR system components (1) Tabletop (2) Head end (3) Table Stop button (4) Handle to pull out the table top in case of emergency (5) Emergency release The tabletop can be moved horizontally into the magnet bore. When moved completely out of the magnet, the tabletop may be moved vertically as well. Coil sockets The coil sockets are located at the head end and the foot end of the patient table.
MR system components Connections 3 Make sure that no liquids such as contrast medium, blood, or cleaning agents get into the table connections. The following connections are located at the foot end of the patient table: (1) Headphones (2) Vacuum cushion (3) Squeeze bulb (4) Placeholder [Intended for future use] Paper roll holder The paper roll holder can be mounted at the foot end of the table below the handle. It includes a holder to reposit the headphones and can be removed if required.
3 MR system components (1) Table Up/Inward button (2) Jogwheel, Center Position button (3) Home Position button (4) Table Down/Outward button To operate the patient table safely and efficiently, operating personnel must be familiar with its most important positions.
MR system components 3 Using the jogwheel 1 Keep the jogwheel turned to move the patient table up/into or down/out of the magnet bore. Depending on how far the jogwheel is turned, the speed increases. The table movement stops immediately once you release the jogwheel. 2 Press the jogwheel for one second to move the patient table into the Center Position. Depending on the situation, you can also move the table horizontally into the Last Scan Position or the Default Position by pressing this jogwheel.
3 MR system components Stopping table movement 1 Press the Table Stop button to stop the table movement. 2 To reset the table stop, turn the Table Stop button clockwise until it releases mechanically. Then simultaneously press the Table Up/ Inward and the Table Down/Outward button fully. Rescuing the patient in an emergency In case of accidents, e.g. patient emergency situation (e.g. heart attack), the tabletop and patient must be moved out of the magnet bore.
MR system components 3 WARNING Patient rescue during emergency situations, e.g. quench with failing quench pipe, fire with strong smoke development, emergency situation involving patient (e.g. heart attack) and simultaneous power failure! Personal injury ◆ After releasing the emergency release, pull the tabletop with the patient manually out of the magnet. 1 Pull the Emergency release (location is indicated by a label) outward up to the end stop.
3 MR system components 3 Press the Home Position button. After reaching the Home Position, the patient table is ready for operation again. 3.5 Dockable patient table 3.5.1 Description The dockable patient table is an optional table that can be completely removed from the magnet system. This enables the transport of immobile patients. The configuration of the dockable patient table is similar to the standard table. This section only mentions the differences.
MR system components 3 (4) Emergency undocking handle (5) Pedals (6) Handle at the foot end Pedals If the table is removed from the system, you can use the pedals to lift and lower the table manually. Side rails The side rails can be folded out to secure patients during transport, or as a arm rest for patients with infusions. Guiding wheel For better maneuverability, a fifth wheel is positioned in the middle, underneath the dockable patient table.
3 MR system components ◆ Position the side rails as required: e.g. in a vertical position to secure the patient, or in a horizontal position as arm supports. Undocking the table ✓ The tabletop is in Home Position. ✓ Brake for the castors is released. ◆ Step completely on the left pedal to undock the table. The table is removed from the system and can be moved in any direction. Moving the dockable patient table You can use the side rails to steer the table.
MR system components 3 CAUTION Dockable patient table may move against the wall or the door! Possible injuries (for example, squashed fingers) ◆ To move the table, always grasp the middle area of the handle (not the outside edges). 4 Move the table with the handle at the foot end of the table. Docking the table If the dockable patient table is not in use, make sure not to move it to the back of the magnet. ✓ Guiding wheel is activated. ✓ Side rails are lowered.
3 MR system components 2 Position the table so that the docking nose is positioned in the docking station and the table is positioned at the end stop of the docking station. The display shows if the table is positioned correctly and completely in the docking station. 3 Check the display if the table is ready for docking. If the table is not ready for docking, reposition the table in the docking nose.
MR system components 3 Table moves downwards despite you want to lift the table In certain cases (for example, after docking), the table must find the reference position and moves slightly down. This is normal behavior. Table does not move horizontally Check that the side rails are fully stored in the carrying frame - otherwise no table movement is possible.
