Esaote O-scan eXP User Manual Download Page 79

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350004900 Rev. 07

/ 48

•

Instructions for Safe Use

EN 60601-2-33:2010

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and

essential performance of magnetic resonance equipment for medical diagnosis

IEC 60601

IEC 60601-2-33: 2010

EN 60601-2-33:2010/A1:2015

IEC 60601-2-33:2010/A1:2013

EN 60601-2-33:2010/A2:2015

IEC 60601-2-33:2010/A2:2015

EN 60601-2-33:2010/AC:2016-03

EN 60601-2-33:2010/A12:2016

EN ISO 10993-1:2009

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process (ISO 10993-1:2009)

EN ISO 10993-1:2009/AC:2010

EN 60950-1:2006+A11:2009+A12:2011+A1:2010+A2:2013

Information technology equipment - Safety - Part 1: General Requirements

IEC 60950-1:2005+A1:2009+A2:2013

EN ISO 14971:2012

Medical devices — Application of risk management to medical devices (ISO 14971:2007,

Corrected version 2007-10-01)

EN 62304:2006

Medical device software - Software life cycle processes

IEC 62304:2006

EN 62304:2006/AC:2008

EN ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes

(ISO 13485:2016)

EN ISO 13485:2016/AC:2016

Reference and title of the Standard (and reference document)

Summary of Contents for O-scan eXP

Page 1: ......

Page 2: ......

Page 3: ...O scan User Manual 350004900 Rev 07 Esaote S p A Genoa...

Page 4: ...ly prohibited without prior authorization from Esaote S p A The information contained in this documentation is subject to change without prior notice Trademarks All names are property of the respectiv...

Page 5: ...ax Planck Str 27a 50858 K ln Germany Tel 49 223 46885600 Fax 49 223 49679628 info esaote de ESAOTE MOSKOW REPRESENTATIVE OFFICE Representative Office 18 Leningradsky prospekt Off 5 and 6 Moscow 125040...

Page 6: ...OTE UK 400 Thames Valley Park Drive Reading Berkshire RG6 1PT Tel 00 44 118 965 3500 Fax 00 44 709 288 0231 infoUK esaote com ESAOTE NORTH AMERICA 8000 Castleway Drive P O Box 50858 Indianapolis India...

Page 7: ...te B2 Shenzhen Digital Technology Park Xinnan 7 Lu Gaoxin Kejiyuan South Area Nanshan Dist 518057 Shenzhen People s Republic of China ESAOTE ASIA PACIFIC DIAGNOSTIC PRIVATE LIMITED F 1 Level 1 Global...

Page 8: ...ient or operator the user must notify ESAOTE S p A associate company or authorized distributor in writing providing the information as specified in the form below Equipment data are found on the relat...

Page 9: ...350004900 Rev 07 7 10...

Page 10: ...8 10...

Page 11: ...sociate company or authorized distributor of the said transfer by means of the following form duly compiled or written notification with the same data as specified in the form Equipment data are found...

Page 12: ...10 10...

Page 13: ...ements Safety Information Conventions 1 Special Terms 2 Chapter 3 Instructions for Safe Use Operator Profile 2 Personnel Qualifications and Training 2 Minimum physical requirements 2 Use Environment 3...

Page 14: ...26 MR personnel 26 MR personnel and patient exposure to contac currents 28 Precautions against localized cutaneous heating 28 Special Precautions for Patient Positioning 30 Precautions against Mechan...

Page 15: ...bols 12 Thermal Stability 13 Environmental Requirements 14 Temperature and humidity requirements 14 Other requirements 14 Site preparation 15 Patient Routine Monitoring Requirements 17 Installation Pr...

Page 16: ...matic examinations of the knee 6 Procedure for standard use 7 Procedure to be followed before knee examinations 8 Procedure to be followed after knee examinations 9 Procedure for using the device for...

Page 17: ...or Knee Coil 1 2 Lumbar support cushion 3 General Use 6 General use 9 Chapter 10 Positioning Protocols Size constraints of the O scan system 1 Centering the Coil and the Anatomy to be Examined 6 Image...

Page 18: ...ocedure 12 Chapter 14 Hand Wrist examinations Usable coils 1 Cushions 2 Hand Examinations Patient Positioning Procedure 2 Wrist Examinations Patient Positioning Procedure 6 Chapter 15 Elbow examinatio...

Page 19: ...positioning 1 Control panel orientation 2 Standard 2 Inclined 2 Turning the control panel on and off 3 Appendix A General Principles of Magnetic Resonance Imaging The nuclear spin system 1 The role of...

Page 20: ...8 8...

Page 21: ...t seat A in figure below 2 Console B in figure below comprising a PC keyboard mouse monitor and operating table 3 Magnetic Unit containing a permanent magnet C in figure below 4 Electronic box D in th...

Page 22: ...Manual These combined provide all instructions necessary for safe and efficient use of the system All information included in the user manual refer to the O scan system and its configurations O scan...

Page 23: ...ife support systems for patients with implanted surgical clips or metal objects in the cranial ocular and vascular areas unless the supervising physician has ascertained that the clip or implants is n...

Page 24: ...rn babies low birth weight infants certain cancer patients for unconscious patients sedated patients or patients in a state of mental confusion with whom no reliable communication can be maintained Se...

Page 25: ...nventions The following labeling conventions are used in this manual to identify safety related information CONTRAINDICATION This information notifies the user of a condition in which the system must...

