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Siemens MAGNETOM Skyra fit Operator'S Manual Download Page 123

Appendix: regulatory
information

Medical devices of other manufacturers

Please note that this manual may also contain information about
medical devices that are NOT legally manufactured by Siemens.
These medical devices are either only distributed by Siemens, or
only mentioned for additional information.

In the following table you will find information about the medical
device, the corresponding legal manufacturer and, if applicable, the
authorized representative.

Product and CE

Legal manufacturer

Respiration cush-
ion, respiratory
belt

Pi-Products GmbH

Heinrich-Hertz-Straße 8a

92224 Amberg, Germany

www.pi-products.de

Application cush-
ion for PMU

Polyform GmbH & Co. KG

Kunststofftechnik

Braasstraße 15

DE-31737 Rinteln, Germany

www.polyform.de

Patient table

TRUMPF Medizin Systeme GmbH + Co.KG

Carl-Zeiss-Str. 7-9

07318 Saalfeld, Germany

www.de.trumpf.com

7

7.1

Appendix: regulatory information

7

MAGNETOM Skyra

fit

 | syngo MR E11

123

Print No. M6-04401.621.02.02.02

Summary of Contents for MAGNETOM Skyra fit

Page 1: ...www siemens com healthcare MAGNETOM Skyrafit Operator Manual MR System syngo MR E11 Answers for life ...

Page 2: ......

Page 3: ...MAGNETOM Skyrafit Operator Manual MR System syngo MR E11 ...

Page 4: ...s buttons and keys for example the Save button Used to emphasize particularly important sections of the text Used for on screen output of the system including code related elements or commands Identifies inputs you need to provide Used for the navigation to a certain submenu entry Identifies variables or parameters for example within a string CAUTION Used with the safety alert symbol indicates a h...

Page 5: ... or serious 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 Legend MAGNETOM Skyrafit syngo MR E11 5 Print No M6 04401 621 02 02 02 ...

Page 6: ...Legend 6 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 7: ...ic field 18 2 2 3 Safety instructions on RF and gradient fields 20 2 2 4 Contraindications 23 2 2 5 Mechanical hazards 25 2 2 6 Compatibility 28 2 3 What else must be observed 30 2 3 1 Ambient conditions 30 2 3 2 Access to the examination room 30 2 3 3 Noise development 31 2 3 4 Patient care 32 2 3 5 Artifacts and imaging errors 33 2 3 6 Maintenance repair 38 2 3 7 Signs and symbols 38 2 3 8 Syste...

Page 8: ... 4 1 Description 57 3 4 2 Operating the patient table 59 3 5 Dockable patient table 64 3 5 1 Description 64 3 5 2 Operating the dockable patient table 65 3 6 Laser light localizer 70 3 6 1 Using the laser light localizer 70 3 7 Alarm box 72 3 7 1 Description 72 3 7 2 Checks 72 3 8 Intercom 74 3 8 1 Description 74 3 8 2 Operating the intercom 75 3 9 In Room syngo Acquisition Workplace 76 3 9 1 Desc...

Page 9: ...on 99 5 1 Daily functionality checks 99 5 1 1 Checking the functionality and cleanliness 99 5 2 Starting up and shutting down the MR system 100 5 2 1 Starting the system System On 101 5 2 2 Shutting down the system System Off 103 5 2 3 Shutting down the syngo MR Workplace 104 5 2 4 Starting ending Standby 105 5 3 Preparing the MR system 105 5 3 1 Connecting the squeeze bulb 106 5 3 2 Setting tunne...

Page 10: ...rs 118 6 1 5 Cleaning the patient table and the straps 118 6 1 6 Cleaning and disinfecting the receptors 118 6 1 7 Disinfecting system components 119 6 1 8 Care and cleaning of floors 119 6 2 Return and disposal 120 6 2 1 MR System 120 6 2 2 Packaging 120 6 2 3 Batteries and accumulators 120 7 Appendix regulatory information 123 7 1 Medical devices of other manufacturers 123 7 2 CE for Physiologic...

Page 11: ... for the system owner of the MR system The extent of the respective operator manual depends on the system configuration used and may vary All components of the complete operator manual may include safety information that needs to be adhered to The operator manuals for hardware and software address the authorized user Basic knowledge in operating PCs and software is a prerequisite The current opera...

Page 12: ...terest contrast agents may be used These images and or spectra and the physical parameters derived from the images and or spectra when interpreted by a trained physician yield information that may assist in diagnosis Your MAGNETOM MR system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in room displays and MR Safe biopsy needles The...

Page 13: ...Please contact Siemens Service for more information on available training options and suggested duration and frequency of such training Definitions of different persons Term used Explanation User Operator Operating per sonnel Person who operates the system or software takes care of the patient or reads images Typically physicians trained radiological techni cians or technologists System owner Pers...

