TD p60 int pnl - Miraheze · PDF fileTable of contents Achieva 3 Philips Healthcare 4598 006 44761/781 * 03/2014 *7 Table of contents 1 Introduction

Technical Description

English

Release 5

Achieva

Table of contents

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Table of contents1 Introduction............................................................................................................................................. 5

2 Controlled Access Area............................................................................................................................. 9

3 Compatibility technical specification sheet............................................................................................. 11

Magnet............................................................................................................................................................ 11

Gradients........................................................................................................................................................ 18

RF system........................................................................................................................................................ 22Body coil............................................................................................................................................ 22SENSE T/R Knee 16ch coil 3.0T.......................................................................................................... 23T/R Head coil..................................................................................................................................... 2431P Phosphorous coil 3.0T (P140)..................................................................................................... 25

4 Transmit / receive coils........................................................................................................................... 27

5 Liquid cryogen and cryogenic gases........................................................................................................ 29

6 Patient environment............................................................................................................................... 33

7 Compatibility protocols for third party equipment validation................................................................. 35

8 Electromagnetic compatibility................................................................................................................ 37

9 Networking and Security........................................................................................................................ 43

10 Important messages and indications, Symbols........................................................................................ 49

Important messages and indications.............................................................................................................. 49

Symbols on System, Coils and Accessories..................................................................................................... 51

Table of contents

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Introduction

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IntroductionPhilips Achieva Release 5 systems comply with relevant international and national standardsand laws. Information on compliance will be supplied on request by your local Philips Health‐care representative.

In particular, the MR system is designed in compliance with IEC60601‐2‐33 (Basic Safety andEssential Performance of MR Systems), which includes IEC60601‐1 (Basic Safety and EssentialPerformance of Medical Electrical Equipment and Systems) and its collaterals.

IEC‐60601‐2‐33 is the MR Safety standard published by the International Electrotechnical Com‐mission.

Philips Achieva Release 5 systems comply with relevant international and national law andstandards on EMC (electromagnetic compatibility) for this type of equipment when used as in‐tended. Such laws and standards define both the permissible electromagnetic emission levelsfrom equipment, and its required immunity to electromagnetic interference from external sour‐ces.

Information in this document is meant for the user of the system and addresses typical systemspecifications and safety related aspects of the system and installation. Information in thisdocument shall be used for improving safety in relation to the use of the system and environ‐ment.

Correctness of the image orientation and location is considered Essential Performance of theMR System, as well as absence of gross technical artifacts. This is part of the (weekly) tests inthe Periodic IQ Test (PIQT), see Instructions for Use. These tests are also part of system accept‐ance criteria in maintenance procedures.

NOTICEUsers of this Technical Description shall also read Chapter 2 of the Instructions for Use ‐ vol‐ume 1 for important safety information, such as warning and safety notices and the explana‐tion of safety signs.

NOTICEThis document is only valid for NEW system installations (hardware) with the current softwareRelease 5.1. It is NOT valid for upgraded systems.

For existing system installations that have been upgraded to Software Release 5.1 please referto the Technical Description document that was originally delivered with your initial systemrelease.

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Introduction

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Installation Instructions

The installation instructions for Philips MRI Systems is supplied by Philips Healthcare in separatedocumentation. This includes Planning Reference Data and Service Manual for Installation,which contain essential information for safe transport, storage, siting and installation.The installation must be performed by appropriately trained personnel.

Philips Healthcare can only accept responsibility for basic safety, reliability and performance, if:

• qualified personnel carry out assembly operations, extensions, readjustments or repairs,

• the electrical installation of the technical room complies with the appropriate require‐ments, and

• the system is used in accordance with the Instructions for Use.

Philips Service will evaluate the safety provisions of the system and the installation for reviewwith the customer before handover.

The MR equipment/system must emit electromagnetic energy in order to perform its intendedfunction. When installed according to Philips guidelines, electromagnetic emission will be com‐pliant to IEC60601‐1‐2. The Responsible Organization is advised to evaluate any nearby elec‐tronic equipment for the need of additional shielding or repositioning to ensure proper opera‐tion. Guidance for such evaluations may be found in e.g. AAMI TIR18:2010.

WARNINGDo not modify the MR System without authorization of the manufacturer.

Principle of operation

MR system operation is based on the principle that certain atomic nuclei present in the humanbody will emit a weak relaxation signal when placed in a strong magnetic field and excited by anRF signal at the precession frequency. The emitted relaxation signals are analyzed by the sys‐tem and a computed image reconstruction is displayed on a video screen.Note: during image acquisition, strong electromagnetic fields are emitted by the system in theMHz and kHz range, and loud acoustic signals are generated.

Equipment Classification

EQUIPMENT CLASSIFICATION

Classification according to IEC‐60601‐1

According to the type of protection against electricalshock:

Class I equipment.

According to the degree of protection against electricshock:

Type B and type BF applied parts.

According to the degree of protection against harmfulingress of water:

Ordinary equipment (enclosed equipment without pro‐tection against ingress of water, IPX0).

Introduction

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EQUIPMENT CLASSIFICATION

According to the methods of sterilization or disinfection: Non sterilizable. Use of Liquid surface disinfectants only.

According to the mode of operation: Continuous operation.

Maintenance and Repair

The owner of the system shall designate a responsible operator who ensures that the PlannedMaintenance Program is fully up to date to ensure Basic Safety and Essential Performance. Inaddition, all user routine checks must have been satisfactorily completed before using the sys‐tem to examine a patient.

Installation, maintenance and repair instructions for the system described are supplied byPhilips Healthcare in separate documentation, which includes circuit diagrams, component partlists, descriptions, calibration instructions. Installation, maintenance and repair must be per‐formed by appropriately trained personnel. Planned maintenance, repairs, or other system modifications, may only be carried out by quali‐fied and authorized Customer Support technicians. Philips provides a full planned maintenanceand repair customer support on both a call basis and a contract basis. Full details of mainte‐nance and repair services, and access to relevant technical documentation, are available fromyour Customer Support Organization.

Accessories supplied by Philips

• VCG module and sensors.

• Respiratory sensor.

• Trolley.

• Tabletop.

• Arm support .

• MammoTrak.

• RF coils.

• Flexible coil cable spacer.

WARNINGExternal equipment from other suppliers needs to be MR compatible and shall not impair theMR performance. Compatibility needs to be declared by Philips MR.

Introduction

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Controlled Access Area

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Controlled Access AreaIt is the responsibility of the operator that the following safety requirements are met.

During the site planning of a Philips MRI system, a controlled access area around the MRI sys‐tem must be defined where the field strength will exceed 0.5 mT (= 5 Gauss). Warning signs"CAUTION Magnetic field permanently switched on" shall be used to indicate this area.

Electromagnetic shielding of the Controlled Access Area shall be designed to ensure compliancewith IEC 60601‐1‐2:2007. This includes the implementation of an RF Door Switch and interlock.Refer to Philips Site Planning information for more details.

All entries to the controlled access area shall be labeled by appropriate warning signs, includingan indication of the presence of magnetic fields and their attractive force or torque on ferro‐magnetic materials. Refer to Philips Site Planning Information for a suitable set of symbols.

The controlled access area must be clearly visible, e.g. by markings on the floor, barriers or oth‐er means to control access to this area by unauthorized persons.

The Planning Reference Document (PRD) gives information where and how to install the actua‐tor of the emergency field shut‐down unit. Contact Philips Service for further information.