Page 26: ...asonable control of risks as specified by the manufacturer ARTIFACTS False features in the image produced by the imaging process and that do not correspond to the spatial distribution of tissues in th...

Page 27: ...bject GRADIENT The amount and direction of the rate of change in space of some quantity such as magnetic field strength GRADIENT COIL Current carrying coils designed to produce a desired magnetic fiel...

Page 28: ...specific zone depends mainly on the density of the spin and tissue relaxation times MAGNETIZATION The magnetic polarization of a material produced by a magnetic field MATRIX RAW DATA Matrix whose sid...

Page 29: ...r to the left side of image R right L left P posterior A anterior H head F foot should be shown on the screen as appropriate PERMANENT MAGNET A magnet whose magnetic field originates from permanently...

Page 30: ...d SAR The icon bears a black text on a yellow background with a black frame SAR Acronym for Specific Absorption Rate Indicates the RF power absorbed by an object per mass unit W kg PARTIAL BODY SAR me...

Page 31: ...s hand wrist forearm and elbow but which excludes the arm USER Any person or entity that owns or controls a O scan system or is responsible for the maintenance safe effective and appropriate use of th...

Page 32: ...8 8 Chapter 2...

Page 33: ...d The assembly maintenance extensions adjustments modifications and repairs are carried out exclusively by authorized Esaote personnel and with original Esaote specified parts The installation area co...

Page 34: ...magnetic and RF field intensity and exposure times used by the O scan system the User should be familiar with current scientific literature on this topic Evaluation of the potential hazards and the ri...

Page 35: ...ive signs and labels and establish adequate rules for the controlled access area for patients operators and others to appropriately restrict entry Restrictions to public access start from the controll...

Page 36: ...ion of the equipment and the RF transmission coil of the O scan system that can generate excessive heating or burns of the patient s skin As the patient s skin is conductive closed conductive loops ca...

Page 37: ...d as MR Safe or MR Conditional may be positioned in the controlled access area W a r n i n g Never use peripheral equipment including monitoring equipment and or RF coils that has not been specificall...

Page 38: ...the O scan system The loss in efficiency of the shielding elements and possible magnetic compensation can be caused by Warning All metal objects must be kept clear of the 0 5 mT controlled access are...

Page 39: ...heral device This test also enables the user to verify the susceptibility of the O scan system to electromagnetic disturbance caused by peripheral equipment located in the vicinity The susceptibility...

Page 40: ...nt area the system guarantees a safety level comparable to that supplied by electro medical equipment conforming to the standard EN 60601 1 and subsequent amendments Warning If the phantom leaks some...

Page 41: ...reas unless the supervising physician has ascertained that the clip or implant is not ferromagnetically active W a r n i n g Never examine patients with pacemakers neurostimulators infusion pumps coch...

Page 42: ...mplant manufacturer inside its accompanying document paying special attention to the following values reported in this User Manual 1 static magnetic field see chapter 5 paragraph Technical Specificati...

Page 43: ...gments in the eyes and prohibit entry of the latter in the controlled access area unless the supervising physician has identified the fragments and approved that it is safe to proceed Examination of p...

Page 44: ...xaminations During an O scan examination it is important to maintain communication with the patient and to monitor the patient s well being Users are advised to limit the examination time to 45 minute...

Page 45: ...ce of magnetic and RF fields and or implement a method to quickly remove the patient from the magnetic and RF field area In the event of an emergency the radio frequency impulses and generation of the...

Page 46: ...the controlled access area Remove the patient from the influence of the magnet following the procedure described in the chapter Positioning Protocols in this document Warning During an examination if...

Page 47: ...efore the gradient output is expressed as an electric field E and the limit on operating mode is determined using the calculation method as defined in the standard In accordance with standard EN 60601...

Page 48: ...he User is advised that some federal state and local laws regarding exposure of employees to noise may apply The user is advised when the weighted sound pressure level LAeq 8 h in the controlled acces...

Page 49: ...g implanted medical devices are dealt with in the paragraph Pre screening of patients in this chapter Peripheral equipment The static field can interfere with peripheral equipment containing ferromagn...

Page 50: ...t slowly The maximum speed of motion in order to not exceed a dB dt value of 3 T s is 1 5 m s that is a speed of motion unlikely reachable for an MR worker moving around the system during the patient...

Page 51: ...350004900 Rev 07 19 48 Instructions for Safe Use fig 3 1 Top view...

Page 52: ...20 48 Chapter 3 fig 3 2 Side view...

Page 53: ...r Safe Use fig 3 3 Front view A tt e n t ion The measured magnetic flux density may vary from the contour plots due to factors such as concentrating effects of nearby ferrous objects and ambient field...

Page 54: ...the main magnetic field and spatial gradient of the main magnetic field is maximum coincide The spatial coordinates of this position are X 19 4 5 cm Y 10 69 5 cm Z 21 5 5 cm with respect to the magnet...

Page 55: ...ces an electric field E according to Faraday s Law The gradient coils in MR systems generate a time varying magnetic field and therefore the body of the patient is exposed to an induced electric field...

Page 56: ...to envisage special precautions for pregnant employees even though there is currently no epidemiological proof of negative health effects It is generally accepted that no published evidence supportin...

Page 57: ...al distribution of the magnetic field gradient along the Z axis detail showing correspondence with system covers Exposure of the operator falls below the action values of 0 1 mT for whole body and hea...