Page 14: ...Group of specially trained persons who are authorized by Siemens to perform certain mainte nance activities References to Siemens Service include service personnel authorized by Siemens 1 Introduction 14 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 15: ...ensures that the patient is free of metallic objects and clothing with metallic yarns or appliqués The following sections provide information on how to avoid the most common mistakes and the resulting safety risks These sections were prepared based on the long time experience of Siemens Responsibility Siemens accepts no responsibility for the safety reliability and performance of the MR system if ...

Page 16: ...Common permanently existing hazards The frequency at which the potential hazards mentioned in this section lead to accidents is still too high Therefore it is especially important to observe the instructions on how to avoid these dangerous situations The most significant hazards include Electromagnetic fields Contraindications Mechanical hazards Incompatible devices Electromagnetic fields In the e...

Page 17: ...and the controlled access area The static basic field is generated by a superconductive magnet and may extend beyond the examination room walls ceilings In order to minimize the hazards mentioned the controlled access area of the basic field is identified on the floor 0 5 mT line Outside the controlled access area the magnetic flux density is less than 0 5 mT See System owner manual Linearly risin...

Page 18: ...s heating claustrophobia and nerve stimulation Safety instructions on the static magnetic field The list of objects in this chapter is not exhaustive It only serves as an illustration of objects that present hazards in the presence of magnetic forces Only use equipment specified or recommended for use in the controlled access area Side effects 2 2 2 2 Safety 18 MR System Operator Manual Print No M...

Page 19: ... and tear and disposable articles with the MR system Use only MR Safe or MR Conditional tools and devices Service work on the MR system may only be performed by Siemens Service Ensure that only authorized personnel enter the controlled access area 0 5 mT exclusion zone for example electricians or cleaning personnel trained in MR safety Keep the door to the examination room closed WARNING Magnetiza...

Page 20: ...T can interfere with electronic implants or other devices The main magnetic field may either affect or destroy electronic data carriers such as check or credit cards hard disks ID cards with magnetic strips and or magnetic tapes diskettes or pocket calculators as well as RFID chips Radio Frequency Identification Safety instructions on RF and gradient fields Do not examine patients unable to commun...

Page 21: ...el as well as proper distance between parts of the body as shown in the green labeled illustration To lower the effects of gradient fields or RF fields keep a sufficient distance from the RF coils and the magnet tunnel gradient coils and reduce the time of exposure during measurements Safety 2 MAGNETOM Skyrafit syngo MR E11 21 Print No M6 04401 621 02 02 02 ...

Page 22: ...r woven metallic yarns Always position the patient so that the patient s arms are aligned with the torso and ensure that hands arms and legs do not touch minimum distance 5 mm Ensure that the minimum distance of 5 mm is maintained between patient and tunnel covering To ensure this distance use positioning aids e g blankets made of linen cotton or paper or dry material that is permeable to air Ensu...

Page 23: ...n is contraindicated for patients with electronic or electronically conductive implants or metals especially those 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 magne...

Page 24: ...in its entirety It is the responsibility of the device manufacturer to declare an implantable medical device as MR Conditional if appropriate and to define the conditions constraints for safe MR scanning The MR operator must be aware of any such conditions for MR scanning It is the obligation of the MR operator to assure that these conditions are strictly adhered to To obtain these specific condit...

Page 25: ...appliqués or woven metallic yarns Inform patients that eyeliners and tattoos may contain ingredients causing artifacts or skin irritations during MR examinations In some cases patients have been burned To prevent injuries instruct patients to remove makeup prior to the examination Instruct patients to seek medical attention in case of discomfort during or following the MR examination Mechanical ha...

Page 26: ...al patient table movement or injury to the patient After completing the intervention the table can be unlocked WARNING Cover of the table lifting column is defective access to moving parts is possible Risk of severe contusion during vertical movement Complete the current examination and then shut down the system Notify Siemens Service 2 Safety 26 MR System Operator Manual Print No M6 04401 621 02 ...

Page 27: ...he patient is not caught between the tabletop and the magnet cover Remain in the MR examination room with helpless patients e g children and patients who are either seriously ill paralyzed unconscious sedated handicapped or medicated even if the patients are secured during the examination Ensure that the sensor for height detection is not obstructed by clothing sheets or accessories etc Keep the p...

Page 28: ...n the side rails Fold the side rails down to move the tabletop The risk of stumbling is related in particular to the unfavorable routing of cables hoses of interventional components CAUTION Cable hoses of interventional components Injury to patient and operating personnel Route cables hoses of interventional components so that it is not possible to trip over them Compatibility Among other things t...

Page 29: ...the MR system with other devices Peripheral equipment e g patient monitoring life support or emergency care equipment which is not specified or recommended for use in the MRI environment including the controlled access area may be disturbed by the RF field or the magnetic fringe field of the MR system This equipment may also disturb the proper function of the MR system ASTM International developed...

Page 30: ...ed information on B0 values gradient and RF data as well as graphic representations of the spatial distributions are included in the MR compatibility data sheet See System Owner Manual What else must be observed Ambient conditions As the ambient conditions and SAR have a considerable effect on the patient s body temperature you must regularly check the ambient conditions The patient s ability to d...