Persons having pacemakers, neuro stimulators, insulin pumps or similar devices, implants ofFerromagnetic material, such as surgical clips, artificial cardiac valves, prostheses or metalsplinters, must stay outside the controlled access zone.

Ferromagnetic objects, such as scissors, tools, gas bottles, vacuum cleaners and stretchers,must not be brought into the neighborhood of the magnet and be kept outside the examinationroom. Such objects will be pulled to the magnet and may cause injury to the patient or staff ordamage to the equipment.

Information on magnetic data carriers such as floppy disks, tapes and credit cards can be erasedby the magnetic field. A safe limit is 1 mT (= 10 Gauss).

The safety procedures at all entrances of the examination room shall prevent prohibited objectsbeing brought into the examination room. Ferromagnetic Detectors (FMD) can only supplementactive screening procedures by trained personnel.

The MRI system is provided with a magnet emergency rundown unit with one or two remotepush buttons to terminate the magnetic field. This shall only be used in case of emergency.

If in a medical emergency instruments must be used, the patient must be removed from theexamination room first.

No liquid helium container may be brought into the magnet area unless it has been ascertainedthat the container is made of nonferrous material.

Special nonferrous containers are available from liquid gas suppliers and must be appropriatelylabeled as nonferrous containers.

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Controlled Access Area

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Magnet Compatibility technical specification sheet

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Compatibility technical specificationsheet

MagnetSuperconductive, actively shielded. Superconducting B0 compensation function for correctingfield variations induced by moving metal objects in the vicinity of the magnet.

Field Strengths

Philips Achieva

1.5T

3.0T

Cryogen Consumption

Fixed site magnets:

System Cryogen consumption

Philips Achieva 1.5T 0.03 l/h typical


Mobile systems:

System Cryogen consumption

Philips Achieva 1.5T 0.03 l/h ‐ 0.1 l/h typical, depending upon transportation conditions.


Bore dimensions

The straight central section of the patient bore is 60 cm long, flaring quickly from a width of 60cm to 110 cm.

Typical spatial distribution of surrounding field

The following figures depict the iso‐magnetic contours up to 1T.

The iso‐magnetic contours of 1.5T, 2T, 3T and 4T do not extend beyond the outer system cov‐ers. For 1.5T systems this also applies to the 1.0T contour.

The plots show the fringe field of the magnet without any additional passive shielding. Site spe‐cific additional passive shielding will significantly reduce the spatial extent of the fringe field.

The front view of the extent of the magnetic field can be derived from these views. The maxi‐mum radial distance shall be accounted for in site planning.

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Compatibility technical specification sheet Magnet

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Fig. 1: Philips Achieva 1.5T, typical spatial distribution of surrounding field

No. View Lines

1a Top view 5, 10, 20, 40, 70, 200 mT, 0.5T

1b Side view 5, 10, 20, 40, 70, 200 mT, 0.5T

2a Top view 0.1, 0.3, 0.5, 1, 3 mT

2b Side view 0.1, 0.3, 0.5, 1, 3 mT


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Fig. 2: Philips Achieva 3.0T, typical spatial distribution of surrounding field

No. View Lines

1a Top view 5, 10, 20, 40, 70, 200 mT, 0.5T, 1.0T

1b Side view 5, 10, 20, 40, 70, 200 mT, 0.5T, 1.0T

2a Top view 0.1, 0.3, 0.5, 1, 3 mT

2b Side view 0.1, 0.3, 0.5, 1, 3 mT


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Spatial gradient of the static magnetic field B0

The "spatial gradient of the static magnetic field B0" is a quantity that expresses how steeply B0

changes as a function of position. This spatial gradient of B0 is indicative of the attraction forceon magnetic objects.The spatial gradient values are highest at the entrance of the bore, and near the system covers;see table A1 for actual values at those locations. Spatial gradients can be expressed in T/m orG/cm. In the figures T/m is used, whereby 1 T/m = 100 G/cm.

WARNINGThe spatial gradient is always present, even when not scanning, because it is the static gradi‐ent of the magnet, not of the gradient coil.

The following figures show the spatial gradient distribution in a top view and a side view of thescanner.

• The spatial gradient is symmetric around the Z‐axis of the scanner; therefore the contourlines in top view and side view are identical.

• The covers of the scanner are not symmetric.

• The yellow colored parts represent the inaccessible space behind the covers.


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Fig. 3: Philips Achieva 1.5T, Top View, horizontal section: Spatial gradient of static magnet field B0

Legend, top view 1.5T

A Highest gradient locally on cover surface: 8 T/m

B Patient table

Fig. 4: Philips Achieva 1.5T, Side View, vertical section: Spatial gradient of static magnet field B0

Legend, side view 1.5T


B Patient table

C Floor level


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Fig. 5: Philips Achieva 3.0T, Top View, horizontal section: Spatial gradient of static magnet field B0

Legend, top view 3.0T


B Patient table

Fig. 6: Philips Achieva 3.0T, Side View, vertical section: Spatial gradient of static magnet field B0

Legend, side view 3.0T


B Patient table

C Floor level


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Fig. 7: Front cover View

Legend, front view

A1 See table A1 for maximum values along the length of the cylindrical tubes

A2 See table A2 for local maximum values on the front cover surface

B Patient table

C Floor level

A1: Maximum spatial gradient of B0 occurring along the length of a cylindrical tube around the Z-axis (see figureabove).

Diameter Philips Achieva 1.5 T Philips Achieva 3.0 T

On the z‐axis 2.5 T/m 4.9 T/m

250 G/cm 490 G/cm

Tube of 20 cm diameter 2.6 T/m 5.1 T/m

260 G/cm 510 G/cm


280 G/cm 550 G/cm


320 G/cm 600 G/cm


370 G/cm 700 G/cm

Compatibility technical specification sheet Gradients

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A1: Maximum spatial gradient of B0 occurring along the length of a cylindrical tube around the Z-axis (see figureabove).



470 G/cm 860 G/cm

The orange ring shown in the front view figure is the location where:

• The spatial gradient of B0 is the highest.

This is very locally on the surface of the front cover, outside the patient area at a radius of0.38 ‐ 0.45 m. At this location the force on a saturated ferromagnetic object resulting fromthe spatial gradient of the static magnetic field B0 is maximum.

• The product of B0 and the spatial gradient of B0 is maximum.

This is very locally on the surface of the front cover, outside the patient area at a radius of0.38 ‐ 0.45 m. At this location the force on a diamagnetic or paramagnetic object, or a ferro‐magnetic material below its magnetic saturation point, is maximum.

A2: Maximum spatial gradient of B0 occurring on the surface of the (front) cover


Value of the static magnetic field B0 1.7 T 2.9 T

Spatial gradient of the static field B0 8.0 T/m (or 800 G/cm) 17 T/m (or 1700 G/cm)

Maximum product of B0 and the spatial gradient of B0 occurring on the surface of the (front) cover at a radius of0.38 - 0.45

Diameter Achieva 1.5 T Achieva 3.0 T

Value of the static magnetic field B0 1.7 T 2.9 T

Product of B0 and spatial gradient ofB0

12.0 T2/m 48.0 T2/m

Gradients

Gradient Type

For all systems: non‐resonant, actively shielded, 100% duty cycle gradients with three fully in‐dependent gradient axes for orthogonal, oblique and double‐oblique imaging.

The gradient system is a whole body gradient system, following the definition for such a gradi‐ent system as defined in IEC 60601‐2‐33.

