Professional Documents
Culture Documents
A CHIEVA 0-1
2.6 Gradient field strength (gradient output) .................................. 2-13
2.6.1 Gradient output.............................................................2-13
2.6.2 PNS levels .....................................................................2-14
2.6.3 Defining a scan..............................................................2-15
2.7 Electrical safety .......................................................................... 2-16
2.8 Explosion safety ......................................................................... 2-16
2.9 Mechanical safety ...................................................................... 2-17
2.9.1 Tabletop movement in the event of an electrical power
failure ...........................................................................2-17
2.9.2 Manual override switch..................................................2-18
2.9.3 Vertical tabletop movement.............................................2-18
2.10 Fire safety .................................................................................. 2-18
2.11 Safety with liquid helium .......................................................... 2-19
2.12 Safety with helium gas ............................................................... 2-20
2.13 Laser light radiation safety (Light visor) ..................................... 2-21
2.14 Emergency procedures ............................................................... 2-22
2.15 Image quality ............................................................................ 2-24
2.15.1 Intrinsic artifacts............................................................2-24
2.15.2 Extrinsic artifacts ...........................................................2-24
2.16 Fluids in phantoms .................................................................... 2-25
2.16.1 Phantoms for 1.5T systems..............................................2-25
2.16.2 Phantoms for 3.0T systems..............................................2-26
2.16.3 Spectroscopy phantoms ....................................................2-27
2.17 Liquid in Gradient System ........................................................ 2-28
2.18 Safety directions concerning a routine MR examination ............ 2-29
2.18.1 Screening prior to MR examination.................................2-29
2.18.2 Contra-indications .........................................................2-30
2.18.3 Patient support and tabletop ...........................................2-33
2.18.4 Communication.............................................................2-33
2.18.5 Acoustic noise protection .................................................2-33
2.18.6 Patient clothing and positioning......................................2-34
2.18.7 Total body scanning........................................................2-36
2.18.8 ECG/VCG ....................................................................2-37
2.18.9 RF receive coils...............................................................2-38
2.18.10 SENSE T/R Knee coil16 ................................................2-39
2.18.11 SENSE XL Torso coil 16 3.0T........................................2-39
0-2 A CHIEVA
2.18.12 Endo-cavitary coil for 1.5T systems .................................2-39
2.18.13 Endo coil with disposable probe.......................................2-41
2.18.14 Coil and cable positioning ..............................................2-43
2.18.15 Moving the patient into the magnet bore..........................2-46
2.18.16 Monitoring ....................................................................2-46
2.18.17 Stereotactic Localization Device ......................................2-47
2.18.18 MammoTrak .................................................................2-47
2.18.19 Acoustic Hood................................................................2-50
2.18.20 BOLD imaging package .................................................2-51
2.18.21 Imaging Techniques........................................................2-51
2.18.22 Data export ...................................................................2-55
2.19 Spectroscopy ............................................................................. 2-55
2.19.1 On Planscan and Review planscan ..................................2-56
2.20 Network safety, security and privacy .......................................... 2-57
2.21 Important messages and indications .......................................... 2-58
2.21.1 Messages concerning the cooling system.............................2-60
2.22 Third party equipment .............................................................. 2-61
2.23 Symbols on the system .............................................................. 2-63
A CHIEVA 0-3
4.2 Screen organization ..................................................................... 4-1
4.2.1 Basic viewing...................................................................4-1
4.2.2 Advanced Viewing ...........................................................4-5
4.3 Keyboard ................................................................................... 4-10
4.3.1 Keyboard overlay............................................................4-10
4.3.2 Stop scan (F12)..............................................................4-10
4.4 Workflow .................................................................................. 4-10
4.5 Preparation for scanning ............................................................ 4-11
4.5.1 Non-magnetic equipment ...............................................4-11
4.5.2 Information towards patient ...........................................4-11
4.5.3 Special cases ...................................................................4-11
4.6 Entering Patient data ................................................................. 4-12
4.6.1 New patient...................................................................4-12
4.7 Patient positioning .................................................................... 4-12
4.8 Run / Create an ExamCard ....................................................... 4-14
4.9 Viewing images ......................................................................... 4-15
4.10 Storage and Transfer of Patient Data ......................................... 4-17
4.11 Exit system software .................................................................. 4-18
4.11.1 Shutdown the computer..................................................4-18
4.12 System start up and switch off ................................................... 4-19
4.12.1 Computer start up..........................................................4-19
4.13 Hospital administrator and user accounts .................................. 4-20
4.14 Help system, User documentation, Instructions for Use and
Technical description ................................................................ 4-21
4.14.1 Accessing from the application software ............................4-21
4.14.2 Accessing from the Windows Start menu ..........................4-22
4.15 Language settings ...................................................................... 4-23
4.16 Hospital/Institution name setting .............................................. 4-24
4.17 Using USB storage devices ........................................................ 4-25
4.17.1 USB Hard Drives ..........................................................4-25
4.18 Remote Desktop ....................................................................... 4-27
4.18.1 Workflow.......................................................................4-28
4.19 Remote Software Installation (RSI) ........................................... 4-31
0-4 A CHIEVA
5 Maintenance ........................................................................................ 5-1
5.1 Planned maintenance .................................................................. 5-1
5.2 User routine checks program ....................................................... 5-1
5.2.1 Weekly magnet check ........................................................5-2
5.2.2 Topping up liquid helium .................................................5-2
5.2.3 Periodic image quality test (PIQT) ....................................5-2
5.2.4 Anti-virus updates............................................................5-3
5.3 Cleaning and disinfection ............................................................ 5-3
5.3.1 Cleaning..........................................................................5-4
5.3.2 Disinfection .....................................................................5-5
A CHIEVA 0-5
0-6 A CHIEVA
1
Principle of operation
Philips Achieva systems are Magnetic Resonance Imaging systems. Their
operation is based on the principle that certain atomic nuclei present in the
human body will emit a weak relaxation signal when placed in a strong
magnetic field and excited by a radio signal at the precession frequency.
The emitted relaxation signals are analyzed by the system and a computed
image reconstruction is displayed on a video screen.
These Instructions for Use are intended to assist users and operators in the
safe and effective operation of the system described.
The ‘user’ is considered to be the body with authority over the system;
‘operators’ are those persons who actually handle the system.
Before attempting to operate the system, you must read, note and strictly
observe all DANGER notices and safety markings on the systems.
A CHIEVA 1-1
Before attempting to operate the system, you must read these Instructions for
Use thoroughly, paying particular attention to all WARNINGS, Cautions
and Notes incorporated in it. You must pay special attention to all the
information given and procedures described in the SAFETY section.
WA R N I N G WARNINGS are directions which if not followed could cause fatal or serious injury to
an operator, patient or any other person, or could lead to a misdiagnosis.
CAUTION Cautions are directions which if not followed could cause damage to the system
described in these Instructions for Use and/or any other equipment or goods, and/or
cause environmental pollution.
Within this These Instructions for Use, the most extensive configuration of
the system is described, with the maximum number of options and
accessories. Not every function described may be available on your system.
Technical description
Apart from these Instructions for Use, Philips also produces a Technical
Description (in English only). It provides additional data essential for safe
operation and measures or conditions necessary for installing the MR system.
The Technical Description can be accessed from the Windows Start Menu. It
does not describe upgraded systems.
1-2 A CHIEVA
1
be used when the safety related siting instructions are fulfilled and
maintained, including the realization of a controlled access area. Also the
siting requirements for required power and cooling supplies, as indicated by
the manufacturer, must be fulfilled and a preventive maintenance program
for both the system and siting requirements must be operational.
A CHIEVA 1-3
regulations which have the force of law. Both users and operators must be
trained appropriately and have taken notice especially of the safety
paragraphs in these Instructions for Use.
WA R N I N G In the United States, Federal law restricts this device to sale, distribution, and use by or
on the order of a physician.
1.4 Compatibility
The system described in these Instructions for Use should not be used in
combination with other equipment or components unless such other
equipment or components are expressly recognised as MR safe or MR
conditional with the system by Philips Healthcare.
Changes and/or additions to the system should only be carried out by Philips
Healthcare or by third parties expressly authorised by Philips Healthcare to
do so. Such changes and/or additions must comply with all applicable laws
and regulations that have the force of law within the jurisdiction(s)
concerned, and with best engineering practice.
Changes and/or additions to the system that are carried out by persons
without the appropriate training and/or using unapproved spare parts may
lead to the PMS warranty being voided. As with all complex technical
systems, maintenance by persons not appropriately qualified and/or using
unapproved spare parts carries serious risks of damage to the system and of
personal injury.
1.5 Compliance
The Philips Achieva systems comply with relevant international and national
standards and laws. Information on compliance will be supplied on request
by your local PMS representative.
1-4 A CHIEVA
1
The Philips Achieva systems comply with relevant international and national
law and standards on EMC (electromagnetic compatibility) for this type of
equipment when used as intended. Such laws and standards define both the
permissible electromagnetic emission levels from equipment, and its required
immunity to electromagnetic interference from external sources.
1.6 Training
Users of the system must have received adequate training on its safe and
effective use before attempting to operate the system described in this.
Training requirements for this type of device will vary from country to
country. Users have to make sure that operators receive adequate training in
accordance with local laws or regulations which have the force of law.
If you require further information about training in the use of this system,
please contact your local Philips Healthcare representative. Alternatively
contact the manufacturer.
On the MR system you can also access a Help system. This Help system gives
you basic and advanced scanning information.
The MR system software includes a context sensitive Help functionality. This
functionality will lead you directly to the related topic of the Help system.
A CHIEVA 1-5
• the electrical installation of the technical room complies with the
appropriate requirements, and
• the Achieva system is used in accordance with the Instructions for Use.
WA R N I N G This system may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures, such as reorienting or
relocating the equipment or system or shielding the location.
EQUIPMENT CLASSIFICATION
Classification according to IEC-60601-1
According to the type of protection against Class I equipment.
electrical shock:
According to the degree of protection against Type BF applied parts
electric shock:
According to the degree of protection against Ordinary equipment (enclosed equipment
harmful ingress of water: without protection against ingress of water).
According to the methods of sterilization or Non sterilizable. Use of Liquid surface
disinfection: disinfectants only.
According to the mode of operation: Continuous operation.
1-6 A CHIEVA
2 Safety
2
Philips Healthcare products are all designed to meet stringent safety
standards. However, all medical electrical equipment require proper
operation and maintenance, particularly with regard to human safety.
It is vital
• that you read, note, and where applicable strictly observe all DANGER
notices and safety markings on the system,
• that you follow strictly all safety directions under the heading SAFETY
and all WARNINGS and Cautions throughout this manual, to help
ensure the safety of both patients and operators.
In particular, you must read, understand and know the Emergency procedures
(section 2.14 ‘Emergency procedures’) before attempting to use the system
for any examination.
A CHIEVA 2-1
• The levels of exposure at which the Normal Operating Mode is left and First level
controlled operation mode is entered are specified in IEC 60601-2-33 and are based
on current scientific literature related to safety.
• The decision on leaving the normal operating mode and entering the first level
controlled operation mode and the possible need for physiological monitoring of
the patients shall be a medical judgement as to the patients potential risk versus
benefit.
WA R N I N G Do not use the system for any application until you have read, understood and know
all the safety information, safety procedures and emergency procedures contained in
this SAFETY chapter.
Operation of the system without a proper awareness of how to use it safely
could lead to fatal or serious personal injury and to clinical misdiagnosis.
N OT E In some countries legislation may exist covering occupational limits for exposure to
EMF (Electro-Magnetic Fields).
WA R N I N G Do not use the system for any application until you have received adequate and
proper training in its safe and effective operation.
2-2 A CHIEVA
If you are unsure of your ability to operate this system safely and effectively
DO NOT USE IT. Operation of this system without proper and adequate
training could lead to fatal or serious personal injury and to clinical
misdiagnosis. 2
For information about training, please refer to Section 1.6 ‘Training’ of this
manual.
WA R N I N G S • Do not use the system for any purpose other than those for which it is intended.
• Do not use the system with any system/devices/accessories other than those which
Philips Healthcare recognises as tested.
Operation of the system for unintended purposes, or with untested
equipment, could lead to fatal or serious injury and to clinical
misdiagnosis.