Page 31: ...otection for these patients should not be omitted even at moderate sound levels Ensure that personnel and accompanying persons in the examination room wear hearing protection during the examination that lowers noise to at least 85 dB A For required level of hearing protection see System Owner Manual Technical data Hearing protection data All hearing protection devices must provide the required lev...

Page 32: ...r persons Patient care Patients must be informed about the hazards and safety measures during MR examinations Before doing so it must be confirmed that an MR examination is permissible and or checked if increased precautions are necessary CAUTION Patient received insufficient clarification of facts Injury to patient Explain to the patient the conduct expected and possible risks involved Inform the...

Page 33: ...mbination All patients should receive at least routine monitoring For some e g sedated physically unstable patients monitoring of the vital parameters is mandatory In the First Level Controlled Operating Mode medical supervision is also mandatory CAUTION Incompatible monitoring devices Patient burns Use only monitoring devices for example ECG electrodes and pulse sensor that meet the conditions fo...

Page 34: ...Siemens Service CAUTION RF 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 CAUTION Phasing of MR signal is not set correct...

Page 35: ...ages to ensure that the MR image does not show differences in brightness spots or cloudiness and check bright objects for afterglow Keep your eyes always in central monitor position with a vertical view angle towards the screen surface for best image quality CAUTION Inhomogeneous RF field Asymmetry of contrast in the MR image Whenever possible use a local coil with transmit characteristics that ar...

Page 36: ...ake localization errors into account while planning stereotactic interventions or breast biopsies CAUTION Distorted slice edges in the margin due to spatial non linearity of the gradient field and inhomogeneity of the static magnetic field Incorrect stereotactic planning When planning stereotactic interventions take into account slice distortion at the margins of the MR image This applies in parti...

Page 37: ...asurement Monitor the patient during the MR examination CAUTION Imprecise localization due to patient movement during functional MR imaging fMRI Incorrect stereotactic planning and injury of the patient Incorrect assignment of active brain areas Prior to the examination inform patients about movements and their negative effects on the measurement Use Siemens scan protocols with motion correction M...

Page 38: ...he transmitting and receiving system ECG and respiratory sensor Disposable electrodes Pulse sensor For detailed information about maintenance of the MR system see System owner manual In case of serious malfunctions shut down the MR system immediately and notify Siemens Service Signs and symbols Magnetic field RF field Observe operator manual 2 3 6 Daily checks Safety relevant accessories Maintenan...

Page 39: ...isk of breaking Maximum load side rails Laser Laser for the US only Refilling with liquid nitrogen and helium The following objects are prohibited in the examination room Prohibition signs Safety 2 MAGNETOM Skyrafit syngo MR E11 39 Print No M6 04401 621 02 02 02 ...

Page 40: ...es and electronic data car riers Fire extinguishers with magnetizable metal housing Metal parts e g tools Electronic data carriers Unauthorized access Implants susceptible to electromagnetic effects Sign requiring mandatory hear ing protection Non ionizing radiation Further symbols 2 Safety 40 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 41: ...r manual In case of emergency 1 Before working with the system familiarize yourself with the location and functionality of the emergency switches installed 2 Report all accidents resulting in personal injury immediately to the appropriate authorities 3 Observe the established emergency plans e g emergency plan in case of coolant accidents emergency plan for fire fighting Emergency switches The MR ...

Page 42: ... 1 Magnet Stop switch 2 Emergency Shut down switch 3 Table Stop button The Magnet Stop switch triggers a controlled magnet quench shutting down the magnetic field The MR system is not disconnected from the power There are two different versions of the Magnet Stop switch on the MR system as an individual switch or as an integral part of the alarm box The switches may also be installed in other plac...

Page 43: ...mation of droplets due to condensation during quenching Personal injury Risk of fire Do not touch the exhaust line Do not stand under the exhaust line Avoid open flames and do not smoke WARNING System indicates Magnet Stop error Hazardous conditions because the magnet cannot be quenched in case of emergency Immediately remove the patient from the magnet Restrict the access to the examination room ...

Page 44: ...tercom and on the patient table Medical emergency WARNING Medical emergency during MR measurements Risk of death to patients Terminate the measurement immediately Remove patients from the examination room for treatment unless it is certain that the medical equipment required is appropriate for use inside an MR room Do not store or operate oxygen bottles defibrillators or other auxiliary tools for ...

Page 45: ...tact with subzero liquids gases and surfaces e g pipes may lead to frostbite The eyes and mucous membranes are especially vulnerable CAUTION Improper handling of liquid helium Skin damage caused by frostbite Do not rub frostbitten skin areas 1 Remove clothing carefully from the locations involved 2 Rinse frostbitten skin with lukewarm water 3 Cover frostbitten skin with sterile bandages 4 Do not a...

Page 46: ... may be used for fire fighting Non magnetic CO2 extinguisher Self contained anti magnetic compressed air breathing apparatus or hose connection Airtight chemical protective suit 2 4 4 2 Safety 46 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 47: ...ional electric power to maintain the magnetic field Under normal operating conditions there is no helium boil off To minimize the effects of the magnetic fringe field on the environment the magnet of the MR system is equipped with active super conducting shielding The gradient system provides precise localizing slice positions For details on the gradient system please refer to the System owner man...