Gradients Compatibility technical specification sheet

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Gradient Performance

Philips Achieva 1.5T

Gradient System Maximum Ampli-tude

Maximum Slew rate Fastest Rise time

Pulsar 33 mT/m 80 mT/m/ms 0.41 ms

Pulsar HP+ 33 mT/m 122 mT/m/ms 0.27 ms

Nova Dual HP

• mode 1

• mode 2

• 33 mT/m

• 66 mT/m

• 180 mT/m/ms

• 90 mT/m/ms

• 0.18 ms

• 0.73 ms

Philips Achieva 3.0T

Gradient System Maximum Ampli-tude

Maximum Slew rate Fastest Rise time

Quasar 40 mT/m 120 mT/m/ms 0.33 ms

Quasar Dual

• mode 1

• mode 2

• 40 mT/m

• 80 mT/m

• 200 mT/m/ms

• 100 mT/m/ms

• 0.20 ms

• 0.80 ms

Gradient (stray) field distribution

Pre-scans dB/dt value:

For evaluating the risk of scanning persons fitted with MR Conditional implants the followinginformation applies.

The maximum value of dB/dt for automatically inserted pre‐scans to calibrate the system is:

• 73 T/s on 1.5T systems.

• 55 T/s on 3.0T systems.

PNS for workers:

The following information may support assessment of potential Peripheral Nerve Stimulation(PNS) for workers if present at the system during scanning.

Compatibility technical specification sheet Gradients

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Fig. 8: Pulsar: gradient output (maximum magnetic field rate of change) along the long axis of the magnet, deter‐mined at 60 cm diameter.

Green Pulsar: d|B|/dt @ SR=80T/m/s ‐ max on cylinder r = 30 cm

Green line, dashed Pulsar: d|B|/dt * 20

Orange line Area with improved openness near the magnet end, outside of the RF transmitcoil

Red line Outer edge of system bore

Fig. 9: Pulsar HP+: gradient output (maximum magnetic field rate of change) along the long axis of the magnet, de‐termined at 60 cm diameter. Z = Patient axis.

Blue line Pulsar HP+: d|B|/dt @ SR=122T/m/s ‐ max on cylinder r = 30 cm

Blue line, dashed Pulsar HP+: d|B|/dt * 20



Gradients Compatibility technical specification sheet

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Fig. 10: Nova Dual HP ‐ mode 1 and mode 2: gradient output (maximum magnetic field rate of change) along the longaxis of the magnet, determined at 60 cm diameter. Z = Patient axis.

Blue line Nova Dual HP mode 1: d|B|/dt @ SR=180T/m/s ‐ max on cylinder r = 30 cm

Blue line, dashed Nova Dual HP mode 1: d|B|/dt * 20

Green Nova Dual HP mode 2: d|B|/dt @ SR=90T/m/s ‐ max on cylinder r = 30 cm

Green line, dashed Nova Dual HP mode 2: d|B|/dt * 20



Fig. 11: Quasar: gradient output (maximum magnetic field rate of change) along the long axis of the magnet, deter‐mined at 60 cm diameter. Z = Patient axis.

Blue line Quasar: d|B|/dt @ SR=120T/m/s ‐ max on cylinder r = 30 cm

Blue line, dashed Quasar: d|B|/dt * 20



Compatibility technical specification sheet RF system

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Fig. 12: Quasar Dual ‐ mode 1 and mode 2: gradient output (maximum magnetic field rate of change) along the longaxis of the magnet, determined at 60 cm diameter. Z = Patient axis.

Blue line Quasar Dual mode 1: d|B|/dt @ SR=200T/m/s ‐ max on cylinder r = 30 cm

Blue line, dashed Quasar Dual mode 1: d|B|/dt * 20

Green Quasar Dual mode 2: d|B|/dt @ SR=100T/m/s ‐ max on cylinder r = 30 cm

Green line, dashed Quasar Dual mode 2: d|B|/dt * 20



RF system

Body coilTransmit system characteristics are specified in the table below.

System Nominal fre-quency (MHz)

Max frequen-cy offset(MHz)

Amplifier PeakPower (kW)

RF coil type Max. TransmitField B1 max (µT)

AverageTransmit FieldB1 rms (µT)

Philips Achieva1.5T

64 ±0.4 18 • Body coilT/R

27 4.5

Philips Achieva3.0T X‐series

128 ±0.5 18 • Body coilT/R

13.5 2.3

Philips Achieva3.0T TX

128 ±0.5 2 x 18 • Body coilT/R

13.5 2.3

Philips Achieva3.0T with op‐tional 31P RFSystem

52 ±0.1 4.4 • P140 31Pcoil T/R

70 ‐

RF system Compatibility technical specification sheet

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Ratio of the RF power deposition along the long axis of the magnet relative to the value atthe isocenter.

The following information may support assessment of SAR exposure of workers if present at thesystem during scanning.

Fig. 13: Normalized RF power depositions along the axis of Philips Achieva 1.5 T (A) and 3.0 T (B) systems.

The picture shows the RF power depositions for Philips Achieva 1.5 T and 3.0 T systems, magni‐tude of the RF magnetic field, | B1(z) |2 / | B1(0) |2, as a function of position along the z‐axis.Numbers 1‐4 represent the location along the z‐axis where the transmit field is reduced by 3and 10 dB.The red vertical lines indicate the outer edge of the system. The orange lines indicate the areawith improved openness near the magnet end, outside of the RF transmit coil.

Locations along the z‐axis where the transmit field is reduced by 3 and 10 dB (also see figureabove):

System No. in fig-ure

RelativeField Value

z-position(mm)

(A) Achieva 1.5T 1 ‐3 dB 210

2 ‐10 dB 295

(B) Achieva 3.0T (B) Achieva 3.0T TX

3 ‐3 dB 145

4 ‐10 dB 225

SENSE T/R Knee 16ch coil 3.0TTransmit system characteristics are specified in the table below.


Max frequen-cy offset (kHz)

Amplifier PeakPower (kW)1)



Achieva 3.0T 127.73 90 4 Tx – twistedbirdcage Rx –16ch

27 5.74

1) Max RF peak power at the Transmit/Receive socket at the UIM.


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Ratio of RF power deposition along the long axis of the coil relative to the value at theisocenter.


Fig. 14: Normalized RF power deposition along the axis of the SENSE T/R Knee 16ch coil 3.0T.

The picture shows the RF power deposition for the SENSE T/R Knee 16ch coil, magnitude of the RF magnetic field, | B1(z) |2 / | B1(0) |2, as a function of position along the z‐axis. Num‐bers 1 and 2 represent the location along the z‐axis where the transmit field is reduced by 3 dBand 10 dB respectively. Note that the points at distance ±200mm from the coil isocenter, wherethe power deposition is already negligible, are still within the system bore (assuming the coil isplaced at magnet isocenter). The red vertical lines indicate the outer edges of the coil.


No. in figure Relative Field Value z-position (mm)

1 ‐3 dB ±100

2 ‐10 dB ±170

T/R Head coilFor both 1.5T and 3.0T the field of the TR head coil is confined inside the coil itself. In all locations accessible to the MR worker the RF output power is 10 dB or more below thevalue at the isocenter.

Coil Nominal fre-quency (MHz)

Max frequen-cy offset(MHz)




1.5T T/R Head 64 ±0.305 4 Birdcage 45 6.00

3.0T T/R Head 128 ±0.360 4 Birdcage 20 2.65


RF system Compatibility technical specification sheet

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31P Phosphorous coil 3.0T (P140)Transmit system characteristics are specified in the table below.