3 MR system components ✓ Tabletop is in Home position. ✓ Brake for the castors is released. ◆ Pull the emergency undocking handle to undock table. The table can be removed from the system. Resetting the emergency undocking handle 1 Press the emergency undocking handle back into its original position. 2 Position the table with the docking nose in the docking station up to the end stop. Then press the left pedal down fully with your foot. 3.
MR system components 3 ✓ The patient is positioned on the tabletop. ✓ The patient table has been moved to measurement height. WARNING Laser beam of the laser light localizer! Eye injury caused by laser beam ◆ Ensure that the operating and adjustment devices as well as methods given are used as described. ◆ Inform the patient about the laser and request that he keeps his eyes closed during positioning. ◆ Ensure that helpless patients keep their eyes closed during the positioning procedure.
3 MR system components 3.7 Alarm box 3.7.1 Description The alarm box has the following functions: ◾ Displays alarm signals ◾ Switches the MR system on and off ◾ Magnet Stop / Magnet Quench The alarm box is installed near the syngo Acquisition Workplace. 3.7.2 Checks WARNING MR system malfunction! Hazardous conditions for patients ◆ Note the sounding alarm and signal. ◆ Do not perform MR examinations. ◆ Notify Siemens Service. 72 MR System | Operator Manual Print No. M6-04401.621.02.02.
MR system components 3 Checking the LEDs (1) WARNING LED (2) POWER LED (3) SYSTEM ON LED LED LEDs light up to indicate WARNING Error message, e.g. helium fill level is too low POWER Voltage supply of MR system is satisfactory SYSTEM ON The MR system is switched on 1 Check the WARNING LED for alarm messages. An alarm is present when a yellow LED lights up and/or an alarm sounds. 2 In case of an alarm: Check the host computer for error messages.
3 MR system components ◆ Please contact Siemens Service regarding questions about remote monitoring. 3.8 Intercom 3.8.1 Description The intercom allows personnel and patients to communicate during the examination. In addition, some important operations like stopping the patient table can be managed from the intercom. Optionally, music or automatic voice outputs can be played in the examination room via the loudspeaker or the headphones.
MR system components Patient alert 3 Patients may use the squeeze bulb to alert the operating personnel (patient alert): ◾ Acoustically: – Continuous tone over the intercom – Brief feedback signal via the patient’s headphones and loudspeaker in the examination room ◾ Visually: – Blinking button on the intercom – Message on the Dot display in the examination room The alert can be reset by pressing the Reset Patient Alert or the Talk button on the intercom.
3 MR system components Button Function Stop Stops the table movement and the measurement immediately Reset Stop Resets the table Stop 1 Press the corresponding button. 2 If necessary, adjust the volume using the +/- buttons. Press and hold the buttons to adjust the volume. If you hold the button for about one second, the volume increases/ decreases until you release the button. Transmitting automatic voice output Automatic voice output can be used for transmission of commands e.g.
MR system components 3 The In-Room syngo Acq WP is connected with the host processor and facilitates the examination process by allowing the operating personnel to remain inside the examination room between procedures.
3 MR system components CAUTION Diagnosis at the In-Room syngo Acquisition Workplace or use for interventional procedures! Risk of patient injury; incorrect diagnosis ◆ Always plan appropriate emergency measures prior to starting an MR-guided or MR-monitored interventional procedure. ◆ Do not use the In-Room syngo Acquisition Workplace for diagnostic purposes. Operating the trackball and the keys (1) Keys (2) Trackball (3) Handle The keys have the same functions as those of the mouse.
MR system components 3 1 Release the locking lever by turning it counter-clockwise by 90°. 2 Press lightly against the upper or lower edge of the display to move the monitor into the desired tilt position. Adjusting the monitor height 1 Turn the wheel clockwise to raise the monitor. 2 Turn the wheel counter-clockwise to lower the monitor. Operating the footswitch The footswitch is used to start and stop the MR measurement in the examination room.
3 MR system components If the protocol is configured for repeated measurements, the next measurement can be started with the footswitch after completing the preceding measurement. For more information regarding the configuration of protocols, see: Software operator manual 1 Push the hose plug into the retaining rings of the pushbutton unit. 2 Load a suitable protocol and start it at the syngo Acq WP or the InRoom syngo Acq WP. The MR system is waiting for the manual start of the protocol.