Intended use of the system is described in Section 1.3 ‘Intended use’ of this
manual, compatibility in Section 1.4 ‘Compatibility’ of this manual.
N OT E S Specific application warnings and notes are described in the online help system.
These warnings and notes involve:
• Intravenous lines application
• Coil application, correct use and cable handling
• Patient positioning
• Possible misinterpretation related to scan techniques
WA R N I N G S • Do not use the system for any application until you are sure that the User Routine
Checks Program has been satisfactorily completed, and that the Planned
Maintenance Program is up to date.
• If any part of the equipment or system is known (or suspected) to be defective or
wrongly-adjusted, DO NOT USE the system until a repair has been made.
A CHIEVA 2-3
Operation of the equipment or system with defective or wrongly-adjusted
components could expose the operator or the patient to safety hazards.
This could lead to fatal or other serious personal injury, or to clinical
misdiagnosis.
• Do not start an examination with the system when the examination-room door is
open.
Operation of the system with the examination-room door open can cause
malfunction of other (medical) devices outside the examination room and
consequently may lead to personal injury.
Other (medical) devices could also interfere with the MR system, possibly
resulting in image artifacts.
• Never use surface coils, cable traps and cables which are damaged.
A damaged cable or connector is hazardous because of high voltage across
the cable during the transmit phase of the system. Sharp edges may cause
injury to patient’s skin.
• Changes to the system and repairs that are carried out by persons without the
appropriate training may lead to the Philips Healthcare warranty being voided.
As with all complex technical equipment, maintenance by persons not
appropriately qualified carries serious risks of damage to the system and of
personal injury.
The user of this product shall have the sole responsibility for any
malfunction which results from improper use, faulty maintenance,
improper repair, damage, or alteration by anyone other than Philips
Healthcare, or its authorized service personnel.
• It is not permitted to log into the system via a terminal or PC as this may interfere
with the running of the system.
• Damaged coils which are returned to Philips Healthcare must be cleaned by the
user as good as practically possible.
(For Japan: please contact Philips Healthcare Japan for returning damaged coils.)
You can find information about the User Routine Checks Program and the
Planned Maintenance Program in chapter 5 ‘Maintenance’ of this manual.
WA R N I N G Never attempt to remove, modify, over-ride or frustrate any safety device on the
equipment or examination room. See also section 3.5 ‘Safety devices’.
2-4 A CHIEVA
Interfering with safety devices could lead to fatal or other serious personal
injury.
N OT E For detailed instructions on cleaning Endo-cavitary coils see section 2.18.12 ‘Endo-
cavitary coil for 1.5T systems’ and section 2.18.13 ‘Endo coil with disposable probe’
A CHIEVA 2-5
2.3 Magnetic safety
N OT E In some countries, legislation may exist prohibiting very high magnetic fields (>2T) for
routine clinical use.
WA R N I N G In First level controlled operating mode, patients may experience dizziness and vertigo
or metallic taste in the mouth when the head is moved rapidly in the MR system.
Patients and technicians must therefore move slowly in the magnetic field
The Controlled Access Area should be marked by the user at all entries by an
appropriate warning sign, e.g.
DANGER - HIGH MAGNETIC FIELD
See section 2.23 ‘Symbols on the system’.
2-6 A CHIEVA
6m 6m 6m
0,5 mT (5 Gauss)
5m 5m 5m
0,5 mT (5 Gauss)
2
4m 0,5 mT (5 Gauss) 4m 4m
3m 3m 3m
2m 2m 2m
4m 3m 2m 2m 3m 4m 4m 3m 2m 2m 3m 4m 4m 3m 2m 2m 3m 4m
2m 2m 2m
3m 3m 3m
4m 4m 4m
5m 5m 5m
Figure 2.1 Top view with 0.5 mT (5 Gauss) lines for 1.5T, XR 1.5T and 3.0T systems.
WA R N I N G S • Objects made of iron or other magnetic materials must not be brought into the
Controlled Access Area:
- Scissors, pocket knifes, lighters, keys, coins, etc.
- Vacuum cleaners, floor polishers, etc.
- Magnetic wheel chair, magnetic trolley, iron stretchers, etc.
Such objects will be attracted by the magnet and may lead to serious or
fatal injury of the patient or operating personnel and may cause system
malfunctions.
A CHIEVA 2-7
Portable metal detectors can be used to check patients and other persons for
metal objects.
CAUTION
Information on magnetic media, such as magnetic strips on credit cards, diskettes and
tapes, may be erased by a magnetic field strength higher than 0.5 mT (= 5 Gauss). Do
not bring magnetic media into the Controlled Access Area.
The perimeters of the Controlled Access Area usually coincide with the walls
of the RF room shield. Inside this shield:
• Elevated RF levels or the magnetic fringe field may disturb electronic
equipment other than equipment tested by Philips.
• The presence of such equipment may interfere with the operation of the
MR system.
N OT E It is the responsibility of the user to establish adequate rules and emergency
procedures for controlling access to the Controlled Access Area in terms of the
potential risk to patients and staff.
2-8 A CHIEVA
Limitation An emergency removal of the magnetic field causes a large amount
of liquid helium to evaporate and can only be restarted by a
Customer Support engineer, which takes about a day to complete.
2
It is therefore very expensive.
Warning label A label with the following text is displayed at the button:
Emergency stop button
Operation of this button will de-energize the magnet
WARNING!
Energizing the magnet is a long and very costly process.
A CHIEVA 2-9
2.5 Specific Absorption Rate (SAR)
The scan procedures always involve the emission of radio frequency (RF)
energy. This RF can heat the patient, and hence, is of concern. The Specific
Absorption Rate (SAR) is the RF power absorbed by the patient per unit
mass expressed in Watts per kg (W/kg).
There are different SAR types each with its own limit:
Whole body SAR the SAR averaged over the total mass of the patient.
Head SAR the SAR averaged over the mass of the patients head.
Local torso SAR the SAR averaged over any 10g of tissue of the patient.
Local extremities SAR the SAR averaged over any 10g of extremity tissue of the
patient.
For each scan one of these SAR types is the limiting SAR type. This is the
SAR type which imposes the strongest restriction on the scan. It depends on
the static magnetic field, the patient position and the transmit or receive coil
applied.
The predicted SAR is calculated for each scan and is a conservative estimate.
Information on the limiting SAR type and expected SAR values for the scan
is displayed on the info page:
Limiting SAR type = whole body, head, local torso or local extremities.
x % = The predicted SAR expressed as a percentage of the maximum for the limiting SAR type.
x W/kg = The predicted SAR for the limiting SAR type.
y W/kg = The predicted whole body SAR.
n = Operating mode (0 or I)
2-10 A CHIEVA
IEC SAR limits Safety measures
Operating
mode
2
Level 0 • Whole body SAR less than or equal to 2 W/kg • Routine patient
(Normal) • Head SAR less than or equal to 3.2W/kg monitoring
• Local torso SAR less than or equal to 10W/kg*
• Local extremities SAR less than or equal to 20W/kg*
Level I • Whole body SAR greater-than or equal to 2 W/kg • Routine patient
(First level and less than or equal to 4 W/kg monitoring
controlled) • Head SAR less than or equal to 3.2W/kg • Particular caution
• Local torso SAR less than or equal to 10W/kg* for patients at risk
• Local extremities SAR less than or equal to 20W/kg*
Level II • Whole body SAR greater-than 4 W/kg The system is limited.
(Second level • Head SAR greater-than 3.2W/kg Level II cannot be
controlled) • Local torso SAR greater-than10W/kg* reached.
• Local extremities SAR greater-than 20W/kg*
A CHIEVA 2-11
• Patients who are unconscious, heavily sedated, or confused, and with
whom no reliable communication can be maintained
• Patients with fever, reduced thermal regulatory capabilities or increased
sensitivity to raised body temperature
• Patients who are thermally insulated. (e.g. in a gypsum cast)
WA R N I N G • The whole body SAR limits are only valid for room temperatures not greater than
24oC and relative humidities not greater than 60%, as specified in the system
installation procedures.
The temperature of the air in the examination room is continuously
monitored by the system. A Warning message is displayed when the room
temperatures is greater than 24oC.
If these conditions are exceeded, e.g. if the patient is warmed by means of
a heated blanket, the whole body SAR must not be greater than 2.0 W/kg
and patient's condition must be monitored.
2-12 A CHIEVA
2.5.3 High SAR scanning
It is advised to use high whole body SAR levels (above 2.5Watt/kg) only if
absolutely necessary. For patient comfort lower SAR levels are preferred, 2
scanning in high SAR mode may result in perspiration of the patient.
WA R N I N G S • Patients who are exposed to high SAR values must be dressed in light clothing (e.g.
light pajamas, nightshirt or T-shirt).
• For scanning a baby in an incubator it is advised to only scan in normal operating
mode. This will avoid a too high SAR value for the baby in the warm and humid
incubator environment.
N OT E For high SAR scanning it is advised to plan breaks between the scans for the patient to
cool down. The breaks can be created by planning low SAR scans between the high
SAR scans.
A CHIEVA 2-13
• PNS/level x%/n
The operator has to decide whether to accept the parameter settings for
execution of the scan or to cancel. If cancelled the parameter settings can be
modified to decrease the gradient output below the PPNS limit.
2-14 A CHIEVA
N OT E This message may be combined with the message warning that a certain SAR value will
be exceeded. See section 2.5 ‘Specific Absorption Rate (SAR)’.
See section 2.5.1 ‘Operating modes’ for patients at risk.
2
Safety Measures
For scans which may produce peripheral nerve stimulation attention must be
paid to the following:
• Inform the patient that peripheral nerve stimulation may occur and describe the
nature of the sensation.
• Clasping hands can create a conductive loop and increase the possibility of
stimulation, therefore it is recommended not to clasp hands.
• Maintain permanent contact with the patient during the scan either directly or via
an observation monitor and intercom.
• If signs of stimulation are observed or reported, terminate the scan.
• Patients should be positioned with the arms alongside the body to reduce the
likelihood of Peripheral Nerve Stimulation. Metal parts such as rings, zippers, belts
may start to vibrate and interpreted as PNS.
A CHIEVA 2-15
• "high": the maximum allowed gradient output will be limited to 100% of
the mean threshold level, i.e. the system may operate in the first level
controlled operating mode.
The probability of PNS is about 50% and may be experienced as painful.
However, the patient may have more tolerance for PNS when properly
informed and motivated.
WA R N I N G S • Do not remove covers or cables from the equipment. High electrical voltages are
present within the equipment.
Removing covers or cables could lead to serious or fatal personal injury.
• Covers, cables or components should only be removed by qualified and authorised
Customer Support personnel.
In this context, qualified means those legally permitted to work on this
type of medical electrical equipment in the jurisdiction(s) in which the
equipment is being used, and authorised means those authorised by the
user of the equipment.
• Do not allow water or other liquids to enter the equipment as they may cause short-
circuits or corrosion. There is no danger from urine and vomit passed by the patient
or from leaking intervention lines.
Only use the MR system in rooms or areas that comply with all applicable
law (or regulations having the force of law) concerning electrical safety for
this type of equipment.
2-16 A CHIEVA
The resultant vapour could ignite, causing fatal or other serious personal
injury and/or damage to equipment.
• When scanning anesthetized patients the use of flammable anaesthetic mixtures
2
with air, oxygen or nitrous oxide is not allowed at the system.
Philips MR systems are not AP (Anaesthetic-Proof ) or APG (Anaesthetic-
Proof Category G) tested.
WA R N I N G S • Special care must be taken that no objects or body parts (e.g. patient in a
wheelchair) are present near the tabletop while lowering the patient support.
Objects can get trapped between tabletop and floor which may lead to
damage or personal injury.
• Do not remove the covers from the patient support as it contains moving parts.
Removing the covers could lead to serious or fatal injury.
The motor driven vertical and horizontal movements are interrupted when
the sensor plate beneath the magnet aperture is pressed.
A CHIEVA 2-17
2.9.2 Manual override switch
If the control electronics break down, it will still be possible to move the
patient support to the highest position and continue scanning. The ‘Manual
override’ switch is located at the magnet end under the patient support.
2-18 A CHIEVA
• Fire regulations for the type of medical area being used should be fully
applied, observed and enforced.