Page 48: ...inet includes different electronics components to operate the MR system The control cabinet includes a sequence programmable optical trigger signal output which can be made externally accessible by Siemens Service via installation of a fiber optic cable Gradient cabinet Control cabinet 3 MR system components 48 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 49: ...he use of any device and resulting consequences in connection with the optical trigger signal output The system separator contains electronics components and cooling equipment to deliver an adequate cooling power for the system If a special cooling system chiller is installed the system separator is not necessary RF coils The description handling and quality measurements for RF coils are included ...

Page 50: ... DVD drive An interface e g USB connection for a paper printer is also available The burn and read process is started via the software See Software operator manual Only CD Rs DVD Rs Recordable labeled Medical Grade and having a gold colored layer are suitable for documenting data for medical purposes Siemens Service will provide you with CD Rs DVD Rs Please take into account the handling care stor...

Page 51: ...ginal Siemens keyboard This keyboard is a modified Windows keyboard where the numeric keys have been replaced with symbol keys The symbol keys are used to access frequently used functions The F4 F5 F6 F7 and F8 function keys enable you to access the individual task cards The F1 function key lets you access the Online help Function Original Siemens key Windows key Increase decrease image brightness...

Page 52: ... Browser Del Copy to film sheet Enter Highlight 3 Send to node 1 If the computer system is connected to a clinic wide processor network HIS RIS use the Examination task card to send images to other network addresses via node 1 Mouse The system is equipped with a wheel mouse 3 2 5 3 MR system components 52 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 53: ...ation documentation and post processing of previously measured images while acquiring images at the syngo Acquisition Workplace It accesses the database of the host processor It is not possible to perform measurements at the syngo MR Workplace It is not connected to the MR scanner or the image reconstruction system System control Description The system control is used to operate the system and the...

Page 54: ...ogwheel and several additional buttons 1 Control unit for positioning the table 2 Control unit for menu navigation and for adjusting settings for patient 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 units 3 MR system components 54 MR System Operator Manual Print ...

Page 55: ...tionally comprise a Table Stop button The Dot Day Optimized Throughput display provides status information as well as several tools The display is located above the magnet bore opening at the front of the magnet cover Optionally at the back of the magnet a second display can be installed for the additional control unit The display shows several pieces of information Information concerning patient ...

Page 56: ...iew Displays the current table position as well as the patient orientation Physio data Displays the physiological data of the patient Table lock Table unlock Activates Deactivates the table lock function for inter ventional examination toggle icon Start Starts a prepared measurement during the measure ments the display will be shut off Info Displays further information e g undocking of the dockabl...

Page 57: ...s 2 Press the jogwheel to confirm the selection 3 If necessary adjust your settings by turning and pressing the jogwheel Patient table Description The patient table is used for positioning the patient and the coils The table comprises several sockets and connections 3 3 2 3 4 3 4 1 MR system components 3 MAGNETOM Skyrafit syngo MR E11 57 Print No M6 04401 621 02 02 02 ...

Page 58: ... magnet bore When moved completely out of the magnet the tabletop may be moved vertically as well The coil sockets are located at the head end and the foot end of the patient table For more information concerning the occupation of the coil sockets see Coil operator manual Coil sockets 3 MR system components 58 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 59: ...paper roll disposable you need to detach the headphone holder If you remove the stick on the paper roll you can pull out the right mounting bracket Then you can replace the roll and let the bracket again lock into place Operating the patient table The patient table can be controlled via the movement buttons and the jogwheel on the larger control unit Page 54 Control units Please note that this sec...

Page 60: ... in the horizontal direction the tab letop can be returned into the position of the last measurement Default Position The center of the Head Neck 20 is in the magnet isocenter Center Position The body region to be measured is in the magnet isocenter Relative Position Distance between the slice marked with the light localizer and the magnet isocenter For interventional examinations a table lock fun...

Page 61: ...ent e g to the Home Position stops the table immediately Turning the jogwheel in this case adjusts the speed and movement direction according to the jogwheel position Press the corresponding button to move the patient table into the required position The Table Up Inward and the Table Down Outward button can be pressed in two stages for horizontal movements Pressing the button softly moves the tabl...

Page 62: ...re The fastest method for moving the tabletop out of the magnet bore is to press the Home Position button Select this method whenever the power supply and or motorized drive are intact 1 Press the Home Position button The tabletop moves completely out of the magnet 2 Rescue the patient In case of power failure and or defective motorized drive pull the tabletop manually out of the magnet bore Stopp...

Page 63: ...measurement is terminated and the table loses the referenced position 2 Turn up the pull out handle and pull the tabletop out of the magnet 3 Rescue the patient The error regarding the power supply and or the motorized drive has been removed 1 Press the Emergency release back into its original position while shifting the tabletop slightly in any direction until it audibly locks into position 2 To ...

