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Safety information for the system owner

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A.1-21

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syngo MR D13

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A.1

Repairs and modifications  

A.1

All work, additions, and modifications to the MR system or to 
the installation site must be checked by Siemens in advance to 
ensure their compatibility with the MR system's functionality.

A.1

Modifications or additions to the product must comply with 
legal regulations.

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The person performing the work must provide a certificate 
describing the nature and extent of work performed. This certif-
icate must include information about changes to the nominal 
data or work area, along with the date, name of company, and 
signature.

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Maintenance at regular intervals 

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In the interest of the safety of patients, operating personnel, 
and third parties, it is strongly recommended that only autho-
rized personnel perform the maintenance procedures pre-
scribed by Siemens. System checks should be conducted more 
frequently if the system is operated under extreme conditions. 
For further information, see (

➡

System Owner Manual: Mainte-

nance Plan).

A.1

◆

Please inform Siemens Service if a maintenance contract 
does not exist.

Upon request, Siemens Service will provide technical docu-
ments for the MR system (e.g. circuit diagrams, spare parts 
lists, descriptions, calibration instructions). However, this 
does not constitute authorization for repairs.

Содержание MAGNETOM Skyra

Страница 1: ...hts reserved Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany Contact Information Siemens AG Healthcare Sector Magnetic Resonance Henkestrasse 127 91052 Erlangen Germany Telephone 49 9131 84 0 www siemens com healthcare Print No M7 03002 629 06 03 24 AG 11 12 ...

Страница 2: ......

Страница 3: ...t 3 Guidance and manufacturer s declaration EMC 4 Technical data 5 Location of labels 6 Maintenance Plan 7 Disposal 8 Correspondence with authorities 9 Certificates 10 Software licenses and warranty 11 Upgrades 12 Room layout 13 Modification level of components 14 Declaration of conformity 15 ...

Страница 4: ......

Страница 5: ...ant documents in the System Owner Manual on delivery of your system The further updating of the Manual now lies in your hands We therefore recommend that you designate an employee right at the start up of your new system who will be responsible for continuously updating the System Owner Manual and who immediately has it at hand as required We wish you much success with your Siemens system Siemens ...

Страница 6: ... and manufacturer s declaration EMC Guidance and manufacturer s declaration regarding electromagnetic compatibility 5 Technical data Technical data Upgrades and additions 6 Location of labels Location of labels 7 Preventive maintenance Maintenance plan Maintenance contract Maintenance certificates 8 Disposal Instructions for disposal of problematic substances 9 Correspondence with authorities File...

Страница 7: ...uding hardware and software level Revision levels after component replacements 15 Declaration of conformity Series certification of the entire system with all possible options Your Siemens service technician will find the appropriate conformity declaration under the following address https intranet medical siemens com Sales Intranet International Divisions Magnetic Resonance CrossProductInformatio...

Страница 8: ...Siemens AG Healthcare Sector 11 12 Introduction Page 4 of 4 ...

Страница 9: ...H MAGNETOM Family Safety Information System Owner Manual MR 2010 2012 MR 04009 623 13 01 02 n a English English 06 2012 n a n a syngo MR D13 MAGNETOM Family 0 0 System Owner Manual Safety Information 0 0 syngo MR D13 0 0 www siemens com healthcare ...

Страница 10: ...dance with the provisions of regulation 93 42 EEC of June 14 1993 for medical products 0 0 The CE marking applies only to medico technical products medical products introduced in connection with the above mentioned comprehensive EC regulation 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ...

Страница 11: ... plan A 1 7 Fire fighting A 1 9 Employee qualifications information A 1 10 Pre screening MR workers and patients A 1 14 Examination room and ambient conditions A 1 15 Air conditioning A 1 15 Magnetic fringe field and controlled access area A 1 16 Equipment room MAGNETOM Verio A 1 16 Signs and symbols A 1 17 Maintenance repair A 1 20 Repairs and modifications A 1 21 Maintenance at regular intervals...

Страница 12: ...0 0 Safety instructions A 2 0 0 MAGNETOM Family Safety Information0 0 ...

Страница 13: ... in the examination room A 1 Common causes of acci dents A 1 Of particular importance is the obligation to inform employees and contractors Operating personnel as well as personnel who are not regulars in the examination room e g cleaning person nel rescue personnel must be informed about the special con ditions in the examination room Magnetizable devices e g floor polishers vacuum cleaners wheel...

Страница 14: ...s are in effect in Germany A 1 Medical Devices Act MPG Electromagnetic Device Compatibility Act EMVG Medical Device Operator Regulations MPBetreibV Accident Prevention Regulations UVV If required the RF source must be registered with local authori ties in accordance with national EMC guidelines A 1 Pressure Equipment Direc tive A 1 The super conductive magnet is classified as pressure equip ment N...

Страница 15: ...not more than 3 0 T For China only If the static magnetic field is higher than 2 0 T the system is operated in the first level mode A 1 The limits of exposure of MR workers to static and time varying magnetic fields may be regulated by local laws Special precau tions are necessary for pregnant MR workers although no epi demiological evidence of any negative health effects currently exists local la...