• The fire precautions stated in this section should be discussed with the 2
local fire department and fire emergency precaution procedures should be
established.
A CHIEVA 2-19
Filling with liquid helium
• Liquid helium is extremely cold and can freeze human tissues. Always use protective
gloves. Injuries caused by freezing must be washed with water and treated as burns.
• There is danger of suffocation as the evaporating helium will dilute or displace the
oxygen in the air. Always ensure that the examination room and the storage room
for liquid gases are well ventilated.
• If liquid helium is accidentally released in the examination room, accumulation of
liquid oxygen may occur, resulting in a potential fire hazard.
2-20 A CHIEVA
WA R N I N G S • A magnet quench must immediately be reported to your Philips support
organization to take proper action. Failure to do so may result in the necessity to 2
perform a costly and time-consuming magnet de-icing procedure, or possible
permanent magnet damage.
• It is the responsibility of the hospital to establish emergency procedures in the event
of quench of the magnet, especially for situations in which the venting system of the
magnet fails and helium gas is released into the examination room.
• In the 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 could build up in
the examination room forming clouds of cold mist.
- Open the door of the examination room.
- Immediately evacuate the patient and personnel from the examination
room.
WA R N I N G S • Do not stare into the beam, Class II (FDA) / Class 2 (IEC) laser.
• Use the Light visor for its intended use only, avoid unnecessary exposure to laser
radiation.
• For non-responsive patients (babies, anesthetized patients) provide adequate
protection to avoid direct laser light in the eyes.
• Use of controls, adjustments or procedures other than those specified in this manual
may result in hazardous radiation exposure.
A CHIEVA 2-21
Labelling
The following warning labels are put on the system:
Outside front cover
CAUTION LABEL
CAUTION
Laser radiation
Do not stare into beam
Max output < 0.35 mW
Emitted wavelength 635nm
Class II Laser product
CAUTION LABEL
Laser radiation
Do not stare into beam
Class 2 Laser product
Max output< 0.35 mW
Emitted wavelength 635 nm
LABEL
LASER APERTURE
WA R N I N G It is required for the hospital to establish emergency procedures for the following
situations:
• emergency medical procedures.
• unauthorized people entering the controlled access area.
2-22 A CHIEVA
• the need for an emergency field shut down.
• fire precautions
• in case of a quench of the magnet.
2
A procedure must be established for rapid removal of the patient from the
examination room in the event of an emergency, if necessary with a
Emergency field shut down as described in section 2.3.4 ‘Magnet
EMERGENCY STOP button’.
In addition, precautions should be taken and an appropriate plan should be
established for use of emergency equipment outside the examination room,
especially for the following classes of patients:
• patients at risk of cardiac arrest
• patients predisposed to seizures or claustrophobic reactions
• patients who are very sick, sedated, confused, or unconscious
• patients with whom no reliable communication can be maintained
WA R N I N G Electronic or other metallic emergency equipment must not be brought into the
examination room.
TTR buttons
• Pressing one of the ‘TTR’ buttons will release the tabletop and allow the
operator to move it out of the magnet and remove the patient even in the
event of power failure.
The red ‘TableTop Release’ buttons (TTR) are located on each side of the
patient support.
To re-enable motorized movement, press the same ‘TTR’ button again.
When a ‘TTR’ button has been pressed to release the tabletop the led of
the Manual mode button will flash.
Pressing the ‘Stop table’ button on the Patient Support Control Panel will
stop the tabletop. This can be reset using the ‘Manual’ button.
A CHIEVA 2-23
2.15 Image quality
WA R N I N G MR images may demonstrate structures that are not present in the patient, which may
lead to misinterpretation.
These structures may occur as a result of technological and physiological
factors or can be introduced by metallic or magnetic objects in the patient.
Technological factors can be spurious signal generated by system components
or other source in the immediate area of the system
WA R N I N G Do not allow magnetic objects or non-magnetic metallic objects to be brought into the
magnet, unless this is needed for the specific study and properly controlled (e.g. biopsy
needles).
2-24 A CHIEVA
2.16 Fluids in phantoms
2
WA R N I N G All phantoms must be handled with care to prevent damage, and spilling of the fluid
contents.
If the phantoms are not used, the phantoms must be stored in the wooden
box and closed appropriately. Note that the contents of the phantoms may
irritate the skin. Washing with water after contact with the human skin is
sufficient.
A CHIEVA 2-25
Fluid in Bottle phantoms
Emergency actions • Spillage: Absorb the liquid in dry sand, diatomite, vermiculite
etc. Shovel the mixture into plastic bags and remove to a
chemical waste depot.
First aid • Skin contact: Rinse for a long time with plenty of water, then
wash with soap and water.
• Eyes: Rinse for a long time with plenty of water.
2-26 A CHIEVA
2.16.3 Spectroscopy phantoms
Proton Phantoms
2
Fluid in proton sphere phantoms A
Personal protection • Eyes: safety goggles
Constituents • 5 ml/l 98% acetate (CH3COOH)
• 10 ml/l 80% ethanol (CH3CH2OH)
• 8 ml/l 98% Phosphorus acid (H3PO4)
• 1 ml/l 1% arquad solution + 120 mg/l CuSO4 in demi water.
Total contents • 524 cc
Emergency actions • Spillage: Absorb the liquid in dry sand, diatomite, vermiculite
etc. Shovel the mixture into plastic bags and remove to a
chemical waste depot.
First aid • Skin contact: Rinse for a long time with plenty of water, then
wash with soap and water.
• Eyes: Rinse for a long time with plenty of water.
Phosphorus phantoms
A CHIEVA 2-27
Fluid in phosphorus disk phantoms A
Emergency actions • Spillage: Absorb the liquid in dry sand, diatomite, vermiculite
etc. Shovel the mixture into plastic bags and remove to a
chemical waste depot.
First aid • Skin contact: Rinse for a long time with plenty of water, then
wash with soap and water.
• Eyes: Rinse for a long time with plenty of water.
Gradient amplifier
Constituents • Distilled water 50%
• Dowtherm SR1 9 (dyed pink) 50%, consisting of:
- Ethylene glycol CAS#000107-21-1 (>95%)
- Dipothassium Phosphate CAS#007758-11-4 (<3%)
- Water CAS#007732-18-5 (<3%)
Toxicity The coolant may irritate the skin by contact.
Emergency actions in • Absorb the liquid with an appropriate absorbent (e.g.
case of a leakage powersorb, dry sand, diatomite etc.).
• Dispose the used absorbent of (in plastic bags) according local
legislations for chemical waste.
• After a leakage, the gradient amplifier cooling system needs
topping up. Contact your local Customer Support
representative.
2-28 A CHIEVA
Gradient amplifier
First aid • Skin contact: Immediately remove contaminated clothing and
rinse the skin with plenty of water.
2
• Eyes: Rinse for a long time with plenty of water.
A CHIEVA 2-29
• Patients with a higher than normal likelihood of requiring emergency
medical treatment, e.g. due to their present medical condition.
• Patients with a higher than normal likelihood of requiring emergency
medical treatment as a result of the strong fields applied, when the system
is operating in first level controlled operating mode.
2.18.2 Contra-indications
• The magnetic and electromagnetic fields may exert strong forces on the metallic
implants, may result in heating of the components of the implants or may interfere
with the operation of these devices.
- e.g. Cardiac pacemakers and Conductive wires
The magnetic and electromagnetic fields may exert strong forces on the
metallic implants or may interfere with the operation of these devices.
- Insulin pumps, nerve stimulators, cochlear implants
These are not necessarily contra-indications, but the examination may
damage or impair them. Consult the referring doctor or radiologist.
WA R N I N G Most metallic implants are only tested for field strengths up to 1.5T.
For 3.0T systems extra care is necessary.
2-30 A CHIEVA
• Metal splinters
Danger of movement depends on location, size and time in situ.
Movement can be limited by fibrosis. Small splinters of 1 mm or less can 2
cause image artifacts and/or patient discomfort. Splinters are a potential
hazard to the patient (if located in the orbit, for example). Ask the patient
if he/she has ever worked in a metal industry or has had shrapnel injuries.
• Pregnancy
Although there have been no documented adverse fetal effects reported it
is the responsibility of the physician to judge the risks/benefits of scanning
a pregnant patient.
When scanning a pregnant patient it is advised that the SAR level be
limited to below 2W/kg (normal mode of operation).
• Patches
Medicinal products in transdermal patches (e.g. nitroglycerin transdermal
delivery patch) may cause burns to the underlying skin due to absorption
of RF energy. The supplier of the patches should be consulted or the patch
should be removed to avoid burns.
A new patch should be applied after the examination.
A CHIEVA 2-31
• Iron or other magnetic objects must not be brought into the neighborhood of the
magnet e.g.
- scissors, pocket knifes
- coins, keys, lighters
- vacuum cleaners
- magnetic trolley, magnetic wheel chair, iron stretchers
Such objects will be attracted by the magnet with a force many times
higher than the earth’s gravity force. This may cause serious or fatal injury
to persons or damage to the system.
• All clothing containing metallic thread or components and all other metallic objects
must be removed from the patient e.g.
- spectacles, dentures
- prostheses, hearing aids, arch supports
- watches, jewelry, medallions
- piercings
- buttons, hairpins, safety pins, buckles
- wigs, hair pieces
- clothing with zips and/or metal buttons
- bra
Failure to do so may result in excessive local heating due to absorption of
RF energy and may also influence the homogeneity of the magnetic field
and lead to clinical misdiagnosis.
CAUTIONS • The operator must inform the patient about the possibility of some system
components (RF coils, interface boxes) warming up during scanning as a result of
the applied electric energy.
Warm elements may frighten the patient when touched. All system
components fulfil the requirements as defined in the IEC standards.
• The operator must inform parents who are accompanying their child in the
examination room, that during scanning physical contact with the child in the
scanner is to be avoided.
Physical contact may result in excessive local tissue heating.
2-32 A CHIEVA
2.18.3 Patient support and tabletop
2
WA R N I N G Use the special arm supports of the accessory set to avoid finger pinching..
The arm supports prevent the patient to grab around the table sides, which
avoids the fingers to get trapped during horizontal table motion, see
2.18.4 Communication
• The ‘Nurse call pinch ball’ must be given to every patient to ensure communication
between the patient and the operator at all times.
Check correct functioning of the ‘Nurse call’ before each examination.
N OT E Pressing the ‘Nurse call pinch ball’ activates a buzzer that can be heard as long as the
ball is squeezed. When the pinch ball is pressed more than once within 4 s or for more
than 1.5 s, a flashing yellow light will also be activated in the control room to draw the
personnel’s attention.
WA R N I N G S • Always apply hearing protection to the patient and anyone else present in the
examination room before start scanning.
Anesthetized patients are more sensitive to high sound pressure, so that
hearing protection for these patients must not be omitted even at
moderate sound levels.
• For scanning of patients to whom the headset or ear plugs cannot be applied
adequately (e.g. neonates and babies), special attention is required to use other
means to obtain maximum hearing protection for these patients.
• It is MANDATORY to use earplugs when scanning with the gradient mode set to
maximum on a 3.0T Quasar Dual or on a 1.5T Nova or Nova Dual system. For
maximum patient comfort it is recommended to use both earplugs and headphones.
• Special training for the operator is required for fitting earplugs for optimal hearing
protection.
A CHIEVA 2-33
Follow the fitting instructions of the earplug manufacturer to assure
maximum noise protection.
• Only use earplugs which provide acoustic damping of at least 30 dB
• Only use hearing protectors which contain no metal parts.
• Due to increased anxiety, accepted sound level may still be of concern to pregnant
women, to neonates, infants and young children and to elderly.
For neonates and very small children the special Acoustic Hood may be
used to reduce the noise level.
The sound level in the control area must comply with local regulations
concerning exposure to noise at work.
N OT E • It is advised to apply SofTone to reduce the noise level.
The A-weighted RMS sound pressure levels, Laeq, 1h , are measured while using
the MR system in the clinical scan condition when the system is producing
the maximum acoustic noise.
Sound level meter settings:
Detector: r.m.s.
Time weighting: fast or slow
Frequency weighting: A-weighting
Measurement duration: >20s.
2-34 A CHIEVA
• Both ankles are in contact.
