Siemens Medical Solutions Department MED EH and S PPU098 Physiological Pulse Unit User Manual MAGNETOM Skyrafit Operator Manual MR System

Siemens Medical Solutions, Department MED EH&S; Physiological Pulse Unit MAGNETOM Skyrafit Operator Manual MR System

Contents

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www.siemens.com/healthcareMAGNETOM SkyrafitOperator Manual – MR Systemsyngo MR E11Answers for life.
MAGNETOM SkyrafitOperator Manual – MR Systemsyngo MR E11
Indicates a hintProvides information on how to avoid operating errors or information emphasizingimportant detailsIndicates the solution to a problemProvides troubleshooting information or answers to frequently asked questionsIndicates a list itemIndicates a prerequisiteA condition that has to be fulfilled before starting a particular operationIndicates a single-step operationIndicates steps within operating sequencesUsed for references and for table or figure titlesUsed to identify a link to related information as well as previous or next stepsUsed to identify window titles, menu items, function names, buttons, and keys, forexample, the Save buttonUsed to emphasize particularly important sections of the textUsed for on-screen output of the system including code-related elements orcommandsIdentifies inputs you need to provideUsed for the navigation to a certain submenu entryIdentifies variables or parameters, for example, within a stringCAUTIONUsed with the safety alert symbol, indicates a hazardous situation which, if notavoided, could result in minor or moderate injury or material damage.CAUTION 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 situationItalicBoldBlueCourierCourierMenu > Menu Item<variable>&$87,21Legend4MR System | Operator ManualPrint No. M6-04401.621.02.02.02
WARNINGIndicates a hazardous situation which, if not avoided, could result in death orserious injury.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:$51,1*LegendMAGNETOM Skyrafit | syngo MR E11 5Print No. M6-04401.621.02.02.02
Legend6MR System | Operator ManualPrint No. M6-04401.621.02.02.02
1 Introduction 111.1 Layout of the operator manual 111.2 The current operator manual 111.3 Intended use 121.4 Authorized operating personnel 131.4.1 Definitions of different persons 132 Safety 152.1 Preface about safety 152.1.1 Hazards and risks 152.1.2 Common causes of accidents 152.1.3 Responsibility 152.1.4 Configuration of hazard hints 162.2 Common/permanently existing hazards 162.2.1 Electromagnetic fields 162.2.2 Safety instructions on the static magneticfield 182.2.3 Safety instructions on RF and gradientfields 202.2.4 Contraindications 232.2.5 Mechanical hazards 252.2.6 Compatibility 282.3 What else must be observed? 302.3.1 Ambient conditions 302.3.2 Access to the examination room 302.3.3 Noise development 312.3.4 Patient care 322.3.5 Artifacts and imaging errors 332.3.6 Maintenance/repair 382.3.7 Signs and symbols 382.3.8 System owner-related advices 412.3.9 Coils/quality assurance 412.4 In case of emergency 412.4.1 Emergency switches 412.4.2 Medical emergency 442.4.3 Coolant accidents 452.4.4 Fire/Fire fighting 46Table of contentsMAGNETOM Skyrafit | syngo MR E11 7Print No. M6-04401.621.02.02.02
3 MR system components 473.1 Overview MR system 473.1.1 About function 473.1.2 Super-conducting magnet 473.1.3 Electronics cabinets 473.1.4 RF coils 493.2 syngo Acquisition Workplace 493.2.1 Host 503.2.2 Data recording 503.2.3 Monitor 503.2.4 Keyboard 513.2.5 Mouse 523.2.6 syngo MR Workplace (optional) 533.3 System control 533.3.1 Description 533.3.2 Operating the Dot display 573.4 Patient table 573.4.1 Description 573.4.2 Operating the patient table 593.5 Dockable patient table 643.5.1 Description 643.5.2 Operating the dockable patient table 653.6 Laser light localizer 703.6.1 Using the laser light localizer 703.7 Alarm box 723.7.1 Description 723.7.2 Checks 723.8 Intercom 743.8.1 Description 743.8.2 Operating the intercom 753.9 In-Room syngo Acquisition Workplace 763.9.1 Description 763.9.2 Operating the In-Room syngo AcquisitionWorkplace 773.10 Other components and accessories 803.10.1 Gradient supervision 80Table of contents8MR System | Operator ManualPrint No. M6-04401.621.02.02.02
4 Physiological imaging 834.1 Triggering methods 834.1.1 Prospective triggering 834.1.2 Retrospective gating 844.2 Physiological Measurement Unit (PMU) 844.2.1 Description 844.2.2 Preparing the measurement 894.3 ECG triggering 914.3.1 Description 914.3.2 Performing 924.4 Pulse triggering 954.4.1 Description 954.4.2 Performing 954.5 Respiratory triggering 964.5.1 Description 964.5.2 Performing 964.6 External triggering 974.6.1 Input for external trigger signal 974.6.2 Performing 985 MR system operation 995.1 Daily functionality checks 995.1.1 Checking the functionality andcleanliness 995.2 Starting up and shutting down the MR system 1005.2.1 Starting the system (System On) 1015.2.2 Shutting down the system (System Off) 1035.2.3 Shutting down the syngo MR Workplace 1045.2.4 Starting/ending Standby 1055.3 Preparing the MR system 1055.3.1 Connecting the squeeze bulb 1065.3.2 Setting tunnel conditions 1065.4 Preparing the patient 1065.4.1 Informing the patient 1075.5 Physiological effects 1085.5.1 Operating modes 1085.5.2 Exposure to low frequencyelectromagnetic fields 1105.5.3 Exposure to RF electromagnetic fields 112Table of contentsMAGNETOM Skyrafit | syngo MR E11 9Print No. M6-04401.621.02.02.02
5.6 Starting/Stopping the measurement 1155.6.1 Starting the measurement 1155.6.2 Stopping the measurement 1156 Maintenance 1176.1 Cleaning 1176.1.1 Cleaning the LCD monitor/video display 1176.1.2 Cleaning the camera lens 1186.1.3 Cleaning the data carrier 1186.1.4 Cleaning the plugs and connectors 1186.1.5 Cleaning the patient table and the straps 1186.1.6 Cleaning and disinfecting the receptors 1186.1.7 Disinfecting system components 1196.1.8 Care and cleaning of floors 1196.2 Return and disposal 1206.2.1 MR System 1206.2.2 Packaging 1206.2.3 Batteries and accumulators 1207 Appendix: regulatory information 1237.1 Medical devices of other manufacturers 1237.2 CE for Physiological Measurement Unit (PMU) 124Table of contents10 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
IntroductionIn order to operate the MR system accurately and safely, theoperating personnel must have the necessary expertise as well asknowledge of the complete operator manual. The operator manualmust be read carefully prior to using the MR system.Layout of the operator manualYour complete operator manual is split up into several volumes toimprove readability. Each of these individual operator manuals coversa specific topic:◾Hardware components (system, coils, etc.)◾Software (measurement, evaluation, etc.)Another element of the complete operator manual is the informationprovided for the system owner of the MR system.The extent of the respective operator manual depends on the systemconfiguration used and may vary.All components of the complete operator manual may includesafety information that needs to be adhered to.The operator manuals for hardware and software address theauthorized user. Basic knowledge in operating PCs and software is aprerequisite.The current operator manualThis manual may include descriptions covering standard as well asoptional hardware and software. Contact your Siemens SalesOrganization with respect to the hardware and software available foryour system. The description of an option does not infer a legalrequirement to provide it.11.11.2Introduction 1MAGNETOM Skyrafit | syngo MR E11 11Print No. M6-04401.621.02.02.02
The graphics, figures, and medical images used in this operatormanual are examples only. The actual display and design of thesemay be slightly different on your system.Male and female patients are referred to as “the patient” for the sakeof simplicity.Intended useYour MAGNETOM MR system is indicated for use as a magneticresonance diagnostic device (MRDD) that produces transverse,sagittal, coronal and oblique cross sectional images, spectroscopicimages and/or spectra, and that displays the internal structure and/orfunction of the head, body, or extremities. Other physical parametersderived from the images and/or spectra may also be produced.Depending on the region of interest, contrast agents may be used.These images and/or spectra and the physical parameters derivedfrom the images and/or spectra when interpreted by a trainedphysician yield information that may assist in diagnosis.Your MAGNETOM MR system may also be used for imaging duringinterventional procedures when performed with MR compatibledevices such as in-room displays and MR Safe biopsy needles.The MAGNETOM MR system is not a device with measuringfunction as defined in the Medical Device Directive (MDD).Quantitative measured values obtained are for informationalpurposes and cannot be used as the only basis for diagnosis.For the USA only: Federal law restricts this device to sale,distribution and use by or on the order of a physician.Your MR system is a medical device for human use only!1.31 Introduction12 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Authorized operating personnelThe MAGNETOM MR system must be operated according to theintended use and only by qualified persons with the necessaryknowledge 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 assafe handling of MR systems. The user must be familiar with potentialhazard and safety guidelines the same way the user is familiar withemergency and rescue scenarios. In addition, the user has to haveread and understood the contents of the operator manual.Please contact Siemens Service for more information on availabletraining options and suggested duration and frequency of suchtraining.Definitions of different personsTerm used ExplanationUser/Operator/Operating per-sonnelPerson who operates the system or software,takes care of the patient or reads imagesTypically physicians, trained radiological techni-cians, or technologistsSystem owner Person who is responsible for the MR environ-ment. This includes legal requirements, emer-gency plans, employee information and qualifica-tions, as well as maintenance/repair.MR worker Person who works within the controlled accessarea or MR environmentUser/Operator as well as further personnel (forexample, cleaning staff, facility manager, servicepersonnel)1.41.4.1Introduction 1MAGNETOM Skyrafit | syngo MR E11 13Print No. M6-04401.621.02.02.02
Term used ExplanationSiemens Serv-ice/service per-sonnelGroup of specially trained persons who areauthorized by Siemens to perform certain mainte-nance activitiesReferences to “Siemens Service” include servicepersonnel authorized by Siemens.1 Introduction14 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
SafetyPreface about safetyHazards and risksAn MR system may present various hazards. Some occur only duringthe examination, while others exist permanently and thus are alsorelevant to non-users (e.g. cleaning personnel).The various hazards and the corresponding safety instructions areexplained in the safety chapter of this operator manual.Common causes of accidentsDespite safety instructions, some hazards lead to accidents time andagain. In particular, this includes magnet accidents and RF burns/loopformation, as well as the use of incompatible devices and the wearingof clothing with electrically conductive materials. A detailed patientscreening ensures that the patient is free of metallic objects andclothing with metallic yarns or appliqués.The following sections provide information on how to avoid the mostcommon mistakes and the resulting safety risks. These sections wereprepared based on the long-time experience of Siemens.ResponsibilitySiemens accepts no responsibility for the safety, reliability, andperformance of the MR system, if the MR system is not used inaccordance with the instructions for use (Operator Manual, SystemOwner Manual). Siemens is also not responsible for any direct orindirect damages caused by incorrect operation. This includes, but isnot limited to, accidents with ferromagnetic objects. This applieseven if the consequences only become obvious at a later point intime.22.12.1.12.1.22.1.3Safety 2MAGNETOM Skyrafit | syngo MR E11 15Print No. M6-04401.621.02.02.02
Configuration of hazard hintsAll hazard hints are identified in a special way. The followingkeywords signal the level of hazard involved:WARNING Warning regarding risks that may result indeath or serious physical injury.CAUTION Warning regarding risks that may result inminor physical injury or material damage.Example:WARNINGSource of danger!Consequences◆Countermeasure.Common/permanently existing hazardsThe frequency at which the potential hazards mentioned in thissection lead to accidents is still too high. Therefore, it is especiallyimportant to observe the instructions on how to avoid thesedangerous situations.The most significant hazards include:◾Electromagnetic fields◾Contraindications◾Mechanical hazards◾Incompatible devicesElectromagnetic fieldsIn the examination room, there are different kinds of electro-magnetic fields and the resulting risks.2.1.42.22.2.12 Safety16 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Fields Most serious hazardsStatic magnetic field Movement by implants and prostheses in the bodyAttraction, alignment, and projectile-like acceleration of magnetizableobjects( 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. patients, physicians, operating and cleaningpersonnel, accompanying persons, and rescue personnel/firefighters) are exposed to these fields in the examination room.Therefore, all limits and safety measures regardingelectromagnetic fields equally apply to patients and MR workers.◆Observe prohibition signs in the area near the entrances to the MRsystem and the controlled access area.The static basic field is generated by a superconductive magnet andmay extend beyond the examination room (walls, ceilings).In order to minimize the hazards mentioned, the controlled accessarea of the basic field is identified on the floor (0.5 mT line). Outsidethe controlled access area, the magnetic flux density is less than0.5 mT. See: System owner manualLinearly rising additional fields of variable strength - gradient fields -are superimposed on the static main magnetic field in three differentorientations. They may cause shifts in charge in the patient's tissueand lead to peripheral nerve stimulation.The nuclear spins of the body tissue are stimulated via pulsedelectromagnetic RF fields. These RF pulses are generated by an RFtransmit amplifier and transferred via RF coils to the object to bemeasured.Static magnetic field/controlledaccess areaGradient fieldsRF fieldsSafety 2MAGNETOM Skyrafit | syngo MR E11 17Print No. M6-04401.621.02.02.02
RF fields lead to warming of the body tissue. In this context, animportant value per body weight is the specific absorption rate orSAR. ( Page 108 Physiological effects)Possible undesirable side effects for MR are dizziness, heating,claustrophobia and nerve stimulation.Safety instructions on the static magnetic fieldThe list of objects in this chapter is not exhaustive. It only serves as anillustration of objects that present hazards in the presence ofmagnetic forces.◆Only use equipment specified or recommended for use in thecontrolled access area.Side effects2.2.22 Safety18 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
WARNINGMovement and/or alignment of implants and prostheses in thebody, as well as attraction, alignment, and projectile-likeacceleration of magnetizable objects may result in very serioushazards!Injury to patient and operating personnel◆Do not use resuscitation devices - for example, defibrillatorsor oxygen bottles - in the examination room.◆Do not use transport trolleys, movable beds, stretchers, etc.that consist of magnetizable parts.◆Do not wear or carry any magnetizable objects on your person- for example, watches, pens, scissors, etc..◆Use only proven MR Safe or MR Conditional accessories, partssubject to wear and tear, and disposable articles with the MRsystem.◆Use only MR Safe or MR Conditional tools and devices.◆Service work on the MR system may only be performed bySiemens Service.◆Ensure that only authorized personnel enter the controlledaccess area (0.5 mT exclusion zone), for example, electriciansor cleaning personnel trained in MR safety.◆Keep the door to the examination room closed.WARNINGMagnetizable objects introduced into the magnetic field becomeprojectiles!Injury to patient and operating personnel◆Inform the operating personnel about the effect of forces onferromagnetic parts or implants, especially on systems with ahigher field strength (for example, 3T). Explain that the forcesincrease with the field strength of the magnet!Safety 2MAGNETOM Skyrafit | syngo MR E11 19Print No. M6-04401.621.02.02.02