Страница 16: ...e direction and respon sibility of the system owner A 1 To generally test the proper operation of peripheral equipment a compatibility protocol is available Manufacturers of periph eral equipment should use this Siemens compatibility protocol to test the functionality of its equipment System Owner Manual Compatibility data sheet A 1 Installation A 1 Ensure that the multiple socket of the computers...

Страница 17: ...tablished and well marked Escape routes must not be obstructed A 1 Establish measures on how to open the door in case of patient is not accessible e g the handle to the door became defective Ensure that you have tools available to break the door open in case of an emergency Ensure that a window in the examination room can be used as an escape route in the case of an emergency A 1 A 1 WARNING A 1 R...

Страница 18: ... A 1 As special precautionary measures a program for medical supervision as well as a plan for using emergency equipment outside the magnet s influence must be in place for patients with a higher than normal risk factor such as A 1 Patients susceptible to cardiovascular collapse Patients who are likely to develop seizures Patients who are at an increased risk of heart attacks or other cardiac prob...

Страница 19: ...aramedics and fire men Quench A 1 During a quench the super conductivity of the magnet is sus pended The energy of the magnetic field is converted into heat The magnet field strength falls off to 20 mT within approx 20 seconds The liquid helium coolant boils off during this pro cess and is released to the outside via the exhaust vent line The escape of gaseous helium via the exhaust line is rather...

Страница 20: ... in the upper area of the room Rise in pressure in the examination room Hypothermia and risk of suffocation e g in case of large leaks A 1 Due to such hazardous conditions as acute hypothermia and suffocation rescue attempts must be performed by at least two persons Persons not directly involved in the rescue should leave the examination room as well as adjacent rooms A filter gas mask without its...

Страница 21: ...with the local fire department and emergency procedures should be established It is in the operator s responsibility to take the necessary initiatives A 1 Mandatory reporting in case of fire A 1 Prior to initial start up of the MR system ensure that the fire department is familiar with MR imaging systems as well as structural on site conditions Inform the fire department about the contents of the ...

Страница 22: ...y and in a way that minimizes their exposure to the elec tromagnetic field In addition the MR system may only be used as intended A 1 The system includes a keyswitch to prevent unauthorized switch on A 1 Informing MR workers A 1 MR personnel must read and understand the operator manual paying special attention to the safety chapter before working with the MR system The safety hints regarding the m...

Страница 23: ... electrically conductive implants Possible effects on pregnant MR workers local laws may apply Safety aspects of the MR conditional tools and accessories used with respect to the static magnetic field B0 Hearing protection Wearing hearing protection when working in the con trolled access area during scanning if the sound level exceeds 99 dB A Required training to correctly apply the hearing pro te...

Страница 24: ...level controlled operating mode on patients and MR work ers A 1 A 1 WARNING A 1 MR workers and all personnel who have access to the MR system are not sufficiently informed Personal injury property damage Ensure that all personnel incl cleaning crews rescue personnel etc are regularly informed about the potential risks inherent in MR systems as well as the rel evant safety information for example r...

Страница 25: ... Combinations with other devices The physician must complete a special training course on inter preting images A 1 A 1 A 1 CAUTION A 1 Untrained or uninformed personnel Injury of persons Damage to measurement phantoms Fire hazard due to lens effect Train all personnel who have access to the MR system incl cleaning crews rescue personnel etc Inform these people with respect to the hazards and prote...

Страница 26: ... at risk due to their professional activities medical history and medical state as well as the influence of the MR equipment such as A 1 Patients and MR workers with implants or with permanent make up with imbedded metal fragments from military activi ties who are pregnant Patients with typical contraindications Operator Manual MR system Contraindications with a higher than normal likelihood of ne...

Страница 27: ... 0100 710 and or national laws A 1 A quench can be released with the Magnet Stop switch This switch is installed on site as well A 1 Air conditioning A 1 An air conditioning system must be used to ensure the required environmental conditions Technical data A 1 A 1 The functions of the air conditioning or the temperature and rel ative humidity of the examination room must be checked at reg ular int...

Страница 28: ...agnet For this reason the required safety distances must be observed For details please refer to the MR compatibility datasheet System Owner Manual MR compatibility datasheet A 1 Equipment room MAGNETOM Verio A 1 A 1 A 1 CAUTION A 1 Discharge of 120 C hot air from the back of the amplifier Risk of burns Do not position objects behind the amplifier Do not touch the back of the amplifier ...

Страница 29: ...omagnetic field the vicinity of the MR system as well as adjacent areas by using the appropriate signs A 1 A 1 A 1 WARNING A 1 Missing hazard labels Personal injury property damage Attach the required warning and prohibition signs and observe national guidelines Mark critical system areas with warning and prohibition symbols Ensure that warning and prohibition signs are legible and clearly visible...

Страница 30: ... to the examination room Depending on the system the field strength is also shown for example 1 5 T or 3 T A 1 A 1 Protective class symbols A 1 Protection class B represents protection against electrical shock with special emphasis on leakage currents A 1 The protective class symbol Type B BF for application parts is located e g at the patient table the components for the physi ological measuremen...

Страница 31: ... The red color inside the glass tube activated shock indicator signals that the respective component was not handled with the required care A 1 However an activated shock indicator does not necessarily indi cate damage to the respective component When the shock indi cator has been activated the respective component must undergo functionality testing prior to actual use A 1 RF coils are subject to ...