• Arms and hands touching other body parts.
• Both hands are in contact. This especially is possible for scanning with
breast coils when patients are imaged lying prone with both arms extended 2
above the head.
Figure 2.3 Current loops (orange arrows) and locations where heating can occur (black
arrows).
A CHIEVA 2-35
1 2 3
WA R N I N G S • Ensure that the Total body tabletop is locked secure on the tabletop before the
patient is positioned.
An unlocked Total body tabletop could suddenly move causing the patient
to fall off and lead to personal injury.
• When using the Total body tabletop with the trolley, ensure that the Total body
tabletop is locked secure on the tabletop before the patient is positioned.
An unlocked Total body tabletop could suddenly move causing the trolley
with tabletop to tip over. This may lead to personal injury.
• Always retract the Total body tabletop completely out of the magnet before
lowering the patient support.
If not fully retracted the Total body tabletop will be damaged and patient
injury may occur.
• The Total body Tabletop is designed for scanning with the patient in "feet first" and
"supine" position only.
2-36 A CHIEVA
2.18.8 ECG/VCG
2
WA R N I N G S
• Do not use the VCG signal for monitoring or diagnostic purposes.
The VCG signal is distorted when the patient is inside the magnet and can
not be used for monitoring or diagnostic purposes. It can only be used as a
trigger signal for cardiac triggered imaging.
• Only use ECG leads provided by Philips Healthcare.
The use of other types of ECG leads may cause heating of the skin.
• Only use MR safe ECG electrodes
The use of other types of ECG electrodes may cause heating of the skin.
Ask your local application representative for MR safe ECG electrodes.
• Before applying the ECG electrodes the patient skin must be prepared with care to
ensure low resistances. See instructions in the system help or in Application Guide
volume1.
• Never reposition or reuse ECG electrodes. Always use new electrodes.
Repositioning or reuse may result in a heating effect, as a result of high
skin resistance.
• Do not use ECG electrodes after they have reached their expiration date.
• Do not use pediatric ECG electrodes on adults and vice versa.
This may result in skin burns.
• Do not place the VCG battery module (VCG or PPU unit) directly on the patient's
skin.
Direct contact may cause heating of the skin. Keep a distance to the
patient's skin of at least 1 cm using pads of the standard accessory set.
• Do not place the VCG battery module (VCG or PPU unit) close to the imaging
volume.
This may cause image artifacts.
• Only use the appropriate InvivoMDE™ battery pack with the VCG module. This
battery pack may only be charged with the InvivoMDE™ battery charger.
N OT E For correct positioning of the electrodes see the system help or the Application Guides.
A CHIEVA 2-37
2.18.9 RF receive coils
Safety and performance considerations
Receive coils can safely be used to investigate any anatomy. The coil
insulation prevents accidental contact with the conductive metal parts. Each
coil has been specially designed for prolonged safe and reliable operation.
All coils are designed to be as robust as possible.
Safety measures
• The operator must always visually inspect the coil before use.
WA R N I N G S • Never use surface coils, cable traps and cables which are damaged.
A damaged cable or connector is hazardous because of high voltage across
the cable during the transmit phase of the system.
Sharp edges may cause injury to patient’s skin.
The coil must be returned to Philips Healthcare Customer Support for
replacement if there is any suspected damage to either the external
covering or the coil's internal components. The patient must never be
allowed to come into contact with the internal coil connections.
• Never use surface coils, coil extension cables and other cables in the magnet bore if
the insulation of a cable or connector is damaged, making the metal shield or leads
visible.
The presence of high voltage across the cable shield beneath the insulation,
due to RF emission during scanning, is hazardous to patients.
• Separable coils
When connected to the system a voltage of 12 volt DC is present at the contacts of
the coil base.
Under normal conditions this voltage is not hazardous to patients. However for
critically ill cardiac patients this low DC voltage may have dramatic consequences.
It must be prevented that these type of patients can touch the contacts while the
coil is connected to the system:
- Always close the coil before connecting it to the system.
- Always disconnect the coil from the system before opening the coil.
- Do not leave unused coils or coil parts on the tabletop.
• Never immerse a coil in liquid.
2-38 A CHIEVA
2.18.10 SENSE T/R Knee coil16
2
WA R N I N G S • Do not scan body parts other than the lower limbs with the SENSE T/R Knee coil16.
• Do not scan pediatric patients with the SENSE T/R Knee coil16 .
WA R N I N G Make sure that the posterior section of the coil is the part on the table and the
anterior section on top of the patient.
WA R N I N G S • Do not use a Endo-cavitary coil for more than 3 months, more than 50 times nor
after the expiration date printed on the coil and its storage box.
• A record shall be kept for each Endo-cavitary coil supplied. Such record shall
contain delivery dates, dates of use and other relevant events (damage, etc.).
The Endo-cavitary coil is made of material that is subject to deterioration
over time as well as to wear and tear.
More frequent use or use after the indicated date may have a negative
influence on the image quality as well as on the physical integrity of the
patient.
• Do not expose Endo-cavitary coils to UV or direct sunlight. Always store the coils in
the storage box at temperatures below 21°C.
Deterioration speed will increase highly when exposed to UV light or high
temperatures.
• Only use clinically approved condoms for the Endo-cavitary coils.
Endo-cavitary coils must always be fitted with a sheath or condom before
insertion into the rectum.
N OT E For USA only: the user should refer to the FDA March 29, 1991 Medical Alert on latex
products, if applicable to the protective sheath selected.
A CHIEVA 2-39
This product contains natural rubber. Natural rubber can cause allergic
reactions such as itching, fever, dyspnea, urtication, asthma, hypotension,
and shock.
When these symptoms occur, immediately stop using the coil and take
proper action.
The Endo-cavitary coil is fitted with a disposable sheath or condom, selected
by the operator, which also may contain Latex.
Contraindications
Do not use the endo cavitary coil when any of the following is indicated:
• Inflammatory bowel disease i.e. ulcerative colitis or Crohn’s disease etc.
• Latex sensitivity.
• Radiation or surgery of the prostate, rectum or surrounding area within the last 8
weeks.
• Rectal fistula.
• Severe hemorrhoids.
• Stricture of the anal canal.
• Any exclusion normally recognized for intrarectal and endorectal devices.
• Gold seed fiducial markers within the last 3 weeks. Please consult your MR safety
officer and manufacturer of the gold seed fiducial markers.
• Brachytherapy seeds within the last 12 weeks. Please consult your MR safety officer
and manufacturer of the brachytherapy seeds.
Use
• Avoid excessive bending of the coil rod.
This can lead to leakage of the non-permeable balloon.
• After insertion, do not rotate the coil once the balloon is inflated.
• After the examination, fully deflate the balloon before removing the coil.
2-40 A CHIEVA
If biosoil/residues are still visible, cleaning must be repeated. After
cleaning, the coil must be rinsed thoroughly with water. Disinfectants may
get cemented to the coil if it is not cleaned properly.
2
Cleaning instructions
• After each patient the coil must be cleaned with a cloth dampened with
detergent. Clean the coil from the balloon up to the grip.
Follow the instructions of the detergent manufacturer.
It is recommended to remove biosoil (blood, mucous, etc.) with a cloth
and rinse the coil before cleaning it with a cloth dampened with detergent.
Disinfection instructions
• After cleaning, disinfect the coil by immersing it vertically from the
balloon up to the last mark of the ruler on the grip in a high-level
disinfectant solution per recommendation below. Do not use low- or
intermediate-level disinfectants.
Follow the instructions of the disinfectant manufacturer.
• Remove any disinfectant solution residue with a soft cloth dampened with
water. Do not allow disinfectant solution to air-dry on the coil.
WA R N I N G S • Do not expose Endo-probes to UV or direct sunlight. Always store the probes in the
storage box at temperatures below 21°C.
Deterioration speed will increase highly when exposed to UV light or high
temperatures.
• The probe (endo-coil) is intended for single use only. The interface device is
reusable.
N OT E • For USA only: the user should refer to the FDA March 29, 1991 Medical Alert on
latex product.
A CHIEVA 2-41
This product contains natural rubber. Natural rubber can cause allergic
reactions such as itching, fever, dyspnea, urtication, asthma, hypotension,
and shock. When these symptoms occur, immediately stop using the coil
and take proper action.
Contraindications
Do not use the endo cavitary coil when any of the following is indicated:
• Inflammatory bowel disease i.e. ulcerative colitis or Crohn’s disease etc.
• Latex sensitivity.
• Radiation or surgery of the prostate, rectum or surrounding area within the last 8
weeks.
• Rectal fistula.
• Severe hemorrhoids.
• Rectal obstruction or stricture.
• Impacted or excessive stool in the rectum.
• Stricture of the anal canal.
• Any exclusion normally recognized for intrarectal and endorectal devices.
• Gold seed fiducial markers within the last 3 weeks. Please consult your MR safety
officer and manufacturer of the gold seed fiducial markers.
• Brachytherapy seeds within the last 12 weeks. Please consult your MR safety officer
and manufacturer of the brachytherapy seeds.
Use
• Avoid excessive bending of the coil rod.
This can lead to leakage of the non-permeable balloon.
• After insertion, do not rotate the coil once the balloon is inflated.
• After the examination, fully deflate the balloon before removing the coil.
2-42 A CHIEVA
WA R N I N G Emergency Patient Removal:
Stop the scan, disconnect the probe from Endo-coil Interface Device, and remove the 2
patient from the examination room. After the patient is removed, deflate the balloon
and remove probe.
WA R N I N G S • Avoid placing cable loops and twisted cables (RF coil cables, interface boxes and
ECG leads) inside the body coil (RF area).
Loops can cause excessive heating of the cables which may result in burns
upon contact to patient’s skin.
A CHIEVA 2-43
The cables must be routed parallel to the axis of the bore.
• Avoid routing of the RF coil cable assembly in proximity to the RF transmit coil.
Avoid direct contact of the patient’s skin with the RF coil cable assembly.
All this may result in excessive local heating and ultimately in skin burns.
Positioning of the RF coil cable assembly must therefore be done with
care. Keep a distance to the patient’s skin of at least 2 cm. Use the special
spacer or pads of the standard accessory set where the cable assembly may
touch the skin.
• Avoid contact of the patient’s body or extremities with the RF transmit coil or
quadrature body coil surface
This may result in excessive local heating.
• Never attempt to bend or force the coil into an abnormal shape.
• Do not place the coil perpendicular to the main magnetic field.
• Always run the cable directly away from the region of interest.
• Position and secure the cable using the clips provided in the accessory gutter
(Achieva 1.5T and 3.0T), or in the grooves under the mattress (3.0T TX systems).
• Do not position any coil interface-box on the patient’s body.
The interface box may be positioned on the patient in exceptional cases
only (e.g Total Neuro studies, see below). Use the special spacer or pads of
the standard accessory set to create a distance to the patients skin.
N OT E Combination of receive coils is restricted by the SW. In case of combination of RF
receive coils, cable handling is even more critical to avoid excessive local heating.
WA R N I N G The combined use of RF coils, high SAR levels and direct skin contact of the coils cables
may cause local cable heating and can lead to skin burns.
Strictly follow the instructions below to avoid the risk of cable heating:
• DO NOT combine the SENSE Body coil with any other Receive Coil.
• Leave a 2 cm distance between the patient’s skin and the RF cables and
interface boxes as described in section 2.18.14 ‘Coil and cable
positioning’.
Contact of the RF coil cable and the patient can be prevented by using the
special spacer and pads of the standard accessory set, see Figure 2.5
(showing the SENSE Flex-S coil in combination with the Head coil).
2-44 A CHIEVA
2
WA R N I N G S • Never scan with the SENSE Head Coil positioned more than 5 centimeters off-
center. Always position the SENSE Head Coil in the isocenter by using the Light
visor.
• Never use the transmit/receive Q-Head Coil, connected or unconnected, when the
Q-Body Coil is used for RF transmission.
• When on the tabletop, all coils must always be connected to the system, whether
they are being used for imaging or not.
Failure to do this will cause RF energy to destroy the preamplifiers inside
the coil.
WA R N I N G S The application of the Interface Box (RF cable trap) for the linear and quadrature coils
may under very specific circumstances result in heating of the box.