For China only: In 3-T systems medical supervision is required forall patients according to IEC 60601-2-33 (2nd edition).When persons (e.g. MR workers or patients) are exposed to the staticmagnetic field, possible effects are dizziness, light-headedness, ormetallic taste, especially in 3-Tesla magnetic fields.1Ask the patient to lie still during the measurement.2Keep a sufficient distance to the magnet and avoid rapidmovements of the head.CAUTIONDizziness, light-headedness or metallic taste in the patient‘smouth during measurements and/or table movements in a 3-Tesla magnetic field!Reaction of fear by the patient◆Prior to the examination, inform the patient about thepossible occurrence of these symptoms.Magnetic flux densities exceeding 0.5 mT can interfere withelectronic implants or other devices. The main magnetic field mayeither affect or destroy electronic data carriers such as check or creditcards, hard disks, ID cards with magnetic strips and/or magnetictapes, diskettes or pocket calculators, as well as RFID chips (RadioFrequency Identification).Safety instructions on RF and gradient fields◆Do not examine patients unable to communicate potentialoverheating effects (e.g. small children, seriously ill, paralyzed,unconscious, sedated, or handicapped patients).Dangerous current loops may be generated when parts of thepatient's body touch. These loops may lead to burns or increase theprobability of stimulation.Current loops are also generated when the patient's skin contacts thetunnel lining or RF coil cables.Dizziness during exposureDevice malfunctions2.2.3Patients at riskCurrent loops and bore wallcontact2 Safety20 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Ensure to prevent potential current loops as shown in the redlabeled illustration.Ensure the patient is positioned with proper distance (5 mm) tomagnet tunnel as well as proper distance between parts of thebody as shown in the green labeled illustration.◆To lower the effects of gradient fields or RF fields, keep a sufficientdistance from the RF coils and the magnet tunnel (gradient coils),and reduce the time of exposure during measurements.Safety 2MAGNETOM Skyrafit | syngo MR E11 21Print No. M6-04401.621.02.02.02
CAUTIONThe patient is wearing electrically conductive material! Incorrectpatient positioning!Formation of electric current loopsPeripheral nerve stimulation of the patient◆Ensure that the patient does not wear clothing that is wet ordampened by perspiration.◆Ensure that the patient is free of metallic rings, chains, orelectrically conductive materials worked into items of clothing(for example, brassiere support wires, metallic appliqués orwoven metallic yarns).◆Always position the patient so that the patient's arms arealigned with the torso and ensure that hands, arms, and legsdo not touch (minimum distance: 5 mm).◆Ensure that the minimum distance of 5 mm is maintainedbetween patient and tunnel covering.◆To ensure this distance, use positioning aids, e.g. blanketsmade of linen, cotton, or paper, or dry material that ispermeable to air.◆Ensure sufficient ventilation.CAUTIONHeating up/ignition of synthetic blankets via the RF field duringthe measurement!Patient burns◆Use only covers made of paper, cotton or linen.2 Safety22 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
CAUTIONHeating up of RF blankets or shields used to avoid aliasingartifacts!Patient burns◆Never use RF blankets or other conductive sheets within theMR system.ContraindicationsThis chapter contains very important information about MRsafety: In principle, a qualified physician must evaluate the risk/benefit ratio of the MR examination for every patient.To date, there is no scientific proof that MR examinations areharmless for pregnant women, the unborn (embryos or fetuses)and children under two years of age.In general, an MR examination is contraindicated for patients withelectronic or electronically conductive implants or metals, especiallythose containing ferromagnetic foreign matter.Typical contraindications for MR examinations are:◾Electronic implants: e.g. pacemakers, stimulators, insulin pumps◾Artificial heart valves, aneurysm clips◾Metal splinters in the eye (danger of retinal detachment)◾Artificial anus (anus praeter) with magnetic closure◾Transdermal drug patches with metallic backings◾Electrically conductive implants and prostheses◾Metallic spirals for contraception (IUDs = Intrauterine Devices)◾Transdermal or other similar implants (for example, body piercingsas well as magnetic piercings)2.2.4Safety 2MAGNETOM Skyrafit | syngo MR E11 23Print No. M6-04401.621.02.02.02
WARNINGElectronic and/or electrically conductive implants andmagnetizable inclusions in static and low-frequency magneticfields and RF fields!Risk of patient death/patient injury◆Ask the patient about implants and inclusions.◆Do not perform MR examinations on patients with electronicor electrically conductive implants and magnetizableinclusions.◆Ensure that patients wearing such implants and/or inclusionsremain outside the exclusion zone (0.5 mT line).Exceptions: Certain implantable medical devices have been cleared,approved and/or licensed by the Competent GovernmentalAuthorities and/or labeled by the device manufacturer as “MRConditional”. For such implantable medical devices, the previouslymentioned list of general contraindications and the warning may notbe applicable in its entirety.It is the responsibility of the device manufacturer to declare animplantable medical device as MR Conditional if appropriate and todefine the conditions (constraints) for safe MR scanning. The MRoperator must be aware of any such conditions for MR scanning. It isthe obligation of the MR operator to assure that these conditions arestrictly adhered to. To obtain these specific conditions the MRoperator may refer to the labeling of the implantable medical deviceor contact the device manufacturer. Siemens MR does not assumeresponsibility or liability for the operation of the MR system with anyimplantable medical device. Especially, Siemens MR is not responsiblefor controlling technical parameters of the MR system other thanthose defined by the normal operating mode, the first level controlledoperating mode and the data provided in the system owner manual,such as spatial gradient field plots.2 Safety24 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
CAUTIONEddy currents induced by low-frequency magnetic fields!Patient burns◆Do not examine patients with electrically conducting implantsor prostheses.CAUTIONElectrically conducting objects!Injury to patient due to warmingIncorrect diagnosis due to artifacts◆Request that the patient removes all electrically conductingobjects, e.g. necklaces, rings, braces, rubber bands for longhair, piercings as well as jewelry.◆Request that the patient removes all clothing includingelectrically conducting material, for example, bras, metallicappliqués or woven metallic yarns.◆Inform patients that eyeliners and tattoos may containingredients causing artifacts or skin irritations during MRexaminations. In some cases, patients have been burned.◆To prevent injuries, instruct patients to remove makeup priorto the examination.◆Instruct patients to seek medical attention in case ofdiscomfort during or following the MR examination.Mechanical hazardsCollisions and injuries are more prevalent when using theexchangeable tabletop, the patient table or when performingmaintenance activities.◆Observe the warning and prohibition signs as well as the safetyinformation.2.2.5Collision and points of injurySafety 2MAGNETOM Skyrafit | syngo MR E11 25Print No. M6-04401.621.02.02.02
CAUTIONAccidental patient table movement!Injury to the patient◆If you plan an intervention outside the magnet, activate theTable Lock function at the Dot display with the control unit toavoid accidental patient table movement, or injury to thepatient. After completing the intervention, the table can beunlocked.WARNINGCover of the table lifting column is defective; access to movingparts is possible!Risk of severe contusion during vertical movement◆Complete the current examination and then shut down thesystem.◆Notify Siemens Service.2 Safety26 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
CAUTIONVertical and horizontal movement of the patient table!Injury to patient and other personsDamage to the patient table◆Ensure that there are no obstacles (e.g. extending oroverhanging body parts, hair, clothing, straps) between tableand the magnet, or that the additional equipment (e.g. IVtube, respirator or ECG) does not get caught and remains inand on the patient when moving the tabletop.◆Secure the patient’s arms and legs with straps so that thepatient is not caught between the tabletop and the magnetcover. Remain in the MR examination room with helplesspatients (e.g. children and patients who are either seriouslyill, paralyzed, unconscious, sedated, handicapped ormedicated), even if the patients are secured during theexamination.◆Ensure that the sensor for height detection is not obstructedby clothing, sheets, or accessories, etc.◆Keep the patient under visual or acoustic control.◆In case of hazardous conditions, press the Table Stop button.◆Explain the significance of protocol-controlled tablemovements to the patient.Safety 2MAGNETOM Skyrafit | syngo MR E11 27Print No. M6-04401.621.02.02.02
WARNINGImproper patient transport with the dockable patient table,improper use of the side rails!Injury to the patientDamage 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 toavoid any unintended horizontal movement.◆Use the side rails as intended (as an arm rest or in the verticalposition e.g. for securing the patient). Always make sure thatthe side rails are completely engaged after moving them andconsider possible pinching parts on the side rails.◆Fold the side rails down to move the tabletop.The risk of stumbling is related in particular to the unfavorablerouting of cables/hoses of interventional components.CAUTIONCable/hoses of interventional components!Injury to patient and operating personnel◆Route cables/hoses of interventional components so that it isnot possible to trip over them.CompatibilityAmong other things, the following hazards or complications mayoccur through the use of third-party products during MRexaminations:◾Heating of system cables or connection cables◾Interference with MR image quality◾Malfunctioning of third-party productsRisk of stumbling2.2.6Combinations with othersystems, accessories2 Safety28 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Auxiliary equipment, which has not been specifically tested andapproved for use in the environment of the MR equipment, mayresult in burns or other injuries to the patient.If the MR system is combined with other systems or components, itmust be ensured that the planned combination and cable routing donot affect the safety of patients, personnel, or the environment.Ensure that the devices used in the examination room arecompatible with the field strength of the MR system. Forexample, devices compatible with 1.5 T systems may beunsuitable for 3 T systems, and vice versa. See also MRConditional: ( Page 29 Labeling)◆Contact Siemens Service prior to combining the MR system withother devices.Peripheral equipment (e.g. patient monitoring, life support oremergency care equipment) which is not specified or recommendedfor use in the MRI environment, including the controlled access area,may be disturbed by the RF field or the magnetic fringe field of theMR system. This equipment may also disturb the proper function ofthe MR system.ASTM International developed a new classification system forimplants and ancillary clinical devices. The following definitionsapply:MR Safe An item that poses no known hazards in all MR environments. MR Safe itemsinclude nonconducting, nonmagnetic items such as a plastic petri dish. Anitem may be determined to be MR Safe by providing a scientifically basedrationale rather than test data.InterferencesLabelingSafety 2MAGNETOM Skyrafit | syngo MR E11 29Print No. M6-04401.621.02.02.02
MR Conditional An item that has been demonstrated to pose no known hazards in a specifiedMR environment with specified conditions of use. Field conditions that definethe specified MR environment include field strength, spatial gradient, dB/dt(time rate of change of the magnetic field), RF fields, and SAR. Additionalconditions, including specific configurations of the item, may be required.MR Conditional devices (for example, RF communications equipment) maypresent hazards as well. Observe the manufacturer's operator manual toavoid potential hazards and injuries.MR Unsafe An item that is known to pose hazards in all MR environments. MR Unsafeitems include magnetic items such as a pair of ferromagnetic scissors.Detailed information on B0 values, gradient and RF data, as well asgraphic representations of the spatial distributions are included in theMR compatibility data sheet. See: System Owner ManualWhat else must be observed?Ambient conditionsAs the ambient conditions and SAR have a considerable effect on thepatient’s body temperature, you must regularly check the ambientconditions.The patient’s ability to dissipate surplus heat is increasingly affectedas the room temperature and relative humidity increase.◆Ensure that the room temperature is at or below 22°C and therelative humidity does not exceed 60%.Access to the examination roomFree access to and exit from the examination room must be ensuredat all times.1Regularly check the correct functioning of the door to theexamination room.Technical data2.32.3.1Regulating the roomtemperature2.3.22 Safety30 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
2Ensure that the door to the examination room opens and closescorrectly.Noise developmentBy 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 exceed99 dB(A) in the bore.CAUTIONNoise development during the MR examination!Injury to patient and people in the examination room(hearing impairment)◆Provide the patient with appropriate hearing protection thatlowers noise to at least 99 dB(A).◆Mandatory provide anesthetized or unconscious patients withhearing protection. Ear protection for these patients shouldnot be omitted even at moderate sound levels.◆Ensure that personnel and accompanying persons in theexamination room wear hearing protection during theexamination that lowers noise to at least 85 dB(A).◆For required level of hearing protection, see: System OwnerManual, Technical data: Hearing protection data. All hearingprotection devices must provide the required level of soundattenuation.Adequate attenuation levels can be achieved by using, for example,ear plugs. Ear plugs offering sufficient hearing protection can befound in the Siemens Accessories catalog.The standard Siemens headphones are intended for communicationwith the patient and can be used in combination with ear plugs.2.3.3Safety 2MAGNETOM Skyrafit | syngo MR E11 31Print No. M6-04401.621.02.02.02
◾For appropriate sound attenuation, the proper use of hearingprotection is important. All personnel should be trained to correctlyapply the hearing protection.◾Special attention and training of the operator is required for properpositioning of the hearing protection for neonates and infants. Inaddition this applies to any other condition where an alternativeform of hearing protection might be necessary.◾For MR examinations of infants special hearing protection may berequired.◾Due to increased anxiety the permissible sound pressure level maybe a reason for concern for pregnant women and their unborn, fornewborns, infants and small children as well as older persons.Patient carePatients must be informed about the hazards and safety measuresduring MR examinations. Before doing so, it must be confirmed thatan MR examination is permissible and/or checked if increasedprecautions are necessary.CAUTIONPatient received insufficient clarification of facts!Injury to patient◆Explain to the patient the conduct expected and possible risksinvolved.◆Inform the patient about the monitoring and communicationequipment e.g. squeeze ball, intercom.◆Instruct the patient regarding possible heat developmentduring the MR examination.◆Inform the patient about noise developing during the MRexamination.◆Prior to the MR examination, instruct patients of possiblestimulations during the examination i.e. twitching muscles,tingling sensation.2.3.4Patient information2 Safety32 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Patients may be acoustically as well as visually and physiologicallymonitored in the MR system.◾The viewing window or a video system is used for visualmonitoring.◾The intercom can be used to acoustically contact the patient.( Page 74 Description)◾Medical supervision: MR Conditional monitoring devices are usedto monitor the patient's vital parameters, provided the conditionsfor safe operation are observed.Medical supervision means adequate medical management ofpatients who can be at risk from some parameters of exposure to theMR equipment, either because of the medical condition of thepatient, the levels of exposure or a combination.All patients should receive at least routine monitoring. For some(e.g. sedated, physically unstable) patients, monitoring of thevital parameters is mandatory. In the First Level ControlledOperating Mode medical supervision is also mandatory.CAUTIONIncompatible monitoring devices!Patient burns◆Use only monitoring devices, for example, ECG electrodes andpulse sensor, that meet the conditions for safe use (MR Safeor MR Conditional).Artifacts and imaging errorsDue to their magnetizability, foreign objects in the area of themagnet bore cause strong local distortions of the basic field and leadto considerable image artifacts. Depending on the level of distortion,diagnosis may be difficult, impaired or completely impossible.Patient monitoring2.3.5Safety 2MAGNETOM Skyrafit | syngo MR E11 33Print No. M6-04401.621.02.02.02