Page 64: ...etely removed from the magnet system This enables the transport of immobile patients The configuration of the dockable patient table is similar to the standard table This section only mentions the differences For the standard patient table please refer to Page 57 Description 1 Side rails 2 Docking station 3 Lateral pedal 3 5 3 5 1 3 MR system components 64 MR System Operator Manual Print No M6 044...

Page 65: ...e label at the foot end of the dockable table indicates that your table can only be operated on the 1 5 T system or the 3 T system respectively Operating the dockable patient table To avoid injuries during vertical table movement a safety shut down is available at the carriage of the dockable patient table and a safety switch is available at the docking station If the table is docked table movemen...

Page 66: ...r better directional stability and easier steering 1 Guiding wheel is lifted deactivated 2 Guiding wheel is lowered activated 3 Table is braked 1 For turning the table in place navigating in curves and moving the table straight ahead set the lateral pedal to the middle position 2 to lower activate the guiding wheel 2 For moving the patient table laterally lift the lateral pedal position 1 to lift ...

Page 67: ...ke sure not to move it to the back of the magnet Guiding wheel is activated Side rails are lowered CAUTION Points 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 of clothing do not get caught between the table and the system 1 Use the table s momentum to save strength and move the table into the docking stat...

Page 68: ...to the reference position Do not undock the table again before the tabletop is in the reference position Table cannot be docked to the system Position the table again so that the docking nose is positioned correctly and completely in the docking station Try again to press the right pedal Pedal cannot be pressed Check that the tabletop is completely in Home position and the emergency undocking hand...

Page 69: ... pedal to the middle position to deactivate the brake and make sure that the tabletop is completely in Home position If undocking via the pedals does not work the table can be undocked by using the emergency undocking handle at the foot end between the pedals WARNING Wrong tabletop position for emergency undocking Uncontrolled table movement tabletop crashes Use the emergency undocking handle only...

Page 70: ...t the entrance to the magnet bore All laser relevant locations at the MR system are identified by warning labels affixed directly next to the laser opening For some examinations a manual alignment of the laser light localizer to the coil is not necessary If all relevant data e g patient orientation body height examination are registered auto positioning is indicated on the Dot display at the magne...

Page 71: ...n on the control unit The laser light localizer is switched on A crosshair is visible directly below the area 2 Move the tabletop so that the crosshairs point precisely to the region of interest The slice for measurement is marked The display shows the relative tabletop position of the marked slice 3 If the laser is correctly positioned press the Center Position button for one second to move the t...

Page 72: ...agnet Quench The alarm box is installed near the syngo Acquisition Workplace Checks WARNING MR system malfunction Hazardous conditions for patients Note the sounding alarm and signal Do not perform MR examinations Notify Siemens Service 3 7 3 7 1 3 7 2 3 MR system components 72 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 73: ...fy that the POWER LED is green 4 If the POWER LED is not on Check the power supply of the MR system The POWER LED is off even though the power supply is functioning properly Notify Siemens Service After a power failure the battery powers the circuit of the magnet emergency shutdown for another 14 days During this time the magnet can still be quenched i e the magnetic field can be shut down by pres...

Page 74: ... managed from the intercom Optionally music or automatic voice outputs can be played in the examination room via the loudspeaker or the headphones The operating unit of the intercom is located at the syngo Acquisition Workplace 1 Stop button 2 Talk button 3 Reset Patient Alert button 4 Listen button 5 Physio Signal button 6 Audio connection 7 Reset Stop button 3 8 3 8 1 3 MR system components 74 M...

Page 75: ...ust be monitored by a person present in the examination room Operating the intercom The intercom operation is partially software based The Patient Comfort Configuration dialog box allows for several settings for example Active Noise Cancellation to reduce background noise from the system can be activated For detailed information regarding the operation of the software see Software operator manual ...

Page 76: ...the Patient Comfort Configuration dialog box to the desired level in the examination room To play music in the examination room an audio device can be connected at the intercom 1 Connect a suitable cable to the audio device and to the connection at the intercom 2 Adjust the final volume to the desired level using the control unit at the magnet or the Patient Comfort Configuration dialog box 3 Star...

Page 77: ...room allows uninterrupted patient care and quick intervention in case of 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 For this option the tray with trackball and keys is not available Operating the In Room syngo Acquisition Workplace The I...

Page 78: ...m syngo Acquisition Workplace for diagnostic purposes 1 Keys 2 Trackball 3 Handle The keys have the same functions as those of the mouse 1 Roll the trackball to move the pointer on the program interface 2 Press the keys to execute a specific application The monitor height and tilt can be adjusted for easy and comfortable operation Operating the trackball and the keys Adjusting the monitor tilt 3 M...

Page 79: ...n the examination room 1 Hose 2 Hose connector 3 Pushbutton unit 4 Footswitch Start Stop For additional support labels can be affixed to the footswitches Start label Stop label MR measurements with the footswitch are only possible for protocols that were configured for manual start up This is the case e g for protocols with MR measurements after administering contrast medium Adjusting the monitor ...

