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System Owner Manual
MAGNETOM
Skyra
© Siemens AG 2010–2012
All rights 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

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   Summary of Contents for Siemens MAGNETOM Skyra

  • Page 1

    System Owner Manual MAGNETOM Skyra © Siemens AG 2010–2012 All rights 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...

  • Page 3: Table Of Contents

    Contents Introduction Safety Information MR compatibility data sheet Guidance and manufacturer’s declaration EMC Technical data Location of labels Maintenance Plan Disposal Correspondence with authorities Certificates Software licenses and warranty Upgrades Room layout Modification level of components Declaration of conformity System Owner Manual...

  • Page 5: Introduction

    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 AG Healthcare Sector P.S.: The table on the following page shows which documents are filed in the System Owner Manual...

  • Page 6: Safety Information

    Safety information Important safety aspects for the owner of a MR system MR compatibility data sheet Information for evaluating the MR compatibility of non-Siemens MR products Guidance and manufacturer’s declaration EMC Guidance and manufacturer’s declaration regarding electromagnetic compatibility Technical data...

  • Page 7

    List of the delivered components including hardware and software level Revision levels after component replacements 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/ CrossProductInformation/?languagecode=de Select the “Certificates &...

  • Page 8

    Siemens AG Healthcare Sector 11/12 Introduction – Page 4 of 4...

  • Page 9

    Siemens AG, Healthcare syngo MR D13 dito! GmbH MAGNETOM Family Safety Information System Owner Manual 2010-2012 MR-04009 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 .

  • Page 10

    Manufacturer's notes: 0 . 0 This product bears a CE marking in accordance with the provisions of regulation 93/42/EEC of June 14, 1993 for medical products. 0 . 0 0 . 0 The CE marking applies only to medico-technical products/ medical products introduced in connection with the above-mentioned comprehensive EC regulation.

  • Page 11

    Safety instructions A.1 Safety information for the system owner A.1-1 Preamble A.1-1 Legal regulations A.1-2 Emergency plans A.1-5 Emergency procedures A.1-6 Quench emergency 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...

  • Page 12

    Safety instructions 0 . 0 MAGNETOM Family - Safety Information 0 . 0 0 . 0...

  • Page 13

    Safety information for the system owner Safety information for the system owner A . 1 Preamble A . 1 This section of the system owner manual contains the most important safety aspects for which you, as the owner of the MR system, will be responsible.

  • Page 14

    Safety instructions Legal regulations A . 1 Country-specific regulations Local and national legal regulations must be observed. It is the A . 1 operator’s responsibility to follow local statutory requirements regarding access to the controlled access area. A . 1 The local regulations also define the acceptable exposure limits regarding noise as well as magnetic stray fields for users and patients.

  • Page 15

    Safety information for the system owner Electromagnetic fields The 0.5 mT line in the examination room defines the controlled A . 1 access area of the RF field. For controlling access to this area adequate rules must be established. Therefore, regard the potential risks from the attraction of magnetizable objects or from torque on such materials.

  • Page 16

    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 .

  • Page 17

    Safety information for the system owner Emergency plans A . 1 Specific provisions must be taken for possible emergencies. This includes the generation of emergency plans (instructions on how to proceed/rescue scenarios) to prevent incorrect behavior under special circumstances. A . 1 Access to the examination Escape routes for the building must be established and well room...

  • Page 18

    Safety instructions Emergency procedures A . 1 Instructions on how to proceed in emergency situations must be defined to ensure the safety of patients. For this purpose, MR-specific risks must be included (e.g. the presence of a mag- netic field). A .

  • Page 19

    Safety information for the system owner Quench emergency plan A . 1 It is strongly recommended that the system owner establishes an emergency plan in case gaseous helium escapes into the examination room. A . 1 The emergency plan should include the following information: A .

  • Page 20

    Safety instructions Defective vent line If the vent line fails in part or fully, gaseous helium will enter the A . 1 examination room. In this case, the air conditioning unit will not be able to ensure sufficient air exchange and the following haz- ardous situations may arise: A .