Strictly follow the instructions below to avoid heating of the Interface Box:
• DO NOT position the interface box inside or on the edge of the
Quadrature Body coil.
A CHIEVA 2-45
• Always position the RF cables of the coils parallel to the magnetic field
(away from the Quadrature Body coil).
• Position the Interface box always upright in the system (Velco strip
downwards).
• Avoid positioning of the RF coil cables parallel to the interface box.
Parallel positioning may reduce the functionality of the RF filtering of the
interface box.
For total neuro studies a combination of the Synergy Spine coil and the
SENSE Flex Large coil is applied. The SENSE Flex Large coil can be used for
imaging the head of the patient. It will be positioned at both sides of the
patient’s head.
• The coil interface box must be positioned on the abdomen or between the legs of
the patient. Do not position the coil interface box on the side of the patient.
WA R N I N G S • Before starting a scan which initiates tabletop movement, always check that
nothing can get caught or hit during tabletop movement.
Check patient, patient clothing, cables, intravenous lines and other
equipment and accessories
• Due care must be taken to ensure that no part of the patient's body, hair, clothing
cables or infusion lines can be trapped or injured by any part of the equipment.
N OT E S • The operator must be aware that the patient may experience oppressive effects
when moved into the magnet.
This could result in patient injury or equipment damage.
2.18.16 Monitoring
• Visual monitoring is required for all patients who cannot attract the operator’s
attention (e.g. pediatric, unconscious or sedated patients).
• Pay special attention to scanning of sedated or unconscious patients or patients
with loss of feeling in any body part, e.g. paralysis of arms or leg.
2-46 A CHIEVA
These patients are unable to sense excessive local heating, excessive sound
or peripheral nerve stimulation and are unable to alert the operator.
WA R N I N G : Before first use, the metal needle guides must be sterilized and the compression plates
disinfected.
2.18.18 MammoTrak
General safety
A CHIEVA 2-47
The MammoTrak only matches with one system. Using the trolley with a
different system may cause personal injury while moving the tabletop into
the magnet.
• The maximum patient weight allowed for using the mammoTrak is 180 kg.
• Ensure that no person is sitting on the tabletop at the end of the magnet.
The tabletop could tip over causing injury to the patient.
• For scanning always move the tabletop to its end stop in the magnet.
This is the only position for which correct repositioning is guaranteed.
• Do not use the Tumble switch on the patient support control panel when the
MammoTrak trolley is docked to the system.
Raising the patient support can damage the MammoTrak trolley.
Patient positioning
Patient transport
2-48 A CHIEVA
• ensure that tabletop is locked securely to the trolley, do not use the tabletop lock
handles to move the trolley.
When unlocked the tabletop can be pushed off the trolley, which may lead
to the tabletop falling off and personal injury of the patient. 2
• ensure that the patient’s extremities remain to be on the tabletop.
Patient’s extremities can get squashed between the MammoTrak and
possible colliding objects.
• ensure that the trolley brake pedal does not collide with people or objects.
The brake pedal protrudes from the trolly and may cause injuries or
damage to the brake system.
WA R N I N G S • Do not use the Tumble switch on the patient support control unit when the
MammoTrak trolley is docked to the system.
Raising the patient support can damage the MammoTrak trolley.
• While docking the MammoTrak ensure that the patient’s arms and hands are on the
tabletop.
Arms and hands can get caught between trolley and (lowered) patient
support when docking.
• Lock the brakes after docking the MammoTrak to the system.
When the brakes are unlocked the trolley may move while the tabletop is
pushed into the magnet.
A CHIEVA 2-49
Objects in the cable slabs may obstruct table movement. The tabletop can
not be moved out of the magnet. Emergency removal of the tabletop is not
possible.
• when using drug or contrast agent delivery, ensure that no intra-venous lines can get
caught during tabletop movement.
Doing a biopsy
WA R N I N G S • Do NOT use the SENSE Head coil with the acoustic hood.
• Do not block the flow of air through the bore, around the coil and the patient when
the acoustic hood is used.
Free convection is necessary in order for the coil to work at the specified
ambient temperature.
• Patient monitoring is advised.
• Use Earplugs - the acoustic hood provides additional protection.
• Place the hood over the patient and coil before moving the patient into the bore.
In this way one will have control over peripheral equipment, cables, tubes
and lines.
• If an adjustment is made to the position of the acoustic hood, always pull it straight
watching carefully that cables, tubes and lines are not affected by the movement.
• Do not sterilize or disinfect the hood.
The hood is water resistant but cannot be sterilized or disinfected.
If it becomes very dirty we advise that a new one be purchased.
2-50 A CHIEVA
2.18.20 BOLD imaging package
The BOLD imaging package contains a Functional Brain Imaging box. Its
intended use is to synchronize external devices to create functional imaging 2
protocols/paradigms by means of a galvanic separated trigger pulse generated
by the functional imaging pulse sequence.
WA R N I N G S • Safe use of the Functional Brain Imaging box is only guaranteed by Philips in
connection with external devices that are compliant with IEC 950 class I or class II
equipment.
Only devices that are compliant with the aforementioned IEC standards
may be connected to the box outside the examination room.
• Philips warns the user that the EMC immunity complies with the IEC 60601-1-2
standard in case that a maximum level of discharges of 2.5 kV at a distance of 50 cm
from the box is not exceeded.
Under certain circumstances when static discharges occur in the direct
vicinity of the Functional Brain Imaging box, false trigger pulses may
occur which may distort the synchronization of the functional imaging
protocol or paradigm and the functional imaging sequence. Consequently,
such a false trigger may compromise the image quality of the functional
brain study.
WA R N I N G Applying imaging techniques must always be done with great care to avoid any
unwanted effects like artifacts.
Correct parameter optimization is essential for optimal image quality.
SENSE
The SENSE/CLEAR parallel imaging technique must be applied carefully to
avoid unexpected and possibly unidentified image artifacts. The technique
can be used effectively to speed up the scan technique, get a perfect
homogeneity correction or optimize the protocol in a number of other ways
(SAR reduction, acoustic noise reduction, resolution improvement, etc.).
A number of specific warnings and notes are given in the following.
A CHIEVA 2-51
WA R N I N G S • When using SENSE, do NOT plan with fold-over.
• If SENSE is used with P-Reduction greater than 1, the field-of-view must be chosen
large enough to completely encompass the whole object in the phase-encode
direction to avoid artifacts appearing in or around the center of the image.
NOTE: for scanning of the head the FOV must also encompass the nose and ears.
Preferably, the field-of-view is planned on a three-plane multi-stack survey
scan, in order to completely visualize above compliance.
• With CLEAR and SENSE significant artifacts may occur if the reference scan covers
a different "view" than the CLEAR or SENSE scans. This is relevant in anatomies
which are prone to respiratory motion. To limit these artifacts, the reference scan
consists of several averages.
• With CLEAR and SENSE significant artifacts may occur in case of gross patient
motion between the reference scan and the CLEAR or SENSE scans. The patient
must to be instructed not to move head or limbs between scans.
• Artifacts may occur if the SENSE or CLEAR scan is performed with inspiration
breath hold.
N OT E • Both SENSE reduction factors will decrease the actually encoded FOV in P and S
direction, respectively. This implies increased k-space steps.
Geometry compensation
WA R N I N G For comparing images the same type of geometry compensation must be used.
• Erroneous distance, area and volume measurements may lead to
misinterpretations.
• Stereotaxy guidance can be distorted which may lead to personal injury.
k-t Blast
WA R N I N G The k-t BLAST acquisition technique assumes repeated cyclic behavior of the moving
tissue in time. Changes in this behavior can result in incorrect interpretation of details.
2-52 A CHIEVA
FiberTrak
The FiberTrak package is able to visualize white matter tracts in the brain. In
order to achieve results an algorithm is applied using specific settings. These
2
fibertract settings include signal-threshold, FA values and curvature of the
fibertract.
WA R N I N G When fibertract settings are changed to low values (meaning no signal threshold, very
low FA, and very high curvature acceptance) the white matter tracts may include
erroneous results. This may consequently lead to misdiagnosis. It is advised to use
default settings whenever possible.
WA R N I N G With FibreTrak the resulting fibers depend strongly on the parameter settings in the
package.
Low SNR in the DTI dataset can influence the results, leading to structures
without anatomical relevance.
NeuroPerfusion tool
The NeuroPerfusion tool is able to measure absolute CBV and CBF using a
deconvolution between the time courses of tissue signal and an arterial-
input-function.
WA R N I N G The results of deconvolution perfusion analysis may under- or overestimate the true
perfusion depending on various factors:
• Inaccurate definition of the AIF. The AIF may suffer from partial-volume effects,
thus it does not represent a 100% blood signal. For this reason the AIF time course
will not correctly represent a 100% blood signal.
• Patient motion. Patient motion during the scan may introduce irregularities in the
definition of the AIF and individual tissue signal time courses, causing deviations
from the correct CBF/CBV.
• Temporal resolution. The temporal resolution of the measurement may be too low,
causing large errors on the blood flow/volume results.
• Poor bolus injection. If the contrast bolus is too slow, the CBV / CBF may be
incorrectly calculated.
A CHIEVA 2-53
Diffusion
WA R N I N G For ADC measurements the FOV must be positioned in the isocenter of the magnet to
avoid misinterpretations due to incorrect ADC calculations.
Q-flow
WA R N I N G S • For Q-Flow measurements the FOV must be positioned in the isocenter of the
magnet to avoid misinterpretations due to incorrect Q-Flow calculations.
• The option to export the results to a file just gives the user a momentary snapshot
of the results as displayed on screen.
Philips does not guarantee the correctness of these values.
SameScan
N OT E After planning the scans using SameScan, the operator should verify whether the
planned geometries are correct
Special operator attention is required for deviations between slice geometries
possibly caused by wrong correlation of landmarks or changed patient
position or orientation not accounted for by operator misuse.
Operator training is essential for this functionality
MobiView
WA R N I N G After applying the fusion operation, check whether the result of the fusion operation is
correct.
Horizontal lines on the image indicate where the operation took place.
Check for any artifacts that could indicate a fusion error, like cut-off objects
or anatomy
IViewBold
2-54 A CHIEVA
Overlaying the resulting parameter maps from the BOLD analysis on
anatomical images, is very helpful in finding the anatomical location of
specific areas in the parameter maps. However the anatomical location of
these areas should be verified using the source images from the dynamic 2
scan at all times. This verification is required since various factors (like
patient movement and differences in scan techniques) may disturb the
geometrical correspondence between the overlaid parameter map and the
anatomical image resulting in an under/over estimation of the activation
area.
• For the interpretation of the displayed correlation values and its threshold, the user
is referred to the literature. Philips makes no claims about their interpretation.
Correlation of the functional images and their underlying anatomical
images may be influenced by patient motion and therefore depends on the
accuracy of fixation of the patient. The operator is responsible for the
correspondence between the programmed paradigm and the actually
applied paradigm.
N OT E Attention is needed for operator instructions displayed on the viewing screen.
WA R N I N G To limit the output size, Export2Office uses storage formats with lossy compression.
This compression can result in loss of detail important for diagnoses.
2.19 Spectroscopy
WA R N I N G S • On 1.5T systems, do NOT use the 31P surface coil for head studies, the used power
levels of this coil may cause heating of the eyes of the patient.
• Do NOT open the 31P surface coil. They contain a cell with saturated Methyl
Phosphoric Acid:
- In case of contact with the skin, wash with great amounts of water and
soap.
- In case of contact with the eyes, wash with much water and contact a
doctor.
A CHIEVA 2-55
• The system supports export to a proprietary file format. However, since this is not a
published standard, Philips makes no claims about the correctness of this file.
WA R N I N G In 3.0T applications, distortions in spatial shift of the CSI PRESS box may lead to
misdiagnoses.
Analogous to the fat-water slice shift in imaging, the voxel volume localized using
STEAM or PRESS for one metabolite is displaced relative to that for a different
metabolite with a different chemical shift. The relative size of this spatial displacement
is greater at higher field strengths, because chemical shift differences in Hz scale with
the main magnetic field. In chemical shift imaging (CSI), the displacement of
localization volumes will give rise to distorted relative intensities and incorrect peak
area ratios in spectra from voxels at the edges of the region of interest, where the
volumes do not overlap.