Page 58: ...e directly compared with the heat that is induced by the radio frequency MR personnel The maximum transmission of the RF magnetic field in the isocenter of the magnet is B1 2 0 equal to 22 08 T The ma...

Page 59: ...already below the exposure limit decreases as the distance from the magnet increases This means that the exposure limit values prescribed by the directive are never exceeded The user is advised that...

Page 60: ...tion creates closed conductive loops and thereby of electrical circuits via the parts of the body localized cutaneous heating may occur in the vicinity of contact points Closed conductive loops may al...

Page 61: ...ns of sedated or unconscious patients or patients not sensitive in the anatomical regions to be examined who therefore cannot alert the user in the event of excessive cutaneous heating W a r n i n g R...

Page 62: ...d are compatible with that of the gantry and the coil required for the examination It is also the full responsibility of the user to verify that the examination can be performed without excessive vasc...

Page 63: ...ed for use in evaluation of diffuse pathologies that may extend beyond the homogeneity region Users are advised to conclusively determine that tumors or other diffuse pathologies are entirely within t...

Page 64: ...possible injury to the patient or operator Warning The operator must help the patient on and off the seat ensuring that the patient uses exclusively the front part of the seat and does not attempt to...

Page 65: ...ted in the boxes below the supports The padded lateral supports are not designed to accommodate the seated patient and or operator W a r n i n g The maximum load capacity of the support for SC1 or SC1...

Page 66: ...s such as drinks or water could easily be knocked over and spill into the active components of the circuits causing an electrical shock hazard Warning Peripheral devices connected to O scan must compl...

Page 67: ...of fire Never use organic solvents to clean the system or use the system in the presence of such substances if flammable The use above or in the vicinity of the system may lead to explosion or fire E...

Page 68: ...side effects such as rashes Warning Use exclusively paramagnetic contrast agents gadolinium compounds approved by competent Regulation Authorities for use in magnetic resonance imaging Before using a...

Page 69: ...ces thoroughly using neutral pH factor detergent 2 treat surfaces with a detergent solution with electrolytic chloroxidant base and 1 15 of active chlorine e g AMUCHIN A diluted to 5 Apply the product...

Page 70: ...o not use other products that may damage electrical contacts of the keyboard and mouse and dried thoroughly the monitor which must be cleaned according to the instructions in the user manual supplied...

Page 71: ...the PC and console every six months checking and cleaning of cooling fans every six months cleaning the receiving coils and checking correct insertion into the gantry every six months checking the wo...

Page 72: ...he parameters of which are described in the chapter Technical Specifications in the manual Image Quality and Sequences S N ratio calculation after performing the test sequence the system evaluates the...

Page 73: ...omatically corrected any deviations in uniformity of the magnetic fringe field and that optimal conditions have been restored If the test does not detect conditions requiring corrections the same mess...

Page 74: ...n and use of the system complies with all local federal and or state regulations regarding the operation of MR equipment and the safety of patients personnel and others On approach to the expiry of th...

Page 75: ...the following items any recyclable parts of the system and or packaging are marked with the relative symbol with the exception of the protection barrier all packaging components can be recycled or reu...

Page 76: ...2 EEC and is CE marked O scan is a device in Class IIA according to directive 93 42 EEC 1993 and subsequent amendments O scan is a device in class I and relative parts are classified type B according...

Page 77: ...ubsequent amendments Parts of the O scan system that come into contact with the patient comply with standard EN ISO 10993 1 and subsequent amendments in the category of devices subject to superficial...

Page 78: ...or medical electrical systems IEC 60601 1 1 2000 EN 60601 1 2 2015 Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagn...

Page 79: ...Part 1 Evaluation and testing within a risk management process ISO 10993 1 2009 EN ISO 10993 1 2009 AC 2010 EN 60950 1 2006 A11 2009 A12 2011 A1 2010 A2 2013 Information technology equipment Safety P...

Page 80: ...48 48 Chapter 3...

Page 81: ...to properly operate the equipment is an area of around 2 7 x 3 7 m2 around 8 85 x 12 14 square feet including electronic unit and operation console or 2 5 x 3 2 m2 around 8 20 x 10 5 square feet exclu...

Page 82: ...connection of the system modem to the telephone line must have the properties described below LAN connection Ethernet cable length less than or equal to 5 m with load impedance of 100 Ohm N o t e The...

Page 83: ...ublic low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Compliant Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Compli...

Page 84: ...decreased electromagnetic immunity of this equipment and result in improper operation Warning Portable RF communications equipment including peripherals such as antenna cables and external antennas s...

Page 85: ...shall be at least 45 The PC unit and the monitor are in compliance with the immunity levels of their applicable international EMC standards It is however suggested to observe the following caution whe...

Page 86: ...lity should be that of a typical commercial or hospital environment If the user of the O scan system requires continued operation during power mains interruptions it is recommended that the system be...

Page 87: ...symbol NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by ab...

Page 88: ...ical effect and which may alter the diagnosis O scan according to the definition of the IEC 60601 1 2 ed 4 standard is suitable to be installed in professional healthcare facility environment The oper...

Page 89: ...ason turn off or move away any RF sources operating in this frequency during examinations with O scan In the case of particularly noisy areas additional external shielding may be required to tolerate...

Page 90: ...al current circuit breaker must not be less than 2 5 mm Creepage distance between different polarity of residual current circuit breaker must not be less than 4 0 mm If the power mains is not equipped...

Page 91: ...icators Under normal conditions the system is turned on and off via PC turning on the PC turns on even the O scan system and vice versa A green indicator light located on the front of the electronic b...