  • Page 21

    Safety information for the system owner Fire fighting A . 1 In the event of fire, the fire has to be extinguished with methods appropriate to the surroundings. Respective fire fighting equip- ment must be available. Fire precautions should be discussed with the local fire department and emergency procedures should be established.

  • Page 22

    Safety instructions Employee qualifications/ information A . 1 MR workers are individuals (e.g. operator, further personnel) who work within the controlled access area or MR environment. The system owner is responsible for ensuring that only trained and qualified MR workers and physicians are working on the MR system, so that they can perform all their tasks safely and effi- ciently, and in a way that minimizes their exposure to the elec- tromagnetic field.

  • Page 23

    Safety information for the system owner The personnel must pay special attention to the following aspects: A . 1 Effects of the magnetic field ( Operator Manual MR Sys- tem: Electromagnetic fields) Special effects of 3 T magnetic fields like dizziness, vertigo, and metallic taste, especially when moving the head rapidly inside or close to the MR equipment;...

  • Page 24

    Safety instructions The operator should be particularly aware of: A . 1 Adherence to the positioning information for patients (to avoid current loops and burns) Careful input of the patient weight/position and orientation Possible peripheral nerve stimulation, as effect of the First level controlled operating mode on patients and MR work- A .

  • Page 25

    Safety information for the system owner Training MR workers and Personnel and physicians must be trained in the safe and effec- physicians tive use of MR systems. The training must include the following A . 1 topics: A . 1 Emergency medical care Controlled access area Emergency switches...

  • Page 26

    Safety instructions Pre-screening MR workers and patients A . 1 To lower the risks during exposure to the magnetic field, all patients as well as MR workers have to accomplish a pre-screen- ing to avoid accidents and to establish safety measures. There- fore a pre-screening program shall be established by the opera- tor, which helps the user to identify the patients and MR workers at risk.

  • Page 27

    Safety information for the system owner Examination room and ambient conditions A . 1 Explosion protection The MR system is not intended for operation in areas prone to A . 1 explosive anesthetic gases. A . 1 Emergency switches The voltage to the MR system can be turned off via a Power-Off A .

  • Page 28

    Safety instructions Magnetic fringe field and controlled access area A . 1 The fringe field can affect devices in the vicinity of the magnet. 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 .

  • Page 29: Signs And Symbols

    Safety information for the system owner Signs and symbols A . 1 The system owner is responsible for properly identifying the accessible areas (e.g. regarding the electromagnetic field), the vicinity of the MR system, as well as adjacent areas by using the appropriate signs.

  • Page 30

    Safety instructions Overview table The following table of warning and prohibition signs must be A . 1 installed in a clearly visible location at eye level, preferably at the door to the examination room. Depending on the system, the field strength is also shown (for example, 1.5 T or 3 T). A .

  • Page 31

    Safety information for the system owner Shock indicator A . 1 Shock indicators for monitoring the transport are affixed to the packaging and to sensitive components, for example, RF coils. The red color inside the glass tube (activated shock indicator) signals that the respective component was not handled with the required care.

  • Page 32: Maintenance/repair A

    Safety instructions Maintenance/repair A . 1 Responsibility As a supplier, Siemens will not be held responsible for the safety, A . 1 reliability, and performance of the system in the following cases: A . 1 Installations, additions, adjustments, modifications, and repairs to the MR system, or changes to the software that are not performed by Siemens Service.

  • Page 33

    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.

  • Page 34

    A . 1 Annual checks The annual technical safety inspections are listed in this system A . 1 owner manual and may only be performed by Siemens Service. A . 1 0 . 0 A.1-22 MAGNETOM Family - Safety Information 0 .

  • Page 35

    If the helium fill level is too low, the alarm box or the syngo Acquisition Workplace will signal this accordingly. A . 1 In case of alarm, notify Siemens Service and/or ensure refill- ing only through trained and experienced personnel. 0 . 0 syngo MR D13 A.1-23...

  • Page 36

    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 that the magnet is only filled by Siemens Ser- vice. A . 1 0 . 0 A.1-24 MAGNETOM Family - Safety Information 0 .