Max frequen-cy offset (kHz)




Achieva 3.0T 51.704 146 4 Circular singleloop,d=160mm

60 1.98


Ratio of RF power deposition along the long axis of the coil relative to the value at theisocenter.


Fig. 15: Normalized RF power deposition along the axis of the 31P Phosphorous coil 3.0T. The coil is positioned 7 cmunderneath the isocenter.

The picture shows the RF power deposition for the 31P Phosphorous coil, magnitude of the RFmagnetic field,| B1(z) |2 / | B1(0) |2, as a function of position along the z‐axis. Numbers 1 and 2 represent thelocation along the z‐axis where the transmit field is reduced by 3 dB and 10 dB respectively.Note that the points at distance ±200mm from the coil isocenter, where the power depositionis already negligible, are still within the system bore (assuming the coil is placed at magnet iso‐center). The red vertical lines indicate the outer edges of the coil.


No. in figure Relative Field Value z-position (mm)

1 ‐3 dB ±50

2 ‐10 dB ±100


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RF system Transmit / receive coils

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Transmit / receive coilsRF information about transmit/receive coils can be found in previous chapter.

Body Coil

The Body coil is a transmit/receive coil for scanning large parts of the body and when largeFOV's are required. It is also used for RF excitation in case of imaging with receive‐only coils.

Transmit/Receive coils

Philips provides an interface for dedicated T/R coils. Refer to IFU2 and the Accompanying Docu‐ments of those coils for technical specifications.

The following transmit/receive coils are available:

• SENSE T/R Knee 16ch coil 3.0T

• T/R Head coil 1.5T

• T/R Head coil 3.0T

• 31P Phosphorous coil 3.0T

4

Transmit / receive coils RF system

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RF system Liquid cryogen and cryogenic gases

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Liquid cryogen and cryogenic gasesA venting system for cryogen gasses is connected to the outside of the examination room and isdesigned to withstand a quench and to protect near‐by persons in the case of a quench. Thisprovision assures that the oxygen concentration in the accessible area remains at acceptablelevels during a quench.

Safety with liquid helium and helium gas

Helium gas has the following properties:

• odorless

• nonflammable

• non‐poisonous

• on evaporation a cold mist is formed

• lighter than air

A high concentration of helium gas in the examination room can lead to suffocation, as it willdilute the oxygen in the air.Under normal operating conditions a small amount of helium may evaporate caused by boil‐offof the liquid helium in the magnet. It will escape via the helium gas exhaust pipe.

A large amount of helium gas may escape when the magnet emergency stop button is used forimmediate shutdown of the magnetic field, or during a spontaneous magnetic field shutdown.

Philips MRI systems are equipped with a helium venting system, which ensures that under nor‐mal operation and emergency switch‐off conditions the escaping helium gas from the magnet isvented outside of the building.

NOTICEGuidelines for the construction (dimension, position, assembly and material to be applied) ofthe venting system for the superconducting magnet inside and outside the examination roomare available from your customer support organization.

NOTICEIt is recommended to install a preventive maintenance program, which states that regularchecks of the adequate function of the venting system for the superconducting magnet are tobe made. Full details are available from your customer support organization.

The design of the examination room must guarantee safety of the patient and other personsinside and outside the examination room in the event of failure of the venting system during aquench.

The design shall address the issues of reducing pressure build‐up, temperature decrease andoxygen depletion during a quench. Acceptable solutions of such provisions are:

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• Configurations in which the RF door opens outwards or is a sliding RF door. This will enablethe door to be opened easily in case of pressure build‐up in the examination room.

• Configurations where the RF door opens inwards, if these include extra precautions to pre‐vent pressure build up. This can be realized by one of the following:

– an extra examination room ventilator system, which can be switched on (possibly auto‐matically via an oxygen monitor in the ceiling of the examination room to detect theescape of helium gas) in case of a quench, or

– an opening in the wall or ceiling or RF door of the examination room, venting towardsan open area, or

– a possibility of opening the observation window in the examination room outward or bysliding, or

– a second independent venting system for the superconducting magnet that remains op‐erational in case the regular venting system for the superconductive magnet is obstruct‐ed.

WARNINGIn the very unlikely event of a failure of the venting system (e.g. venting system is blocked),AND shutdown of the magnetic field, a high concentration of helium gas may penetrate quick‐ly into the examination room, which will be visible as clouds of cold mist.

If this situation occurs, the patient and personnel must immediately be evacuated from theexamination room.The system owner shall develop and rehearse an evacuation plan.

NOTICEDO NOT switch off the air conditioning or air circulation in the room (normal procedure in theevent of fire), but maintain circulation and replenishment of air to allow the helium gas to dis‐sipate.

Additional controls may be required to bypass a smoke‐detector initiated stop of air circula‐tion. Install extra control measures for the patient ventilation system to prevent that the pa‐tient is exposed to helium transported by the ventilation system.

Liquid helium is extremely cold and will cause frostbite when in contact with the human body.Use protective gloves, goggles and clothing when handling liquid helium.

Only properly trained staff shall handle cryogenic liquids such as helium.

Under normal circumstances, always keep the ventilation of the examination room running.

RF system Liquid cryogen and cryogenic gases

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The magnet system has a dedicated venting system, which is to be connected to a helium gasexhaust pipe, leading outside the building. This system prevents escape of helium into the ex‐amination room. The helium gas exhaust pipe outside opening shall be located at a non‐accessi‐ble area. It must be periodically checked that the exhaust pipe is not blocked, dislocated ordamaged.

Under no circumstances should the magnet be energized prior to the installation of the heliumgas exhaust pipe and the emergency run‐down unit.

Monitoring of the oxygen content of the ambient air, may be obligatory under local regulations.

During refill of liquid helium an amount of helium gas will evaporate in the examination roomand will dilute the oxygen in the air. For sites with small examination rooms or low ceilings, it ishighly recommended to install an oxygen detector with audible alarm, and a remote sensor ontop of the magnet. In case of low oxygen level the engineer will be warned. An oxygen detectorwith audible alarm will be useful as an additional warning instrument in case of an immediatemagnetic field shutdown (quench) or failure of the venting system.

NOTICEInstall extra control measures for the patient ventilation system to prevent that the patient isexposed to helium transported by the ventilation system.

The patient ventilation system shall have its inlet opening at a safe place (i.e. at low level in theexamination room or directly connected to the air conditioning of the examination room) or beconnected to a quench detector, so that the patient ventilation system can be automaticallycontrolled when a quench occurs preventing helium to be transported to the patient inside thescanner.

Decay characteristics of magnetic field

Decay characteristics of the magnet in case of a quench or of an emergency field shutdown aregiven to enable the user to implement adequate life supporting and other safety procedures.

In case of an emergency field shutdown, the time for the field strength in the centre of themagnet to fall to 10 mT is less than 20 seconds.

Note that the fringe field of the magnet decreases in a similar way.

The system's installation manual gives information where and how to install the actuator of theemergency field shut‐down unit.

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Fig. 16: Schematic magnet field decrease in the center of the magnet as a function of time when initiated by anemergency field shutdown t=0.

Pressing an Emergency Stop button will initiate a quench of the magnet within a few seconds.The magnet will then make a loud noise caused by the rapid relief of helium gas through thequench pipe.This loud noise is proof that the magnet has actually quenched and that the magnet centralfield has decreased from nominal field to less than 10 mT.