Causes: Artifacts and imaging errors are listed according to theirsource for error:◾System-related artifacts/imaging errors◾Patient-related artifacts/imaging errors◾User-related artifacts/imaging errors, see: Software operatormanualUser-related and patient-related artifacts/imaging errors can belargely avoided through patient instructions and proper conduct ofpatient and personnel.The MR image may show system-related artifacts/imaging errorsdespite careful preparation.◆If the same artifact/imaging error appears repeatedly, documentand submit it to Siemens Service.CAUTIONRF-signal interference caused by incompatible accessories e.g.patient monitoring devices!Streaks and bright spots in the MR image◆Use only accessories tested and approved for the MR system.◆Keep the door to the examination room closed.◆Vary the bandwidth of the MR sequence.◆Whenever possible, use local coils for the MR examination.CAUTIONPhasing of MR signal is not set correctly!Structure is shown in the wrong position◆Repeat the measurement for the structure in question byusing a second orthogonal slice and check whether theposition of the structure is reproducible nor not.System-related artifacts/imaging errorsStripe artifactsIncorrect slice positioning2 Safety34 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
CAUTIONLocal variation in the sensitivity of local coils!Continuous fluctuations in MR image brightness◆Whenever possible, use a local coil with transmitcharacteristics that are more suitable for the field of viewdesired.◆Use the normalization filter.CAUTIONStatic and/or stationary brightness errors on the LCD monitordue to aging!Incorrect diagnosis◆Scroll through the images to ensure that the MR image doesnot show differences in brightness, spots, or cloudiness andcheck bright objects for afterglow.◆Keep your eyes always in central monitor position with avertical view angle towards the screen surface for best imagequality.CAUTIONInhomogeneous RF field!Asymmetry of contrast in the MR image◆Whenever possible, use a local coil with transmitcharacteristics that are more suitable for the desired field ofview.Variations in brightnessVariations in signal andcontrastSafety 2MAGNETOM Skyrafit | syngo MR E11 35Print No. M6-04401.621.02.02.02
CAUTIONSpatial non-linearity of the gradient field and inhomogeneity ofthe static magnetic field!Pin-cushion and barrel-shaped distortions and/or loss ofsignal in the margins of the MR image◆Go through a distortion correction.◆Position the region to be examined as close to the magnetisocenter as possible.◆Use phantoms for the control measurements.CAUTIONIncorrect localization data due to spatial non-linearity of thegradient field and inhomogeneity of the static magnetic field!Incorrect stereotactic planning or breast biopsy◆Take localization errors into account while planningstereotactic interventions or breast biopsies.CAUTIONDistorted slice edges in the margin due to spatial non-linearity ofthe gradient field and inhomogeneity of the static magneticfield!Incorrect stereotactic planning◆When planning stereotactic interventions, take into accountslice distortion at the margins of the MR image. This applies inparticular to graphic slice positioning (GSP) as well as othergraphic slice displays and slice positioning data independentof the possible use of distortion correction.Distortions/signal obliterationalong the edgesLocalization errors due todistortionPotato chip artifact2 Safety36 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
WARNINGWhen using the DIXON method, water and fat swaps mightoccur!Incorrect diagnosis◆Diagnosis should be confirmed by a second contrast and/or adifferent orientation.CAUTIONPoor image quality! Wrong image position!Incorrect diagnosis◆Prior to the examination, inform patients about movementsand their negative effects on the measurement.◆Ensure that the patient does not move during themeasurement.◆Monitor the patient during the MR examination.CAUTIONImprecise localization due to patient movement duringfunctional MR imaging (fMRI)!Incorrect stereotactic planning and injury of the patientIncorrect assignment of active brain areas◆Prior to the examination, inform patients about movementsand their negative effects on the measurement.◆Use Siemens scan protocols with motion correction.◆Monitor the patient to ensure that the task is performedcorrectly.DIXON swappingPatient-related artifacts/imaging errorsSafety 2MAGNETOM Skyrafit | syngo MR E11 37Print No. M6-04401.621.02.02.02
Maintenance/repairWARNINGHigh voltage and currents inside the electronics cabinets!Risk of death by electrocution◆Electronics cabinets should only be opened by SiemensService.Windows, doors, and emergency flaps must not be blocked.The following safety-relevant accessories should be checked:◾All RF coils for the transmitting and receiving system◾ECG and respiratory sensor◾Disposable electrodes◾Pulse sensorFor detailed information about maintenance of the MR system, see:System owner manualIn case of serious malfunctions, shut down the MR systemimmediately and notify Siemens Service.Signs and symbolsMagnetic field RF field Observe operator manual2.3.6Daily checksSafety-relevant accessoriesMaintenanceSerious malfunctions2.3.7Warning signs2 Safety38 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Potential injury to persons Risk of injury Laser radiationRisk of breaking Maximum load side railsLaserLaser (for the US only)Refilling with liquid nitrogen and heliumThe following objects are prohibited in the examination room:Prohibition signsSafety 2MAGNETOM Skyrafit | syngo MR E11 39Print No. M6-04401.621.02.02.02
Implants susceptible toelectromagnetic effectsOpen flames, no smok-ingMetallic implants andother metallic objectsinside the bodyMechanical watchesand electronic data car-riersFire extinguishers withmagnetizable metalhousingMetal parts, e.g. tools Electronic data carriersUnauthorized access Implants susceptible to electromagnetic effectsSign requiring mandatory hear-ing protectionNon-ionizing radiationFurther symbols2 Safety40 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Protective class symbol B forapplication partsProtective class symbol BF forapplication partsSystem owner-related advicesSome safety instructions address the system owner. They areincluded as “Safety information” in a separate operator manual, see:System owner manual. This manual also contains the technicaldescription of the system.Coils/quality assuranceSafety instructions covering the intended use of coils andmeasurement phantoms are included in a separate operator manual.See: Coil operator manual.In case of emergency1Before working with the system, familiarize yourself with thelocation and functionality of the emergency switches installed.2Report all accidents resulting in personal injury immediately to theappropriate authorities.3Observe the established emergency plans (e.g. emergency plan incase of coolant accidents, emergency plan for fire fighting).Emergency switchesThe MR system has different types of emergency switches.Switch Effect EmergencyMagnet Stop Shutting down the static magneticfield (quenching)E.g. in case of accidents with attractedmetal parts or in case of fire2.3.82.3.92.42.4.1Safety 2MAGNETOM Skyrafit | syngo MR E11 41Print No. M6-04401.621.02.02.02
Switch Effect EmergencyEmergency Shut-downElectric power of the entire MR systemis switched off, but magnet remains atfieldE.g. in case of fireTable Stop Motorized table movement is stopped In case of accidents or injury due totable movementIn case of emergency, the relevant switch should be pressed.(1) Magnet Stop switch(2) Emergency Shut-down switch(3) Table Stop buttonThe Magnet Stop switch triggers a controlled magnet quench(shutting down the magnetic field). The MR system is notdisconnected from the power.There are two different versions of the Magnet Stop switch on theMR system: as an individual switch or as an integral part of the alarmbox. The switches may also be installed in other places of the MRsystem.Magnet Stop switch2 Safety42 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
After the Magnet Stop switch has been pressed, an alarm is triggeredat the alarm box. The WARNING LED will light up and an alarm signalwill sound.As a rule, Siemens Service must be called following a quench.The magnet must only be put back into operation by SiemensService personnel.WARNINGFormation of droplets due to condensation during quenching!Personal injuryRisk of fire◆Do not touch the exhaust line.◆Do not stand under the exhaust line.◆Avoid open flames and do not smoke.WARNINGSystem indicates Magnet Stop error!Hazardous conditions because the magnet cannot bequenched in case of emergency◆Immediately remove the patient from the magnet.◆Restrict the access to the examination room.◆Notify Siemens Service.Safety 2MAGNETOM Skyrafit | syngo MR E11 43Print No. M6-04401.621.02.02.02
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 MRsystem.WARNINGFire or electrical accidents!Personal injury◆Press the Emergency Shut-down switch immediately.◆Contact your fire department.It is located on the intercom and on the patient table.Medical emergencyWARNINGMedical emergency during MR measurements!Risk of death to patients◆Terminate the measurement immediately.◆Remove patients from the examination room for treatmentunless it is certain that the medical equipment required isappropriate for use inside an MR room.◆Do not store or operate oxygen bottles, defibrillators, or otherauxiliary tools for resuscitation in the examination room.Emergency Shut-down switchTable Stop button2.4.22 Safety44 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
CAUTIONSqueeze bulb is defective!Risk of injury to patient because emergencies cannot becommunicated◆Check the functionality of the squeeze bulb daily.Coolant accidentsDuring a quench, a person might become unconscious due to severeshortness of breath:1Remove unconscious persons immediately from the examinationroom.2Start adequate first aid measures and contact a physicianimmediately.Direct contact with subzero liquids, gases, and surfaces (e.g. pipes)may lead to frostbite. The eyes and mucous membranes areespecially vulnerable.CAUTIONImproper handling of liquid helium!Skin damage caused by frostbite◆Do not rub frostbitten skin areas.1Remove clothing carefully from the locations involved.2Rinse frostbitten skin with lukewarm water.3Cover frostbitten skin with sterile bandages.4Do not apply powder or creams.5Contact a physician immediately.2.4.3First aid in case of shortness ofbreathFirst aid in case of frostbiteSafety 2MAGNETOM Skyrafit | syngo MR E11 45Print No. M6-04401.621.02.02.02
Fire/Fire fightingThe 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 suit2.4.42 Safety46 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
MR system componentsOverview MR systemAbout functionA detailed specification of the systems hardware and software isavailable in the Info dialog box (main menu Help > Info).Super-conducting magnetThe super-conducting magnet generates a strong homogeneousmagnetic field with a field strength of 3 T.The magnet is filled with liquid helium as a coolant. Followinginstallation, it is adjusted to the desired operating field strength. Theramped-up magnet does not require additional electric power tomaintain the magnetic field. Under normal operating conditions,there is no helium boil-off.To minimize the effects of the magnetic fringe field on theenvironment, the magnet of the MR system is equipped with activesuper-conducting shielding.The gradient system provides precise localizing slice positions.For details on the gradient system, please refer to the System ownermanual.Electronics cabinetsThe electronics cabinets are located in the engineering room or theoperating room.33.13.1.13.1.2Magnetic fieldCooling systemShieldingGradient system3.1.3MR system components 3MAGNETOM Skyrafit | syngo MR E11 47Print No. M6-04401.621.02.02.02
(1) Gradient cabinet(2) Control cabinet(3) System separatorThe gradient cabinet contains the power electronics for generatingthe magnetic field gradients.The control cabinet includes different electronics components tooperate the MR system.The control cabinet includes a sequence-programmable, opticaltrigger signal output which can be made externally accessible bySiemens Service via installation of a fiber optic cable.Gradient cabinetControl cabinet3 MR system components48 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Please note that Siemens provides customers with the opticaltrigger signal output for research purposes only. No devicesconnected to this output have been tested by Siemens. Beforeconnecting devices to the MR suite using the optical triggersignal output, they must be tested for safety by trainedpersonnel.Before using devices in the proximity of the magnet, their non-magnetic properties and clinical operation in the magnetic fieldhave to be confirmed.The use of devices connected to the optical trigger signal outputhas to comply with any applicable governmental or local hospitalInstitutional Review Boards (IRBS).Siemens will not be held responsible for the use of any deviceand resulting consequences in connection with the optical triggersignal output.The system separator contains electronics components and cooling-equipment to deliver an adequate cooling power for the system. If aspecial cooling system (chiller) is installed, the system separator is notnecessary.RF coilsThe description, handling and quality measurements for RF coils areincluded in a separate operator manual. See: Coil operator manualsyngo Acquisition WorkplaceThe workplace in the control room is known as syngo AcquisitionWorkplace (syngo Acq WP). It includes the host processor with theoperating elements monitor, keyboard, and mouse.An additional component of the syngo Acquisition Workplace is theintercom. ( Page 74 Description)System separator3.1.43.2MR system components 3MAGNETOM Skyrafit | syngo MR E11 49Print No. M6-04401.621.02.02.02
HostAmong other things, the host processor includes the followingfunctions:◾Patient management◾Image selection and storage◾Measurement sequence managementMeasured MR images may be transferred to other systems orcomputers via the network connection (e.g. PACS or RISsystems). MR images from other systems or computers can bereceived via the network as well.Information about network connections is displayed in the Info...dialog window.Data recordingThe MR system provides the following modules for data recording:◾CD/DVD burner◾DVD driveAn interface (e.g. USB connection) for a paper printer is alsoavailable.The burn and read process is started via the software. See: Softwareoperator manualOnly CD-Rs/DVD-Rs (Recordable) labeled “Medical Grade” and having agold-colored layer are suitable for documenting data for medicalpurposes. Siemens Service will provide you with CD-Rs/DVD-Rs.Please take into account the handling, care, storage of CDs/DVDsand CD-Rs/DVD-Rs as specified by the respective manufacturers.MonitorThe monitor is used for displaying MR images as well as user dialogs.It is switched on or off as part of the overall MR system.3.2.13.2.2Data carrier3.2.33 MR system components50 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
All other adjustments are blocked since the monitor is alreadyoptimally configured by Siemens Service.Do not touch the surface of the screen using sharp, pointedobjects.Do not position containers holding fluids, e.g. cups or glasses, ontop of the monitor.In addition, general cleaning instructions must be observed.The monitor may only be opened by authorized Siemens Servicepersonnel.KeyboardThe syngo Acquisition Workplace is equipped with an originalSiemens keyboard. This keyboard is a modified Windows keyboardwhere the numeric keys have been replaced with symbol keys.The symbol keys are used to access frequently used functions. TheF4, F5, F6, F7, and F8 function keys enable you to access theindividual task cards. The F1 function key lets you access the Onlinehelp.Function Original Siemens key Windows keyIncrease/decrease image brightness (set windowposition) / NUM / /Increase/decrease contrast (set the window width) / * / -Automatically set contrast and brightness 9Page forth/back in the examination / 8 / 73.2.4MR system components 3MAGNETOM Skyrafit | syngo MR E11 51Print No. M6-04401.621.02.02.02