2-56 A CHIEVA
Double volume
The planscan and review planscan show the correct volume numbers only
after postprocessing with the available postprocessing batch DOUBLE.scom.
2
2.20 Network safety, security and privacy
Customer Role in the Product Security Partnership
We recognize that the security of Philips Healthcare products is an important
part of your facility's security-in depth strategy. However, these benefits can
only be realized if you implement a comprehensive, multilayered strategy
(including policies, processes, and technologies) to protect information and
systems from external and internal threats.
Following industry-standard practice, your strategy should address physical
security, operational security, procedural security, risk management, security
policies, and contingency planning. The actual implementation of technical
security elements varies by site and may employ a number of technologies,
including firewalls, virus-scanning software, authentication technologies, etc.
As with any computer-based system, protection must be provided such that
firewalls and/or other security devices are in place between the medical
system and any externally accessible systems.
Although the system incorporates state-of-the-art protection mechanisms to
protect it against the intrusion of malware (viruses etc.) a remote probability
remains that a system can become infected. In all circumstances system safety
remains guaranteed, but the user might notice unfamiliar system behavior
and/or performance. If this happens repeatedly, e.g. also after the system has
been switched off and on again, the user is advised to call service to have the
system checked and if needed cleaned from malware.
The USA Veterans Administration has developed a widely used Medical
Device Isolation Architecture for this purpose. Such perimeter and network
defenses are essential elements in a comprehensive medical device security
strategy.
CAUTION "The internal electronic log files generated by this product as a part of its normal
operations, will contain the names of storage folders created by the user, and therefore
will include any patient, clinician or other personal identifying information used in
such folder names. In the course of maintenance, monitoring or repair of this product
or of related development and other product-related activities, Philips may access,
store or otherwise use those log files."
A CHIEVA 2-57
Additional security and privacy information can be found on the Philips
product security web site at
http://www.medical.philips.com/main/productsecurity/
Messages
English <Language name>)
Allow system-controlled tabletop movement?
A Look Over The Shoulder/Take Over (LOTS/TO) session has been
requested.
If you accept this LOTS/TO request, you confirm that you know that
this is an authorized LOTS/TO session.
You further confirm that you are the responsible local operator for the
system during this LOTS/TO session and have been fully informed about
the possible consequences regarding Safety, Security and Privacy arising
from permitting remote operation of the system, including those
discussed in the system's "Instructions for Use."
During a single windows Take Over session, you must stay at the system
console and monitor the activities performed by the remote user. You
can end the LOTS/TO session any time by pressing the "STOP" button
on your screen. As the local operator of the system, you are responsible
for ensuring the safe and secure use of the system.
Note that certain private information, including electronic Protected
Health Information (ePHI) about patients, will become accessible to the
remote operator. Be sure to stay within your institution's policy
regarding disclosure of confidential information to third parties.
Cancel
Change SAR mode to low
Change SAR mode to moderate
Examinations modified in presentation mode are no longer compatible
with their original
High B1 in scan(s)
2-58 A CHIEVA
Messages
English <Language name>)
High dB/dt in scan(s) 2
High SAR in scan(s):
High SAR. Medical supervision of the patient is required for this and
following high SAR scans. SAR can be reduced by lowering the SAR
mode.
Image geometries do not match. Fused images are not guaranteed to be
correct.
Image geometries do not match. Fused images are not guaranteed to
have a correct geometry.
Medical supervision of the patient is required
Medical supervision of the patient is required for this and following
scans with elevated SAR levels. The SAR can be reduced by setting the
SAR mode to 'low'.
Patient support is under manual control, slice position may be incorrect.
Possible failure of STOP button at magnet (front-left). Please call Philips
Service.
Possible failure of STOP button at magnet (front-right). Please call
Philips Service.
Possible failure of STOP button at magnet (rear-left). Please call Philips
Service.
Possible failure of STOP button at magnet (rear-right). Please call Philips
Service.
Potential peripheral nerve stimulation in scan(s)
PPNS. Some of the following scans may possibly cause Peripheral Nerve
Stimulation. PPNS can be reduced by lowering the PNS mode.
Proceed
Reduce by lowering the 'SAR mode'
SAR
SAR value(s):
Segmentation failed. SmartPlan and image based shimming are not
possible, please plan scans manually and select a different shim method.
Sound level limit exceeded by {0:##.#} dB(A). Make sure that
appropriate hearing protection is applied for the patient. Refer to
Instructions-for-use for appropriate hearing protection.
A CHIEVA 2-59
Messages
English <Language name>)
Stacks are of incorrect sizes. Perform a single axis MPR before loading
the dataset in Mobiview for better results.
Stop Scan
The patient support is moving under remote control.
A (as abbreviation for Anterior)
F (as abbreviation for Feet)
H (as abbreviation for Head)
L (as abbreviation for Left)
P (as abbreviation for Posterior)
R (as abbreviation for Right)
2-60 A CHIEVA
2.22 Third party equipment
2
WA R N I N G S • All accessories used with the MR system must be labeled MR safe or MR conditional
safe, see table below for labeling.
Claims of third parties about MR compatibility of accessories must be interpreted
with care: not all claims have been verified by Philips.
• After an upgrade of the system, e.g. to higher gradients, do not use third party
equipment approved for use with the system configuration before the upgrade,
unless recognized as tested for use with this configuration after the upgrade.
• Changes and/or additions to the MR system that are carried out using untested third
party equipment may lead to the Philips Healthcare warranty being voided. Do not
use unapproved third party equipment.
This equipment carries serious risks to cause damage to the system or
personal injury.
• Only use Philips tested and approved third party RF coils when using the
MultiConnect or Synergy MultiConnect box.
Ask your local sales or Customer Support representative for approved RF
coils.
• Third party RF coils can not be used in combination with Philips RF coils nor with
SENSE and CLEAR.
• Application of physiological monitoring and sensing devices must be done under the
user’s directions and responsibility.
• The use of auxiliary equipment, such as physiological monitoring and gating
equipment and radio frequency coils, which have not been specifically tested and
approved for use with Philips MR systems may result in burns or other injuries to the
patient.
• Auxiliary devices labeled as MR conditional may cause injury if the manufacturers
instructions, especially with respect to electrically conducting lead positioning, are
not followed.
• Auxiliary devices labeled as MR conditional may only be used in combination with
Philips MR systems when the conditions specified in the manufacturer’s instructions
for use are fulfilled.
A CHIEVA 2-61
• Auxiliary devices not labeled as compatible with MR equipment may be affected by
electromagnetic interference (EMI). This may influence the proper functioning of
the Auxiliary device.
N OT E For description and further Instructions for Use on compatibility test protocols, see the
Technical Description of the system.
MR safe
MR conditional
MR unsafe
2-62 A CHIEVA
2.23 Symbols on the system
The following symbols are used with the system:
2
General symbols Meaning
A CHIEVA 2-63
Warning symbols Meaning
ECG
N OT E For laser light safety symbols and labels see section 2.13 ‘Laser light radiation safety
(Light visor)’.
2-64 A CHIEVA
3 System overview
3
Magnet with Ambient ring Interactive display
(only on 3.0T TX)
Patient support
control panel
Patient Support Control Panel
(only on 3.0T TX)
Patient support
Gradient system
The gradient coils, which are integrated in the system, provide the relative
small magnetic field variations needed for the localization of the weak
magnetic resonance relaxation signal emitted by the human body.
Philips’ MR imaging systems are available with different gradient field
strengths.
A CHIEVA 3-1
The tabletop can be moved longitudinally to transport the patient into the
magnet. It can also be moved vertically for convenient patient transfer.
Interactive display
The optional Interactive display is suspended from the ceiling of the
examination room. It shows the same view as on the display of the operator’s
console.
Operator’s console
The operator’s console consists of:
• a wide-screen display unit with front USB connectors,
• keyboard and a mouse,
• patient-operator intercom with nurse call reset,
• computer system:
- computer with Windows operating system and MR system software,
- external DVD recorder. A DVD provides high-capacity storage of
images.
N OT E The DVD recorder is compatible with Philips DVD+RW 4-speed media only.
Network
The network facility can be used to exchange images and data with other
systems (RIS, PACS).
3-2 A CHIEVA
Physiology display system
A physiology display system provides synchronization of the MRI sequences
with physiology signals. The systems detects respiration, Vector
CardioGraphy (VCG) and peripheral pulse signals.
WA R N I N G The physiology signals are distorted when the patient is inside the magnet and can not
be used for monitoring or diagnostic purposes.
3
3.2 Panels Achieva 3.0T TX systems
3.2.1 Patient Support Control Panel
There is a Patient Support Control Panel located on both sides of the magnet
bore. Both panels have the same functionality, but the layout is mirrored.
N OT E In this section the Patient Support Control Panel at the left side of the magnet bore is
displayed. The location of the buttons on the right side panel are mirrored.
A CHIEVA 3-3
Tumble switch
The Tumble switch initiates all motorized movements of patient support and
Travel to scanplane TTS tabletop.
Tumble switch
Light visor Horizontal and vertical movement
With the Tumble switch the patient support is moved:
• up or down when the tabletop is totally moved out of the magnet bore, the
vertical speed is fixed.
• in or out the magnet bore when the patient support is at its highest
position, two different speeds are available.
Operating the Tumble switch
Push the Tumble switch up for the up or in movement of the tabletop and
push the switch down for the out or down movement.
As long as the Tumble switch is returned gently to the middle position, the
horizontal movement will be smooth and comfortable for the patient.
N OT E If the Tumble switch is released suddenly it will result in an emergency stop of the
tabletop movement: it will stop within a distance 15 mm.
Light visor
By pressing this button a laser light beam is projected onto the patient.
This selects the patient reference point, i.e. the plane which will be
positioned in the isocenter of the magnet.
• The laser light will automatically switch off after 15 seconds.
• Typical use of the Light visor is only once for every patient.
• Use of the Light visor during the performance of an exam will be ignored:
a new patient reference point cannot be defined.
3-4 A CHIEVA
The direction of movement to the isocenter is indicated: when tabletop
movement is away from the isocenter, the button will flash slowly.
Patient reference point
After the patient reference point is positioned in the isocenter of the magnet,
a survey is performed and all subsequent scans are planned with the
information of this patient reference point. All tabletop movements which
are required for optimal image quality are deduced from this point.
3
Stop scan
Stop scan
Pressing the ‘Stop scan’ button will stop the currently running scan.
Start/Pause scan
Pressing this button will also abort travel to scanplane tabletop movement. It
will also stop tabletop movement during a MobiTrak scan.
The button has a ridge around it to prevent it from being pressed by
accident.
N OT E Pressing the ‘Stop scan’ button twice will also stop image reconstruction.
If pressed only once, reconstruction will continue if enough data is available.
A CHIEVA 3-5
Bore illumination and Ambient Ring
Bore illumination Talk The bore lights can be adjusted to three levels, which are indicated on the
Ventilation LED bar: off, medium and full light.
Music
The Ambient Ring is switched on and off simultaneously with the bore
lights.
Ventilation
The amount of ventilation through the magnet bore can be controlled with
the ‘Ventilation’ button. The level of ventilation is indicated on the LED bar.
Music volume
This button can be used to adjust the volume of music for the patient. The
level is indicated on the LED bar.
Talk
The ‘Talk’ button enables communication between the operator in the
examination room and the patient wearing a headset.
• Press the ‘Talk’ button when the headset is plugged in.
This connects the magnet microphone to the patient headset (the button
illuminates), and switches off the music speakers in the examination room.
This allows easy communication with the patient. Once pressed, it will
remain active until pressed again (the LED goes off ).
The Talk button on the intercom at the console can temporarily overrule the
magnet microphone, but cannot switch it off.
N OT E S • Remember to turn on the music after talking to the patient.
• If the headset is not in use, it should be unplugged from the control panel.
3-6 A CHIEVA
Emergency stop
Resume Pressing the ‘Emergency stop’ button will stop the tabletop movement. This
Emergency stop
can be reset using the ‘Resume’ button. The ‘Stop’ button has a ridge around
Manual mode
it to prevent it from being pressed by accident.
Resume
Pressing this button will reset the tabletop after an emergency stop.
Operation is re-enabled. 3
Manual mode
‘Manual mode’ can be used to toggle between motorized and manual mode.