RF system Patient environment

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Patient environmentThe design of the scanner allows easy access to the patient and provides optimal patient visibili‐ty for the operator.The bore dimensions are given in Chapter 3 of this Technical Description.

Variable lighting in the magnet bore contributes to patient comfort, as do the in‐bore micro‐phone and ceiling‐mounted loudspeakers. The headset, which fully covers the ears, provides music to the patient with minimal disturb‐ance from environmental or MRI system acoustic noise. The connector for the patient headsetis located on the patient support unit.

A passive headset is available for personnel or other people in the examination room.

A hand‐held nurse call button allows the patient to attract the operator's attention at any timeand without talking. The sound pressure of the Nurse call is designed to be at least 80 dB(A).

Ventilation of the patient space is provided by controllable forced air flow from the rear side ofthe magnet bore. Sufficient air flow contributes to patient comfort especially in high SAR scans.Air flow through the magnet bore for patient ventilation is maintained up to 60 m3/h.

When audio and visual contact to the patient is likely to be limited by the design of the exami‐nation room, the patient headset and a system microphone allow two‐way communication withthe operator during the MRI examination.The responsible organization shall ensure that audio visual contact to the examination room isestablished so that routine monitoring or medical supervision of the patient can be guaranteed.Visual contact shall be ensured through a window between operating and examination room orvia camera monitoring.

Tabletop positions can be controlled at the front of the magnet or from the operator's console.

A light visor facilitates patient positioning. A laser light reference cross for patient positioning isavailable. Head or feet‐first patient positioning is possible. There is an automatic calculation oftabletop position adjustment to move the planned slice package to the isocenter in feet headdirection.

Patient Handling Features

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Patient Support Safe working Load 250 kg

Patient Support Safe working Loadwith Vertical Motion

150 kg

Controls on Gantry (UIM) Located left or right on the front magnet covers and some controls are du‐plicated at the rear.TX only: Located left and right on the front magnet covers, no controls atthe rear.

Coil Connections Integrated in front patient control.

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Horizontal Drive Patient control or console operation. Automatic movement of slices to iso‐centre.MobiTrak/MobiFlex option provides automated multi‐station imaging.

Tabletop Travel 215 cm

Tabletop acceleration 150 mm/s2

Tabletop Speed 20, 80 and 180 mm/sec

Tabletop Accuracy ±0.5 mm

Patient Positioning Laser line marker: table travel to isocenter.

Vertical Drive 89 cm

Electrically powered.

Patient Support Height (working posi‐tion)

89 cm

Patient Support Height (minimum posi‐tion)

52 cm

Docking Patient Trolley Optional trolley

MammoTrak

Safe working Load 180 kg

Height, trolley with tabletop, workingposition

89 cm

Optional Trolley

Safe working Load 150 kg

Height, trolley with tabletop, workingposition

82 cm

NOTICEThe Safe working Load is the maximum allowable sum of patient weight and accessories andcoils.

NOTICEAll values in the table(s) above are nominal values only.

RF system Compatibility protocols for third party equipment validation

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Compatibility protocols for third partyequipment validationThe MRI system contains a set protocols, which can be run routinely on the MRI equipment,and enable the manufacturer of peripheral equipment to test the functionality of its equip‐ment. The protocols are designed to run the MRI equipment with high transmit RF field or highgradient slew rates and amplitudes so that the manufacturer of peripheral equipment can in‐vestigate the influence of the MRI equipment on its peripheral equipment. The tests are notintended for estimation of the possible effect of the peripheral equipment on the resultingimage quality of the MRI equipment and are no guarantee that the peripheral equipment willfunction properly.

Measurement Configuration

During the evaluation of third party equipment, the equipment has to be set up in the sameway as during clinical use of the equipment.

The next set of protocols can be used.

Name Maximum gradi-ent amplitude

Maximum gradi-ent slew rate

Maximum RFamplitude

Maximum SAR Remark

MaxGrad Yes Yes No No Amplitude andslew rate

MaxB1+SAR No No Yes Yes B1 and SAR

MaxGrad+RF Yes Yes Yes Yes Gradient and RF

Tab. 1: Protocol table

All protocols use the System Body coil.

Scanner info

For each scan the calculated B1 +rms is displayed on the info page. The B1 +rms value is defined asthe square root of the averaged squared transmit field, whereby the integral over the averagedsquared transmit field is taken over an interval equal to the scan repetition time. B1 is ex‐pressed in µT (micro Tesla).

Measurement Procedure

Place a 3‐liter bottle vertical on the tabletop and bring the bottle in the isocenter using the trav‐el to scanplane function.

In the new examination window the option Gender = Phantom/Other is available for phantomscanning purposes. After the creation of new examination entry, and selecting the created ex‐amination for scanning, protocols can be selected from the folder Phantom studies, Third Par-ty.

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RF system Electromagnetic compatibility

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Electromagnetic compatibilityPhilips MR systems are designed in compliance with IEC 60601‐1‐2: 2007 requirements on elec‐tromagnetic emissions and immunity requirements for medical electrical equipment.The system is designed to be safe and to perform as intended in the electromagnetic environ‐ment as specified on the next pages. The customer or user of the system shall assure that it isused in such an environment.

The system is classified as:

Group 2 equipment, Class A non‐life supporting equipment.

• The system is a large permanently installed system.

• The system uses an intentional transmitter of RF electromagnetic energy for the purpose ofits operation.

• The system uses an intentional receiver of RF electromagnetic energy for the purpose of itsoperation.

For the receive frequency the exclusion band is applicable.

NOTICEFor applicable frequencies see section 4.

WARNINGThe MRI system is extremely sensitive in the applicable frequencies mentioned in chapter 4.Any RF disturbance above 60 dBμV/m nearby the system may have influence on the imagequality.

WARNINGThe RF door shall be closed during scanning. Do not alter or by‐pass the RF door switch. Thisswitch is implemented to ensure international and local EM emission regulations.

A list of cables in the system is incorporated in the Service documentation supplied with thesystem.

WARNINGThe use of accessories, transducers and / or cables other than those specified, with the excep‐tion of transducers and / or cables sold by the manufacturer of the system as replacementparts for internal components, may result in increased emissions and / or decreased immunityof the system.

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The system is designed to be safe and to perform as intended in the electromagnetic environ‐ment as specified on the next pages. The customer or user of the system shall assure that it isused in such an environment.

WARNINGIf systems are used near other MR systems with the same fieldstrength, verifiy that the sys‐tems do no interfere with each other.

NOTICEIn order to assure proper functioning of the MRI system the site conducted and radiated emis‐sions shall remain within the limits as described in the tables below.

Guidance and manufacturer's declaration - electromagnetic emission

The MR system is intended for use in an electromagnetic environment specified below. The cus‐tomer of the system should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment -guidance

RF emissions CISPR11 Group 2 The system must emit electromagnetic energy in orderto perform its intended function. Nearby electronicequipment may be affected

RF emissions CISPR11 Class A The system is suitable in all establishments other thandomestic, and those directly connected to the publiclow‐voltage power supply network that supplies build‐ings used for domestic purposes

Harmonic emissions IEC61000‐3‐2

Not applicable Mains power connection is above 16A

Voltage fluctuation/flicker emis‐sions IEC 61000‐3‐3

Not applicable Mains power connection is above 16A

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTICEITE equipment complies to CISPR22.