Страница 32: ...e electrical wiring in the room does not meet the require ments of VDE regulation 0100 710 or applicable national laws Siemens is not responsible for potential damage in the event non authorized personnel refilling the magnet with helium A 1 Assembling and modifications during the actual service life require evaluation to the requirements of IEC 60601 1 A 1 A 1 A 1 WARNING A 1 Unauthorized work on...

Страница 33: ...or work area along with the date name of company and signature A 1 A 1 Maintenance at regular intervals A 1 In the interest of the safety of patients operating personnel and third parties it is strongly recommended that only autho rized personnel perform the maintenance procedures pre scribed by Siemens System checks should be conducted more frequently if the system is operated under extreme condi...

Страница 34: ...hanges in the environment at the output of the exhaust line e g window installed retrospectively inlet and outlet of air conditioning units new buildings or temporarily installed containers Changes to the air conditioning unit or venting system e g by adding air inlets and outlets in neighboring rooms Installation of additional MR systems e g prohibited use of the same exhaust line for several MR ...

Страница 35: ...lium perform the necessary tasks carefully and accurately observing all regulations Wear protective clothing to prevent frostbite A 1 Helium related risks A 1 Liquid helium presents the following properties that among other things may result in hazardous conditions when not han dled professionally A 1 Extremely cold causes frostbites when it comes in touch with skin Oxygen in ambient air is displa...

Страница 36: ...1 WARNING A 1 Improper storing of coolant containers and escaping gas eous helium during refill activities Injury to persons danger of suffocation frostbite Ensure that the rooms are ventilated via an air condi tioning system This includes refilling with helium as well Ensure that escape routes have been determined are identified as such and are not obstructed e g by cool ant containers Ensure tha...

Страница 37: ...A 1 ...

Страница 38: ... Siemens Healthcare Headquarters Siemens AG Healthcare Sector Henkestrasse 127 91052 Erlangen Germany Phone 49 9131 84 0 www siemens com healthcare Global Business Unit Siemens AG Medical Solutions Magnetic Resonance Henkestr 127 DE 91052 Erlangen Germany Phone 49 9131 84 0 www siemens com healthcare Legal Manufacturer Siemens AG Wittelsbacherplatz 2 DE 80333 Muenchen Germany ...

Страница 39: ...MR MAGNETOM System Owner Manual MR compatibility data sheet Skyra ...

Страница 40: ...ensure that use of the non Siemens MR product does not conflict with the functions of the MR system and vice versa According to IEC 60601 2 33 the manufacturer of the MR system is obligated to provide a data sheet covering technical information of the MR system to enable items to be assessed for MR compatibility A display of the contours of equal field strength of the MR system begins on page 5 of...

Страница 41: ...sed in the system The tests are not used to evaluate the effects of the non Siemens MR product on the image quality of the MR system Successful tests with the below protocols do not guarantee MR compatibility of non Siemens MR products Directory Protocol head library T2 t2_tse_tra_320_p2 head library SPACE t2_spc_sag_p2_iso abdomen library T1 t1_fl2d_fs_tra_mbh_320 abdomen library T2 t2_tse_tra_fs...

Страница 42: ... z axes of the magnet Magnetic flux density Minimum distances x y radial z axial Examples Devices affected 3 mT x 2 1 m z 3 2 m Small motors watches cameras credit cards magnetic media 1 mT x 2 3 m z 4 0 m Oscilloscopes computers disk drives shielded color monitors 0 5 mT x 2 60 m z 4 60 m B W monitors magnetic media cardiac pacemakers insulin pumps 0 2 mT x 3 1 m z 5 7 m Siemens CT systems 0 1 mT...

Страница 43: ...y influence the form of the stray field The plots represent three orthogonal planes through the isocenter to illustrate maximum spatial extent of iso magnetic contours Each plot contains the iso magnetic contours with values of 0 5 mT 1 mT 3 mT 5 mT 10 mT 20 mT 40 mT and 200 mT as well as a distance scale and a superimposed outline of the MR system The 0 5 mT line marks the exclusion zone of the s...

Страница 44: ...MR compatibility data sheet 6 View in the direction of the magnet axis The graphic is referenced to plane z 0 2 1 0 1 2 3 4 5 5 4 3 5 4 3 2 1 0 1 2 3 4 5 1 m T 3 m T 5 m T 1 0 m T 2 0 m T 4 0 m T 2 0 0 m T 0 5 m T Horizontal m Vertical m ...

Страница 45: ...s AG Healthcare Sector 11 12 MR compatibility data sheet Side view of the magnet 5 4 3 2 1 0 1 2 3 4 5 3 4 5 5 4 3 2 1 0 1 2 0 5 m T 1 m T 3 m T 5 m T 1 0 m T 2 0 m T 4 0 m T 2 0 0 m T Z Axis m Vertical Axis m ...

Страница 46: ...AG Healthcare Sector 11 12 MR compatibility data sheet 8 Top view of the magnet 5 4 3 2 1 0 1 2 3 4 5 3 4 5 5 4 3 2 1 0 1 2 0 5 m T 1 m T 3 m T 5 m T 1 0 m T 2 0 m T 40 m T 2 0 0 m T Horizontal Axis m Z Axis m ...