Page 80: ...s an alternative you can start and end the measurement via the In Room syngo Acq WP or the syngo Acq WP 4 Press the Stop footswitch to end the measurement Other components and accessories Gradient supervision To prevent damage to the MR system by a malfunction of the gradient system a specially designed supervision is installed at your MAGNETOM system This supervision monitors that cables connecti...

Page 81: ...mage the system will be switched to Standby within 1 minute Call Siemens Service immediately 1 Immediately move the patient out of the magnet bore by pressing the Home Position button Within the next 60 seconds the system will be switched to Standby automatically Then the patient table motors can not be operated any longer 2 Call Siemens Service Acting in case of an alarm MR system components 3 MA...

Page 82: ...unctional 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 the operation of your MR scanner is still possible Acting in case of a supervision malfunction 3 MR system components 82 MR System Operator Manual Print No M6 04401 621...

Page 83: ...nt s physiological signal This signal is usually defined based on the time period during which organ movement is as low as possible The trigger delay is for example set to the end of the systole for certain cardiac examinations so that the measurement is running during the akinetic diastole For respiratory triggering during abdominal examinations it is recommended to start the measurement at the e...

Page 84: ...n selected for the measurement Retrospective gating can be used for ECG pulse or external trigger signal curves Physiological Measurement Unit PMU Description The Physiological Measurement Unit PMU lets you control MR measurement 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...

Page 85: ...surement sequences The unit does not replace a patient monitoring system The wireless PERU simultaneously acquires three ECG channels as well as the respiratory channel of the patient 1 ECG leads with clips 2 Plug for respiration cushion 3 Transmitter unit 4 Control LEDs The ECG electrodes and respiratory cushion are connected to the PERU To prevent skin irritations the PERU has to be located in t...

Page 86: ...tory belt The PPU acquires the patient s peripheral pulse It consists of a transmitter unit a fiber optic sensor and a removable finger adapter available in different sizes 1 Finger adapter 2 Fiber optic cable 3 Transmitter unit 4 Control LEDs Wireless pulse sensor PPU 4 Physiological imaging 86 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 87: ... cover approximately 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 the charging station Page 88 Control LEDs Use only the charger included with delivery Charging the units with non Siemens equipment may destroy the PERU and PPU If proper charging of the accumulators is not possible anymore please contact Sieme...

Page 88: ... regular as the green LEDs Transmit function deactivated unit is positioned outside the static mag netic field no electrode application fault detected Red LED is off Transmit function activated unit is positioned on the patient table in the static magnetic field no electrode application fault detected Red LED flashes rapidly PERU electrode fault one or more ECG electrodes are not applied cor rectl...

Page 89: ...Monitoring vital parameters via the Dot display Anomalies of the vital parameters are not recognized or recognized too late Never use the Dot display to monitor the vital parameters of a patient Use only suitable patient monitoring systems for monitoring vital parameters 1 Ask the patient to lie still during the measurement Physiological Display 4 2 2 Informing the patient Physiological imaging 4 ...

Page 90: ...Home position CAUTION Hot ECG cables Patient burns Place absorbent natural material between the ECG cables leads of the PERU and the patient s skin 1 Position the patient on the patient table with the head toward the magnet bore 2 Position the PERU in the application cushion Especially with respect to whole body examinations it should be noted that artifacts homogeneity distortions may occur in th...

Page 91: ...G triggering is a method for measuring heart sequences including dynamic studies It is also suitable for studies where pulse flow causes artifacts Provided that special sequences are in use ECG triggering can 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 difference betwe...

Page 92: ...algorithm VCG activated default trigger method If Auto is used the signal characteristics can be relearned by selecting 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 electrodes are used the recommended ones are available through the Accessories catalog Performing...

Page 93: ...ent select locations with minimal muscle and fat tissue for attaching the electrodes 3 In case of hairy skin shave the points where you intend to attach the electrodes Shave the patient outside the examination room to prevent accidents 4 Thoroughly clean the patient s skin at the locations involved However do not use solutions containing alcohol 5 Then dry the skin with a paper towel 6 Use a suita...

Page 94: ...lay Information about the ECG signal quality is also available at the display 2 In case you are using the Body 18 coil position it over the heart Connect the coil and secure it with the belts See Coil operator manual The display shows the following message Initial Learningphase active Don t move table 3 Wait at least 10 heart beats learning phase for triggering before you move the patient table in...

Page 95: ...uitable finger adapter is attached 1 Ensure that the cable is not bent 2 Attach the pulse sensor to a finger or on a toe 3 Ensure 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 manual 4 4 4 4 1 4...

Page 96: ...a the respiratory belt Retrospective gating cannot be applied Performing 1 Ask the patient to lie still during the measurement 2 Inform the patient that the knocking sounds during the measurement are caused by switching the gradients on and off The PERU may also vibrate slightly The plug of the respiration cushion is NOT connected CAUTION Incorrect MR image due to disconnected respiratory cushion ...

Page 97: ...ERU Page 89 Preparing the measurement 2 For respiratory triggering alone position the electrode leads loosely on the respiratory belt 3 Connect the plug for the respiratory cushion to the appropriate socket on the PERU 4 Ensure that the pressure hose of the respiration cushion is not crimped or bent Make sure the respiration cushion is not unduly compressed With quiet patients a periodic signal wi...