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Guidance and manufacturer's declaration - electromagnetic immunity


Immunity tests IEC 60601-1-2:2004Test level

Compliance lev-el

Electromagnetic environment - guidance

Electrostatic discharge(ESD)IEC 61000‐4‐2

±6kV contact ±6kV contact Relative humidity should be at least 30% inthe examination room and the operatorroom, and at least 20% in the technical room

±8kV air ±8kV air

Electrical fast transients/burstsIEC 61000‐4‐4

±2kV for power sup‐ply lines

Mains power quality shall be that of a typicalcommercial hospital environment

±1kV for input/output lines

Voltage dips short inter‐ruptions and voltage var‐iations on power supplyinput lines IEC 61000‐4‐11

<5% UT (>95% dip inUT) for 0.5 cycle

Not applicable The system is suitable in all establishmentsother than domestic, and those directly con‐nected to the public low‐voltage power sup‐ply network that supplies buildings

40% UT (60% dip inUT) for 5 cycles

70% UT (30% dip inUT) for 25 cycles

5% UT (95% dip in UT)for 5 sec

Power frequency(50/60Hz) magnetic fieldsIEC 61000‐4‐8

3 A/m Power frequency magnetic fields shall be atlevels characteristic of a typical location in atypical commercial hospital environment

Tab. 2: ELECTROMAGNETIC IMMUNITY

Note: ITE equipment complies to CISPR24.

Guidance and manufacturer's declaration - electromagnetic immunity


Immunity tests IEC 60601-1-2: Testlevel

Compliancelevel


Portable and mobile RF communications equip‐ment shall not be used closer to any part of thesystem, including cables, than the recommendedseparation distance calculated from the equationapplicable to the frequency of the transmitterRecommended separation distance d (m)

Conducted RF IEC61000‐4‐6

3V

150kHz ‐ 80MHz

3V d = 1.2√P


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Immunity tests IEC 60601-1-2: Testlevel

Compliancelevel


Radiated RF IEC61000‐4‐3

3V/m

80MHz ‐ 2.5GHz

3V/m d = 1.2√P 80 MHz‐800 MHz

d = 2.3√P 800 MHz‐2.5 GHz

where P is the maximum output power rating ofthe transmitter in watts (W) according to thetransmitter manufacturer, and d is the recom‐mended separation distance in meter (m). Fieldstrengths from fixed RF transmitters, as deter‐mined by an electromagnetic site survey [remarka], should be less than the compliance level in eachfrequency range [remark b&c].

[Remark a] Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephonesand land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoreti‐cally with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagneticsite survey may be considered. If the measured field strength in the location in which the system is used exceedsthe applicable RF compliance level above, the system must be observed to verify normal operation. If abnormalperformance is observed, additional measures may be necessary, such as reorienting, shielding or relocating thesystem.[Remark b] Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.[Remark c] The MRI system is a device that intentionally receives RF electromagnetic radiation for the purpose ofits operation and is exempt from performance requirements in the exclusion band (frequency of operation) asmentioned in clause 4 of this document. This may include other MRI devices nearby the system using the samefrequency of operation.

Recommended separation distances between portable and mobile RF communications equipment and the sys-tem.The system is intended for use in an electromagnetic environment in which radiated RF disturbances are control-led. The customer or the user of the system can help prevent electromagnetic interference by maintaining a min-imum distance between portable and mobile RF communications equipment (transmitters) and the system asrecommended below, according to the maximum output power of the communications equipment.

Rated maximum outputpower of transmitter

Separation distance according to frequency of transmitter

m

W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 1.2√P d = 1.2√P d = 2.3√P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23


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Recommended separation distances between portable and mobile RF communications equipment and the sys-tem.The system is intended for use in an electromagnetic environment in which radiated RF disturbances are control-led. The customer or the user of the system can help prevent electromagnetic interference by maintaining a min-imum distance between portable and mobile RF communications equipment (transmitters) and the system asrecommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distance d inmeter (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maxi‐mum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTICEAt 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTICEThese guidelines may not apply in all situations. Electromagnetic propagation is affected byabsorption and reflection from structures, objects and people.

NOTICEThese values are applicable for all frequencies except for the frequencies in the exclusion bandas mentioned in the previous table and the Site reference Guide.


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RF system Networking and Security

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Networking and SecurityThis chapter provides documentary information on the technical security controls embedded inthe system. This information may prove beneficial for risk managers tasked with maintainingthe organizations risk management file for IT networks incorporating medical devices.

Network Characteristics

Although the system can operate as standalone, it can only aid the clinical workflow whengranted access to services on the healthcare facility network. The following is required:

Physical

Number of wall outlets 1

Connector type UTP

Network cable CAT 6A

Logical

Number of IP addresses 1

IP address sizes (IPv4/IPv6) Native IPv4 + IPv6

Private IP address range 192.168.70.0 – 192.168.74.255

DHCP support Client

Clinical accessible ports and interfaces

Network interfaces wired Yes DICOM

Network interfaces wireless None

Infra Red None

Removable media Multimedia file export via USB

Performance

Device class Network end device (client)

Network bandwidth 1 Gbps

Quality of service Data only; no audio/video streaming. No need for data coloring orlabeling.

IP package frame size 1500 bytes (no jumbo frames)

Network peak load estimation 360 MB in 50 sec, 5 times per hour (using Enhanced‐MR)

Network latency requirements None

Centralized IT management

Single sign‐on (SPNEGO) Not supported

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Centralized IT management

Identity life cycle management (LDAP) Not supported

Policy management (LDAP) Prohibited for device integrity reasons

Audit trails and alerts (Syslog) Syslog UDP only

Domain name spaces (DNS/DNSSEC) Not supported

Neighborhood discovery (NDP) Not supported

Time synchronization (SNTP/NTP) NTP based

This medical device is multi‐homed. Addresses in the private IP range are reserved for internaluse only and shouldn’t be utilized on the healthcare facility network, for network services inter‐nal to this device may interfere with services on the healthcare facility network. An IP addressconflict can be resolved within the application; the private range can be altered.

CAUTIONWhen using addresses in the Private IP address range on the healthcare facility network, theAvailability of this medical device is at risk.

Network context

In a typical room setup, the technical equipment is located in a separate room with climate con‐trol, and physical access control for authorized service personnel only.

The examination room is reserved for the examination of a patient by supporting staff.

An operator in the Control Room may assist the staff from outside the examination room usingsome optional user interface modules, as present in the examination room. Shielded glass pro‐vides for visual access to the working spot.


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Included are the accessible ports and interfaces, as these can be relevant from a security per‐spective.

1. The MR Console is a multi‐homed network node connecting to the facility network and twointernal networks for control and acquisition of image data. There is no routing betweenthese networks.

2. The clinical application executes on the MR Console. This console is connected to the ORD(Operating Room Display), a paper printer as well as the optional ERD (Examination RoomDisplay).

3. USB memory sticks can be connected to the MR Console. Accessibility for these devices isconfigurable (default disabled).

4. he healthcare facility network allows for access to network services such as DICOM print‐ers, the Radiology Information System (RIS), or the departments Picture Archive Communi‐cation System (PACS).

5. The uptime and provisions of services can be enhanced when the equipment status andbehavior is monitored at Philips. This also allows for remote application support. Variousconfigurations for Philips Remote Service Network (RSN) access exist. Some require a dedi‐cated router, to setup a Virtual Private Network (VPN). RSN connectivity and service sup‐port is optional.