  • Page 37

    A . 1...

  • Page 38

    © Siemens AG 2010-2012 Global Business Unit Order No. MR-04009.623.13.01.24 Siemens AG 06/2012 Medical Solutions Magnetic Resonance Henkestr. 127 DE-91052 Erlangen Germany Phone: +49 9131 84-0 www.siemens.com/healthcare Global Siemens Headquarters Global Siemens Legal Manufacturer Healthcare Headquarters Siemens AG Siemens AG...

  • Page 39: Mr Compatibility Data Sheet

    MAGNETOM System Owner Manual MR compatibility data sheet Skyra...

  • Page 40

    “testing the effect of non-Siemens MR products on MR systems” as well as “testing the effect of MR systems on non-Siemens MR products”. In all other cases, the operator has to ensure that use of the non-Siemens MR product does not conflict with the functions of the MR system and vice versa.

  • Page 41

    According to IEC 60601-2-33, protocols need to be proposed for testing the functionality of non-Siemens MR products. The protocols listed below are routinely used 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.

  • Page 42

    0.1 mT x = 3.9 m Siemens linear accelerators z = 6.8 m 0.05 mT x = 4.9 m X-ray I.I., gamma cameras, third party z = 8.2 m linear accelerators Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 43

    Note: The magnetic field is rotationally symmetric about the z-axis and mirror symmetric about the horizontal axis. The multiple plots are shown to provide information about the accessible space in different orientations. This note also applies to the other magnetic field related plots. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 44

    View in the direction of the magnet axis The graphic is referenced to plane z = 0. −1 −2 −3 −4 −5 −5 −4 −3 −2 −1 Horizontal (m) Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 45

    Side view of the magnet − − − − − −5 −4 −3 −2 −1 Z Axis (m) Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 46

    Top view of the magnet − − − − − −5 −4 −3 −2 −1 Z Axis (m) Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 47

    Top view Magnet Z Axis (m) Side view Patient table Z Axis (m) A small overview graphic is displayed on the following pages to indicate the area mapped by the respective graph. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 48

    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. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 49

    3.4 T −0.6 −0.8 −1 Top view −1.2 −1.4 −1.6 −1.8 −2 Z Axis (m) ⊗ : At this location, the value of the magnetic field B is greatest. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 50

    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. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 51

    − 11 T/m − −0.8 −1 Top view −1.2 −1.4 −1.6 −1.8 −2 Z Axis (m) ⊗ : At this location, the force on a magnetically saturated ferromagnetic object is greatest. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 52

    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. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 53

    Top view −1.2 −1.4 −1.6 −1.8 −2 Z Axis (m) ⊗ : At this location, the force on a diamagnetic/paramagnetic object or on a ferromagnetic material below its magnetic saturation is greatest. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 54

    MR workers The diagram shows the magnetic stray field distribution of the gradient system along the patient axis of the MAGNETOM Skyra with the XQ gradient system according to the requirements of the IEC 60601-2-33 standard. The magnetic fields generated by each of the three orthogonal gradient axis are calculated on a coordinate grid on a virtual cylinder surface.

  • Page 55

    |B| [T] 0.06 0.05 0.04 End of magnet 0.03 0.02 0.01 0.00 z [m] 0.00 Magnet isocenter The area shaded in grey indicates the length of the magnet. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 56

    0.04 0.03 End of gradient coil 0.02 0.60 m 0.40 m 0.01 0.20 m 0.00 z [m] Magnet isocenter The area shaded in grey indicates the length of the gradient coil. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 57

    RF power distribution relevant for assessing exposure to MR workers The diagram shows the RF power distribution along the patient axis of the MAGNETOM Skyra according to the requirements of the IEC 60601-2-33 standard. End of magnet 0.01 0.001 0.0001 0.00001...

  • Page 58

    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. Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 59

    Tx/Rx Knee 15 MR coil Max. applied RF field B1+ 47 µT Max. specified B1+ rms 8 µT Tx/Rx CP Head coil Max. applied RF field B1+ 41.1 µT Max. specified B1+ rms 6 µT Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 60

    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 Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 61

    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% Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 62

    Siemens AG Healthcare Sector 11/12 MR compatibility data sheet...