Страница 47: ...t as indicated below The plot lines each run symmetric to the axis to the isocenter of the magnet As a result the graphs can be unfolded A small overview graphic is displayed on the following pages to indicate the area mapped by the respective graph Top view Z Axis m Magnet X Axis m Side view Patient table Y Axis m Z Axis m ...

Страница 48: ...ld Bo is greatest The iso magnetic contour lines are accurate to a value better than 1 There is very lit tle influence from the environment to the scanner The graphic shows the cover in nominal position On a variety of scanners the position can vary 5 mm in the axial direction The maximum value therefore has a tolerance of 10 as small geometric deviations can cause a significant change in the valu...

Страница 49: ...11 12 MR compatibility data sheet At this location the value of the magnetic field Bo is greatest 0 0 2 0 4 0 6 0 8 1 1 2 1 4 1 6 1 8 2 2 1 8 1 6 1 4 0 1 2 1 0 8 0 6 0 4 0 2 1 5 T 1 T 0 5 T 2 T 3 T 3 4 T Z Axis m Horizontal m Top view ...

Страница 50: ... location the force on a magnetically saturated ferromagnetic object is greatest The iso magnetic contour lines are accurate to a value better than 1 There is very lit tle influence from the environment to the scanner The graphic shows the cover in nominal position On a variety of scanners the position can vary 5 mm in the axial direction The maximum value therefore has a tolerance of 10 as small ...

Страница 51: ...tion the force on a magnetically saturated ferromagnetic object is greatest 0 0 2 0 4 0 6 0 8 1 1 2 1 4 1 6 1 8 2 2 1 8 1 6 1 4 0 1 2 1 0 8 0 6 0 4 0 2 11 T m 5 T m 7 T m 10 T m 0 3 T m 0 3 T m 0 5 T m 0 5 T m 1 T m 1 T m 3 T m 3 T m 0 1 T m 0 1 T m Z Axis m Horizontal m Top view ...

Страница 52: ...tic contour lines are accurate to a value better than 1 There is very lit tle influence from the environment to the scanner The graphic shows the cover in nominal position On a variety of scanners the position can vary 5 mm in the axial direction The maximum value therefore has a tolerance of 10 as small geometric deviations can cause a significant change in the value 0 0 2 0 4 0 6 0 8 1 1 2 1 4 1...

Страница 53: ... or on a ferromagnetic material below its magnetic saturation is greatest 0 0 2 0 4 0 6 0 8 1 1 2 1 4 1 6 1 8 2 2 1 8 1 6 1 4 0 1 2 1 0 8 0 6 0 4 0 2 10 T2 m 26 5 T2 m 13 T2 m 20 T2 m 15 T2 m 0 1 T 2 m 0 3 T 2 m 0 5 T 2 m 1 T 2 m 3 T 2 m 5 T 2 m 5 T 2 m 3 T 2 m 1 T 2 m 0 5 T 2 m 0 3 T 2 m 0 1 T 2 m Z Axis m Horizontal m Top view ...

Страница 54: ...s defined by a point pattern on the surface of a virtual cylinder with a diameter of 70 cm i e max bore liner points on circles on the cylinder surface perpendicular to the cylinder axis with an azimutal step width of 10 degrees i e 36 points at the circumference and an axial step width of 4 cm The field values are calculated at max currents that can be handled by the gradient ampli fiers At each ...

Страница 55: ...lthcare Sector 11 12 MR compatibility data sheet The area shaded in grey indicates the length of the magnet B T z m 0 2 0 4 0 6 0 8 1 0 1 2 1 4 1 6 0 00 0 00 0 01 0 02 0 03 0 04 0 05 0 06 Magnet isocenter End of magnet ...

Страница 56: ...enerated by each of the three gradient units simulta neously at positions on virtual cylinders coaxial with the patient axis with diameters of 0 2 m 0 4 m and 0 6 m The virtual cylinders have the same length as the gradient coil In the cylinder axis direc tion the points have a separation of 0 02 m The area shaded in grey indicates the length of the gradient coil z m B T 0 20 m 0 40 m 0 60 m 0 0 0...

Страница 57: ...grey indicates the length of the magnet The ratio B1 z 2 B1 0 2 provides a worst case estimation of the SAR contribution to a per son who is positioned at a distance z from the isocenter The SAR contribution is relative to the SAR that is applied to a person in the center of the patient bore For example a person standing in front of the system aperture absorbs a maximum of 0 2 of the RF power whic...

Страница 58: ... design1 1 incl shim coils gradient coil RF body coil 70 cm System length cover to cover 173 cm Refill interval typical 2 2 For typical clinical use depending on sequences and operating time with running helium compressor The system needs to be serviced at regular interval Undisturbed magnet cooling for 24 hours and 7 days a week Not applicable Boil off rate typical 2 0 0 l year Max helium capacit...

Страница 59: ...oil Max applied RF field B1 24 µT Max specified B1 rms 3 6 µT Distance to isocenter where RF transmit field is reduced by 3 dB 0 15 m 10 dB 0 27 m CP Extremity coil Max applied RF field B1 47 µT Max specified B1 rms 9 µT Tx Rx 15 Channel Knee coil Max applied RF field B1 47 µT Max specified B1 rms 8 µT Tx Rx Knee 15 MR coil Max applied RF field B1 47 µT Max specified B1 rms 8 µT Tx Rx CP Head coil...