Ports and protocols

The table below provides an overview of the socket ports and protocols utilized, as can be rele‐vant for the proper setup of firewalls and intrusion detection systems. Since the network of thesystem can be configured in 2 modes (Transparent or iSSLlink), 2 sets of ports are described. Inthe iSSLlink mode all service traffic is tunneled through an encrypted (SSL) tunnel.


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Custom-er use

PhilipsServiceuse

Usage Port no. Inbound Out-bound

Protocol Optional Configu-rable

Transparent

● Time synchronization withcentral server

123:UDP ● ● NTP ●

● Audit trail to central server 514:UDP/TCP ● Syslog ● ●

● Image Transfer 104:TCP ● ● DICOM ●

● Image Sharing 445,139:TCP ● SMB ●

● Anti‐Virus package updates 80:TCP ● HTTP

● Active Directory connections 53:TCP/UDP

389:TCP/UDP

●

●

●

●

DNS

LDAP

●

● ● Web Browser 80,443:TCP ● HTTP(S)

● Remote Service and Utiliza‐tion services

22:TCP ● SSH

● Remote Desktop 5900:TCP ● VNC (encrypted)

● Remote Field Service frame‐work

9903:TCP ● .NET Remoting

● Smart Client 9044:TCP ● .NET Remoting

● Philips Remote ServiceAgent

443:TCP ● HTTPS

iSSL link

● Time synchronization withcentral server

123:UDP ● ● NTP ●

● Audit trail to central server 514:UDP/TCP ● Syslog ● ●

● Image Transfer 104:TCP ● ● DICOM ●

● Image Sharing 445,139:TCP ● SMB ●

● Anti‐Virus package updates 80:TCP ● HTTP

● Active Directory connections 53:TCP/UDP

389:TCP/UDP

●

●

●

●

DNS

LDAP

●

● ● Web Browser 80,443:TCP ● HTTP(S)

● Philips Remote ServiceAgent

443:TCP ● HTTPS

Tab. 3: Socket port usage and associated protocols


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Relevant risks

Assumed present in the healthcare facility infrastructure are industry standard practices on net‐work security like intrusion detection and a comprehensive network isolation/segregation ar‐chitecture with perimeter defenses that limits network exposure of medical devices. In particu‐lar towards the Internet and the (non‐medical) healthcare facility back office.

The technical security controls embedded in the medical device can be adjusted to local needs.Service level access is required for these modifications. The threat score assumes that thesecontrols are enabled.

Relevant risks – Patient records

This medical device is processing personal data related to the health of patients including per‐sonally identifiable information.

Physical storage is limited to two internal devices:

• The hard disk drive for the main clinical application.

• The hard disk drive(s) for image storage.

Both devices are mounted in the console computer behind metal covers. The console computeris mounted in the Operator Equipment Cabinet with brackets. The console computer can be in‐stalled in the technical room by obtaining an ScandiLink option.

The patient’s personal data resides at this device for a limited time only; once the examinationis closed, the patient related information is transferred to the department’s medical imagingarchive and can be deleted to free‐up storage capacity for subsequent use. On customer re‐quest, the partitions containing patient data can be encrypted (Bitlocker Windows 7)

This device is not intended for long‐term storage of patient records. No particular security con‐trols are implemented with regards to storage confidentiality or integrity; backup/recovery ofpatient data, and/or integrity checks that may signal tampering of records.

Relevant risks – Account credentials

Four distinct pools of account credentials are recognized:

• Clinical users are forced to authenticate themselves with a user‐account/password combi‐nation. Their credentials are maintained on the device or on Customer Active Directory andrequire Service or Hospital Admin level access for administration. Emergency access is notsupported.

• Hospital Admins are users with administrative privileges, and are allowed to manage Clinicaluser accounts, configuring the Anti‐malware solution and installation of Service Packs/Security Fixes provided by Philips. Their credentials are maintained on the device or on Cus‐tomer Active Directory and require Service or Hospital Admin level access for administra‐tion.

• Service users are users with elevated service level privileges. Accounts are managed byService. Accounts exist for Local and Remote service.

• Machine accounts are non‐human accounts reserved for internal usage within the device orcommunication. These accounts are predefined, fixed, and can’t been altered.

Password Complexity rules can be changed by the Service user and by the Hospital Admins.


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Centralized Identity life cycle management like LDAP or Active Directory is supported. Grouppolicy management is prohibited for this may interfere with the device integrity.

Automatic log off of medical personnel isn’t offered as security control for it interferes with thedevice’s intended use. Only non‐password protected screen savers are configurable, since lock‐ing the system would interfere with the safe use of the system. Manual Screen Lock is support‐ed.

Software updates and patch management

Philips is systematically analyzing sources of information related to the vulnerability landscapeof this medical device. This includes an assessment on the applicability and need for applyingsecurity patches, while mitigating circumstances as intended use and design are taken into ac‐count.

Philips may recommend specific customer or service actions or issue service recommendationsto update, alter, or even replace the security controls embedded in the products design. Rec‐ommended customer actions and latest information can be found in the product‐specific listingof known vulnerabilities. Be sure to monitor it for updates.

Software updates and security patches alter the design of this medical device and thus requireproper validation and approval by Philips. After releasing the updates are distributed via thePhilips Field Change Order process.

Operating systems and hardening

The Console PC located in Control room runs the main clinical application. This PC is the sys‐tem's User Interface (UI) and the interface for hospital network services. The operating systemused is Microsoft ® Windows Embedded Standard 7 with Service Pack 1 and patches up‐to‐dateas on date of product design release. McAfee ® VirusScan Enterprise 8.8 patch 1 is pre‐installed.

When powered‐on, the Console will start system application tasks, but the UI is not availableuntil an Operator is logged on. Embedded in the design, but not exposed to UI, are SQL Server2008 R2 SP1 databases.

The operating systems used by the internal components are: Windriver ® VxWorks and Micro‐soft ® Windows Embedded Standard 7 SP1.These internal components boot automatically. Autologon is not provided.

Clinical users are locked into the application and do not have direct access to the underlyingoperating system.

Service users can access the equipment configuration including user accounts, and the underly‐ing operating system using the Service password.

Important messages and indications Important messages and indications, Symbols

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Important messages and indications,Symbols

Important messages and indicationsImportant messages and indications are displayed in the language of the user interface. The table below displays the English messages and their translation.

Messages

English Translation

Allow First Level Controlled Operating Mode for SAR?

Medical supervision of the patient is required. Whole Body SAR ofscan is between 2 and 4 W/kg.

See Instructions for Use.

Allow all scans which require Whole Body SAR > 2 W/kg?

• Confirm and Start

• Cancel

Allow First Level Controlled Operating Mode for SAR?

Medical supervision of the patient is required. Whole Body SAR ofscan is between 2 and 4 W/kg.

See Instructions for Use.

Allow all scans which require Whole Body SAR > 2 W/kg?


• Cancel

Allow First Level Controlled Operating Mode for PNS?

Medical supervision of the patient is required. Peripheral NerveStimulation of scan is between 80 and 100 %. See Instructions forUse.

Allow all scans which require PNS > 80%?


• Cancel

Allow First Level Controlled Operating Mode for PNS?

Medical supervision of the patient is required. Peripheral NerveStimulation of scan is between 80 and 100 %. See Instructions forUse.

Allow all scans which require PNS > 80%?


• Cancel

Scan will exceed maximum SED level

Cannot start scan. Execution would exceed the maximum allowedSpecific Energy Deposition in the patient. See Instructions for Use.