Function Original Siemens key Windows keyPage forth/back in the series / 5 / 4Page forth/back image by image / 2 / 1Open patient registration InsSelecting the Patient Browser DelCopy to film sheet EnterHighlight 3Send to node 1 +If the computer system is connected to a clinic-wide processornetwork (HIS/RIS), use the Examination task card to send images toother network addresses via node 1.MouseThe system is equipped with a wheel mouse.3.2.53 MR system components52 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
◾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 themouse pointer)syngo MR Workplace (optional)The syngo MR Workplace allows for evaluation, documentation andpost-processing of previously measured images while acquiringimages at the syngo Acquisition Workplace. It accesses the databaseof the host processor.It is not possible to perform measurements at the syngo MRWorkplace. It is not connected to the MR scanner or the imagereconstruction system.System controlDescriptionThe system control is used to operate the system and the patienttable. It comprises control units and the Dot display.3.2.63.33.3.1MR system components 3MAGNETOM Skyrafit | syngo MR E11 53Print No. M6-04401.621.02.02.02
The control units are located at the right and the left side of thepatient table at the front of the magnet cover. Optionally, additionalcontrol units are located at the back of the magnet.Each control unit consists of a jogwheel and several additionalbuttons.(1) Control unit for positioning the table(2) Control unit for menu navigation and for adjusting settings forpatient comfort( Page 59 Operating the patient table)( Page 57 Operating the Dot display)( Page 105 Preparing the MR system)For better user guidance, the jogwheels and buttons are backlit.Control units3 MR system components54 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Depending on the situation, the small jogwheel can have differentfunctions:◾Rotate: e.g. for navigating through the display menu or forchanging settings of, for example, ventilation◾Push: e.g. for resetting the patient alert or for starting ameasurementAlternatively, use the intercom to reset the patient alert or tochange the volume settings of the headphones andloudspeakers.The optional control units at the back of the magnet additionallycomprise a Table Stop button.The Dot (Day Optimized Throughput) display provides statusinformation as well as several tools.The display is located above the magnet bore opening at the front ofthe magnet cover. Optionally, at the back of the magnet, a seconddisplay can be installed for the additional control unit.The display shows several pieces of information:◾Information concerning patient positioning (e.g. patientorientation, current table position, auto-positioning)◾Information about the connected coilsDot displayInformation serviceMR system components 3MAGNETOM Skyrafit | syngo MR E11 55Print No. M6-04401.621.02.02.02
◾Guidance for attaching ECG electrodes, docking the table andemergency evacuation◾General patient information submitted from the software◾Information concerning troubleshootingYou can navigate between the depicted icons by using the smalljogwheel. The selected icon is highlighted.Confirm patient dataDisplays the patient data of the registered patientTable overviewDisplays the current table position as well as thepatient orientationPhysio dataDisplays the physiological data of the patientTable lock/Table unlockActivates/Deactivates the table lock function for inter-ventional examination (toggle icon)StartStarts a prepared measurement, during the measure-ments, the display will be shut offInfoDisplays further information (e.g. undocking of thedockable patient table)Close patient comfortConfirms the patient comfort settingsTool bar3 MR system components56 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Operating the Dot displayTo operate the Dot display, use the jogwheel of the smaller controlunit. ( Page 54 Control units)1Turn the jogwheel to navigate through the icons.2Press the jogwheel to confirm the selection.3If necessary, adjust your settings by turning and pressing thejogwheel.Patient tableDescriptionThe patient table is used for positioning the patient and the coils. Thetable comprises several sockets and connections.3.3.23.43.4.1MR system components 3MAGNETOM Skyrafit | syngo MR E11 57Print No. M6-04401.621.02.02.02
(1) Tabletop(2) Head end(3) Table Stop button(4) Handle to pull out the table top in case of emergency(5) Emergency releaseThe tabletop can be moved horizontally into the magnet bore. Whenmoved completely out of the magnet, the tabletop may be movedvertically as well.The coil sockets are located at the head end and the foot end of thepatient table. For more information concerning the occupation of thecoil sockets, see: Coil operator manualCoil sockets3 MR system components58 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Make sure that no liquids such as contrast medium, blood, orcleaning agents get into the table connections.The following connections are located at the foot end of the patienttable:(1) Headphones(2) Vacuum cushion(3) Squeeze bulb(4) Placeholder [Intended for future use]The paper roll holder can be mounted at the foot end of the tablebelow the handle. It includes a holder to reposit the headphones andcan be removed if required. To replace the paper roll (disposable),you need to detach the headphone holder. If you remove the stick onthe paper roll, you can pull out the right mounting bracket. Then youcan replace the roll and let the bracket again lock into place.Operating the patient tableThe patient table can be controlled via the movement buttons andthe jogwheel on the larger control unit. ( Page 54 Control units)Please note that this section only describes the operation of thepatient table. For details on positioning the patient, see: OperatorManual CoilsConnectionsPaper roll holder3.4.2MR system components 3MAGNETOM Skyrafit | syngo MR E11 59Print No. M6-04401.621.02.02.02
(1) Table Up/Inward button(2) Jogwheel, Center Position button(3) Home Position button(4) Table Down/Outward buttonTo operate the patient table safely and efficiently, operatingpersonnel must be familiar with its most important positions.Home Position Table is at the height of moving into the magnet bore, tabletop ismoved completely out of the magnetLast Scan Position If the tabletop was moved only in the horizontal direction, the tab-letop can be returned into the position of the last measurementDefault Position The center of the Head/Neck 20 is in the magnet isocenterCenter Position The body region to be measured is in the magnet isocenterRelative Position Distance between the slice marked with the light localizer and themagnet isocenterFor interventional examinations, a table lock function is available viathe Dot display. ( Page 55 Dot display)For some measurements, the tabletop is moved automatically.3 MR system components60 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
1Keep the jogwheel turned to move the patient table up/into ordown/out of the magnet bore.Depending on how far the jogwheel is turned, the speed increases.The table movement stops immediately once you release thejogwheel.2Press the jogwheel for one second to move the patient table intothe Center Position.Depending on the situation, you can also move the tablehorizontally into the Last Scan Position or the Default Position bypressing this jogwheel.Pressing the jogwheel during an automatic table movement(e.g., to the Home Position) stops the table immediately. Turningthe jogwheel in this case adjusts the speed and movementdirection according to the jogwheel position.◆Press the corresponding button to move the patient table into therequired position.The Table Up/Inward and the Table Down/Outward button canbe pressed in two stages for horizontal movements. Pressing thebutton softly moves the table slowly. Pressing the buttonforcefully moves the table more quickly.Pressing one of these buttons during an automatic tablemovement (e.g., to the Home Position) stops the tableimmediately.Using the jogwheelUsing the buttonsMR system components 3MAGNETOM Skyrafit | syngo MR E11 61Print No. M6-04401.621.02.02.02
1Press the Table Stop button to stop the table movement.2To reset the table stop, turn the Table Stop button clockwise untilit releases mechanically. Then simultaneously press the Table Up/Inward and the Table Down/Outward button fully.In case of accidents, e.g. patient emergency situation (e.g. heartattack), the tabletop and patient must be moved out of the magnetbore.The fastest method for moving the tabletop out of the magnetbore is to press the Home Position button. Select this methodwhenever the power supply and/or motorized drive are intact.1Press the Home Position button.The tabletop moves completely out of the magnet.2Rescue the patient.In case of power failure and/or defective motorized drive, pull thetabletop manually out of the magnet bore.Stopping table movementRescuing the patient in anemergencyRescuing the patient manually3 MR system components62 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
WARNINGPatient rescue during emergency situations, e.g. quench withfailing quench pipe, fire with strong smoke development,emergency situation involving patient (e.g. heart attack) andsimultaneous power failure!Personal injury◆After releasing the emergency release, pull the tabletop withthe patient manually out of the magnet.1Pull the Emergency release (location is indicated by a label)outward up to the end stop.The MR measurement is terminated and the table loses thereferenced position.2Turn up the pull-out handle and pull the tabletop out of themagnet.3Rescue the patient.✓The error regarding the power supply and/or the motorized drivehas been removed.1Press the Emergency release back into its original position whileshifting the tabletop slightly in any direction until it audibly locksinto position.2To reset the table, simultaneously press the Table Up/Inwardbutton and the Table Down/Outward button fully.Resetting the EmergencyreleaseMR system components 3MAGNETOM Skyrafit | syngo MR E11 63Print No. M6-04401.621.02.02.02
3Press the Home Position button.After reaching the Home Position, the patient table is ready foroperation again.Dockable patient tableDescriptionThe dockable patient table is an optional table that can be completelyremoved from the magnet system. This enables the transport ofimmobile patients.The configuration of the dockable patient table is similar to thestandard table. This section only mentions the differences. For thestandard patient table, please refer to: ( Page 57 Description)(1) Side rails(2) Docking station(3) Lateral pedal3.53.5.13 MR system components64 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
(4) Emergency undocking handle(5) Pedals(6) Handle at the foot endIf the table is removed from the system, you can use the pedals to liftand lower the table manually.The side rails can be folded out to secure patients during transport, oras a arm rest for patients with infusions.For better maneuverability, a fifth wheel is positioned in the middle,underneath the dockable patient table. This fifth wheel functions ascenter of rotation - the table can rotate around this center.The label at the foot end of the dockable table indicates that yourtable can only be operated on the 1.5 T system or the 3 T system,respectively.Operating the dockable patient tableTo avoid injuries during vertical table movement, a safety shut-downis available at the carriage of the dockable patient table and a safetyswitch is available at the docking station. If the table is docked, tablemovement stops automatically if obstacles constrict vertical tablemovement.Undock the table only if the tabletop is in the Home position.PedalsSide railsGuiding wheelIdentification label3.5.2MR system components 3MAGNETOM Skyrafit | syngo MR E11 65Print No. M6-04401.621.02.02.02
◆Position the side rails as required: e.g. in a vertical position tosecure the patient, or in a horizontal position as arm supports.✓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 anydirection.You can use the side rails to steer the table.The guiding wheel (5th wheel underneath the table) allows for betterdirectional stability and easier steering.(1) Guiding wheel is lifted/deactivated(2) Guiding wheel is lowered/activated(3) Table is braked1For turning the table in place, navigating in curves and moving thetable straight ahead, set the lateral pedal to the middle position (2)to lower/activate the guiding wheel.2For moving the patient table laterally, lift the lateral pedal (position1) to lift/deactivate the guiding wheel.3Lower the pedal to the lowest position (3) to brake the table.Undocking the tableMoving the dockable patienttable3 MR system components66 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
CAUTIONDockable patient table may move against the wall or thedoor!Possible injuries (for example, squashed fingers)◆To move the table, always grasp the middle area of thehandle (not the outside edges).4Move the table with the handle at the foot end of the table.If the dockable patient table is not in use, make sure not to moveit to the back of the magnet.✓Guiding wheel is activated.✓Side rails are lowered.CAUTIONPoints of injury during docking of the table!Damage to the system, injury to the patient◆Ensure that the patient’s hair, parts of the body, or items ofclothing do not get caught between the table and the system.1Use the table‘s momentum (to save strength) and move the tableinto the docking station.Docking the tableMR system components 3MAGNETOM Skyrafit | syngo MR E11 67Print No. M6-04401.621.02.02.02
2Position the table so that the docking nose is positioned in thedocking station and the table is positioned at the end stop of thedocking station.The display shows if the table is positioned correctly andcompletely in the docking station.3Check the display if the table is ready for docking. If the table is notready for docking, reposition the table in the docking nose.4Press the right pedal down fully with your foot to lock the table tothe MR system - in doubt press the pedal twice.5Wait for the table to get ready after docking.The “Wait” message at the display disappears and the tabletopmoves into the reference position.Do not undock the table again, before the tabletop is in thereference position.Table cannot be docked to the system?◆Position the table again so that the docking nose is positionedcorrectly and completely in the docking station. Try again topress the right pedal.Pedal cannot be pressedCheck that the tabletop is completely in Home position and theemergency undocking handle is not activated/pulled (reset withleft pedal).Control units flashMake sure that the Table Stop buttons are not pressed (at thetable and at the intercom) and that the intercom is powered on.Table cannot be loweredRemove any weight from the docking station and the table carriagecover.Troubleshooting: Problemsduring docking3 MR system components68 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Table moves downwards despite you want to lift the tableIn certain cases (for example, after docking), the table must findthe reference position and moves slightly down. This is normalbehavior.Table does not move horizontallyCheck that the side rails are fully stored in the carrying frame - oth-erwise no table movement is possible.Pedal cannot be pressed and the table is not pushed away fromthe MR SystemSet the lateral pedal to the middle position to deactivate the brakeand make sure that the tabletop is completely in Home position.If undocking via the pedals does not work, the table can be undockedby using the emergency undocking handle at the foot end (betweenthe pedals).WARNINGWrong tabletop position for emergency undocking!Uncontrolled table movement, tabletop crashes◆Use the emergency undocking handle only when the tabletopis in the outermost position (Home position).Troubleshooting: Problemsduring undockingUndocking in case ofemergencyMR system components 3MAGNETOM Skyrafit | syngo MR E11 69Print No. M6-04401.621.02.02.02