Page 92: ...12 22 Chapter 4 Safety Symbols Part of the Unit is turned ON Part of the Unit is turned OFF Type B equipment ionizing radiation Alternated current AC Earth Protective earth Neutral connection point...

Page 93: ...n led on the front of the electronic cabinet indicates that the O scan system is powered To avoid disabling the thermal control circuit do not switch off external power unnecessarily If the electrical...

Page 94: ...tioned to assure the stability of the temperature and humidity specifications Other requirements Attention Never install O scan in locations exposed to direct sunlight air draughts and temperature var...

Page 95: ...the Operating Console For distances up to 1 5 m connection cables are routed through cable ducting with a diameter of 10 cm placed on the floor For greater distances the connection cables must be inse...

Page 96: ...16 22 Chapter 4 fig 4 2 Complete installation with operating console and Electronic unit fig 4 3 Example of installation without Operating Console and Electronic unit...

Page 97: ...around the O scan system to ensure that the magnetic fringe field outside this area does not exceed 0 5 mT and that the level of electromagnetic interference complies with Standard EN 60601 1 2 and s...

Page 98: ...etic and radio frequency field PROHIBITED SYMBOLS No active implants e g pace makers neurostimulators infusion pumps cochlear implants defibrillators No metal implants and or other metal objects in th...

Page 99: ...19 22 Installation No fire extinguishers with magnetizable metal housing No ferromagnetic hospital equipment e g wheelchairs stretchers No mechanical watches pocket calculators etc No magnetic cards m...

Page 100: ...lectrically magnetically or mechanically activated implants surgical clips or other ferromagnetic implants shall approach the magnetic unit Do not put ferromagnetic objects near the magnetic unit crat...

Page 101: ...350004900 Rev 07 21 22 Installation Temperature range must be between 0 and 50 C Never incline more than 10 degrees Recyclable material Fragile High Non water proof package Magnet center of gravity...

Page 102: ...22 22 Chapter 4...

Page 103: ...ations of the knee secures the foot and leg safely and comfortably in the ideal position for dynamic studies of the hand and wrist a special positioner secures the hand and wrist safely and comfortabl...

Page 104: ...t of the unit without any moving parts The same applies to the magnet as an individual component which has no electronics as it comprises a piece of magnetic material but it is controlled by specific...

Page 105: ...350004900 Rev 07 3 20 Technical Description fig 5 1 Equipment components...

Page 106: ...lemented by the user are shown on screen for example selection menus acquired images error messages image database etc To record images of patients the commercial PC is supplied as standard with a DVD...

Page 107: ...ces connected to O scan must comply with safety standard EN 60601 1 and subsequent amendments or safety standard EN 60950 1 and subsequent amendments If the devices comply with the safety standard EN...

Page 108: ...ts AC 100 120 V 200 240 V 50 60 Hz integrated power supply power consumption standby 0 3 W 12 35 W typical 36 55 W max The monitor also meets the minimum requirements specified below LCD TFT LED panel...

Page 109: ...mit leakage current to earth according to standard EN 60601 1 and subsequent amendments referred to permanently installed medical systems 2 DISTR unit a distribution box for power of the various modul...

Page 110: ...d quadrature of the MR signal reception of the MR signal of the receiving coils via two independent channels analog conversion to 3 MHz of MR signal of each channel gain amplification of each channel...

Page 111: ...fier to avoid geometrical distortion f piloting controllers of gradient amplifiers g synchronizing gradient amplifiers RF amplifier The RF amplifier can supply the transmission coils with a maximum po...

Page 112: ...plitude of the transmission signal on output also the input of the RF amplifier and local oscillator used by the RF reception system to demodulate the signals received the RF reception system controll...

Page 113: ...must be installed This comprises a magnetic sensor located inside the room where the unit is installed selecting the position where fluctuation readings are most intense The sensor is connected to the...

Page 114: ...set of receiving coils each dedicated to the examination of a specific anatomical region but during signal acquisition only one is connected to the device and the signal read is acquired and processed...

Page 115: ...sition with reconstruction by transformed by Fourier 3D in isotropic 3D the reconstructed volume can be stored on hard disk for subsequent multiplanar reslicing in anisotropic 3D a multi slice is prod...

Page 116: ...manent in NdFeB with closed geometry Direction of field transverse to magnet axis Intensity of static field 0 31 T 4 mT f0 13 03 MHz 170 KHz Homogeneity 4 ppm FWHM on semi axes oblate 8 2 9 5 cm Poles...

Page 117: ...1161 Radiofrequency system DPA receiving coils Knee Coil 1 15 x 7 2 x 16 8 int cm w x d x h 17 2 x 22 1 x 28 6 ext cm w x d x h hand wrist coil 2 optional 9 35 x 27 6 x 15 4 int cm w x d x h 17 3 x 27...

Page 118: ...pep RF amplifier bandwidth 12 7 13 3 Mhz at 1 dBpp Patient positioning Patient seat maximum admissible weight 150 kg fixed backrest height and inclination leg rest washable covering material manual p...

Page 119: ...k AC up to 0 15 7 pk pk at 50 60 Hz up to 0 06 7 pk pk at 16 7 Hz With magnetic field compensator opt DC up to 3 7 pk pk AC up to 2 7 pk pk at 50 60 Hz up to 1 5 7 pk pk at 16 7 Hz The installation fe...