Page 98: ...nt sequence is triggered by the rising edge of the external signal The external trigger signal can be supplied via the connections in the magnet cover Performing 1 Connect the source of the external trigger signal to the cinch jack trigger input magnet cover left 2 Perform external triggering See Software operator manual 4 6 2 4 Physiological imaging 98 MR System Operator Manual Print No M6 04401 ...

Page 99: ...mount of liquid for example phantom fluid spilled onto patient 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 MR system SYSTEM OFF Notify Siemens Service 1 Check the LEDs on the alarm box 2 Check if all warning symbols and signs are present inside and outside the exa...

Page 100: ...sidue has been cleaned off the patient table 7 Check the functionality of the squeeze bulb The patient must be able to trigger the patient alert using the squeeze bulb Starting up and shutting down the MR system There are three operating modes System On full operation All MR system components are switched on Examinations may be performed System Off system is not working All MR system components ex...

Page 101: ...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 the patient table connecting coils at the MR system while starting up the system Prior to starting the system the patient table should be in the Home P...

Page 102: ...lace and the syngo MR Workplace the system requires approx 18 minutes to warm up and get ready for acquisition 1 If a dialog window is displayed at the syngo Acquisition Workplace informing you that the helium fill level is too low Close the window and notify Siemens Service or have the magnet refilled 2 Check all Table Stop buttons at the intercom and at the patient table Ensure that these button...

Page 103: ...r to shutting down the system the patient table should be in the Home Position To avoid possible data losses at the syngo MR Workplace shut down the syngo MR Workplace before the syngo Acquisition Workplace If the user is logged on the system must be shut down using System Control or System End Session Otherwise data are lost All data have been saved at the syngo Acquisition Workplace as well as a...

Page 104: ...hoose 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 message that the system can be switched off 1 Press SYSTEM OFF 2 Turn the keyswitch to the left Shutting down the syngo MR Workplace In the System On mode you can only shut down the syngo MR Workplace 1 Save your data 2 At the syngo MR...

Page 105: ...ontrol to open the System Manager 2 To start Standby On the Meas Recon tab click the Standby button The System Manager Scanner StandBy dialog box opens 3 To end Standby At the alarm box press the SYSTEM ON button Preparing the MR system To use the holder for infusion bottles you can position the rod on the right side of the patient table head end If not in use you can clamp the holder in the affix...

Page 106: ...Jogwheel for settings 3 Tunnel ventilation button 4 Loudspeaker button 5 Tunnel lighting button 1 Click the corresponding button and use the jogwheel to increase or decrease the setting 2 Confirm your setting by pressing the jogwheel The setting of the music volume has no effect on the voice volume of patient announcements Preparing the patient To use the holder for infusion bottles you can positi...

Page 107: ...MR systems For example devices approved for low and medium field systems 0 2 1 5T must not be used on a 3T system Informing the patient 1 Please note the safety instructions 2 Inform the patient about the possible effects of MR examinations and the risks associated with the magnetic field 3 Show the patient how to activate the patient alert by pressing the squeeze bulb 4 Ensure that the patient ho...

Page 108: ...s national health organizations have published guidelines and limit values In compliance with country specific approval guidelines they are the basis for the monitoring functions integrated in the MR system with respect to stimulation and warming effects The limits against too intense stimulation and warming effects for example dB dt limits and SAR limits are based on current scientific literature...

Page 109: ...k or medicated patients Do not examine patients unable to communicate potential overheating effects e g small children seriously ill paralyzed unconscious sedated or handicapped patients Ensure that patients wear light clothing e g light pajamas or nightgown Remove all additional insulation e g blankets which could interfere with heat dissipation Carefully observe the patient and advise the patien...

Page 110: ...Normal Operating Mode to the First Level Controlled Operating Mode the user must explicitly select and confirm the change The request appears in the dialog window of the syngo Acquisition Workplace In the First Level Controlled Operating Mode medical supervision is mandatory Dialog window SAR Monitor Exposure to low frequency electromagnetic fields During the measurement patients are exposed to an...

Page 111: ...ation monitor checks whether the stimulation limits may be exceeded If so the measurement cannot be started To perform the examination the parameters of the measurement sequence must be adjusted accordingly Online monitoring If the stimulation limit is exceeded while a measurement is in progress the active measurement is aborted The MR system can be operated in two operating modes which differ wit...

Page 112: ... system The B1 rms value root mean square value of the MR relevant component of B1 which is indicated by the is displayed at the syngo Acquisition Workplace for each sequence and may serve as an indication of the RF magnetic field intensity This can be used to assess the risk of scanning a patient with an active or passive implant The energy absorbed in the course of the MR measurement warms the t...

Page 113: ...lues quantities are always calculated based on the worst case assumption This ensures that the specific SAR limit is maintained Depending on the medical question different coils are used for the RF transmission for example head extremity or body coil The different coils lead to different RF exposure situations for the patient Therefore different SAR quantities and corresponding limits have been es...