✓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.1Press the emergency undocking handle back into its originalposition.2Position the table with the docking nose in the docking station upto the end stop. Then press the left pedal down fully with yourfoot.Laser light localizerThe laser light localizer facilitates correct patient positioning. Thelaser light localizer is located on top at the entrance to the magnetbore.All laser-relevant locations at the MR system are identified by warninglabels affixed directly next to the laser opening.For some examinations, a manual alignment of the laser lightlocalizer to the coil is not necessary. If all relevant data (e.g. patientorientation, body height, examination) are registered, auto-positioning is indicated on the Dot display at the magnet cover.Using the laser light localizerAnesthetized patients or patients who do not have an eye blink reflexmust be protected against the effects of the laser beam.Resetting the emergencyundocking handle3.63.6.13 MR system components70 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
✓The patient is positioned on the tabletop.✓The patient table has been moved to measurement height.WARNINGLaser beam of the laser light localizer!Eye injury caused by laser beam◆Ensure that the operating and adjustment devices as well asmethods given are used as described.◆Inform the patient about the laser and request that he keepshis eyes closed during positioning.◆Ensure that helpless patients keep their eyes closed duringthe positioning procedure.1Press the Laser Light Localizer button on the control unit.The laser light localizer is switched on. A crosshair is visible directlybelow the area.2Move the tabletop so that the crosshairs point precisely to theregion of interest.The slice for measurement is marked. The display shows therelative tabletop position of the marked slice.3If the laser is correctly positioned, press the Center Position buttonfor one second to move the table into the magnet isocenter.The tabletop moves to the selected position and the laser shuts offautomatically.When the table is not moving, the laser light localizer shuts offautomatically after 60 seconds.MR system components 3MAGNETOM Skyrafit | syngo MR E11 71Print No. M6-04401.621.02.02.02
Alarm boxDescriptionThe alarm box has the following functions:◾Displays alarm signals◾Switches the MR system on and off◾Magnet Stop / Magnet QuenchThe alarm box is installed near the syngo Acquisition Workplace.ChecksWARNINGMR system malfunction!Hazardous conditions for patients◆Note the sounding alarm and signal.◆Do not perform MR examinations.◆Notify Siemens Service.3.73.7.13.7.23 MR system components72 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
(1) WARNING LED(2) POWER LED(3) SYSTEM ON LEDLED LEDs light up to indicateWARNING Error message, e.g. helium fill level is toolowPOWER Voltage supply of MR system is satisfactorySYSTEM ON The MR system is switched on1Check the WARNING LED for alarm messages.An alarm is present when a yellow LED lights up and/or an alarmsounds.2In case of an alarm: Check the host computer for error messages.Press the Audio Alarm Off button to silence the alarm, and notifySiemens Service.3Verify that the POWER LED is green.4If the POWER LED is not on: Check the power supply of the MRsystem.The POWER LED is off, even though the power supply isfunctioning properly?◆Notify Siemens Service.After a power failure, the battery powers the circuit of themagnet emergency shutdown for another 14 days. During thistime, the magnet can still be quenched i.e. the magnetic fieldcan be shut down by pressing the Magnet Stop switch in case ofemergency.After installing remote monitoring, various error messages can beoutput centrally (e.g. to the front door or gate):Checking the LEDsRemote monitoringMR system components 3MAGNETOM Skyrafit | syngo MR E11 73Print No. M6-04401.621.02.02.02
◆Please contact Siemens Service regarding questions about remotemonitoring.IntercomDescriptionThe intercom allows personnel and patients to communicate duringthe examination. In addition, some important operations likestopping the patient table can be managed from the intercom.Optionally, music or automatic voice outputs can be played in theexamination room via the loudspeaker or the headphones.The operating unit of the intercom is located at the syngo AcquisitionWorkplace.(1) Stop button(2) Talk button(3) Reset Patient Alert button(4) Listen button(5) Physio Signal button(6) Audio connection(7) Reset Stop button3.83.8.13 MR system components74 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
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 andloudspeaker in the examination room◾Visually:–Blinking button on the intercom–Message on the Dot display in the examination roomThe alert can be reset by pressing the Reset Patient Alert or the Talkbutton on the intercom. Alternatively, the alert reset is possible at thecontrol unit in the examination room.Patients, for example, sedated patients, who may not be able toalert the personnel must be monitored by a person present in theexamination room.Operating the intercomThe intercom operation is partially software-based. The PatientComfort Configuration dialog box allows for several settings, forexample, Active Noise Cancellation to reduce background noisefrom the system, can be activated. For detailed information regardingthe operation of the software, see: Software operator manualButton FunctionListen Enables listening to the patient in the exami-nation roomTalk Allows speaking to the patient (as long as thebutton is pressed)Reset PatientAlertResets the patient alertPhysio Signal Switches the transmission of physiological sig-nals on/offPatient alert3.8.2MR system components 3MAGNETOM Skyrafit | syngo MR E11 75Print No. M6-04401.621.02.02.02
Button FunctionStop Stops the table movement and the measure-ment immediatelyReset Stop Resets the table Stop1Press the corresponding button.2If necessary, adjust the volume using the +/- buttons. Press andhold the buttons to adjust the volume.If you hold the button for about one second, the volume increases/decreases until you release the button.Automatic voice output can be used for transmission of commandse.g. breath hold commands.1Use the Patient Comfort Configuration dialog box in the softwareto initiate automatic voice output: Software Operator Manual2On request, adjust the volume in the Patient ComfortConfiguration dialog box to the desired level in the examinationroom.To play music in the examination room, an audio device can beconnected at the intercom.1Connect a suitable cable to the audio device and to the connectionat the intercom.2Adjust the final volume to the desired level using the control unitat the magnet or the Patient Comfort Configuration dialog box.3Start the music at the audio device.In-Room syngo Acquisition WorkplaceDescriptionThe In-Room syngo Acquisition Workplace (In-Room syngo Acq WP) isan additional operating console in the examination room. It is usedfor image viewing and MR system operation.Transmitting automatic voiceoutputTransmitting music3.93.9.13 MR system components76 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
The In-Room syngo Acq WP is connected with the host processor andfacilitates the examination process by allowing the operatingpersonnel to remain inside the examination room betweenprocedures.The In-Room syngo Acq WP is used as follows:◾Displaying MR guided procedures◾Quickly adjusting patient positioning for survey measurements◾Immediately starting the measurement after administeringcontrast mediumThe constant presence of operating personnel inside the examinationroom allows uninterrupted patient care and quick intervention in caseof complications.The In-Room syngo Acq WP comprises the following components:(1) LCD monitor(2) Tray with trackball and keys(3) Foot switch (optional)As an alternative, the monitor can be suspended from the ceiling. Forthis option, the tray with trackball and keys is not available.Operating the In-Room syngo Acquisition WorkplaceThe In-Room syngo Acquisition Workplace (In-Room syngo Acq WP) isoperated via the trackball and three keys. The same softwarefunctions are available as with the syngo Acquisition Workplace.3.9.2MR system components 3MAGNETOM Skyrafit | syngo MR E11 77Print No. M6-04401.621.02.02.02
CAUTIONDiagnosis at the In-Room syngo Acquisition Workplace or use forinterventional procedures!Risk of patient injury; incorrect diagnosis◆Always plan appropriate emergency measures prior tostarting an MR-guided or MR-monitored interventionalprocedure.◆Do not use the In-Room syngo Acquisition Workplace fordiagnostic purposes.(1) Keys(2) Trackball(3) HandleThe keys have the same functions as those of the mouse.1Roll the trackball to move the pointer on the program interface.2Press the keys to execute a specific application.The monitor height and tilt can be adjusted for easy and comfortableoperation.Operating the trackball and thekeysAdjusting the monitor tilt3 MR system components78 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
1Release the locking lever by turning it counter-clockwise by 90°.2Press lightly against the upper or lower edge of the display to movethe monitor into the desired tilt position.1Turn the wheel clockwise to raise the monitor.2Turn the wheel counter-clockwise to lower the monitor.The footswitch is used to start and stop the MR measurement in theexamination room.(1) Hose(2) Hose connector(3) Pushbutton unit(4) Footswitch Start/StopFor additional support, labels can be affixed to the footswitches.Start labelStop labelMR measurements with the footswitch are only possible for protocolsthat were configured for manual start-up. This is the case e.g. forprotocols with MR measurements after administering contrastmedium.Adjusting the monitor heightOperating the footswitchPerforming the measurementMR system components 3MAGNETOM Skyrafit | syngo MR E11 79Print No. M6-04401.621.02.02.02
If the protocol is configured for repeated measurements, the nextmeasurement can be started with the footswitch after completing thepreceding measurement. For more information regarding theconfiguration of protocols, see: Software operator manual1Push the hose plug into the retaining rings of the pushbutton unit.2Load a suitable protocol and start it at the syngo Acq WP or the In-Room syngo Acq WP.The MR system is waiting for the manual start of the protocol.3Press the Start footswitch to begin the measurement.As an alternative, you can start and end the measurement via theIn-Room syngo Acq WP or the syngo Acq WP.4Press the Stop footswitch to end the measurement.Other components and accessoriesGradient supervisionTo prevent damage to the MR system by a malfunction of thegradient system, a specially designed supervision is installed at yourMAGNETOM system.This supervision monitors that cables, connections, or othercomponents of the gradient system do not show excessive heating. Incase of a malfunction, the measurement is stopped and an alarmmessage is issued.After 1 minute the system will be automatically switched toStandby.3.103.10.13 MR system components80 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
✓Gradient malfunction is detected.✓An alarm message appears at the syngo Acquisition Workplace.Dialog box at the syngo Acquisition Workplace(1) Scanner hardware errorAutomatic shutdown! Evacuate patient immediately from theexamination room! To prevent further damage, the system willbe switched to Standby within 1 minute! Call Siemens Serviceimmediately.1Immediately move the patient out of the magnet bore by pressingthe Home Position button.Within the next 60 seconds, the system will be switched toStandby automatically. Then, the patient table motors can not beoperated any longer.2Call Siemens Service.Acting in case of an alarmMR system components 3MAGNETOM Skyrafit | syngo MR E11 81Print No. M6-04401.621.02.02.02
✓A malfunction within the supervision system is detected.✓A corresponding error message appears at the syngo AcquisitionWorkplace.Dialog box at the syngo Acquisition Workplace(1) Scanner hardware malfunctionFunctional problem within automatic shutdown mechanism.Please restart software of MeasRecon. If the problem persists,please call Siemens Service immediately.◆Call Siemens Service.The supervision sensitivity is potentially affected, but theoperation of your MR scanner is still possible.Acting in case of a supervisionmalfunction3 MR system components82 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Physiological imagingTriggering methodsMR imaging procedures are sensitive to patient movement. Imagesmay exhibit artifacts in the form of smears when motion times - forinstance, during respiration or heartbeat - are short compared tomeasurement times. In particular, this problem occurs as a result ofthe patient's heartbeat during cardiac examinations or as a result ofthe patient's breathing during abdominal examinations.Two different procedures are used to avoid motion artifacts inimages: prospective triggering and retrospective gating. Bothprocedures are based on the correlation between measurement andphysiological signal (ECG signal, respiratory signal, pulse signal).Prospective triggeringDuring prospective triggering (or antegrade triggering), ameasurement is triggered by using a so-called trigger signal derivedfrom the patient's physiological signal. This signal is usually definedbased on the time period during which organ movement is as low aspossible. The trigger delay is, for example, set to the end of thesystole for certain cardiac examinations so that the measurement isrunning during the akinetic diastole. For respiratory triggering duringabdominal examinations, it is recommended to start themeasurement at the end of the respiratory period.To determine the start time for the measurement, an acquisitionwindow is defined based on the signal form (e.g. R-wave in ECG,minimum of respiratory curve). For example, the size of theacquisition window is approx. 80 % of the RR interval for ECGmeasurements. The acquisition window defines the range in whichthe measurement can be triggered. The trigger time is defined by thetrigger delay.Prospective triggering can be used for ECG, pulse, or respiratorysignal curves as well as for external trigger signal curves.44.14.1.1Physiological imaging 4MAGNETOM Skyrafit | syngo MR E11 83Print No. M6-04401.621.02.02.02
Retrospective gatingRetrospective gating fundamentally differs from prospectivetriggering. No actual triggering is taking place. The physiologicalsignal and data acquisition times are recorded simultaneously. Themeasurement is performed completely independently of the patient’sheartbeat or pulse. A temporal assignment of images to thecorresponding phase (e.g. heart stimulation) is performed after themeasurement (retrospectively).In particular, retrospective gating is used to acquire images of thebeating heart. As compared to measurements using prospectivetriggering, this technique is especially useful for displaying the latediastole. Temporal resolution is freely selectable and may be higheror lower than selected for the measurement.Retrospective gating can be used for ECG, pulse, or external triggersignal curves.Physiological Measurement Unit (PMU)DescriptionThe Physiological Measurement Unit (PMU) lets you control MRmeasurement sequences using a patient's physiological signals (ECG,respiration and pulse).The PMU consists of the following components:◾PERU (Physiologic ECG and Respiratory Unit): ECG and respiratorysensor◾PPU (Peripheral Pulse Unit): Pulse sensor◾External trigger inputThe physiological signals are acquired with receptors - ECGelectrodes, respiratory cushion and pulse sensor - directly at thepatient via the PERU (ECG, respiration) and PPU (pulse). Themeasured data can be viewed at the Dot display in the examinationroom and in the Physiological Display dialog window at the syngoAcquisition Workplace.4.1.24.24.2.14 Physiological imaging84 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Only one PERU or PPU can be located in the examination room!Two ECG and respiratory sensors in the examination roominterfere with one another in signal transmission. It is notpossible to determine the results.Patient monitoring systems are optional accessories and are not partof the PMU.The Physiological Measurement Unit may be used only forcontrolling MR measurement sequences. The unit does notreplace a patient monitoring system.The wireless PERU simultaneously acquires three ECG channels aswell as the respiratory channel of the patient.(1) ECG leads with clips(2) Plug for respiration cushion(3) Transmitter unit(4) Control LEDsThe ECG electrodes and respiratory cushion are connected to thePERU.To prevent skin irritations, the PERU has to be located in theapplication cushion during the examination.ECG and respiratory sensor(PERU)Physiological imaging 4MAGNETOM Skyrafit | syngo MR E11 85Print No. M6-04401.621.02.02.02