Page 120: ...th 69 cm depth 45 cm height 43 2 59 cm weight 15 kg Patient positioning seat width 62 cm depth 125 cm height 79 cm weight 81 kg Patient positioning seat packed width 82 cm depth 196 cm height 106 cm w...

Page 121: ...e option E MRI Viewer Wrist sequences option Cinematic acquisitions option AC DC magnetic compensation module mounted on magnetic unit UPS DICOM is a registered trademark of National Electrical Manufa...

Page 122: ...20 20 Chapter 5...

Page 123: ...the rear C This support slides backward and forward on a track anchored to the floor To enable movement the support is equipped with two front and four rear castors The track ensures that the patient...

Page 124: ...n by pressing the pedal brake on at least one of the front wheels and both wheels of the column support The seat height and inclination are fixed The patient seat is fitted with a leg rest Fig 6 2 on...

Page 125: ...the seat and does not attempt to get on laterally and or from the rear The patient and or operator must never lean with their entire body weight on the lateral and or rear sections of the patient s se...

Page 126: ...4 20 Chapter 6 fig 6 3 The O scan Premium and O scan eXP patient seat with armrests fig 6 4 Armrest detail...

Page 127: ...not examined during examinations of the knee calf ankle or foot A and B in the figure below fig 6 5 Supports on the magnetic unit W a r n i n g The maximum load capacity of each of the lateral padded...

Page 128: ...static examinations of the knee and lower limbs where necessary The device can be positioned on the rear of the O Scan system and consists in a type of plantar known as a foot setting lock and a slide...

Page 129: ...aduated scale on the track enables identification of the position Slightly raise the foot setting lock positioning the hand in the part below so that it is released and can rotate to the right or left...

Page 130: ...sertion of the leg if necessary release by means of knob A and move it away 2 To simplify the positioning procedure prepare the device in advance so that the foot setting lock is at the centre of the...

Page 131: ...knob B 2 Release the foot setting lock by means of knob A 3 Hold the ankle with one hand and with the other move the device away from the gantry 4 Remove the patient s limb after opening the shieldin...

Page 132: ...er comprises a support marked A in the figure 6 8 to enable connection of the device to the hand wrist coil 2 a support marked D in the figure 6 8 to enable connection of the device to the foot ankle...

Page 133: ...n the coil 2 and coil 3 SUPPORT There are two different supports depending on whether the positioner is used with the Hand Wrist coil 2 or with the Foot Ankle coil 3 Both supports marked A and D in th...

Page 134: ...necessary to enter the notch indicated by y in Fig above into the groove shown as u in Fig above present on both sides of the coil The supports are equipped with two screws h and k in fig 6 10 for su...

Page 135: ...ert the plate in the guide The graduated scale on the guide must be located on the part of the coil with the connectors the coil section that enters the gantry first fig 6 11 Fixing the plate guide to...

Page 136: ...umber 16 one in the hole set from number 17 to number 32 one in the hole set from number 33 to number 35 one in the hole set from number 36 to number 38 one in the hole set from number 39 to number 42...

Page 137: ...s both on the cushions male strip and the plate female strip The pins have a threaded terminal and must therefore be screwed into the relative holes according to the procedure above Handle the pins wi...

Page 138: ...ert the coil with the positioner support and plate guide assembled inside the gantry as described in the chapter Hand Wrist examinations of this document 5 place cushions no 1 and no 2 on the plate ta...

Page 139: ...us reproduce the identical positioning of the limb with respect to the plate 11 close the three Velcro straps around the region examined 12 insert the plate on the guide mounted on the support and coi...

Page 140: ...of the plate by means of the graduated scales on the guide and plate If the patient is monitored subsequently follow up the operator can thus reproduce the identical positioning of the plate and there...

Page 141: ...ical areas and or the cinematic acquisition knee and hand wrist anatomical regions only staying close to the patient in order to facilitate the small corrections required to the anatomical area positi...

Page 142: ...20 20 Chapter 6...

Page 143: ...rt of the limb examined and the other to shield the rear part and a pair of aluminum straps to increase the contact surface between the cover and limb examined These enable earthing of the limb and in...

Page 144: ...ct between the internal conductive part of the collar and patient s skin The front and rear shielding collars must be fixed to the gantry and opened to the maximum limit to avoid any type of interfere...

Page 145: ...is strap enables the shielding collar to be tightened onto the patient and secured around the limb examined The strap is equipped with a tear opening closing mechanism making application on the limb e...

Page 146: ...e shielding straps special aluminum straps are used to surround the patient s limb in the specific contact zone These are available in two sizes one large strap to surround the thigh and a smaller ver...

Page 147: ...ailable to avoid contact of the thigh with the gantry in the case of large patients Use of this strap is essential for correct operation of O Scan during the examination The insulating strap can be fi...

Page 148: ...edure is to wipe the surfaces with a gauze dampened with alcohol The shielding collars and straps deteriorate with use Replacement is recommended approximately every 1000 hours of use or in the event...

Page 149: ...use as with linear coils fig 8 1 Operational diagram of dual phased array coils As the examined limb is the same the DPA coils considerably improve the signal to noise ratio compared to the solenoida...

Page 150: ...n time Description of DPA Knee Coil 1 This coil enables examinations of standard size knees and calfs and large size ankles It has a roughly cylindrical shape and its internal dimensions are 15 x 7 2...

Page 151: ...the gantry A in fig 8 3 fitted with a quick connector B in fig 8 3 that ensures electrical connection to the gantry and automatic coil recognition Press the lever C in fig 8 3 to release the coil at t...