  • Page 63: Guidance And Manufacturer's Declaration Emc

    MAGNETOM System Owner Manual Guidance and manufacturer’s declaration EMC Skyra...

  • Page 64

    Data sheet The following document applies to all products provided by the Magnetic Resonance (MR) product group of Siemens AG, Siemens Healthcare Sector. Deviations and additions to this document are provided in accompanying product-specific documents. This information has to be followed respectively applied.

  • Page 65

    IEC 61000-3-3 Note: It is essential that the actual shielding effectiveness and filter attenuation of the shielded location be verified to assure that they meet the minimum specification. Siemens AG Healthcare Sector 11/12 Guidance and manufacturer’s declaration EMC...

  • Page 66

    The MR system or equipment should not be used adjacent to other equipment, if adja- cent or beside use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used. Siemens AG Healthcare Sector 11/12 Guidance and manufacturer’s declaration EMC...

  • Page 67

    ±1 kV differential ±1 kV differential Mains power quality should be IEC 61000-4-5 mode mode that of a typical commercial or hospital environment. ±2 kV common mode ±2 kV common mode Siemens AG Healthcare Sector 11/12 Guidance and manufacturer’s declaration EMC...

  • Page 68

    IEC 61000-4-8 a typical commercial or hospital environment. Note: U is the a.c. mains voltage prior to applying the test level. Siemens AG Healthcare Sector 11/12 Guidance and manufacturer’s declaration EMC...

  • Page 69

    If abnormal performance is observed, additional measures may be necessary, such as relocating the MR system or using a shielded location with a higher RF shielding effectiveness and filter attenuation. Siemens AG Healthcare Sector 11/12...

  • Page 70

    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 amplifier 9 kHz to 3.2 GHz Siemens AG Healthcare Sector 11/12 Guidance and manufacturer’s declaration EMC...

  • Page 71

    Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The MR system may be interfered with by other equipment, even if that other equip- ment complies with CISPR emission requirements. Siemens AG Healthcare Sector 11/12 Guidance and manufacturer’s declaration EMC...

  • Page 72

    Basic safety and essential performance As a result of the risk management process for the MR systems (according to IEC 60601- 1:2005 (3 Edition)), no essential performance was identified. Siemens AG Healthcare Sector 11/12 Guidance and manufacturer’s declaration EMC...

  • Page 73: Technical Data

    MAGNETOM System Owner Manual Technical data Skyra...

  • Page 74

    Field stability over time <0.1 ppm/h Weight (with cryogens) 5755 kg Magnet length 163 cm Open Bore design 70 cm System length cover to cover 173 cm 1. incl. shim coils, gradient coil, RF body coil Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 75

    Both: passive and active shimming. Passive shimming during installation. Standard active shim with 3 linear channels (1 order) and 5 non linear channels order). 3D Shim Patient-specific automated shim Time to shim = approx. 30 s Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 76

    1. 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. Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 77

    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 Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 78

    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 Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 79

    Patients require hearing protection with an = 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 Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 80

    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% Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 81

    Extremely compact, water-cooled solid state amplifier, fully integrated at the magnet as part of DirectRF™ tech- nology Transmit amplifier band- 800 kHz width Peak power 40.0 kW ≥16.0 KW Channel 0 ≥24.0 KW Channel 1 Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 82

    Preamplifier noise figure <0.5 dB Dynamic range at coil connector 164 dB instantaneous at receiver (referred to 1 Hz resolution bandwidth) 169 dB with automatic gain control at local coil connector 1. Optional Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 83

    ±65 ±50 width [kHz] 23Na 129Xe Center frequency [MHz] 115.9040 32.5885 49.8719 34.0816 Usable transmitter band- ±50 ±50 ±50 ±50 width [kHz] Usable receiver band- ±235 ±65 ±100 ±70 width [kHz] 1. Optional Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 84

    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 Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 85

    CP Extremity Coil Knee • Ankle • Peripheral MR Angiography • Pediatric imaging • Tx/Rx 15-Channel Knee coil Examinations of joints in the area of the lower extremities • High resolution knee imaging Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 86

    Uni- or bi-lateral imaging of the breasts in sagittal direction • High resolution 2D and 3D breast imaging • Sentinelle Vanguard for Siemens Simultaneous imaging of both breasts in 2-/4-/8-Channel Configuration all directions • Uni- or bi-lateral imaging of the breasts in sagittal direction •...