MR system components Acting in case of an alarm 3 ✓ Gradient malfunction is detected. ✓ An alarm message appears at the syngo Acquisition Workplace. Dialog box at the syngo Acquisition Workplace (1) Scanner hardware error Automatic shutdown! Evacuate patient immediately from the examination room! To prevent further damage, the system will be switched to Standby within 1 minute! Call Siemens Service immediately. 1 Immediately move the patient out of the magnet bore by pressing the Home Position button.
3 MR system components Acting in case of a supervision malfunction ✓ A malfunction within the supervision system is detected. ✓ A corresponding error message appears at the syngo Acquisition Workplace. Dialog box at the syngo Acquisition Workplace (1) Scanner hardware malfunction Functional problem within automatic shutdown mechanism. Please restart software of MeasRecon. If the problem persists, please call Siemens Service immediately. ◆ Call Siemens Service.
Physiological imaging 4 4 Physiological imaging 4.1 Triggering methods MR imaging procedures are sensitive to patient movement. Images may exhibit artifacts in the form of smears when motion times - for instance, during respiration or heartbeat - are short compared to measurement times. In particular, this problem occurs as a result of the patient's heartbeat during cardiac examinations or as a result of the patient's breathing during abdominal examinations.
4 Physiological imaging 4.1.2 Retrospective gating Retrospective gating fundamentally differs from prospective triggering. No actual triggering is taking place. The physiological signal and data acquisition times are recorded simultaneously. The measurement is performed completely independently of the patient’s heartbeat or pulse. A temporal assignment of images to the corresponding phase (e.g. heart stimulation) is performed after the measurement (retrospectively).
Physiological imaging 4 Only one PERU or PPU can be located in the examination room! Two ECG and respiratory sensors in the examination room interfere with one another in signal transmission. It is not possible to determine the results. Patient monitoring systems are optional accessories and are not part of the PMU. ECG and respiratory sensor (PERU) The Physiological Measurement Unit may be used only for controlling MR measurement sequences. The unit does not replace a patient monitoring system.
4 Physiological imaging (1) Application cushion (2) Respiratory cushion with pressure hose (3) Respiratory belt The respiratory cushion is attached to the patient using the respiratory belt. Wireless pulse sensor (PPU) The PPU acquires the patient's peripheral pulse. It consists of a transmitter unit, a fiber-optic sensor and a removable finger adapter (available in different sizes). (1) Finger adapter (2) Fiber optic cable (3) Transmitter unit (4) Control LEDs 86 MR System | Operator Manual Print No.
Physiological imaging 4 External trigger input External trigger sources (e.g. patient monitoring system) may be connected with the help of the trigger input to drive MR sequences. The connection for the trigger input is located on the cover of the MR system. Trigger input is galvanically isolated with respect to the MR system. Charging station Both the PERU and the PPU are supplied with power via accumulators. All other components of the PMU are supplied by system-internal voltage sources.
4 Physiological imaging Control LEDs The transmitter unit includes three green LEDs for signaling the battery status and one red LED as fault indicator (for example, insufficient skin contact of the ECG electrodes). (1) 3 Green LEDs (battery status) (2) 1 Red LED (fault) (3) Transmitter unit Battery status and faults are also indicated on the Dot display and the Physiological Display dialog window. If the accumulator is not in the charging station, the green LEDs flash regularly and simultaneously.
Physiological imaging 4 Additionally, battery status and electrode/application fault are indicated on the display. Physiological Display The Physiological Display lets you view the patient's physiological signals at the syngo Acquisition Workplace. See: Software operator manual 4.2.
4 Physiological imaging 2 Inform the patient that the knocking sounds during the measurement are caused by switching the gradients on and off. The PERU may also vibrate slightly. Attaching the PERU Knocking sounds may affect the heart rate of patients, either consciously or subconsciously. The resulting irregular cardiac cycles adversely affect image quality. The PERU is used together with ECG and respiratory triggering. ✓ ECG electrodes are attached. ✓ The patient table is in the Home position.
Physiological imaging 4 4 Align the PERU on the patient in the direction of the patient’s feet. 5 For the special case of triggered flow measurements/flow quantification in the head region, please position the PERU next to the patient's head (as shown in the picture) to reduce gradient interference. Position and connect the PERU and electrodes as usual.
4 Physiological imaging The characteristic QRS complex of the ECG signal is used as a trigger signal. Simultaneous acquisition and overlaying of the orthogonal leads (vector cardiography) is used to minimize triggering errors due to gradient switching and the magneto-hydrodynamic effect (i.e. excess T-wave amplitude).