The LED next to the button illuminates when the tabletop is in manual
mode. Tabletop position information is available in manual mode.
N OT E S • When one of the ‘Tabletop release’ buttons on the patient support is pressed, the
manual mode LED will flash.
• Pressing the same ‘Tabletop release’ button will re-engage the tabletop.
Spectroscopy and
transmit/receive coils
Receive coils
A CHIEVA 3-7
Coil connector adapter
For connecting Synergy/SENSE and surface coils with a previous type
connector a special connector adapter is provided.
Headset
Nurse call
3-8 A CHIEVA
3
Tumble switch
The Tumble switch initiates all motorized movements of patient support and
tabletop.
Horizontal and vertical movement
The Tumble switch moves the patient support up or down when the tabletop
is totally moved out of the magnet bore (end stop). In this case, the speed is
fixed.
The Tumble switch moves the tabletop in or out the magnet bore, when the
patient support is at its highest position. Three different speeds are available.
Operating the Tumble switch
Tumble switch
As long as the Tumble switch is returned gently to the middle position, the
horizontal movement will be smooth and comfortable for the patient.
N OT E If the Tumble switch is released suddenly it will result in an emergency stop of the
movement of the tabletop: it will stop within 15 mm.
A CHIEVA 3-9
Stop
Pressing the ‘Stop button’ will stop the tabletop movement. This can be reset
Stop using the ‘Manual’ button. The Stop button has a ridge around it to prevent
Manual mode it from being pressed by accident.
Light visor
Manual mode
‘Manual mode’ can be used to toggle between motorized and manual mode.
The LED next to the button illuminates when the tabletop is in manual
mode. Tabletop position information is available in manual mode.
Pressing the ‘Manual mode’ button will reset the ‘Stop table’ button.
N OT E S • When one of the ‘Tabletop release’ buttons on the patient support is pressed, the
manual mode LED will flash.
• Pressing the same ‘Tabletop release’ button will re-engage the tabletop.
Light visor
A laser cross projected onto the patient selects the patient reference point i.e.
the plane which will be positioned in the isocenter of the magnet.
• The laser cross will automatically switch off after 15 seconds.
• Typical use of the Light visor is only once for every patient.
• Use of the Light visor during the performance of an execution list will be
ignored: a new patient reference point cannot be defined.
3-10 A CHIEVA
Patient reference point
After the patient reference point is positioned in the isocenter of the magnet,
a survey is performed and all subsequent scans are planned with the
information of this patient reference point. All tabletop movements which
are required for optimal image quality are deduced from this point.
Bore illumination
The bore lights can be adjusted to three levels: off, low light and full light. 3
Bore illumination
15 minutes after the tabletop is fully out of the magnet, the lights will
Ventilator
Talk
automatically dim for 45 minutes before they are switched off.
Ventilation
The amount of ventilation through the magnet bore can be controlled with
the ‘Ventilation’ knob.
Talk
The ‘Talk’ button enables communication between the operator in the
examination room and the patient wearing a headset.
• Press the ‘Talk’ button when the headset is plugged in.
This connects the magnet microphone to the patient headset (the LED
illuminates), and switches off the music speakers in the examination room.
This allows easy communication with the patient. Once pressed, it will
remain active until pressed again (the LED goes off ).
The Talk button on the intercom at the console can temporarily overrule the
magnet microphone, but cannot switch it off.
N OT E S • Remember to turn on the music after talking to the patient.
• If the headset is not in use, it should be unplugged from the control panel.
A CHIEVA 3-11
Music volume
This knob can be used to adjust the volume of music for the patient.
Stop scan
Start scan Start scan
Music volume
This green button can be used to start a scan in the examination room.
N OT E In a MobiTrak scan this button will also initiate tabletop movement and start the scan
automatically.
Stop scan
Pressing the ‘Stop scan’ button will stop the currently running scan.
Pressing this button will also abort tabletop movement when initiated by
‘TTS’ and also during a MobiTrak scan when initiated by pressing the ‘Start
scan’ button or clicking the |Proceed| button.
The button has a ridge around it to prevent it from being pressed by
accident.
N OT E Pressing the ‘Stop scan’ button twice will also stop reconstruction.
If pressed only once, reconstruction will continue if enough data is available.
3-12 A CHIEVA
Start scan
Stop scan
Talk
Manual mode 3
Figure 3.6 Control panel at the back of the magnet
The buttons on this panel have the same function as their equivalent on the
Patient Support Control Panel.
Figure 3.7 Sockets on the Patient Support Control Panel of Achieva systems
A CHIEVA 3-13
Coil connector adapter
For connecting coils with a previous type connector a special connector
adapter is provided.
Nurse call
Head phone
On the patient support at the same side of the magnet bore as the Patient
Support Control Panel a connection panel is located.
On this connection panel sockets are provided for nurse call pinch ball, head
phone and ComfortZone (if available).
3-14 A CHIEVA
Intera systems
On the patient support at the same side of the magnet bore as the Patient
Support Control Panel a connection panel is located.
On this connection panel sockets are provided for head phone, ECG signal,
peripheral pulse and respiratory sensors and the nurse call pinch ball.
Talk volume
Speaker
Nurse call LED
Talk push button
Patient music On/Off
Listen On/Off
A CHIEVA 3-15
Talk push button
Pressing the ‘Talk’ button will open the talk channel, releasing will close it. A
flashing ‘Nurse call’ LED will be turned off by pressing the ‘Talk’ button.
3-16 A CHIEVA
The ‘Talk’ button toggles between on and off. The ‘Talk’ button on the
intercom at the console can temporarily overrule the ‘Talk’ button in the
examination room.
A CHIEVA 3-17
3-18 A CHIEVA
4 System Operation
4
4.1 System logon
1 Type in Username and Password.
2 Confirm by clicking |OK| or pressing the |Return| key.
The system software will start
N OT E Initial settings of username and password are "MRuser" and "Philips". After first logon
a different password must be entered of at least seven characters.
Image area
• is to display images, the results of analysis functions (e.g. graphs),
messages, queries, prompts and temporary control information.
A CHIEVA 4-1
Control area
Main Menu
Scan button and Advanced Examination for viewing
Viewing button
Image Information Panel
Packages
Viewing Tools
Scan Button
Physiology display
Main menu
• Clicking on one of the ’main menu items’, the following submenus appear:
Patient Function
Figure 4.2 Main Menu
New Exam... To scan a new patient.
View Exam… To view an existing examination.
Administration... Provides the Patient administration panel.
Cleanup Clears examination from viewing context list
4-2 A CHIEVA
System Function
Advanced Viewing Switches the system to the advanced viewing mode
Queue manager Displays a panel with list of background processes.
Print Job Control Displays the printer dialog panel
HC Protocols Displays the HC dialog panel
Screen Capture Creates a secondary capture
Advanced Tools Selects Text suppression, Service and Research functions,
Develop Utilities or Delayed Reconstruction.
Autopush to DICOM node Sends an examination automatically to a DICOM node (when
connected)
Bumping Policy To set the bumping policy 4
FPR utility Opens the Field Problem Report utility
Show Taskbar Shows the Windows taskbar
Exit ... To exit the system software
Help Function
User Documentation Displays the User Documentation window
About Displays system name, release number, software options etc..
Help Topics Opens the Help system.
A CHIEVA 4-3
Packages
To select post-processing packages (from left to right, top to bottom):
• MPR package
• Interactive MIP package
• Compare package
• Review Planscan package
• Cardiac Analysis package
• System Performance Test
• MR Spectroscopy
Viewing tools
The following functions are provided here:
• Hardcopy
• Screen Setup
• Movie
• Scrolling through and in scans
• Panning
• Windowing
• Zooming
Scan button
Switches the system to scan mode.
• The ExamCards panel is automatically displayed.
• The ’Packages’ panel is replaced by the Planscan panel.
Physiology signal
To select physiology signals to be displayed:
• VCG (also VCG1 + VCG2)
• PPU
• Resp. (Respiratory signal)
• any combination of the above mentioned signals
4-4 A CHIEVA
Scan control panel
First click on |Stop scan| will stop the scan immediately, the
reconstruction commences if enough data is available.
Second click on |Stop scan| will stop the reconstruction.
If tabletop movement is initiated by the TTS function, clicking
the |Stop scan| button will abort tabletop movement.
4
Image area
• is to display images, the results of analysis functions (e.g. graphs),
messages, queries, prompts and temporary control information.
A CHIEVA 4-5
Control area
Examination for viewing
Main Menu
Basic viewing button Tool bar
ExamCard and
Postprocessing status Image information area
button
Pictorial index
Scan Button
Physiology display
Main menu
• Clicking on one of the ’main menu items’, the following submenus appear:
Session Function
Switch to viewing Switches back to the basic viewing screen.
Switch to acquisition Switches to the acquisition screen.
Case Function
<case name> To Select a case.
4-6 A CHIEVA
Views Function
Tile To arrange all selected series in a tiled layout.
Stack To arrange all selected series in a stack layout.
Apply Link Applies a link between a selected views.
Current link The views of the link are highlighted.
Add to link Adds the selected view to the current link.
Remove from link Removes the selected view from the current link.
Unlink all To remove all links.
Tool Function
Screen Capture as... Make a screen capture and saves it. 4
Screen Capture Make a screen capture.
Analysis Function
ImageView Opens the ImageView package.
QFlow Opens the QFlow package.
IView Bold Opens the IView Bold package.
Basic T1 Perfusion Opens the Basic T1 Perfusion package.
MobiView Opens the MobiView package.
PicturePlus Opens the PicturePlus package.
SpectroView Opens the SpectroView package.
ImageAlgebra Opens the ImageAlgebra package.
VolumeView Opens the Volume View package.
Neuro Perfusion Opens the Neuro Perfusion package.
FiberTrak Opens the FiberTrak package.
Diffusion Opens the Diffusion package.
Diffusion Registration Automatically performs a registered diffusion dataset.
Help Function
Help Topics Opens the Help system.
User Documentation Displays the User Documentation window
A CHIEVA 4-7
Tool bar
Following tools are available on the tool bar by clicking on the icon.
Icon Function
1. Tile view Divides the Image are into 4 views.
1 2 3 4 5 6 7
2. Stack all view Displays one stack.
3. Apply link Applies a link between selected views.
4. Current link The views off the link are highlighted.
5. Add to link Adds the selected view to the current link.
6. Remove from link Removes the selected view from the current link.
7. Capture the Screen Make a screen capture.
Pictorial index
A representative image per series is displayed in the pictorial index.
4-8 A CHIEVA
Scan button
Switches the system to scan mode.
Physiology signal
Displays the physiology signals.
A CHIEVA 4-9
4.3 Keyboard
4.3.1 Keyboard overlay
A special overlay explains the function of all function keys on your keyboard
in the system application software.
4.4 Workflow
In this chapter, the general workflow of an examination is listed. Alternatives
are omitted. For more information on the items, refer to the corresponding
sections.
The table below describes the workflow when scanning with ExamCards. For
each processing step, a link to the available documentation is provided.
4-10 A CHIEVA
Step With ExamCard More information
View the scans • In general in this chapter
• Select a suitable layout. • For detailed description see Help system
• Perform windowing and zooming. ‘Viewing’
Post-processing • For detailed description see Help system
• Depending on the kind of scan. ‘Postprocessing Packages’
Hardcopy • For detailed description see Help system
‘Hardcopy’
Data storage • For detailed description see section 4.10
‘Storage and Transfer of Patient Data’
4
4.5 Preparation for scanning
WA R N I N G Before using the system, it is essential that you read and familiarize yourself with all
Warnings and Cautions given in chapter 2 ‘Safety’.
A CHIEVA 4-11
4.6 Entering Patient data
4.6.1 New patient
1 Select ‘Patient’ on the main menu bar and ‘New Exam’.
2 Enter examination data.
3 Click |Proceed| or press |Enter|.
The patient data are added to the examination list and highlighted.
4 Click |Proceed| at the bottom of the panel.
The highlighted examination becomes the current examination. The system
switches to scan mode.
WA R N I N G Before using the system, it is essential that you read and familiarize yourself with all
Warnings and Cautions given in chapter 2 ‘Safety’.
4-12 A CHIEVA
5 Make sure that patients fit easily into the system when positioned off-center
or semi-sitting.