(1) Application cushion(2) Respiratory cushion with pressure hose(3) Respiratory beltThe respiratory cushion is attached to the patient using therespiratory belt.The PPU acquires the patient's peripheral pulse. It consists of atransmitter 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 LEDsWireless pulse sensor (PPU)4 Physiological imaging86 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
External trigger sources (e.g. patient monitoring system) may beconnected with the help of the trigger input to drive MR sequences.The connection for the trigger input is located on the cover of the MRsystem. Trigger input is galvanically isolated with respect to the MRsystem.Both the PERU and the PPU are supplied with power via accumulators.All other components of the PMU are supplied by system-internalvoltage sources. The charging station is installed separately near thesyngo Acquisition Workplace and is used for storing both units.Accumulators should not be fully discharged before recharging them.If only one green LED flashes, you should charge the accumulator forthe next patient. The maximum charging time is approx. 3 hours.After being fully charged, the operating hours for the units coverapproximately 24 hours.To charge a unit, it has to be placed firmly in the charging station.The PERU and PPU can be charged together or separately in thecharging station. ( Page 88 Control LEDs)Use only the charger included with delivery. Charging the unitswith non-Siemens equipment may destroy the PERU and PPU.If proper charging of the accumulators is not possible anymore,please contact Siemens Service, as the PMU accumulators cannot beexchanged.The red LED goes out when the unit is positioned correctly in thecharging station. While charging, the green LEDs flash alternately asmoving light. If the accumulator is nearly discharged, only one LEDflashes at the beginning. With increasing charging status, a secondgreen LED flashes and then also the third LED. If the accumulators arefully charged, the 3 green LEDs are on and stop flashing.External trigger inputCharging stationLEDs during chargingPhysiological imaging 4MAGNETOM Skyrafit | syngo MR E11 87Print No. M6-04401.621.02.02.02
The transmitter unit includes three green LEDs for signaling thebattery 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 unitBattery status and faults are also indicated on the Dot display and thePhysiological Display dialog window.If the accumulator is not in the charging station, the green LEDs flashregularly and simultaneously.3 Green LEDs flash Fully or nearly fully (2/3) charged accumulator2 Green LEDs flash 1/3 to 2/3 fully charged accumulator1 Green LED flashes Nearly discharged accumulator; remaining operating duration is 1 hourRed LED flashes (as regular asthe green LEDs)Transmit function deactivated, unit is positioned outside the static mag-netic field; no electrode/application fault detectedRed LED is off Transmit function activated; unit is positioned on the patient table inthe static magnetic field; no electrode/application fault detectedRed LED flashes rapidly PERU: electrode fault - one or more ECG electrodes are not applied cor-rectly or fell offPPU: application fault - pulse sensor is not applied correctly at the fingerA second set of sensors with charging station may be useful inhospitals or radiology facilities because one PPU and PERU can bepermanently ready for operation, while a second PPU and PERUare being charged.The physiological signals are shown on the Dot display.( Page 55 Dot display)Control LEDsData display4 Physiological imaging88 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Additionally, battery status and electrode/application fault areindicated on the display.The Physiological Display lets you view the patient's physiologicalsignals at the syngo Acquisition Workplace. See: Software operatormanualPreparing the measurementWARNINGMonitoring vital parameters via the Dot display!Anomalies of the vital parameters are not recognized orrecognized too late◆Never use the Dot display to monitor the vital parameters of apatient.◆Use only suitable patient monitoring systems for monitoringvital parameters.1Ask the patient to lie still during the measurement.Physiological Display4.2.2Informing the patientPhysiological imaging 4MAGNETOM Skyrafit | syngo MR E11 89Print No. M6-04401.621.02.02.02
2Inform the patient that the knocking sounds during themeasurement are caused by switching the gradients on and off.The PERU may also vibrate slightly.Knocking sounds may affect the heart rate of patients, eitherconsciously or subconsciously. The resulting irregular cardiaccycles 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.CAUTIONHot ECG cables!Patient burns◆Place absorbent natural material between the ECG cables/leads of the PERU and the patient’s skin.1Position the patient on the patient table with the head toward themagnet bore.2Position the PERU in the application cushion.Especially with respect to whole-body examinations, it should benoted that artifacts (homogeneity distortions) may occur in thedirect vicinity of the PERU transmitter unit.3Use the application cushion and position it together with the PERUon the patient.Attaching the PERU4 Physiological imaging90 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
4Align the PERU on the patient in the direction of the patient’s feet.5For the special case of triggered flow measurements/flowquantification in the head region, please position the PERU next tothe patient's head (as shown in the picture) to reduce gradientinterference.Position and connect the PERU and electrodes as usual. Then usethe electrodes as a pivot point and turn the PERU with theapplication cushion counterclockwise until the cushion is lying nextto the patient's head.ECG triggeringDescriptionECG triggering is a method for measuring heart sequences includingdynamic studies. It is also suitable for studies where pulse flow causesartifacts. Provided that special sequences are in use, ECG triggeringcan be applied in combination with respiratory-controlled methods.A number of special sequences support retrospective gating.The ECG leads are selected according to the potential differencebetween the connected electrodes.The three leads I, II and III are used and acquired in parallel via theECG channels. All curves display a prominent R wave when the ECGelectrodes and leads are correctly attached.4.34.3.1ECG leadsPhysiological imaging 4MAGNETOM Skyrafit | syngo MR E11 91Print No. M6-04401.621.02.02.02
The characteristic QRS complex of the ECG signal is used as a triggersignal. Simultaneous acquisition and overlaying of the orthogonalleads (vector cardiography) is used to minimize triggering errors dueto gradient switching and the magneto-hydrodynamic effect (i.e.excess T-wave amplitude).In the dialog box of the Physiological Display several triggermethods are available:◾VCG standard: VCG activated◾ECG I: VCG inactive◾ECG II: VCG inactive◾ECG III: VCG inactive◾Auto: Improved trigger algorithm; VCG activated; default triggermethodIf Auto is used, the signal characteristics can be relearned byselecting Relearn in the context menu of the Physiological Display.If triggering with Auto fails, preferably VCG standard should be used.For ECG triggering, special MR Conditional and disposable electrodesare used (the recommended ones are available through theAccessories catalog).PerformingThe quality of the ECG signal for triggered measurements is enhancedby:◾Proper placement of the electrodes◾Good skin contact of the electrodesTrigger methodsDisposable electrodes4.3.2Image quality4 Physiological imaging92 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
◾Reduction of interference signals caused by electromagneticinduction.–Due to cable loops–Interferences from electrical potentials caused by musclemovementAttach the electrodes so that interferences from electricalpotentials caused by muscle movement and baseline drifts areminimized. Suitable contact points are therefore areas that showvery little muscle or fatty tissue.1Prepare the patient for the examination as early as outside theexamination room.2On the chest of the patient, select locations with minimal muscleand fat tissue for attaching the electrodes.3In case of hairy skin: shave the points where you intend to attachthe electrodes.Shave the patient outside the examination room to preventaccidents.4Thoroughly clean the patient's skin at the locations involved.However, do not use solutions containing alcohol.5Then dry the skin with a paper towel.6Use a suitable gel to prepare the skin for better signal transmission.Finding the best position for the electrodes is a matter of trial anderror. ( Page 91 ECG leads)Preparing the patientApplying ECG electrodesPhysiological imaging 4MAGNETOM Skyrafit | syngo MR E11 93Print No. M6-04401.621.02.02.02
Patients with an offset heart axis (e.g. dilatative cardiomyopathy)may require a different orientation than parallel to the spine.1Check the expiration date of disposable electrodes and order newones if necessary.2Pull the protective foil off the electrodes and attach them.3Use the application cushion and position it together with the PERUon the patient. ( Page 89 Preparing the measurement)4Connect the electrode clips of PERU to the ECG electrodes.◆Perform the examination. See: Software operator manual1Check to see if the leads show a preferably pronounced R-wave onthe Dot display. Information about the ECG signal quality is alsoavailable at the display.2In case you are using the Body 18 coil, position it over the heart.Connect the coil and secure it with the belts. See: Coil operatormanualThe display shows the following message: Initial Learningphaseactive. Don´t move table.3Wait at least 10 heart beats (learning phase for triggering) beforeyou move the patient table into the magnet.The patient must not move during this learning phase. Thepatient table is in the Home position.The red LED (fault) at the PERU is flashing rapidly?No analyzable signal is available.◆Ensure that the ECG electrodes are attached correctly.Performing the examinationEvaluating the signal quality4 Physiological imaging94 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Pulse triggeringDescriptionPulse triggering uses the patient's pulse to trigger the measurement.A pulse sensor is connected to the patient's toe or finger. The firstpulse wave (“premature pulse wave”) is used for triggering. This wavecorresponds to the systolic blood pressure.A number of special sequences support retrospective gating.Performing✓Suitable finger adapter is attached.1Ensure that the cable is not bent.2Attach the pulse sensor to a finger or on a toe.3Ensure that the pulse sensor is attached properly.The red LED (fault) at the PPU is flashing rapidly?No analyzable signal is available.◆Ensure that the pulse sensor is attached correctly.✓The pulse sensor is attached.◆Perform the examination. See: Software operator manual4.44.4.14.4.2Attaching the pulse sensorPerforming the examinationPhysiological imaging 4MAGNETOM Skyrafit | syngo MR E11 95Print No. M6-04401.621.02.02.02
Respiratory triggeringDescriptionTo keep respiratory artifacts to a minimum, respiratory triggering isprimarily used in abdominal imaging. Data acquisition for respiratorytriggering begins when the respiratory signal reaches a predefinedlevel (approx. 20 % of the maximum value). Respiratory movement isminimal in this range.(1) Expiration(2) InspirationThe respiratory signal is acquired using a respiratory cushionconnected via a pressure hose to the ECG and respiratory sensor(PERU). The respiratory cushion is attached to the patient via therespiratory belt.Retrospective gating cannot be applied.Performing1Ask the patient to lie still during the measurement.2Inform the patient that the knocking sounds during themeasurement are caused by switching the gradients on and off.The PERU may also vibrate slightly.✓The plug of the respiration cushion is NOT connected.CAUTIONIncorrect MR image due to disconnected respiratory cushion!Incorrect diagnosis◆As a last step, plug the connector of the respiratory cushioninto the allocated jack.1Determine whether the patient is a thoracic or abdominal breather.4.54.5.14.5.2Informing the patientAttaching the respiratorycushion and belt4 Physiological imaging96 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Women and athletes are usually thoracic breathers.Men and obese patients are usually abdominal breathers.2If the patient is an abdominal breather, place the respiration beltaround his abdomen.– or –If the patient is a thoracic breather, place the respiration beltaround his chest.As an alternative, the respiratory cushion and belt can be used incombination with the Body 18.3Slide the respiratory cushion underneath the respiratory belt.✓The respiratory cushion is attached.1Use the application cushion and position it on the patient togetherwith the PERU. ( Page 89 Preparing the measurement)2For respiratory triggering alone, position the electrode leadsloosely on the respiratory belt.3Connect the plug for the respiratory cushion to the appropriatesocket on the PERU.4Ensure that the pressure hose of the respiration cushion is notcrimped or bent. Make sure the respiration cushion is not undulycompressed.With quiet patients, a periodic signal will appear on-screen.◆Perform the examination. See: Software operator manualExternal triggeringInput for external trigger signalThe external trigger signal has to meet the following specifications:Connecting the respiratorycushionPerforming the examination4.64.6.1Physiological imaging 4MAGNETOM Skyrafit | syngo MR E11 97Print No. M6-04401.621.02.02.02
Voltage-tim diagram for external triggering of the PMUName ValueUL0 V ... 0.8 VUH2.5 V ... 5 VtL(min.) 10 mstH(min.) 10 msInput current min. 5 mAInput voltage max. ± 5 VInternal contact +External contact -The measurement sequence is triggered by the rising edge of theexternal signal.The external trigger signal can be supplied via the connections in themagnet cover.Performing1Connect the source of the external trigger signal to the cinch jacktrigger input (magnet cover, left).2Perform external triggering. See: Software operator manual4.6.24 Physiological imaging98 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
MR system operationDaily functionality checksBefore using the MR system, the functionality and/or cleanliness ofthe following parts and areas must be checked:◾Alarm box◾Warning signs◾Floor◾Magnetizable materials◾Exhaust vent◾Patient table◾Squeeze bulbChecking the functionality and cleanlinessWARNINGLarge amount of liquid (for example, phantom fluid) spilled ontopatient table and seeping into electrical connections!System malfunction due to electrical hazards◆Immediately stop the running examination.◆Shut down the computer system and power off the MRsystem (SYSTEM OFF).◆Notify Siemens Service.1Check the LEDs on the alarm box.2Check if all warning symbols and signs are present inside andoutside the examination room.55.15.1.1MR system operation 5MAGNETOM Skyrafit | syngo MR E11 99Print No. M6-04401.621.02.02.02
CAUTIONLeaking hydraulic system!Slipping hazard◆Check the area around the patient table for hydraulic fluidson the floor.3Check the examination room, control room, and electronics roomfor liquid spills and puddles on the floor.4Ensure that no magnetizable materials or objects such as vacuumcleaners, carts, ladders, and tools are present in the examinationroom.5Ensure that the outlet of the exhaust vent line is not obstructed.6Ensure that any contrast medium residue has been cleaned off thepatient table.7Check the functionality of the squeeze bulb. The patient must beable to trigger the patient alert using the squeeze bulb.Starting up and shutting down the MRsystemThere are three operating modes:◾System On (full operation)All MR system components are switched on. Examinations may beperformed.◾System Off (system is not working)All MR system components except cooling are switched off.◾Standby (standby operation)Only the host computer is switched on. Standby is useful forpatient evaluations on the computer after performing anexamination.5.25 MR system operation100 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
The operating modes can be selected by pressing the correspondingbutton on the alarm box or by using the System Manager in thesyngo MR software. See: Software operator manualAdditionally a main circuit breaker is located in the control roomwhich should NOT be used during proper functioning of the MRsystem. It switches off the overall system including cooling, whichleads to helium boil-off.Starting the system (System On)System start-up includes the following steps:◾Switching on the MR system at the alarm box◾Switching on the syngo MR Workplace◾Checking the MR system componentsDo not perform preliminary examination steps (e.g. moving thepatient table, connecting coils) at the MR system while startingup the system.Prior to starting the system, the patient table should be in the HomePosition.After “system off” or Standby, wait at least 30 seconds before youswitch on the system again.5.2.1MR system operation 5MAGNETOM Skyrafit | syngo MR E11 101Print No. M6-04401.621.02.02.02