Physiological imaging 4 ◾ Reduction of interference signals caused by electromagnetic induction. – Due to cable loops – Interferences from electrical potentials caused by muscle movement Preparing the patient Attach the electrodes so that interferences from electrical potentials caused by muscle movement and baseline drifts are minimized. Suitable contact points are therefore areas that show very little muscle or fatty tissue.
4 Physiological imaging Patients with an offset heart axis (e.g. dilatative cardiomyopathy) may require a different orientation than parallel to the spine. 1 Check the expiration date of disposable electrodes and order new ones if necessary. 2 Pull the protective foil off the electrodes and attach them. 3 Use the application cushion and position it together with the PERU on the patient. ( Page 89 Preparing the measurement) 4 Connect the electrode clips of PERU to the ECG electrodes.
Physiological imaging 4 4.4 Pulse triggering 4.4.1 Description Pulse triggering uses the patient's pulse to trigger the measurement. A pulse sensor is connected to the patient's toe or finger. The first pulse wave (“premature pulse wave”) is used for triggering. This wave corresponds to the systolic blood pressure. A number of special sequences support retrospective gating. 4.4.2 Attaching the pulse sensor Performing ✓ Suitable finger adapter is attached. 1 Ensure that the cable is not bent.
4 Physiological imaging 4.5 Respiratory triggering 4.5.1 Description To keep respiratory artifacts to a minimum, respiratory triggering is primarily used in abdominal imaging. Data acquisition for respiratory triggering begins when the respiratory signal reaches a predefined level (approx. 20 % of the maximum value). Respiratory movement is minimal in this range.
Physiological imaging 4 Women and athletes are usually thoracic breathers. Men and obese patients are usually abdominal breathers. 2 If the patient is an abdominal breather, place the respiration belt around his abdomen. – or – If the patient is a thoracic breather, place the respiration belt around his chest. As an alternative, the respiratory cushion and belt can be used in combination with the Body 18. 3 Slide the respiratory cushion underneath the respiratory belt.
4 Physiological imaging Voltage-tim diagram for external triggering of the PMU Name Value UL 0 V ... 0.8 V UH 2.5 V ... 5 V tL(min.) 10 ms tH(min.) 10 ms Input current min. 5 mA Input voltage max. ± 5 V Internal contact + External contact - The measurement sequence is triggered by the rising edge of the external signal. The external trigger signal can be supplied via the connections in the magnet cover. 4.6.
MR system operation 5 5 MR system operation 5.1 Daily functionality checks Before using the MR system, the functionality and/or cleanliness of the following parts and areas must be checked: ◾ Alarm box ◾ Warning signs ◾ Floor ◾ Magnetizable materials ◾ Exhaust vent ◾ Patient table ◾ Squeeze bulb 5.1.
5 MR system operation CAUTION Leaking hydraulic system! Slipping hazard ◆ Check the area around the patient table for hydraulic fluids on the floor. 3 Check the examination room, control room, and electronics room for liquid spills and puddles on the floor. 4 Ensure that no magnetizable materials or objects such as vacuum cleaners, carts, ladders, and tools are present in the examination room. 5 Ensure that the outlet of the exhaust vent line is not obstructed.
MR system operation 5 The operating modes can be selected by pressing the corresponding button on the alarm box or by using the System Manager in the syngo MR software. See: Software operator manual Additionally a main circuit breaker is located in the control room which should NOT be used during proper functioning of the MR system. It switches off the overall system including cooling, which leads to helium boil-off. 5.2.
5 MR system operation Switching on the MR system at the alarm box ✓ The daily functionality checks have been completed. ( Page 99 Daily functionality checks) ✓ The coils used are fully connected to the coil sockets. ✓ Coils comprising several parts (e.g. head coils) are closed. 1 Turn the keyswitch to the right. 2 Press the SYSTEM ON button. The SYSTEM ON LED lights up. The MR system is switched on. The software starts at the syngo Acquisition Workplace.
MR system operation 5 6 Check if the contact spring connectors at the door frame and the door to the examination room are free of residues, such as cleaning agents, oil, grease, paint splatters, blood drops, etc. 5.2.2 Shutting down the system (System Off) Shutting down the system includes the following steps: ◾ Shutting down the computer system ◾ Switching off the MR system at the alarm box When shutting down the system, the software of the syngo MR Workplace is automatically ended as well.