Page 114: ... the syngo Acquisition Workplace SAR Limit s Exceeded To ensure correct calculation of the SAR values the weight of the patient must be entered during registration This dialog window includes suggested changes to the examination parameters which allow the examination to continue In addition a button in the dialog window may be used to change the operating mode In the First Level Controlled Operati...

Page 115: ...erspiration accompanied by an increase in pulse rate Patients with reduced thermoregulatory capability and higher sensitivity toward increases in body temperature e g patients with fevers or cardiac decompression patients with perspiratory impairments or pregnant women may experience additional effects Display of SAR values The current SAR values encoded according to the body regions of interest c...

Page 116: ...The measurement is stopped The display is activated 5 MR system operation 116 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 117: ...two months 2 Prior to cleaning switch off the LCD monitor video display and disconnect the main power plug But if the monitor display is under hot running conditions please wait till the monitor display is chilled this can take up to one hour 3 Clean the monitor video display using a microfiber cloth 4 If the LCD monitor video display cannot be effectively cleaned with the microfiber cloth use win...

Page 118: ...ly wipe the plugs and connectors with the cloth Do not touch the contacts Cleaning the patient table and the straps 1 Clean the patient table using a liquid household agent 2 Wash the straps of the patient table at a temperature of 60 C 3 Use commercial disinfecting materials However do not use solutions with alcohol or acetone Cleaning and disinfecting the receptors 1 Do not use cleaners or disin...

Page 119: ... with commercial disinfecting materials However do not use solutions with alcohol or acetone Follow manufacturer s instructions Siemens does not test alcohol containing phenol alkaline and alkaline based disinfectants for harmful effects on surfaces Avoid disinfecting system components with these materials Care and cleaning of floors Do not use the following cleaning or care products Sprays Silico...

Page 120: ...uestions about returning and disposing the MR system and or its components and accessories 2 Observe national regulations Packaging Siemens AG is obligated to accept the return of packaging material 1 Contact Siemens Service regarding questions with respect to the return as well as subsequent disposal of packaging material 2 Observe national regulations Batteries and accumulators Siemens AG is obl...

Page 121: ...emens Service with respect to questions regarding the return and disposal of batteries and accumulators 2 Observe national regulations Maintenance 6 MAGNETOM Skyrafit syngo MR E11 121 Print No M6 04401 621 02 02 02 ...

Page 122: ...6 Maintenance 122 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 123: ... the corresponding legal manufacturer and if applicable the authorized representative Product and CE Legal manufacturer Respiration cush ion respiratory belt Pi Products GmbH Heinrich Hertz Straße 8a 92224 Amberg Germany www pi products de Application cush ion for PMU Polyform GmbH Co KG Kunststofftechnik Braasstraße 15 DE 31737 Rinteln Germany www polyform de Patient table TRUMPF Medizin Systeme ...

Page 124: ... complies with Industry Canada licence exempt RSS standard s and part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Le présent appareil est conforme aux CNR d Industrie Canada applicables aux appareils radio exemp...

Page 125: ...5 Information service 55 Dockable patient table Docking 67 Moving 66 Operation 65 Undocking 66 Dockable patient table Description 64 Docking Dockable patient table 67 Documentation Data recording Overview 50 Dot display Operation 57 E ECG triggering Description 91 Performing 92 Electromagnetic fields Description 16 Safety instructions 16 Electronics cabinets Description 47 Emergency Emergency swit...

Page 126: ... the system 101 Starting ending Standby 105 Switching on off 100 N Nerve stimulation Low frequency fields 111 Noise development Safety information 31 O Online monitoring Low frequency fields 111 SAR monitoring 113 Operating consoles In Room syngo Acq WP 76 syngo Acquisition Workplace 49 syngo MR WP 53 Operating mode First Level Controlled Operating Mode 109 low frequency fields 111 Normal Operatin...

Page 127: ...and symbols Warning and prohibition signs 38 Squeeze bulb Connection 106 Standby Starting ending Standby 105 Static magnetic field Device malfunctions 20 Safety instructions 18 Super conducting magnet Description 47 syngo Acquisition Workplace Description 49 Host processor 50 Keyboard 51 Monitor 50 Mouse 52 syngo MR WP Description 53 Shutting down 104 Starting up 102 System control Control units 5...

Page 128: ...This page has been intentionally left blank 128 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 129: ...This page has been intentionally left blank MAGNETOM Skyrafit syngo MR E11 129 Print No M6 04401 621 02 02 02 ...

Page 130: ...This page has been intentionally left blank 130 MR System Operator Manual Print No M6 04401 621 02 02 02 ...

Page 131: ...nd the related Declaration of Conformity Please note For products that are not legally manufactured by Siemens but distributed please refer to the Appendix of this manual Global Business Unit Siemens AG Medical Solutions Magnetic Resonance Henkestr 127 DE 91052 Erlangen Germany Phone 49913184 0 www siemens com healthcare Global Siemens Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Ge...

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