Page 152: ...ide of the gantry A in fig 8 4 and a quick connector B in fig 8 4 to ensure electrical connection to the gantry and automatic recognition of the coil Press the lever C infig 8 4 to release the coil at...

Page 153: ...115 mm for use with knee ankle coil 1 for system tuning and for the quality tests Signal Noise and Uniformity a cylindrical container bottle containing distilled water with a diameter of 115 mm for us...

Page 154: ...tor are exclusively those described in the chapter System management of the user interface manual paragraphs System quality test and Auxiliary equipment compatibility test All other tests using phanto...

Page 155: ...350004900 Rev 07 7 8 Coils fig 8 5 Spherical uniform phantom fig 8 6 Cylindrical uniform phantoms...

Page 156: ...8 8 Chapter 8 fig 8 7 Geometric phantom fig 8 8 Centering support for the spherical phantom diameter 140 mm...

Page 157: ...en the limb and coil even in the case of small residual spaces without causing any pressure on the limb The cushions therefore ensure that the limb is locked in place inside the coil thus preventing a...

Page 158: ...e Coil 1 The holder for generic cushions shown in the following figure has to be used to correctly position the knee inside the Coil 1 in the top bottom direction and to get the patent positioning ope...

Page 159: ...d with a Velcro strip that allows a stable coupling with the generic cushions also equipped with Velctro strip for the patient positioning Lumbar support cushion The cushion to be placed between the s...

Page 160: ...4 10 Chapter 9 fig 9 4 Lumbar support cushion fig 9 5 Positioning of the lumbar support cushion on the seat...

Page 161: ...350004900 Rev 07 5 10 Soft cushion Set fig 9 6 Use of lumbar support cushion...

Page 162: ...een used alone for the examination of small and medium patients whereas needs the extension SC2 for the examination of large patients The extension SC2 has to be placed on the cushion SC1 as indicated...

Page 163: ...ed in order to cover the two edges of the holder if the two edges were not covered complaints in the large patient knee should happen fig 9 9 Cushion P1 4 2 rectangular cushions with the dimensions 15...

Page 164: ...pe placed in the central position of the convex surface in order to be coupled with the cushions holder 8 2 generic cradle shaped cushions with the dimensions 15 x 10 x 1 2 cm for the knee examination...

Page 165: ...tion of the most suitable cushions to be used and how these are positioned inside the coil and or gantry The optimal cushion is specified with its abbreviated name P1 P2 P3 etc This section provides s...

Page 166: ...ct could cause incorrect calibration of the RF transmission coil and therefore lead to noisy or even black images the cushions deteriorate with use check the condition periodically and replace when ne...

Page 167: ...s of the O scan system are as follows 1 the gantry opening dimensions are 39 cm in height and 18 cm in width which sets a size limit on the access to the center of the magnet 2 the distance of the poi...

Page 168: ...ensions fig 10 2 Internal size of the coil Knee Coil 1 is shown in the figure limits the girth of the anatomy that can be examined 4 The maximum size of the displayed image in relation to the homogene...

Page 169: ...o enable optimization of Signal to Noise ratio and image resolution refer to chapter on Image Quality in MR in the manual Image and Sequence Quality If the user chooses a FOV in acquisition larger tha...

Page 170: ...he displayed image constraints diffuse pathologies such as large tumors may extend beyond the homogeneity region and therefore cannot be examined entirely using the O scan system In this case O scan U...

Page 171: ...gies that may extend beyond the homogeneity region Users are advised to conclusively determine that tumors or other diffuse pathologies are entirely within the homogeneity region before attempting to...

Page 172: ...ted cushion for feet ankle examinations which enable positioning and immobilizing of the region examined at the centre of the coil For examinations of non joint regions where well defined anatomical f...

Page 173: ...ity images good S N ratio the shielding straps and covers supplied should be used RF shielding is efficient when it is perfectly closed around the limb examined re close the covers on the straps exert...

Page 174: ...easy descent for the patient without any obstruction by the magnetic unit 7 If the ankle foot region is examined position the knee of the limb not examined on the cushion inserted in the relative supp...

Page 175: ...ent the coil that can be used to examine the knee is Knee coil 1 DPA Wa rni ng Ensure that the coil does not exert pressure on the nervous and or vascular structures of the limb and in particular the...

Page 176: ...is no coil in the gantry and that the cavity is totally free 5 After releasing the brakes place the patient s seat in the front position with respect to the magnetic unit Lock the seat by pressing the...

Page 177: ...limb through the inside of the rear shielding cover 13 Center the knee inside the coil precisely 14 Raise the limb not examined and position on the lateral leg rest 15 Adjust the distance between the...

Page 178: ...o the large shielding strap in the direction of the knee and if necessary any standard cushions between the calf and the gantry The insulating strap may partially overlap the shielding strap provided...

Page 179: ...p for knee examinations 23 Close the shielding collar to guarantee perfect contact with the shielding straps refer to chapter 7 fig 11 4 Position of the patient and seat during knee examinations 24 Ac...

Page 180: ...7 Help the patient to place the limb removed from the coil gently onto the floor Also ensure that the limb not examined and positioned on the lateral leg rest is placed gently onto the floor 8 Lock t...

Page 181: ...pressing the rear brake and at least one of the two front brakes refer to chapter 6 in this document 6 Help the patient on to the seat taking care to instruct the patient to use exclusively the front...