5 MR system operation 2 Select the Shutdown System option. The computer system shuts down. The software does not respond? ◆ Simultaneously press the Ctrl, Alt, and S keys on the keyboard and shut down the system with the System Manager. The System Manager cannot be opened? Switching off the MR system at the alarm box You can shut down the syngo Acquisition Workplace via the Windows platform, which can cause data loss.
MR system operation 5 3 Select the Shutdown System option. The computer system shuts down. 5.2.4 In case of problems during shutting down, see troubleshooting information: ( Page 103 Shutting down the computer system) Starting/ending Standby Standby can be switched on by using the System Manager in the syngo MR software. See: Software operator manual 1 Select System > Control to open the System Manager. 2 To start Standby: On the Meas & Recon tab, click the Standby button.
5 MR system operation 5.3.1 Connecting the squeeze bulb (1) Connection for headphones (2) Connection for squeeze bulb 1 Connect the hose connector of the squeeze bulb to the corresponding connector at the foot end of the patient table. 2 Connect the headphone to the corresponding connector at the foot end of the patient table. 5.3.2 Setting tunnel conditions Use the buttons and the jogwheel of the small control unit to set the conditions in the magnet tunnel.
MR system operation 5 CAUTION Heat development during the examination! Patient burns ◆ Instruct patients to press the squeeze bulb in case of strong heat sensations. WARNING Use of unapproved fMRI stimulation devices for the given magnetic field strength! Injury to patient and operating personnel ◆ Ensure that the stimulation devices are approved for the field strength of your MR systems. For example, devices approved for low and medium field systems (0.2 – 1.5T) must not be used on a 3T system. 5.
5 MR system operation 5.
MR system operation First Level Controlled Operating Mode 5 In the First Level Controlled Operating Mode, patients may experience noticeable stress levels depending on the measurement programs selected. The decision to change to the First Level Controlled Operating Mode must be based on a medical consideration of the potential risks and benefits for the patient.
5 MR system operation CAUTION Stereotactic frames and similar devices: tips of screws may heat up considerably, especially if MR examinations are performed in the First Level Controlled Operating Mode! Localized burns of the patient ◆ Please observe the recommendations and notes of the manufacturer of the stereotactic frame. ◆ If the device consists of conductive material, only perform measurements in the Normal Operating Mode, if possible.
MR system operation Peripheral nerve stimulation 5 Stimulation threshold: The electrical field affects the patient. If the strength of the electrical field exceeds a certain threshold (stimulation threshold), the patient experiences peripheral nerve stimulation. Nerve stimulation manifests itself as e.g. tingling sensations or slight muscle spasms in the ribs, side, abdomen, hip, buttock, or thoracic regions, along the upper arms or the back muscles in the shoulder region.
5 MR system operation First Level Controlled Operating Mode: In the First Level Controlled Operating Mode, the performance limits are determined directly from the statistically determined stimulation limits. Accordingly, at the maximum performance allowed in this operating mode, up to 50 % of all patients may experience stimulations. 5.5.3 Exposure to RF electromagnetic fields During the course of an MR measurement, the patient’s body absorbs energy from the RF field of the transmitter coil.
MR system operation Noticeable effects on the patient 5 During the MR measurement, patients may experience heat sensations on the skin and, as a consequence of the RF energy absorption, patients may begin to perspire during the course of the MR examination. Their pulse rate may increase as well. The individual effects vary from patient to patient. The intensity of these effects depends on the measurement program selected.
5 MR system operation Look Ahead monitoring: Prior to each measurement, the values of the SAR quantities to be observed are calculated (always as worstcase values) and compared with the corresponding limit values. If one of the calculated SAR values exceeds the corresponding limit, the measurement cannot be started.
MR system operation 5 Online monitoring: The system constantly measures the transmit power and ensures that the appropriate limit values are observed. Examinations in progress will be aborted if the limit is exceeded. Limit values: The SAR limits used by the Look Ahead monitoring function are set according to country-specific approval guidelines at the time of the syngo MR installation. Normal operating mode: In the Normal Operating Mode, the patient barely notices the effects of the RF field.