  • Page 87

    Optional coils Applications • Sentinelle Vanguard for Siemens Simultaneous imaging of both breasts in 8-Channel Configuration/Upgrade to all directions Biopsy Configuration • Uni- or bi-lateral imaging of the breasts in sagittal direction • High-resolution 2D and 3D imaging • For quantitative spectroscopy...

  • Page 88

    2D/3D Time-of-Flight (ToF) Angiography – single slab and multi slab; triggered and segmented • 2D/3D Phase Contrast Angiography • syngo BEAT Tool – TrueFISP segmented; 2D FLASH segmented; Magnetization-prepared TrueFISP (IR, SR, FS); IR TI scout; Retrogating Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 89

    Parallel Scan and Recon Simultaneous scan and recon- struction of up to 8 data sets Reconstruction speed 12195 recons per second (256 FFT, full FoV) 37914 recons per second (256 FFT, 25% recFoV) Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 90

    14800 recons per second (256 FFT, full FoV) 56338 recons per second (256 FFT, 25% recFoV) Parallel Scan and Recon Simultaneous scan and recon- struction of up to 8 data sets GPGPU 2×Tesla C2075 Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 91

    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 Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 92

    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. Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 93

    Rectangle • Freehand ROI • Pixel lens with position marker • Statistical evaluation • Area • Standard deviation • Mean value • Min/max values • Image scrolling • Magnification • Distance • Angle Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 94

    Displaying reference images on the film sheet • Windowing, image zoom and pan on film sheet • Configurable image text • Simultaneous handling of multiple film jobs • Up to 100 virtual film sheets Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 95

    Several evaluation functions may be started consecutively in the background Printing on paper Interface and software for printing images on paper (laser printer not included) • Grey levels and color printing supported • Data format Postscript Level 2 Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 96

    Three-dimensional display of surfaces, such as vessels • Selectable variable threshold values • Multiple view angles around any orthogonal axis • Rectangular and irregular Volumes of Interest (VoI) can be defined to improve image quality Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 97

    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 Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 98

    If the temperature is less than –10 °C (14 °F) the decrease energy cost chiller is switched off 1. Water temperature: 12 °C (45 °F) 2. Free Cooling Unit, optional 3. In case of clinical routine measurement conditions Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 99

    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 Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 100

    Degree of safety in the presence of a No AP or APG category equipment flammable anesthetics mixture with air or with oxygen or with nitrous oxide Mains operated equipment with addi- None tional power sources Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 101

    1. With Tim Whole Body Suite option 2. Including Heightening Kit, if necessary 3. Depending on the floor conditions 4. Finished floor to finished ceiling 5. Without attachments 6. Only ventilation might be required Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 102

    Siemens AG Healthcare Sector 11/12 Technical data...

  • Page 103: Location Of Labels

    MAGNETOM System Owner Manual Location of labels Skyra...

  • Page 104

    Within the EU, products identified 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.

  • Page 105

    Patent label Siemens AG Healthcare Sector 11/12 Location of labels...

  • Page 106

    On the magnet cover Name plate label Approval identification for Canada/USA CSA = Canadian Standards Association For laser light localizer Safety certificate label (International) Siemens AG Healthcare Sector 11/12 Location of labels...

  • Page 107

    Safety certificate label (U.S.A. only) Siemens AG Healthcare Sector 11/12 Location of labels...

  • Page 108

    Siemens AG Healthcare Sector 11/12 Location of labels...

  • Page 109: Maintenance Plan

    Skyra © Siemens, 2009 Including “Safety-related Tests” according All documents may only be used for rendering services on Siemens Healthcare Products. Any §6 MPBetreibV (Germany) 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.