Страница 60: ...ring scan capable 1 With Tim Whole Body Suite option 2 Including Heightening Kit if necessary 3 Depending on the floor conditions Tim Dockable Table Max patient weight for vertical and horizontal table movement 250 kg 550 lbs Max scan range 140 cm optional 205 cm1 Vertical table movement Range 56 106 cm2 13 mm3 Speed 6 cm s Horizontal table move ment Max range 275 cm Max speed 20 cm s Positioning ...

Страница 61: ...can be set at 6 different levels In bore intercom including loudspeaker microphone and earphones 1 incl shim coils gradient coil RF body coil XQ gradients Performance for each axis Max amplitude 45 mT m Min rise time 225 µs Max slew rate 200 T m s Vector gradient performance vector addition of all 3 gradient axes Max eff amplitude 78 mT m Max eff slew rate 346 T m s Gradient duty cycle 100 ...

Страница 62: ...Siemens AG Healthcare Sector 11 12 MR compatibility data sheet 24 ...

Страница 63: ...MR MAGNETOM System Owner Manual Guidance and manufacturer s declaration EMC Skyra ...

Страница 64: ... without introducing intolerable electromagnetic disturbance to anything in that environment Portable and mobile RF communications equipment can affect medical electrical equip ment Note Fixed equipment or system cabeling which can not be removed by the user is not listed This cabeling is part of the system and was regarded at all EMC considerations Without this cabeling there is no complete funct...

Страница 65: ...nly in a shielded location with a minimum RF shielding effective ness and for each cable that exits the shielded location a minimum RF filter attenuation of 80 dB from 10 MHz to 20 MHz 100 dB from 20 MHz to 80 MHz and 80 dB from 80 MHz to 100 MHz The minimum at 20 MHz is 100 dB and the minimum at 80 MHz is 80 dB The MR system when installed in such a shielded location is suitable for use in all es...

Страница 66: ...r implant is completely non magnetic non electri cally conductive non RF reactive and indicates no known haz ards in all MRI environments MR conditional The device or implant may contain magnetic electrically con ductive or RF reactive components These devices are safe while being used in proximity to the MRI provided the conditions for safe operation are defined and observed Similarly MR condi ti...

Страница 67: ...tic dis charge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood con crete or ceramic tile If floors are covered with syn thetic material the relative humidity should be at least 30 Electrical fast tran sient burst IEC 61000 4 4 2 kV for power sup ply lines 1 kV for signal lines 2 kV for power sup ply lines 1 kV for signal lines Mains power quality should be that ...

Страница 68: ...ntinued opera tion during power mains interruptions it is recom mended that the equipment or system be powered from an uninterruptible power supply The MR system has a rated input current of more than 16 A per phase 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 5 s Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels char acteristi...

Страница 69: ...may occur in the vicinity of equip ment marked with the following symbol Radiated RF inter ference IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m Note 1 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Note 2 It is essential that the actual shielding effectiveness and filter attenuation of the shie...

Страница 70: ...01 1 2 Edition 2 1 2004 11 and 6 2 3 2i of IEC 60601 1 2 Edition 3 2007 03 has been used and the equipment was not tested for radiated RF immunity over the entire frequency range 80 MHz to 2 5 GHz The MR system has been tested for radiated RF immunity only at selected frequencies Tested ISM frequencies 80 MHz 2 5 GHz Modulation characteristic 1 kHz 80 AM Test level 3 V m Signal generator with ampl...

Страница 71: ... with CISPR emission requirements Rated maximum output power of the transmitter in watts W Separation distance according to the frequency of the transmitter in meters m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the r...

Страница 72: ... 12 Guidance and manufacturer s declaration EMC 10 Basic safety and essential performance As a result of the risk management process for the MR systems according to IEC 60601 1 2005 3rd Edition no essential performance was identified ...

Страница 73: ...MR MAGNETOM System Owner Manual Technical data Skyra ...

Страница 74: ...erence Shielding magnet technology Operating mode First Level controlled operating mode according to IEC 60601 2 33 Magnet parameters Operating field strength 3 Tesla Magnet type Superconductor Field stability over time 0 1 ppm h Weight with cryogens 5755 kg Magnet length 163 cm Open Bore design1 1 incl shim coils gradient coil RF body coil 70 cm System length cover to cover 173 cm ...

Страница 75: ...spherical volume x y and z direction DEV Diameter elliptical volume Homogeneity based on highly accurate 24 plane plot Guaranteed Typical 10 cm DSV 0 01 ppm 0 003 ppm 20 cm DSV 0 05 ppm 0 03 ppm 30 cm DSV 0 3 ppm 0 2 ppm 40 cm DSV 1 4 ppm 1 2 ppm 50 50 45 cm3 DEV 4 0 ppm 3 6 ppm Shimming Both passive and active shimming Passive shimming during installation Standard active shim with 3 linear channe...

Страница 76: ...ssion of external magnetic field interferences during measurement caused by moving ferromagnetic objects or nearby power lines 1 pacemaker safety limit Magnet cooling system Refill interval typical 1 Not applicable Boil off rate typical 1 0 0 l year Max helium capacity approx 1200 liters Minimum helium level 35 Cryostat Stainless steel 1 For typical clinical use depending on sequences and operatin...