Page 182: ...k secure the limb in the maximum extension position between those selected for the cinematic examination and ensure that this position is comfortable for the patient and in particular does not cause v...

Page 183: ...ted in the subsequent steps of the procedure fitted on the gantry 5 Remove any cushions positioned between the coil and the knee 6 Release the seat pushing the front locking brake pedals upwards and t...

Page 184: ...10 10 Chapter 11...

Page 185: ...ils As explained in detail in chapter 8 of this document the coil that can be used to examine the calf is DPA Knee coil 1 Wa rni ng Ensure that the coil does not exert pressure on the nervous and or v...

Page 186: ...as far away as possible from the gantry 3 Check that there are no obstacles in the patient seat movement area 4 Ensure that there is no coil in the gantry and that the cavity is totally free Warning...

Page 187: ...nee coil 9 Insert along the longitudinal direction of the coil one cradle shaped cushion in case of small patients or two cradle shaped cushion in case of medium patients or two P1 cushion in case of...

Page 188: ...e P1 or P2 during calf examinations DPA knee coil 1 20 Place one or more cushion types P3 under the ankle fig 12 3 Using cushions type P3 when examining the calf 21 Lock the seat by pressing the rear...

Page 189: ...s and the rear brake pedal downwards 6 Move the patient s seat back using the handle situated in the rear to remove the limb 7 Help the patient to place the limb removed from the coil gently onto the...

Page 190: ...6 6 Chapter 12 10 Help the patient off the seat taking care to instruct the patient to use exclusively the front part of the seat without attempting to get off the side...

Page 191: ...s explained in detail in chapter 8 in this document the coils that can be used to examine the anatomical foot ankle region are DPA Knee Coil 3 when examining most women children and men with an averag...

Page 192: ...hilles tendon cushion SC1 to be placed inside the relative retracting support for small and medium patients cushions SC1 SC2 for large patients see chapter Soft cushion set of them present User Manual...

Page 193: ...t by pressing the rear brake and at least one of the two front brakes refer to chapter 6 4 Help the patient on to the seat taking care to instruct the patient to use exclusively the front part of the...

Page 194: ...ort for cushion type C in the maximum extension position exerting traction towards the rear opening of the gantry 11 Insert cushion type C on the relative support 12 Release the brakes and move the se...

Page 195: ...g to the space available between the ankle and the coil fig 13 3 Positioning cushion types P between the DPA coil and ankle 17 Take care to ensure that the toes are not compressed by the upper wall of...

Page 196: ...cover 22 Close the front cover to guarantee perfect contact with the shielding strap refer to chapter 7 23 Acquire the Scout sequence see chapter Examination environment of the User Interface Manual...

Page 197: ...he side Forefoot Examinations Patient Positioning Procedure Use of DPA Foot Ankle Coil 3 is recommended for examining the ankle of patients with an average or small shoe size DPA Knee Coil 1 is recomm...

Page 198: ...of interference with insertion of the limb Always leave the covers fitted on the gantry If using the DPA Foot Ankle Coil 3 9 Insert the coil in the gantry it clicks into place to confirm correct posi...

Page 199: ...g firmly in contact with the cushion fig 13 5 Position of the limb during forefoot examinations 14 Raise the limb not examined and position on the lateral leg rest 15 If the limb is not completely cen...

Page 200: ...r brake and at least one of the two front brakes refer to chapter 6 20 Position the large shielding strap on the thigh precisely at the point of closure of the front shielding cover 21 Close the front...

Page 201: ...ut any obstruction by the magnetic unit 7 Raise the patient s legs and remove the cushion type SC1 or SC1 SC2 from the front of the seat 8 Gently accompany the patient s legs until the feet touch the...

Page 202: ...nt to use exclusively the front part of the seat without attempting to get off the side 5 Position cushion type SC1 for large patients SC1 SC2 in the pocket at the front of the patient s seat 6 Positi...

Page 203: ...lways leave the covers fitted on the gantry If using the DPA Foot Ankle Coil 3 8 Insert the coil in the gantry it clicks into place to confirm correct positioning 9 Adjust the support for cushion type...

Page 204: ...tioning cushion types P between the DPA coil and Achilles tendon 15 Take care to ensure that the toes are not compressed by the upper wall of the gantry 16 Positioning with this coil proceeds from poi...

Page 205: ...ving it if no problems are created in the subsequent steps of the procedure fitted on the gantry 2 Remove any cushions positioned between the anatomical region examined and the coil 3 Release the seat...

Page 206: ...e patient to use exclusively the front part of the seat without attempting to get off the side Attention If examining large patients and or patients with limited functionality the operation described...

Page 207: ...chapter 8 of this document the coils that can be used to examine the hand wrist region are DPA Hand Wrist Coil 2 in the case of standard or small size patients DPA Foot Ankle Coil 3 in case of large s...

Page 208: ...ions required are as follows depending on the specific area to be examined hand or wrist rectangular cushion types P RB Cushion Lumbar support cushion Warning If the coil is too small with respect to...

Page 209: ...position parallel to the magnetic unit Lock the seat by pressing the rear brake and at least one of the two front brakes refer to chapter 6 4 Place the lumbar support cushion on the seat refer to chap...

Page 210: ...rightness in the images and difficulties with diagnosis fig 14 2 Position of the limb during hand examinations 10 Insert an RB cushion in the gantry to support the arm 11 If used close the rear shield...