✓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.1Turn the keyswitch to the right.2Press the SYSTEM ON button.The SYSTEM ON LED lights up. The MR system is switched on.The software starts at the syngo Acquisition Workplace.Since the syngo MR Workplace has its own voltage supply, it isswitched on separately from the syngo Acquisition Workplace.◆Press the Power On switch at the computer of the syngo MRWorkplace.The software of the syngo MR Workplace starts.After switching on the syngo Acquisition Workplace and thesyngo MR Workplace, the system requires approx. 18 minutes towarm up and get ready for acquisition.1If a dialog window is displayed at the syngo Acquisition Workplaceinforming you that the helium fill level is too low: Close thewindow and notify Siemens Service or have the magnet refilled.2Check all Table Stop buttons (at the intercom and at the patienttable). Ensure that these buttons function properly and stop thetable immediately.3Check if pressing the squeeze bulb triggers the patient alert.4Check if communication with the patient in the examination roomworks properly.5Check if image transmission of the video systems works properly.Switching on the MR system atthe alarm boxSwitching on the syngo MRWorkplaceChecking the MR systemcomponents5 MR system operation102 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
6Check if the contact spring connectors at the door frame and thedoor to the examination room are free of residues, such ascleaning agents, oil, grease, paint splatters, blood drops, etc.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 boxWhen shutting down the system, the software of the syngo MRWorkplace is automatically ended as well.Prior to shutting down the system, the patient table should be in theHome Position.To avoid possible data losses at the syngo MR Workplace, shutdown the syngo MR Workplace before the syngo AcquisitionWorkplace.If the user is logged on, the system must be shut down usingSystem > Control... or System > End Session. Otherwise, dataare lost.✓All data have been saved - at the syngo Acquisition Workplace aswell as at the syngo MR Workplace.1Select System > End Session at the syngo Acquisition Workplace.The End Session dialog window is displayed.5.2.2Shutting down the computersystemMR system operation 5MAGNETOM Skyrafit | syngo MR E11 103Print No. M6-04401.621.02.02.02
2Select the Shutdown System option.The computer system shuts down.The software does not respond?◆Simultaneously press the Ctrl, Alt, and S keys on the keyboardand shut down the system with the System Manager.The System Manager cannot be opened?You can shut down the syngo Acquisition Workplace via theWindows platform, which can cause data loss.◆Simultaneously press the Ctrl, Alt, and Del keys on thekeyboard and choose the shutdown option.System Manager and Windows do not respond?◆Switch off the syngo Acquisition Workplace.✓The computer system has been shut down (indicated by a messagethat the system can be switched off).1Press SYSTEM OFF.2Turn the keyswitch to the left.Shutting down the syngo MR WorkplaceIn the System On mode, you can only shut down the syngo MRWorkplace.1Save your data.2At the syngo MR Workplace, select System > End session.The End Session dialog window is displayed.Switching off the MR system atthe alarm box5.2.35 MR system operation104 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
3Select the Shutdown System option.The computer system shuts down.In case of problems during shutting down, see troubleshootinginformation: ( Page 103 Shutting down the computer system)Starting/ending StandbyStandby can be switched on by using the System Manager in thesyngo MR software. See: Software operator manual1Select System > Control to open the System Manager.2To start Standby: On the Meas & Recon tab, click the Standbybutton.The System Manager - Scanner StandBy dialog box opens.3To end Standby: At the alarm box, press the SYSTEM ON button.Preparing the MR systemTo use the holder for infusion bottles you can position the rod on theright side of the patient table (head end). If not in use, you can clampthe holder in the affixing elements at the side of the table.5.2.45.3MR system operation 5MAGNETOM Skyrafit | syngo MR E11 105Print No. M6-04401.621.02.02.02
Connecting the squeeze bulb(1) Connection for headphones(2) Connection for squeeze bulb1Connect the hose connector of the squeeze bulb to thecorresponding connector at the foot end of the patient table.2Connect the headphone to the corresponding connector at thefoot end of the patient table.Setting tunnel conditionsUse the buttons and the jogwheel of the small control unit to set theconditions in the magnet tunnel.(1) Headphone button(2) Jogwheel for settings(3) Tunnel ventilation button(4) Loudspeaker button(5) Tunnel lighting button1Click the corresponding button and use the jogwheel to increase ordecrease the setting.2Confirm your setting by pressing the jogwheel.The setting of the music volume has no effect on the voicevolume of patient announcements.Preparing the patientTo use the holder for infusion bottles you can position the rod on theright side of the patient table (head end). If not in use, you can clampthe holder in the affixing elements at the side of the table.5.3.15.3.25.45 MR system operation106 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
CAUTIONHeat development during the examination!Patient burns◆Instruct patients to press the squeeze bulb in case of strongheat sensations.WARNINGUse of unapproved fMRI stimulation devices for the givenmagnetic field strength!Injury to patient and operating personnel◆Ensure that the stimulation devices are approved for the fieldstrength of your MR systems. For example, devices approvedfor low and medium field systems (0.2 – 1.5T) must not beused on a 3T system.Informing the patient1Please note the safety instructions.2Inform the patient about the possible effects of MR examinationsand the risks associated with the magnetic field.3Show the patient how to activate the patient alert by pressing thesqueeze bulb.4Ensure that the patient holds the squeeze bulb in his/her handduring the measurement.5.4.1MR system operation 5MAGNETOM Skyrafit | syngo MR E11 107Print No. M6-04401.621.02.02.02
Physiological effectsDue to the presence of alternating electromagnetic fields, patientsmay experience various physiological effects during MRmeasurements:◾Peripheral nerve stimulation through low-frequency fields of thegradient coils ( Page 110 Exposure to low frequencyelectromagnetic fields)◾Warming of body tissue through RF fields of the RF transmitter coil( Page 112 Exposure to RF electromagnetic fields)These physiological effects can be evaluated by the technicalquantities dB/dt (stimulations) and SAR (warming) respectively.It is generally accepted that no published evidence supporting theoccurrence of cumulative and/or long-term effects after exposure toEMF emitted by the MR equipment exists.Operating modesTo prevent health risks during MR measurements, severalinternational organizations (for example, IEC) and various nationalhealth organizations have published guidelines and limit values. Incompliance with country-specific approval guidelines, they are thebasis for the monitoring functions integrated in the MR system withrespect to stimulation and warming effects. The limits against toointense stimulation and warming effects (for example, dB/dt limitsand SAR limits) are based on current scientific literature related tosafety.Two different operating modes are available depending on thepatient’s tolerance. With respect to stimulation and warming effects,the operating modes are defined independently of each other andcan be selected separately.The Normal Operating Mode can be used safely for all patients. This isthe standard mode. Routine patient monitoring is required.( Page 33 Patient monitoring)Scanning of pregnant patients with the Body coil must be limited tothe Normal Operating Mode with respect to the SAR level.5.55.5.1Normal Operating Mode5 MR system operation108 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
In the First Level Controlled Operating Mode, patients mayexperience noticeable stress levels depending on the measurementprograms selected. The decision to change to the First LevelControlled Operating Mode must be based on a medicalconsideration of the potential risks and benefits for the patient.CAUTIONExposure to RF electromagnetic fields in the First LevelControlled Operating Mode!General or local hyperthermia of the patient◆Do not examine patients with restricted thermoregulatorycapability (e.g. small children, elderly, sick, or medicatedpatients).◆Do not examine patients unable to communicate potentialoverheating effects (e.g. small children, seriously ill,paralyzed, unconscious, sedated, or handicapped patients).◆Ensure that patients wear light clothing (e.g. light pajamas ornightgown).◆Remove all additional insulation, e.g. blankets which couldinterfere with heat dissipation.◆Carefully observe the patient and advise the patient onceagain about the squeeze bulb.Ensure medical monitoring of the patient (as required by the IECstandard). Also consider the need for breaks during themeasurements, to allow the patient to cool off, for example.First Level ControlledOperating ModeMR system operation 5MAGNETOM Skyrafit | syngo MR E11 109Print No. M6-04401.621.02.02.02
CAUTIONStereotactic frames and similar devices: tips of screws may heatup considerably, especially if MR examinations are performed inthe First Level Controlled Operating Mode!Localized burns of the patient◆Please observe the recommendations and notes of themanufacturer of the stereotactic frame.◆If the device consists of conductive material, only performmeasurements in the Normal Operating Mode, if possible.◆If you still need to switch to the First Level ControlledOperating Mode, please observe the related safety notes.To switch from the Normal Operating Mode to the First LevelControlled Operating Mode, the user must explicitly select andconfirm the change. The request appears in the dialog window of thesyngo Acquisition Workplace. In the First Level Controlled OperatingMode, medical supervision is mandatory.Dialog window SAR MonitorExposure to low frequency electromagnetic fieldsDuring the measurement, patients are exposed to an electrical fieldcreated by the time-varying magnetic fields of the gradient coils.Assuming all other conditions remain constant, the strength of theelectrical field is directly proportional to the change of the magneticflux (dB/dt).Switching operating modes5.5.25 MR system operation110 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Stimulation threshold: The electrical field affects the patient. If thestrength of the electrical field exceeds a certain threshold(stimulation threshold), the patient experiences peripheral nervestimulation. Nerve stimulation manifests itself as e.g. tinglingsensations or slight muscle spasms in the ribs, side, abdomen, hip,buttock, or thoracic regions, along the upper arms or the backmuscles in the shoulder region. Depending on physiologicalconditions, the stimulation threshold may vary greatly from patient topatient.Stimulation limits: So-called stimulation limits were determined byaveraging the individual stimulation thresholds of test subjects duringan extensive clinical trial. Based on the statistical distribution, it canbe expected that up to 50 % of all patients will experience at leastmild stimulations after reaching this stimulation limit.The MR system software includes a monitoring feature (stimulationmonitor) which monitors how close patients are to the stimulationlimit.Look Ahead monitoring: Prior to starting an MR measurementprotocol, the stimulation monitor checks whether the stimulationlimits may be exceeded. If so, the measurement cannot be started. Toperform the examination, the parameters of the measurementsequence must be adjusted accordingly.Online monitoring: If the stimulation limit is exceeded while ameasurement is in progress, the active measurement is aborted.The MR system can be operated in two operating modes which differwith respect to different levels of stimulation.The power limits are based on stimulation models derived from thestatistically determined stimulation limits. The higher the gradientoutput is, the higher the probability and the intensity of the effects(for example, peripheral nerve stimulation). To minimize theoccurrence of peripheral nerve stimulations, it is recommended tooperate the system in the Normal Operating Mode. However, heartstimulations can be excluded.Normal Operating Mode: In the Normal Operating Mode, the limit isset to 80 % of the stimulation limit according to IEC 60601-2-33. Atthe maximum performance allowed in this operating mode, the ratioof patients affected by peripheral nerve stimulation is rather low.Peripheral nerve stimulationMonitoringOperating modesMR system operation 5MAGNETOM Skyrafit | syngo MR E11 111Print No. M6-04401.621.02.02.02
First Level Controlled Operating Mode: In the First Level ControlledOperating Mode, the performance limits are determined directly fromthe statistically determined stimulation limits. Accordingly, at themaximum performance allowed in this operating mode, up to 50 % ofall patients may experience stimulations.Exposure to RF electromagnetic fieldsDuring the course of an MR measurement, the patient’s body absorbsenergy from the RF field of the transmitter coil. Depending on thetype of transmitter coil used, the absorption is either concentratedlocally (when using so-called “Local RF Transmit Coils”) or relativelyuniform across the part of the body examined (when using volumecoils, for example, head, extremity, or body coil).The Specific Absorption Rate (SAR), expressed as W/kg, serves as astress indicator.Unacceptably high local SAR values may lead to RF burns. High globalSAR values (head, exposed part of the body, whole body) may lead tooverstress the patient’s thermoregulation and the cardiovascularsystem.The B1+ rms value (root mean square value of the MR-relevantcomponent of B1, which is indicated by the “+”) is displayed at thesyngo Acquisition Workplace for each sequence and may serve as anindication of the RF magnetic field intensity. This can be used toassess the risk of scanning a patient with an active or passive implant.The energy absorbed in the course of the MR measurement warmsthe tissue. The heat generated is dissipated by the thermoregulationmechanisms of the patient, e.g. through increased perspiration andblood flow.The body temperature increases if the patient absorbs more energyper unit of time than can be dissipated through thermoregulation.The longer this condition lasts, the greater the increase intemperature.The increase in core body temperature is usually well below 1°Cduring the course of the MR examination (if the SAR limits describedbelow are maintained). Nevertheless, patients with a coretemperature higher than 39.5°C must not be scanned and patientswith a core temperature higher than 39.0°C must only be scanned inthe Normal Operating Mode.5.5.3Warming of body tissue5 MR system operation112 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
During the MR measurement, patients may experience heatsensations on the skin and, as a consequence of the RF energyabsorption, patients may begin to perspire during the course of theMR examination. Their pulse rate may increase as well. The individualeffects vary from patient to patient. The intensity of these effectsdepends on the measurement program selected. As compared to theNormal Operating Mode, measurement programs with considerablyhigher intensities may be used in the First Level Controlled OperatingMode. Following the examination, the body will cool off. The pulserate will return to normal.Temperature control inside the examination room: A temperaturesensor, located near the air intake for the tunnel ventilation, monitorsthe room temperature. If the room temperature exceeds 25°C, theSAR limits are regulated and lowered by 0.25 W/kg per °C exceeding25°C. As a result, the parameters of certain MR measurementsequences may need to be adjusted.Considering all possible tolerances, the SAR values (quantities)are always calculated based on the worst-case assumption. Thisensures that the specific SAR limit is maintained.Depending on the medical question, different coils are used for theRF transmission (for example, head, extremity or body coil). Thedifferent coils lead to different RF exposure situations for the patient.Therefore, different SAR quantities and corresponding limits havebeen established (for example, head SAR, whole body SAR, local SAR,and SAR of the exposed part of the body). According to the guidelinefor monitoring SAR, the software automatically determines the SARquantities and the corresponding limits to be monitored and to beapplied respectively. For the actual RF exposure situation, one of theabove-mentioned SAR quantities will show the highest “value to limitratio”. For example, in the case of a head examination with a typicalhead coil, this will be the global head SAR. If however, a transmittingcoil with an inhomogeneous RF field is applied, this will be the localSAR.SAR limits are observed by a software monitoring function.Noticeable effects on thepatientSAR limitsSAR monitoringMR system operation 5MAGNETOM Skyrafit | syngo MR E11 113Print No. M6-04401.621.02.02.02