  • Page 110

    Copyright / Version / Disclaimer Copyright “© Siemens, 2009” refers to the copyright of a Siemens entity such as Siemens Aktienge- sellschaft – Germany, Siemens Shenzhen Magnetic Resonance Ltd. – China, Siemens Shanghai Medical Equipment Ltd. – China, Siemens Medical Solutions USA Inc. – USA and/ or Siemens Healthcare Diagnostics Inc.

  • Page 111

    This staff member is responsible for archiving all certificates in the “System Owner Manual” binder. In addition to our repair service, Siemens also offers you a complete range of services for the preventive inspection and maintenance of your system. These services can be called on as required or agreed upon in a flexibly drafted maintenance contract.

  • Page 112

    Detailed working instructions for all maintenance work are provided in the service docu- mentation for this system. These documents are not included in the shipment of the sys- tem. MAGNETOM M7-000.664.01.04.02 Page 4 of 14 © Siemens, 2009 03.12 CS SD MR...

  • Page 113

    Annually system Magnet Optimum function within speci- Check pressure of the magnet Annually fications Check for ice formation Safety of patient, personnel, and Check for leaks system © Siemens, 2009 M7-000.664.01.04.02 Page 5 of 14 MAGNETOM 03.12 CS SD MR...

  • Page 114

    Prevent hazards caused by mag- The 0.5 mT zone is marked Annually netic field netic field The examination room is identi- fied with the warning “strong magnetic field” MAGNETOM M7-000.664.01.04.02 Page 6 of 14 © Siemens, 2009 03.12 CS SD MR...

  • Page 115

    Inspect table movement and Annually system end switches Operation of the emergency stop and safety switches Operation of the emergency release Checking tolerance limits Marking of the hazard area © Siemens, 2009 M7-000.664.01.04.02 Page 7 of 14 MAGNETOM 03.12 CS SD MR...

  • Page 116

    Annually measurements fications components according to the guaranteed system characteris- Patient protection tics using the complete QA mea- surement 1. According to manufacturer recommendations 2. If installed MAGNETOM M7-000.664.01.04.02 Page 8 of 14 © Siemens, 2009 03.12 CS SD MR...

  • Page 117: Leakage Current Measurements

    (2 MOPP), • applied part does not have dangerous voltages, as per IEC 60601-1, section 17.a.3 and 17.a.4 (2nd edition), and section 8.5.2 (3rd edition). © Siemens, 2009 M7-000.664.01.04.02 Page 9 of 14 MAGNETOM 03.12...

  • Page 118

    ECG/Pulse module is powered by a battery, • the applied part of the ECG/Pulse module is completely electrically isolated by a wireless RF operation. MAGNETOM M7-000.664.01.04.02 Page 10 of 14 © Siemens, 2009 03.12 CS SD MR...

  • Page 119

    Check water pressure and add water if necessary Air filters, fans Preventive measure to Replace air filter Annually avoid pollution Check functionality of fans Chiller (option) Preventive measure to avoid overheating © Siemens, 2009 M7-000.664.01.04.02 Page 11 of 14 MAGNETOM 03.12 CS SD MR...

  • Page 120

    Adsorber Optimum function Replace adsorber Every within specifications 3 years Patient table Preventive measure to Check the hydraulic system Annually avoid wear and tear Check/refill hydraulic oil MAGNETOM M7-000.664.01.04.02 Page 12 of 14 © Siemens, 2009 03.12 CS SD MR...

  • Page 121

    The system needs to be serviced at regular intervals. Undisturbed magnet cooling for 24 hours and 7 days a week. 4. If the system is not connected to Siemens Remote Service (SRS) the replacement has to be performed according to manu- facturer recommendations.

  • Page 122

    Reason What is checked: Interval QA measurements Optimum function within speci- Interaction of all system compo- Every fications. nents according to the guaran- 3 months teed characteristics MAGNETOM M7-000.664.01.04.02 Page 14 of 14 © Siemens, 2009 03.12 CS SD MR...

  • Page 123: Disposal

    MAGNETOM System Owner Manual Disposal Skyra...

  • Page 124

    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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