Страница 77: ...zontal table movement 250 kg 550 lbs Max scan range 140 cm optional 205 cm1 1 With Tim Whole Body Suite option Vertical table movement Range 52 102 cm2 13 mm3 2 Including Heightening Kit if necessary 3 Depending on the floor conditions Speed 6 cm s Horizontal table movement Max range 275 cm Max speed 20 cm s Positioning accuracy 0 5 mm Continuous table movement during scan capable ...

Страница 78: ...s Max scan range 140 cm optional 205 cm1 Vertical table movement Range 56 106 cm2 13 mm3 Speed 6 cm s Horizontal table movement Max range 275 cm Max speed 20 cm s Positioning accuracy 0 5 mm Continuous table movement during scan capable 1 With Tim Whole Body Suite option 2 Including Heightening Kit if necessary 3 Depending on the floor conditions ...

Страница 79: ... NEMA MS 4 2006 National Electrical Manufacturers Association using the maximum gradient acoustic noise MGAN method Patient noise XQ gradients Patients require hearing protection with an SNR1 30 dB or more 1 SNR Single Number Rating Noise for personnel in the examination room XQ gradients Noise measured 88 3 dB A Hearing protection SNR 7 dB or more ...

Страница 80: ...r Water cooled highly compact modular design Ultra fast solid state technology with very low switching losses XQ gradients Max output voltage1 1 Values for each of the 3 gradient axes 2250 V Max output current1 750 A XQ gradients Performance for each axis Max amplitude 45 mT m Min rise time 225 µs Max slew rate 200 T m s Vector gradient performance vector addition of all 3 gradient axes Max eff am...

Страница 81: ... rungs Optimized RF efficiency and signal to noise ratio SNR Transmitter path Real time feedback loop for excellent RF stabilization Transmit amplitude 16 bit control 25 ns resolu tion Gain stability after first minute 0 05 dB 1 s 0 2 dB 5 min Transmitter amplifier Extremely compact water cooled solid state amplifier fully integrated at the magnet as part of DirectRF tech nology Transmit amplifier...

Страница 82: ...batic excitation pulses which are insensitive to B1 spatial variations B1 Filter An adaptive inline image filter that reduces any remnant B1 effects without affecting image contrast RF receiver technology Number of coil elements Up to 204 Number of independent receiver chan nels 48 641 1281 Quadrature demodulation and filtering Digital Receiver bandwidth 500 Hz 1 MHz for each channel Receiver sign...

Страница 83: ...3C 31P Hyperpolarization nuclei 3He 13C 129Xe Frequency band 3He 7Li 13C 17O Center frequency MHz 93 8524 47 8799 30 9806 16 7012 Usable transmitter band width kHz 50 50 50 50 Usable receiver band width kHz 190 100 65 50 19F 23Na 31P 129Xe Center frequency MHz 115 9040 32 5885 49 8719 34 0816 Usable transmitter band width kHz 50 50 50 50 Usable receiver band width kHz 235 65 100 70 1 Optional ...

Страница 84: ...ination MR Head Neck Angiography Combined head neck examination TMJ temporomandibular joints Spine 32 High resolution imaging of the whole spine Various applications in combination with additional coils Flex Large 4 Imaging of large regions such as medium to large shoulder hip and knee Flex Small 4 Imaging of small regions such as small to medium shoulder wrist elbow and ankle ...

Страница 85: ...xaminations1 Loop coil small Examination of small structures near the surface e g joints of fingers and toes wrist skin temporo mandibular joints TMJ Hand Wrist 16 High resolution hand and wrist imaging Foot Ankle 16 High resolution foot and ankle imaging Shoulder Large 16 Shoulder Small 16 Excellent visualization of small anatomical structures e g labrum High SNR and excellent field homogeneity C...

Страница 86: ...imaging of both breasts in all directions Uni or bi lateral imaging of the breasts in sagittal direction High resolution 2D and 3D breast imaging Sentinelle Vanguard for Siemens 2 4 8 Channel Configuration Simultaneous imaging of both breasts in all directions Uni or bi lateral imaging of the breasts in sagittal direction Uni lateral biopsy imaging for lateral and medial access High resolution 2D ...

Страница 87: ...giography of the head Functional imaging of the brain Endorectal Visualization of the prostate colon rectum and cervix Non invasive preoperative diagnostic evaluation and treatment planning Tx Rx CP Head Coil Head examinations High resolution brain spectroscopy 4 Channel Special Purpose Coil Carotids Examinations with small Field of View Small structures near the surface 1 MR scanning has not been...

Страница 88: ...sed phase imaging 3D VIBE Volume Interpolated Breathhold Examination quick fat saturation double echo for in phase opposed phase 3D imaging DynaVIBE Inline 3D elastic motion correction for multi phase data sets of the abdomen 2D 3D MEDIC Multi Echo Data Image Combination for high resolution T2 weighted orthopedic imaging and excellent contrast 2D 3D TurboFLASH 3D MPRAGE single shot T1 weighted ima...