Look Ahead monitoring: Prior to each measurement, the values ofthe SAR quantities to be observed are calculated (always as worst-case values) and compared with the corresponding limit values. If oneof the calculated SAR values exceeds the corresponding limit, themeasurement cannot be started. The following message appears inthe dialog window of the syngo Acquisition Workplace: SAR Limit(s)Exceeded!To ensure correct calculation of the SAR values, the weight of thepatient must be entered during registration.This dialog window includes suggested changes to the examinationparameters which allow the examination to continue. In addition, abutton in the dialog window may be used to change the operatingmode.In the First Level Controlled Operating Mode, often only minormodifications (if any) may be required.5 MR system operation114 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Online monitoring: The system constantly measures the transmitpower 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 monitoringfunction are set according to country-specific approval guidelines atthe time of the syngo MR installation.Normal operating mode: In the Normal Operating Mode, the patientbarely notices the effects of the RF field. The stress on the cardio-vascular system is negligible.First Level Controlled Operating Mode: In the First Level ControlledOperating Mode, patients may experience noticeable stress levelsdepending on the measurement programs selected. This usuallyincludes perspiration accompanied by an increase in pulse rate.Patients with reduced thermoregulatory capability and highersensitivity toward increases in body temperature (e.g. patients withfevers or cardiac decompression, patients with perspiratoryimpairments, or pregnant women) may experience additional effects.Display of SAR values: The current SAR values, encoded according tothe body regions of interest, can be accessed at any time. See:Software operator manualStarting/Stopping the measurementStarting the measurement✓The measurement protocol is loaded.✓No MR measurement is active.◆Select the Start icon at the Dot display. ( Page 55 Dot display)The measurement begins.The display is deactivated.Stopping the measurement✓The MR measurement is active.◆Press any of the table movement buttons on the control unit.( Page 54 Control units)5.65.6.15.6.2MR system operation 5MAGNETOM Skyrafit | syngo MR E11 115Print No. M6-04401.621.02.02.02
The measurement is stopped.The display is activated.5 MR system operation116 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
MaintenanceCleaningAll instructions in the operator manual regarding cleaning and, whenapplicable, regarding disinfecting and sterilization must be alwaysobserved.WARNINGImproper 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 ManualCoilsCleaning the LCD monitor/video displayThe LCD monitor of the syngo Acquisition Workplace and the videodisplay are cleaned in the same way.1Clean the LCD monitor/video display at least every two months.2Prior to cleaning, switch off the LCD monitor/video display anddisconnect the main power plug. But if the monitor/display is underhot running conditions, please wait till the monitor/display ischilled (this can take up to one hour).3Clean the monitor/video display using a microfiber cloth.4If the LCD monitor/video display cannot be effectively cleaned withthe microfiber cloth: use window cleaner. Do not use windowcleaner on the monitor housing.5Immediately remove any water drops from the LCD monitor/videodisplay.6Avoid scratching the surface area of the LCD monitor/video display.7Avoid impacts to the LCD monitor/video display.66.16.1.1Maintenance 6MAGNETOM Skyrafit | syngo MR E11 117Print No. M6-04401.621.02.02.02
The LCD monitor/video display are highly sensitive to mechanicaldamage.Cleaning the camera lens◆Carefully clean the camera lens with a lint-free cloth and lenscleaner.Cleaning the data carrier1Clean contaminated data carriers with a clean cloth (cotton ormicrofiber).2Follow the manufacturer's notes when cleaning CD/DVD datacarriers.Cleaning the plugs and connectors1Dampen a soft cloth with water or a diluted household cleanersolution. Do not use organic solvents such as alcohol or acetone.2Carefully wipe the plugs and connectors with the cloth. Do nottouch the contacts.Cleaning the patient table and the straps1Clean the patient table using a liquid household agent.2Wash the straps of the patient table at a temperature of 60°C.3Use commercial disinfecting materials. However, do not usesolutions with alcohol or acetone.Cleaning and disinfecting the receptors1Do not use cleaners or disinfectants containing alcohol or ether.2Do not use hard or sharp objects (e.g. knives or tweezers) toremove residue.3Clean the receptors with a commercially available cleaner. Followmanufacturer’s instructions.6.1.26.1.36.1.46.1.56.1.66 Maintenance118 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
4Use a dampened cloth for cleaning.Do not submerge the receptors in cleaning liquid.5Disinfect the receptors with a commercially available disinfectingagent. Follow the manufacturer’s instructions.Disinfecting system componentsDisinfecting sprays damage electronic components. For thisreason, components may only be cleaned with a semi-dry cloth.WARNINGFlammable cleaning or disinfection agents may cause fire orexplosion!Injury to patient◆Disinfect the system components with commercialdisinfecting materials. However, do not use solutions withalcohol or acetone. Follow manufacturer’s instructions.Siemens does not test alcohol-containing, phenol-alkaline andalkaline-based disinfectants for harmful effects on surfaces.Avoid disinfecting system components with these materials.Care and cleaning of floorsDo not use the following cleaning or care products:◾Sprays◾Silicon-based cleaning or care products◾Cleaning or care products with substances that release ammonia◾Cleaning or care products that destroy the anti-static properties ofthe floor covering6.1.76.1.8Maintenance 6MAGNETOM Skyrafit | syngo MR E11 119Print No. M6-04401.621.02.02.02
◆Use commercially available cleaning or care products for the floor.Follow manufacturer's instructions.Return and disposalMR SystemWARNINGExplosion hazard during improper disassembly!Injury of persons◆Ensure that only trained personnel disassemble the MRsystem because the system includes a pressurized containerand cryogenic helium.1Contact Siemens Service in case of questions about returning anddisposing the MR system and/or its components and accessories.2Observe national regulations.PackagingSiemens AG is obligated to accept the return of packagingmaterial.1Contact Siemens Service regarding questions with respect to thereturn as well as subsequent disposal of packaging material.2Observe national regulations.Batteries and accumulatorsSiemens AG is obligated to accept the return of batteries andaccumulators and to dispose of them.6.26.2.16.2.26.2.36 Maintenance120 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
1Contact Siemens Service with respect to questions regarding thereturn and disposal of batteries and accumulators.2Observe national regulations.Maintenance 6MAGNETOM Skyrafit | syngo MR E11 121Print No. M6-04401.621.02.02.02
6 Maintenance122 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
Appendix: regulatoryinformationMedical devices of other manufacturersPlease note that this manual may also contain information aboutmedical devices that are NOT legally manufactured by Siemens.These medical devices are either only distributed by Siemens, oronly mentioned for additional information.In the following table you will find information about the medicaldevice, the corresponding legal manufacturer and, if applicable, theauthorized representative.Product and CE Legal manufacturerRespiration cush-ion, respiratorybeltPi-Products GmbHHeinrich-Hertz-Straße 8a92224 Amberg, Germanywww.pi-products.deApplication cush-ion for PMUPolyform GmbH & Co. KGKunststofftechnikBraasstraße 15DE-31737 Rinteln, Germanywww.polyform.dePatient table TRUMPF Medizin Systeme GmbH + Co.KGCarl-Zeiss-Str. 7-907318 Saalfeld, Germanywww.de.trumpf.com77.1Appendix: regulatory information 7MAGNETOM Skyrafit | syngo MR E11 123Print No. M6-04401.621.02.02.02
CE for Physiological Measurement Unit (PMU)The PMU (PPU, PERU) bears a CE marking in accordance with theprovisions of regulation 1999/5/EC of March 9, 1999 for radio andtelecommunications terminal equipment.7.27 Appendix: regulatory information124 MR System | Operator ManualPrint No. M6-04401.621.02.02.02Changes or modifications not expressly approved by the partyresponsible for compliance could void the user's authority tooperate the equipment.This device complies with Industry Canada licence-exemptRSS standard(s) and part 15 of the FCC Rules. Operation issubject to the following two conditions: (1) this device may notcause interference, and (2) this device must accept anyinterference, including interference that may cause undesiredoperation of the device.Le présent appareil est conforme aux CNR d'Industrie Canadaapplicables aux appareils radio exempts de licence.L'exploitation est autorisée aux deux conditions suivantes :(1) l'appareil ne doit pas produire de brouillage, et(2) l'appareil doit accepter tout brouillage radioélectrique subi,même si le brouillage est susceptible d'en compromettre lefonctionnement.
AAccessoriesSafety instructions 38AccidentsBurns 20Coils 41Coolant accidents 45Measurement phantoms 41Alarm boxChecks 72Description 72ArtifactImaging errors 33Patient-related 37System-related 34BBreathing difficulties 45BurnsFrostbite 45CChecksAlarm box 72Daily functionality checks 99CleaningConnections 118Floor 119Monitor/video display 117MR system 117Patient table 118Receptors 118Straps of the patient table 118CoilsAccidents 41CombinationWith other devices andaccessories 28Compatibility 28Safety information 28Computer systemShutting down 103Starting up 101ConnectionsCleaning 118ContraindicationsImplants 23Safety information 23Control cabinetDescription 48Control units 54Controlled access area 17DDescriptionDockable patient table 64Device malfunctionsSafety information 20DisinfectionReceptors 118System components 119DisplayDot display 55Information service 55Dockable patient tableDocking 67Moving 66Operation 65Undocking 66Dockable patient table|Description 64DockingDockable patient table 67DocumentationData recording, Overview 50Dot displayOperation 57EECG triggeringDescription 91Performing 92Electromagnetic fieldsDescription 16Safety instructions 16Electronics cabinetsDescription 47EmergencyEmergency switches 41Rescuing the patient in anemergency 62Emergency buttonsMagnet Stop 42Table Stop 44Emergency Shut-downSafety instructions 44Emergency switchesEmergency Shut-down 44Safety information 41Environmental conditions 30ExaminationMR system 105Preparation 105External triggeringDescription 97Performing 98FFailuresSafety instructions 38FireSafety instructions 46Foot switchOperation 79, 79Functional checkAlarm box 72Daily 99GGradient cabinetDescription 48HHazard hintsConfiguration 16Verbal signals 16HazardsCommon sources of danger 16Contraindications 23Electromagnetic fields 16Mechanical hazards 25IndexMAGNETOM Skyrafit | syngo MR E11 125Print No. M6-04401.621.02.02.02
Noise development 31Potential hazards 16RF and gradient fields 20Static magnetic field 18HeadphoneConnection 106HostDescription 50IImplantsDevice malfunctions 20In-Room syngo Acq WPDescription 76Operation 77IntercomDescription 74Operation 75Transmit music 76Transmit voice output 76KKeyboardsyngo Acquisition Workplace 51LLaser light localizer|Description 70Look Ahead monitoringLow-frequency fields 111SAR monitoring 113MMagnet StopSafety information 42Magnetic fieldLow frequency fields 110Physiological effects 110Physiological effects; RFfields 112MaintenanceMR system 117Safety information 38MeasurementStart/Stop 115Starting and ending; withfootswitch 79, 79Measurement phantomsAccidents 41Mechanical hazardsSafety instructions 25MonitorCleaning 117In-Room syngo Acq WP 77syngo Acquisition Workplace 50MonitoringIntercom 74Look Ahead monitoring 111Online monitoring 111SAR monitoring 113MR systemOperating modes 100Shutting down the syngo MRWP 104Shutting down the system 103Starting the syngo MR WP 102Starting the system 101Starting/ending Standby 105Switching on/off 100NNerve stimulationLow-frequency fields 111Noise developmentSafety information 31OOnline monitoringLow-frequency fields 111SAR monitoring 113Operating consolesIn-Room syngo Acq WP 76syngo Acquisition Workplace 49syngo MR WP 53Operating modeFirst Level Controlled OperatingMode 109low-frequency fields 111Normal Operating Mode 108Performance limits 111Standby 105Switching operating modes 110OperationDot display 57PPatient carePatient instructions 32Patient monitoring 32Patient monitoringIntercom 74Patient tableCleaning 118Description 57Display 55Operation 59Rescuing the patient 62PERU 85Physiological effectsDescription 108First Level Controlled OperatingMode 109Low frequency fields 110low-frequency fields 111Monitoring 111Normal Operating Mode 108Operating modes 108RF fields 112SAR limit values 113SAR monitoring 113Switching operating modes 110Warming of body tissue 112Physiological Measurement UnitData display 88Description 84Display 89ECG and respiratory sensor 85,85External trigger input 87Pulse sensor 86PreparationMR system 105Patient; For MRexamination 106Pulse sensorIndex126 MR System | Operator ManualPrint No. M6-04401.621.02.02.02
PPU 86Pulse triggeringDescription 95Performing 95QQuality AssuranceCoils 41RRepairSafety information 38Rescuing the patient in anemergency 62Respiratory triggeringDescription 96Performing 96ResponsibilitySafety guidelines 15Return and disposal 120RF and gradient fieldsSafety instructions 20RF coilsDescription 49SSafety guidelinesMR safety 15Responsibility 15Safety informationContraindications 23Emergency switches 41Maintenance/repair 38Preface 15SARLimit values; Safetyinformation 113Limits, high-frequencyfields 113Monitoring 113Signs and symbolsWarning and prohibitionsigns 38Squeeze bulbConnection 106StandbyStarting/ending Standby 105Static magnetic fieldDevice malfunctions 20Safety instructions 18Super-conducting magnetDescription 47syngo Acquisition WorkplaceDescription 49Host processor 50Keyboard 51Monitor 50Mouse 52syngo MR WPDescription 53Shutting down 104Starting up 102System controlControl units 54Description 53TTable StopSafety information 44Temperature controlSafety guidelines 113Tool barDisplay 56Triggering methodsOverview 83UUndockingDockable patient table] 66VVideo displayCleaning 117WWarming of body tissueRadio frequency fields 112Warning labelsWarning and prohibitionsigns 38MAGNETOM Skyrafit | syngo MR E11 127Print No. M6-04401.621.02.02.02
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Manufacturer’s note:This device bears a CE mark in accordance with theprovisions of Council Directive 93/42/EEC of June 14, 1993concerning medical devices and the Council Directive2011/65/EU of June 08, 2011 on the restriction of the useof certain hazardous substances in electrical and electronicequipment.The CE marking applies only to medical devices which havebeen put on the market according to the above-mentionedEC Directives. Unauthorized changes to this product arenot covered by the CE mark and the related Declaration ofConformity.Please note: For products that are not legally manufacturedby Siemens but distributed, please refer to the Appendix ofthis manual!Global Business UnitSiemens AGMedical SolutionsMagnetic ResonanceHenkestr. 127DE-91052 ErlangenGermanyPhone: +49913184-0www.siemens.com/healthcareGlobal Siemens HeadquartersSiemens AGWittelsbacherplatz 280333 MuenchenGermanyGlobal Siemens HealthcareHeadquartersSiemens AGHealthcare SectorHenkestraße 12791052 ErlangenGermanyPhone: +49 9131 84-0www.siemens.com/healthcareLegal ManufacturerSiemens AGWittelsbacherplatz 2DE-80333 MuenchenGermanyPrint No. M6-04401.621.02.02.02 | © 2015, Siemens AGwww.siemens.com/healthcare

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