5 MR system operation The measurement is stopped. The display is activated. 116 MR System | Operator Manual Print No. M6-04401.621.02.02.
Maintenance 6 6 Maintenance 6.1 Cleaning All instructions in the operator manual regarding cleaning and, when applicable, regarding disinfecting and sterilization must be always observed. WARNING Improper cleaning of the MR system! Risk of electric shock ◆ Only clean the MR system with a damp cloth. For information regarding cleaning of RF coils, see: Operator Manual Coils 6.1.
6 Maintenance 6.1.2 The LCD monitor/video display are highly sensitive to mechanical damage. Cleaning the camera lens ◆ Carefully clean the camera lens with a lint-free cloth and lens cleaner. 6.1.3 Cleaning the data carrier 1 Clean contaminated data carriers with a clean cloth (cotton or microfiber). 2 Follow the manufacturer's notes when cleaning CD/DVD data carriers. 6.1.4 Cleaning the plugs and connectors 1 Dampen a soft cloth with water or a diluted household cleaner solution.
Maintenance 6 4 Use a dampened cloth for cleaning. Do not submerge the receptors in cleaning liquid. 5 Disinfect the receptors with a commercially available disinfecting agent. Follow the manufacturer’s instructions. 6.1.7 Disinfecting system components Disinfecting sprays damage electronic components. For this reason, components may only be cleaned with a semi-dry cloth.
6 Maintenance ◆ Use commercially available cleaning or care products for the floor. Follow manufacturer's instructions. 6.2 Return and disposal 6.2.1 MR System WARNING Explosion hazard during improper disassembly! Injury of persons ◆ Ensure that only trained personnel disassemble the MR system because the system includes a pressurized container and cryogenic helium. 1 Contact Siemens Service in case of questions about returning and disposing the MR system and/or its components and accessories.
Maintenance 6 1 Contact Siemens Service with respect to questions regarding the return and disposal of batteries and accumulators. 2 Observe national regulations. MAGNETOM Skyrafit | syngo MR E11 Print No. M6-04401.621.02.02.
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Appendix: regulatory information 7 7 Appendix: regulatory information 7.1 Medical devices of other manufacturers 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.
7 Appendix: regulatory information 7.2 CE for Physiological Measurement Unit (PMU) The PMU (PPU, PERU) bears a CE marking in accordance with the provisions of regulation 1999/5/EC of March 9, 1999 for radio and telecommunications terminal equipment. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This device complies with Industry Canada licence-exempt RSS standard(s) and part 15 of the FCC Rules.
Index A Cleaning 118 Accessories Safety instructions 38 Accidents Burns 20 Coils 41 Coolant accidents 45 Measurement phantoms 41 Alarm box Checks 72 Description 72 Artifact Imaging errors 33 Patient-related 37 System-related 34 B Breathing difficulties 45 Burns Frostbite 45 C Checks Alarm box 72 Daily functionality checks 99 Cleaning Connections 118 Floor 119 Monitor/video display 117 MR system 117 Patient table 118 Receptors 118 Straps of the patient table 118 Coils Accidents 41 Combination With other
Index Noise development 31 Potential hazards 16 RF and gradient fields 20 Static magnetic field 18 Headphone Connection 106 Host Description 50 I Implants Device malfunctions 20 In-Room syngo Acq WP Description 76 Operation 77 Intercom Description 74 Operation 75 Transmit music 76 Transmit voice output 76 K Keyboard syngo Acquisition Workplace 51 Start/Stop 115 Starting and ending; with footswitch 79, 79 Measurement phantoms Accidents 41 Operation Dot display 57 Mechanical hazards Safety instructions
Connection 106 PPU 86 Pulse triggering Description 95 Performing 95 Standby Starting/ending Standby 105 Q Static magnetic field Device malfunctions 20 Safety instructions 18 Quality Assurance Coils 41 Super-conducting magnet Description 47 R Repair Safety information 38 Rescuing the patient in an emergency 62 Respiratory triggering Description 96 Performing 96 Responsibility Safety guidelines 15 syngo Acquisition Workplace Description 49 Host processor 50 Keyboard 51 Monitor 50 Mouse 52 syngo MR WP
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The CE marking applies only to medical devices which have been put on the market according to the above-mentioned EC Directives. Unauthorized changes to this product are not covered by the CE mark and the related Declaration of Conformity.