Page 211: ...ent of the User Interface Manual On completion of the examination proceed as follows 1 Open the front shielding cover to the maximum limit leaving it if no problems are created in the subsequent steps...

Page 212: ...elding strap from the patient 9 Help the patient off the seat taking care to instruct the patient to use exclusively the front part of the seat without attempting to get off the side 10 Remove the lum...

Page 213: ...e position parallel to the magnetic unit Lock the seat by pressing the rear brake and at least one of the two front brakes refer to chapter 6 4 Place the lumbar support cushion on the seat refer to ch...

Page 214: ...comfort no direct contact between the patient s skin and the coil which could lead to areas of excessive brightness in the images and difficulties with diagnosis fig 14 4 Position of the limb during...

Page 215: ...and at least one of the two front brakes refer to chapter 6 14 Position the shielding strap on the arm precisely at the point of closure of the front shielding cover 15 Close the front cover to guaran...

Page 216: ...n the next steps 6 Move the patient s seat parallel to the gantry back to remove the limb 7 Lock the seat pressing the rear brake and at least one of the two front brakes in a position to guarantee ea...

Page 217: ...l in chapter 8 of this document the coils that can be used to examine the elbow are DPA Hand Wrist Coil 2 in the case of small size patients Foot Ankle Coil 3 in case of standard and large size patien...

Page 218: ...ing for elbow examinations use the following rectangular cushion types P Lumbar support cushion Warning If the coil is too small with respect to the size of the limb it may exert pressure on the nervo...

Page 219: ...ed leg rest 6 The front and rear shielding collars optional must be fixed to the gantry and opened to the maximum limit to avoid any type of interference with insertion of the limb Always leave the co...

Page 220: ...Move the seat up to the magnetic unit Raise the arm passing it inside the front cover and rest on the coil opening Slowly slide the arm on the cushion inside the coil with the hand in a vertical posit...

Page 221: ...ination proceed as follows 1 Open the front and rear shielding covers to the maximum limit leaving them if no problems are created in the subsequent steps of the procedure fitted on the gantry 2 Remov...

Page 222: ...nt brakes in a position to guarantee easy descent for the patient without any obstruction by the magnetic unit 7 Remove the shielding strap from the patient 8 Help the patient off the seat taking care...

Page 223: ...l in chapter 8 of this document the coils that can be used to examine the forearm are DPA Hand Wrist coil 2 in the case of small size patients Foot Ankle Coil 3 in case of standard and large size pati...

Page 224: ...ing for forearm examinations use the following rectangular cushion types P Lumbar support cushion Warning If the coil used is too small with respect to the limb size it may exert pressure on the nervo...

Page 225: ...ct the patient to use exclusively the front part of the seat without attempting to get off the side Place the patient s legs on the padded leg rest 6 The front and rear shielding collars optional must...

Page 226: ...ning the forearm in the coil with cushions type P 12 Positioning with this coil proceeds from point 12 If using the DPA Foot Ankle Coil 3 6 Insert the coil in the gantry it clicks into place to confir...

Page 227: ...contact with the shielding strap refer to chapter 7 Close the rear cover on the hand protruding 15 Acquire the Scout sequence see chapter Examination environment of the User Interface Manual On compl...

Page 228: ...parallel to the gantry back to remove the limb 6 Lock the seat pressing the rear brake and at least one of the two front brakes in a position to guarantee easy descent for the patient without any obst...

Page 229: ...f system messages is displayed In case of an emergency stop when the machine is restarted the operative system will automatically run an error routine to recover any errors due to the emergency stop T...

Page 230: ...ows 1 close the user interface as described above File o Exit 2 from the Start menu of Windows select Close session 3 the window end of work session is displayed select Shut down system then press OK...

Page 231: ...refore the thermal control is also turned off to re activate the equipment it is necessary to turn on the mains switch and the system switch and wait for the magnet to return to its working temperatur...

Page 232: ...4 4 Chapter 17...

Page 233: ...on the control panel click on the required button each button is associated with a specific icon fig 18 1 Control panel Real time positioning Real time positioning enables acquisition of an image eve...

Page 234: ...ich has a sequential function To interrupt the real time sequence select Abort this enables interruption of any sequence in operation and therefore also examination sequences and Scout sequences Contr...

Page 235: ...ser interface by selecting the relative command displayed alongside on the main tool bar The control panel remains powered until a scan except for the real time sequence is launched after which it shu...

Page 236: ...4 4 Chapter 18...

Page 237: ...comprises mainly water around 80 When a nuclear spin is placed in a magnetic field it will attempt to line up with the field For a nucleus with I 1 2 there are two stable states namely parallel and a...

Page 238: ...The stronger the magnetic field the faster the precession rate and the higher the precession frequency In more formal terms the rate of precession of a classic spin with angular momentum p and magnet...

Page 239: ...a transverse component this is called transverse magnetization This moves in phase with preceding protons inducing an electrical current which is the actual MR signal This can be picked up by an ante...

Page 240: ...causing unwanted different precession frequencies Moreover each proton is influenced by the small magnetic fields from neighboring nuclei also not distributed uniformly again causing different preces...

Page 241: ...instance one may have a 180 pulse Just after a 90 pulse the transverse magnetization starts to decrease because the protons are losing phase coherence while the longitudinal magnetization increases Tr...

Page 242: ...ion by combining a number of parameters If for example different TEs are used during the same TR it is possible to obtain a set of images weighted in T1 as well as in T2 or a combination of both This...

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