• Close

Scan will exceed maximum SED level

Cannot start scan. Execution would exceed the maximum allowedSpecific Energy Deposition in the patient. See Instructions for Use.

• Close

10

Important messages and indications, Symbols Important messages and indications

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Messages

English Translation

Patient Ventilation Warning

The patient ventilation is below the recommended level.

Press <Modify…> to modify the patient ventilation level. Refer tothe Instructions for Use for information about patient ventilation.

Press <Proceed> to proceed with the current patient ventilationlevel.

Press <Cancel> to cancel the scan.

• Modify

• Cancel

• Proceed

Patient Ventilation Warning

The patient ventilation is below the recommended level.

Press <Modify…> to modify the patient ventilation level. Refer tothe Instructions for Use for information about patient ventilation.

Press <Proceed> to proceed with the current patient ventilationlevel.

Press <Cancel> to cancel the scan.

• Modify

• Cancel

• Proceed

Moving TableTop

The tabletop is moving automatically.

• Stop

Moving TableTop

The tabletop is moving automatically.

• Stop

Enable Remote Desktop Session

A Remote Desktop session has been requested. If you accept thisRemote Desktop request, you confirm that you know that this is anauthorized Remote Desktop session. You further confirm that youare the responsible local operator for the system during this Re‐mote Desktop session and have been fully informed about the pos‐sible consequences regarding Safety, Security and Privacy arisingfrom permitting remote operation of the system, including thosediscussed in the system's "instructions for use". During a singlewindows Take Over session, you must stay at the system consoleand monitor the activities performed by the remote user. You canend the Remote Desktop session any time by pressing the "STOP"button on your screen. As the operator of the system, you are re‐sponsible for the safe and secure use of the system. Note that cer‐tain private information, including electronic Protected Health In‐formation (ePHI) about patients, will become accessible to the re‐mote operator. Be sure to stay within your institution's policy re‐garding disclosure of confidential information to third parties.

• I Agree

• Exit Session

Enable Remote Desktop Session

A Remote Desktop session has been requested. If you accept thisRemote Desktop request, you confirm that you know that this is anauthorized Remote Desktop session. You further confirm that youare the responsible local operator for the system during this Re‐mote Desktop session and have been fully informed about the pos‐sible consequences regarding Safety, Security and Privacy arisingfrom permitting remote operation of the system, including thosediscussed in the system's "instructions for use". During a singlewindows Take Over session, you must stay at the system consoleand monitor the activities performed by the remote user. You canend the Remote Desktop session any time by pressing the "STOP"button on your screen. As the operator of the system, you are re‐sponsible for the safe and secure use of the system. Note that cer‐tain private information, including electronic Protected Health In‐formation (ePHI) about patients, will become accessible to the re‐mote operator. Be sure to stay within your institution's policy re‐garding disclosure of confidential information to third parties.

• I Agree

• Exit Session

Scanner

Patient position needs to be defined. Press 'Proceed' to reuse thecurrent position, or use the light visor.

• Proceed

Scanner

Patient position needs to be defined. Press 'Proceed' to reuse thecurrent position, or use the light visor.

• Proceed

Symbols on System, Coils and Accessories Important messages and indications, Symbols

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Messages

English Translation

Planscan

Position of the tabletop changed since acquisition of survey. Pleaseselect recent survey.

• Close

Planscan

Position of the tabletop changed since acquisition of survey. Pleaseselect recent survey.

• Close

Warning

dS HeadNeck coil is connected. Scanning with a tilted HeadNeckcoil is not allowed. Refer to the Instructions for Use for informationabout the dS HeadNeck coil.

Press <Cancel> to stop scanning.

Press <Proceed> to start scanning, only if the ds HeadNeck coil isnot tilted.

• Cancel

• Proceed

Warning

dS HeadNeck coil is connected. Scanning with a tilted HeadNeckcoil is not allowed. Refer to the Instructions for Use for informationabout the dS HeadNeck coil.

Press <Cancel> to stop scanning.

Press <Proceed> to start scanning, only if the ds HeadNeck coil isnot tilted.

• Cancel

• Proceed

Patient Ventilation Control

Current patient ventilation level

Level 5 is recommended.

Use the <+> and <‐> buttons above to modify the patient ventila‐tion level.

Refer to the Instructions for Use for information about patient ven‐tilation.

• Proceed

Patient Ventilation Control

Current patient ventilation level

Level 5 is recommended.

Use the <+> and <‐> buttons above to modify the patient ventila‐tion level.

Refer to the Instructions for Use for information about patient ven‐tilation.

• Proceed

Scanning in First Level Controlled Operating Mode

Medical Supervision of the patient required.



Specific Absorption Rate Original: <baseline value> W/Kg



Specific Absorption Rate Original: <baseline value> W/Kg



Peripheral Nerve Stimulation Original: <baseline value>%



Peripheral Nerve Stimulation Original: <baseline value>%



Symbols on System, Coils and AccessoriesThe following symbols are used with on system if applicable.

Important messages and indications, Symbols Symbols on System, Coils and Accessories

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General symbols Meaning

Type B applied part (IEC 60601‐1)

Type BF applied part (IEC 60601‐1)

Mandatory Action symbols Meaning

Consult manual (Instructions for use)

Hearing protection required

ONLY screened and approved devices allowed in scanning room

Prohibition symbols Meaning

Active implants, metallic implants prohibited

Metallic implants prohibited

Metallic body implants prohibited


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Prohibition symbols Meaning

Loose ferromagnetic objects and mechanical watches prohibited

Loose ferromagnetic tools prohibited

Wheel chairs and equivalent metal objects prohibited

Magnetic media prohibited (credit cards, diskettes, magnetic tapes)

Loading prohibited

Label on (dS) T/R Knee 16ch 3.0T coil:Scanning pediatric patients is not allowed with this coil

Hazard Identification symbols Meaning

Warning, consult manual (Instructions for use)

Strong magnetic field

Important messages and indications, Symbols Symbols on System, Coils and Accessories

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Hazard Identification symbols Meaning

High frequency electromagnetic field

Danger of pinching

Laser light

Safety marking plate Explanation

Examination room door safety marking plate.

For explanation of symbols see other tables in this chap‐ter.

Medical symbols Meaning

ECG


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Medical symbols Meaning

Peripheral pulse/blood pressure

Disposal symbol Meaning

Dispose of in accordance with your local regulation.

Environmental symbol Meaning

The environment‐friendly use period of this product is 50 years. (accord‐ing to People's Republic of China Electronics Industry Standard SJ/T11364‐2006)

Philips Healthcare is part of Royal Philips

www.philips.com/[email protected]

Manufacturer’s addressPhilips Medical Systems Nederland B.V.Veenpluis 4‐65684 PC BestThe Netherlands

EU RepresentativePhilips Medical Systems Nederland B.V.Quality & Regulatory AffairsVeenpluis 4‐65684 PC BestThe Netherlands

Copyright addressPhilips Medical Systems Nederland B.V.Veenpluis 4‐65684 PC BestThe Netherlands

0344

© 2014 Koninklijke Philips N.V.All rights are reserved. Reproduction or transmission in whole or in part, in any form or by any means, electronic, mechanical or otherwise, is prohib‐ited without the prior written consent of the copyright owner.

Printed in The Netherlands4598 006 44761/781 * 03/2014 *7 ‐ en‐US

Documents

TD p60 int pnl - Miraheze · PDF fileTable of contents Achieva 3 Philips Healthcare 4598 006 44761/781 * 03/2014 *7 Table of contents 1 Introduction