Страница 89: ...ges 2562 DICOM Standard ISO 9660 Media drives CD DVD drive Color LCD monitor Screen size diagonal 19 Horizontal frequency 30 100 kHz Vertical frequency 50 75 Hz Screen matrix 1280 1024 pixels Measurement and reconstruction system Processor Intel E5620 2 4 GHz Quad Core Clock rate 2 2 4 GHz or comparable Main memory RAM 48 GB Hard disk for raw data 300 GB Hard disk for system software 100 GB Parall...

Страница 90: ...25 recFoV Parallel Scan and Recon Simultaneous scan and recon struction of up to 8 data sets GPGPU 1 Tesla C2075 Measurement and reconstruction system optional system con figuration with 128 receiver channels Processor Intel W5580 3 4 GHz Six Core Clock rate 2 3 2 GHz Main memory RAM 128 GB Hard disk for raw data 750 GB Hard disk for system software 100 GB Reconstruction speed 14800 recons per sec...

Страница 91: ... AG Healthcare Sector 11 12 Technical data syngo MR Workplace optional Color LCD monitor and host computer as for syngo Acquistion Workplace Euro Connector System IEC 320 Load rating 100 240 Vac 50 60 Hz max 10 A ...

Страница 92: ...ta 20 Network data coupling The MR system provides the level of safety according IEC 60950 1 outside patient environ ment All equipment connected to the system s network data couplings must also provide minimum level of safety according IEC 60950 1 ...

Страница 93: ...isplay Windowing Freely selectable window width and center Windowing on succeeding images Auto windowing for optimized contrast Saves and sends window values Interactive movie Automatic Movie for cine display Paging by dragging the mouse or Automatic Movie mode by clicking the icon Evaluation Parallel evaluation of up to 40 regions of interest Circle Rectangle Freehand ROI Pixel lens with position...

Страница 94: ...an Curve Time intensity analysis Creates and edits DICOM structured reports Filming Connection via DICOM Basic Print Interactive filming Filming parallel to other activities Independent scanning and documentation no wait time due to camera delays Freely selectable positioning of images onto virtual film sheet Selectable various film layouts Displaying reference images on the film sheet Windowing i...

Страница 95: ...cation division of single images and whole series Arithmetic mean and standard deviation across a range of selected images Calculation of T1 and T2 and logarithmic images Differentiation integration of selected images Calculation of a mean slope image from a range of selected images Calculation of z score t test images for evaluation of BOLD imaging data Blood Oxygenation Level Dependent Time to p...

Страница 96: ...ions of vessels from a 3D data set or a 2D sequential slice data set acquired with dedicated MR Angiography sequences Volume of Interest VoI defined to increase reconstruction speed and to improve image quality Freehand MIP Arbitrary views along any direction can be defined interactively with mouse driven virtual trackball Multiple view angles around any orthogonal axis Projections displayed as si...

Страница 97: ...e 15 30 C 59 86 F Relative air humidity 40 to 60 Absolute air humidity 11 0 g kg Electronics room Temperature 15 30 C 59 86 F Relative air humidity 40 to 80 Absolute air humidity 11 0 g kg Examination room Temperature 18 22 C 64 72 F Relative air humidity 40 to 60 Absolute air humidity 11 0 g kg ...

Страница 98: ...vail able Separator option for connec tion to available cooling sys tem Water consumption 90 l min1 1 Water temperature 12 C 45 F Heat dissipation to water 60 kW Eco Chiller option with auto matic adaptation to the required cooling demands e g different night day mode to decrease energy cost GREEN Cooling Package2 Automatic start if the surrounding temperature is 18 C 64 F or less If the temperatu...

Страница 99: ...countries compliance with local and national legal regulations is required However we strongly recommend compliance with the regulations described herein to the extent per mitted by relevant local and national laws in order to ensure the safety of operating personnel patients and third parties Power rating plate XQ gradients Values Tolerance Voltage 380 V 400 V 420 V 440 V 460 V 480 V 10 Frequency...

Страница 100: ...art Type BF applied part IP protection class according to IEC 60529 IP X0 Explosion protection The MR system is not intended for opera tion in areas prone to explosion e g highly flammable mixtures of anaesthesia gases with air or oxygen or nitrous oxide Operating mode Continuous operation with short term load Disinfection receptors system compo nents Disinfectants without alcohol ether Degree of ...

Страница 101: ... 2 Including Heightening Kit if necessary 3 Depending on the floor conditions Required min room height clearance 2404 4 Finished floor to finished ceiling Min transport dimen sions 231 182 227 Control Room syngo Acquisition Workplace table monitor 120 80 117 72 45 Host computer 22 46 47 syngo MR Workplace optional table monitor 120 80 117 72 45 Equipment Room Electronics cabinet incl system contro...

Страница 102: ...Siemens AG Healthcare Sector 11 12 Technical data 30 ...

Страница 103: ...MR MAGNETOM System Owner Manual Location of labels Skyra ...

Страница 104: ...ntified with this symbol are subject to guidelines 2002 96 EG for old electrical or electronics system modified by guidelines 2003 108 EG Please con tact Siemens Service in case of questions about returning and disposing the MR system and or its components and accessories Approval identification for Canada USA CSA Canadian Standards Association Revision label ...

Страница 105: ...3 Siemens AG Healthcare Sector 11 12 Location of labels Patent label ...

Страница 106: ...thcare Sector 11 12 Location of labels 4 On the magnet cover Name plate label Approval identification for Canada USA CSA Canadian Standards Association For laser light localizer Safety certificate label International ...

Страница 107: ...5 Siemens AG Healthcare Sector 11 12 Location of labels Safety certificate label U S A only ...

Страница 108: ...Siemens AG Healthcare Sector 11 12 Location of labels 6 ...

Страница 109: ...000 664 01 04 02 Replaces M7 000 664 01 03 02 Siemens 2009 All documents may only be used for rendering services on Siemens Healthcare Products Any document in electronic form may be printed once Copy and distribution of electronic docu ments and hardcopies is prohibited Offenders will be liable for damages All other rights are reserved English Doc Gen Date 03 12 ...

Страница 110: ...n addition manuals are subject to change without notice The hardcopy documents corre spond to the version at the time of system delivery and or printout Versions to hardcopy documentation are not automatically distributed Please contact your local Siemens office to order current version or refer to our website http www healthcare siemens com Disclaimer Siemens provides this documentation as is wit...

Страница 111: ...r This work has to be performed by qualified and authorized service engineers only In this context qualified means that the engineers have been trained accordingly or have acquired practical experience through routine service activities Authorized means that the engineers have been authorized permission by the operator of the system to perform maintenance work Upon first start up of the system we ...

Страница 112: ...d and authorized service engineers in the course of periodic maintenance work The maintenance work is subdivided into Safety check including safety related tests Preventive maintenance Quality and function tests Each table contains an introductory explanation Detailed working instructions for all maintenance work are provided in the service docu mentation for this system These documents are not in...

Страница 113: ...mum requirements Compliance with stricter national legislation may occasionally be necessary Object or function Reason What is checked Interval General tests System Safety of patient personnel and system Visual inspection of the system Annually Visible cabling cable routing Safety of patient personnel and system Visual inspection of cables cable routing Annually Options Safety of patient personnel...

Страница 114: ... tube outlet restricted area and warning signs Annually Operating manuals Safety of patient personnel and system Required operating manuals are available and legible Annually User icons button label ing warning labels Safety of patient personnel and system Visual inspection of the user icons button labeling and warning labels Annually Exclusion zone for mag netic field Prevent hazards caused by ma...

Страница 115: ...el from electrical shock The protective conductor resistance can change during system oper ation i e through oxidation corrosion and cable breaks Protective conductor resistance of the entire system Every 2 years Function test Emergency power off cir cuit2 Safety of patient personnel and system Checking function of the power circuit Annually Fix patient table option Safety of patient personnel and...

Страница 116: ... with the patient Function of intercom Function of pneumatic bulb Annually Monitoring the magnet MSUP Magnet stop function ERDU Prevent hazards caused by mag net Operation of the magnet super vision and the magnet stop Annually Gradient supervision Optimum function within speci fications Safety of patient personnel and system Function of the gradient super vision Annually QA Quality Assurance meas...

Страница 117: ...ice related activities Instructions for Measuring the Patient Leakage Current at the Patient Table Patient Table type B part is applied It is not necessary to measure the patient leakage current at the patient table Reasons applied part has a non conducting surface live parts are separated by metallic components with a protective conductor connection as per IEC 60601 1 section 17 a 2 2nd edition a...

Страница 118: ...ated from the applied part by a power supply transformer with double insulation 2 MOPP as per IEC 60601 1 section 17 a 3 and 17 a 4 2nd edition and section 8 5 2 3rd edition Instructions for measuring the Patient Leakage Current at the ECG Pulse Module ECG Pulse Module type BF part applied It is not necessary to measure the patient leakage current at the applied part of the ECG Pulse module Reason...

Страница 119: ...ject to wear is determined by recording and analyzing characteristic values Preventive measures must be adopted or repairs must be undertaken as appropriate The specified maintenance intervals correspond to the minimum requirements Compli ance with stricter national legislation may occasionally be necessary Object or function Reason What is checked Interval Cooling system Preventive measure to avo...

Страница 120: ...ation room door Preventive measure to avoid wear and tear 2 2 Magnet Optimum function within specifications Safety of patient per sonnel and system Check set pressure on magnet and compressor Annually LHe Refill n a 3 Check Replace4 the cold head n a Helium compressor Optimum function within specifications Check for leaks Annually Adsorber Optimum function within specifications Replace adsorber Ev...

Страница 121: ...ftware Preventive measure against data loss in the case of hard disk failure Save dynamic data Clean up directories Every 3 months 1 According to manufacturer recommendations 2 According to manufacturer recommendations 3 Zero helium boil off rate for typical clinical use depending on sequence and operating time with running helium compressor The system needs to be serviced at regular intervals Und...

Страница 122: ...ations from the original status In the case of deviations preventive measures have to be adopted or repairs performed as appropriate The specified maintenance intervals correspond to the minimum requirements Compli ance with stricter national legislation may occasionally be necessary Object or function Reason What is checked Interval QA measurements Optimum function within speci fications Interact...

Страница 123: ...MR MAGNETOM System Owner Manual Disposal Skyra ...

Страница 124: ...amples of environmentally relevant components are Accumulators and batteries Transformers Capacitors Monitor picture tubes Phantoms For details contact your local customer service representative or your Siemens regional office NOTICE System components hazardous to persons or the environment must be dis posed of with care and in compliance with legally binding ordinances ...

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