6 Raise the Tumble switch to the ‘Up/in’ position and hold it there until the
tabletop stops moving.
Nurse call
7 Explain the operation of the nurse call and give it to all patients. Its use
should always be demonstrated. If the nurse call is pressed twice or for a
longer period the alarm light will be activated.
Travel to scanplane
11 Select ’Travel-to-scanplane’ mode by pressing the appropriate button once.
12 Raise the Tumble switch to the ’Up/In’ position and hold it until the
isocenter is reached and the tabletop stops automatically.
13 Close examination room door.
A CHIEVA 4-13
4.8 Run / Create an ExamCard
1 Select either |Philips procedures| or |Hospital procedures|.
2 Double click on the required anatomy with the ‘left mouse button’.
3 Double click on the required subanatomy with the ‘left mouse button’.
4 Click on the required Preset Procedure with the ’left mouse button’.
- Preset procedures are indicated by the Preset Procedure icon.
5 Drag and drop this preset procedure to the Current ExamCard on the left
hand side of the ExamCard panel.
Geometry Reuse
6 Move the cursor over the ’Geometry’ column.
Blue borders appear around the geometry field.
7 Click on the ’Geometry’ column to select it for editing.
8 Enter a Geometry name or edit the current name. The required anatomy
folder opens, and the list of available subanatomies is displayed.
9 Select ‘general’ on Examcard Level and enter an anatomic region.
10 Click |Start scan| to start the ExamCard.
The survey procedure starts. The survey images will automatically be loaded
into the viewports.
Planning
11 Select suitable images for planning.
12 Click on an item (corresponding to a preset procedure) within the scan list to
make it current.
13 Plan the geometry of the imaging volume as e.g. off-center values and
angulation.
To move the volume, stack or slab
- Click on the circle in the center of the stack.
- Drag in any of the four available directions.
4-14 A CHIEVA
The values of the off-center parameters are automatically adapted.
To angulate the volume, stack or slab
- Click on one of the outer circles on the mid slice.
- Drag up- or downwards to angulate.
The values of the Angulation parameters are automatically adapted.
Center
Outer circle Outer circle
A CHIEVA 4-15
Windowing Hold down middle mouse button and move mouse:
Change window level upwards = darker; downwards = brighter
Change window width to the right = less contrast; to the left = more contrast
If view copy is On, subsequent images or all images are zoomed, if view copy
is 'No', only the current image is zoomed.
Pan
Pan is used to move the zoomed part of an image in the current subscreen in the horizontal and
vertical directions.
• Hold down the ‘middle’ + ‘left’ mouse buttons and move the mouse.
If view copy is On, subsequent images or all images are panned, if view copy
is No, only the current image is panned.
Screen setup
• is used to reconfigure the number and size of the images displayed.
The default screen setup is 2 x 2.
• displays all the available screen configurations.
The current configuration is highlighted.
• is also used to enable / disable the display of:
- Inset Planscan
- Image text
- Graphics
- Calliper
- Fold-over indicator
- Descending slice order (default: ascending)
- Align slice orientation (for radial stacks)
4-16 A CHIEVA
4.10 Storage and Transfer of Patient Data
Suppress patient data
The export to (removable) media offers the option to "suppress patient data"
in order to protect the privacy of the patient(s).
N OT E The "suppress patient data" option removes most patient identification fields.
However, this option cannot detect privacy data added by the operator in comment
fields. It is the responsibility of the operator to remove these fields manually to ensure
patient privacy protection.
N OT E The MR system is not designed to be an archive. Always use external systems for
patient data archiving.
A CHIEVA 4-17
4.11 Exit system software
1 Select ‘System’ in the main menu and select ‘Exit’ in the drop down menu.
The Exit confirmation window is displayed:
Confirm the request to exit, cancel/proceed
2 Click |Proceed|.
The ‘Stop’ status box is displayed until the software has been logged off.
The Logon dialog box is then displayed.
To start-up the system software again see section 4.1 ‘System logon’.
Log Off Exits the system software, see also section 4.11 ‘Exit system software’
Shutdown Shuts down the System
Restart Restarts the system
Cancel Cancels the shutdown procedure
4-18 A CHIEVA
4.12 System start up and switch off
WA R N I N G If your system has been upgraded to the current release, your hardware may differ
from the systems described in this manual. If this is the case please refer to the
Instructions for Use originally delivered with your System for proper system start up
and switch off. Even when this system is switched off some subsystems remain powered.
WA R N I N G The system and all subsystems remain powered. Danger of an electric shock.
4
A CHIEVA 4-19
2 When the logon screen appears on the monitor press Ctrl+Alt+Delete keys
on the keyboard. The logon dialog box is displayed.
Log in:
3 Type in Username and Password and confirm by clicking |OK| or pressing
the Return key.
The system software will start
N OT E Initial settings of username and password are "MRuser" and "Philips". After first logon
a different password must be entered of at least seven characters.
4-20 A CHIEVA
4 Select ‘User’ --> ‘Add Local user’.
5 Enter a personal user name, a full name, an account description and define
and confirm a password of minimum 7 characters for the new user.
N OT E On first login the new user or administrator is forced to change its password (minimum
7 characters).
To edit an account
1 Open the ‘User Management (Operators)’ or
‘User Management (Hospital Administrators)’ panel.
2 Right click on a user in the list and select ‘Properties’ or
select a user in the list and click on ‘User’ --> ‘Properties’.
4
3 Change the account as required:
• Full name.
• Account description.
• Password.
• Disable the user account,
• Enable/disable blocking of the user account during a certain time when
the wrong password is entered repeatedly (Blocking time and occurrence
of wrong password to be set by the Service Engineer),
Delete an account
An account can be deleted in the ‘User Management (Operators)’ or ‘User
Management (Hospital Administrators)’ panel.
• Right click on a user in the list and select ‘Delete user’ or
select a user in a list and click on ‘User’ --> ‘Delete user’.
A CHIEVA 4-21
2 Press |F1| on your Keyboard.
If the selected field has context sensitivity the related topic is directly
displayed in the help system. If not, the start page of the help system is
displayed and you can search for a topic manually.
Help system
1 Select ‘Help’ on the main menu bar.
2 Select ‘Help topics’.
The Help system is displayed.
You can search through the help system using the table of contents, the index
or the word search.
User documentation
1 Select ‘Help’ on the main menu bar.
2 Select ‘User Documentation’.
A browser window is opened where you can select the user documentation.
4-22 A CHIEVA
DICOM Conformance Statement
The DICOM conformance statement can be selected from the Windows
start menu by selecting ‘Start’ -> ‘User documentation’ -> ‘DICOM
Conformance Statement.PDF’.
A CHIEVA 4-23
5 Select your language from the scroll list and click |Apply|.
6 Click on |Details...| in the top field and select the ‘Settings’ tab in the new
window.
7 Default input language:
Select the input language from the scroll list.
8 Installed services:
Select your keyboard layout.
If your keyboard layout is not present in the field click |Add...|:
• On the ‘Add Input language’ window select the input language from the
top scroll list and your keyboard layout.
• Confirm by clicking |OK|.
9 Confirm by clicking |OK|, the window closes.
10 Click |OK| on the Regional and language Options window, the system will
warn you that changes will not take effect until after you logoff (exit system
application) and logon again.
CAUTION The system will ask you to logoff. However, when clicking |Yes| it will REBOOT, not
logoff.
4 Click |OK|, the system will warn you that changes will not take effect until
after reboot of your system.
After rebooting your system the hospital or institution name will have
changed.
4-24 A CHIEVA
4.17 Using USB storage devices
USB storage devices (flash drives, hard drives) are recognized by the system
and can be used for exchanging data. The operating system automatically
assigns a drive letter to the device.
CAUTION Do not remove the USB storage device without using the "Safely Remove Hardware"
option. Removing the device without using this option can can corrupt the data on the
USB memory device.
N OT E The USB storage device may contain confidential information. Take appropriate
measures to protect this information.
3 left click once on the ‘Safely Remove Hardware’ icon in the notification area
of the taskbar and select ‘Safely remove USB Mass Storage Device - Drive
(<drive letter>:)’.
4 You can safely remove your USB storage device when the ‘Safe To Remove
Hardware’ message appears.
A CHIEVA 4-25
The problem can be prevented by using an external USB drive with an
external power connection or using an external drive with a data USB cable
and a power-to-USB cable.
When using a power-to-USB cable:
1 First connect both USB cables to the computer.
2 Connect the power-to-USB cable to the external device.
3 Connect the USB data cable to the device.
4-26 A CHIEVA
4.18 Remote Desktop
This section describes the Remote Desktop application of your system.
When facing a system failure or problem the local (system) user can call
Philips customer support to request for help or assistance.
The Remote Desktop functionality enables service engineers (remote user) to
access your system:
• Viewonly: remote viewing of the system desktop.
• Takeover: remote control of the system desktop.
In ‘Fixed Duration’ (Takeover only) you allow the remote user to control
your system for a limited time period, from 1 to 60 hours. The remote user
can access your system independently for the complete duration of the
session by using a password protected connection. This password is set at the
connection start up.
When a reboot of the system is necessary, it can be done by the remote user.
After starting a Fixed Duration session the assistance of the local user is not
required.
A Fixed Duration session may be used to service your system during the time
that it is not used.
WA R N I N G Fixed duration session shall only be performed with appropriate safety, security and
privacy measures taken according to hospital policies.
Every session can be stopped at all times by the local user. The remote
connection is then closed and has to be re-enabled by the local user if
necessary. This also applies to a Fixed Duration session.
N OT E When starting a Remote Desktop session a dialog box appears displaying a warning
text. The session cannot be started before the local user agrees by clicking the |I agree|
button.
A CHIEVA 4-27
WA R N I N G S • During a single windows Takeover session, the local user must stay at the system
console and monitor the activities performed by the remote user.
• The local user must be present at the console at all times during scanning of a
patient in a Remote Desktop session.
• The local user is responsible for ensuring the safe and secure use of the system and
for the safety of his patient. It is possible to terminate a session at all times using
the |Stop| button on the screen.
• Only expert users are allowed to run a Takeover session.
• During a Takeover Fixed Duration session where the local user is not present, the
local user has to ensure that no person is present in the examination room. Take
appropriate measures to inform people that a Takeover session is running.
Remember that scanning is only possible when the door of the
examination room is closed.
4.18.1 Workflow
Contact your Philips customer support in case of a system failure or problem.
The service engineer may want to view your system desktop while you are
scanning or access it to remotely service your system.
N OT E It is advised to keep contact on the phone for the complete length of the session.
1 Click the Windows |Start| button, go to |MR user| and select |Enable
Remote Access| to start the Remote Desktop application.
A dialog box appears displaying the following text:
A Remote Desktop (viewonly/takeover) session has been requested.
If you accept this viewonly/takeover request, you confirm that you know that this is
an authorized viewonly/takeover session.
You further confirm that you are the responsible local operator for the system during
this viewonly/takeover session and have been fully informed about the possible
consequences regarding Safety, Security and Privacy arising from permitting remote
operation of the system, including those discussed in the system's "instructions for
use".
During a single windows Takeover session, you must stay at the system console and
monitor the activities performed by the remote user. You can end the viewonly/
takeover session any time by pressing the "Stop" button on your screen. As the local
operator of the system, you are responsible for ensuring the safe and secure use of the
4-28 A CHIEVA
system.
Note that certain private information, including electronic Protected Health
Information (ePHI) about patients, will become accessible to the remote operator. Be
sure to stay within your institution's policy regarding disclosure of confidential
information to third parties.
2 If in doubt about the message click |Exit Session| to cancel.
Click |I agree| to confirm.
An ‘Enable Remote session’ box appears on the screen.
3 (a) select |Single Windows Session| or
(b) select |Fixed Duration| and the amount of time (1 to max. 60 hours) you
(a) allow the remote user to access your system, and click |OK|.
(b)
The application is active and a ‘VNC’ icon is displayed in the tray of your 4
Windows taskbar.
• Single Windows Session
A red Stop button appears on the screen.
With this button you can stop the session. The button always stays on top
and can be placed anywhere on the screen.
• Fixed Duration
A dialog box appears on the screen with a |Stop| button and fields to enter/
confirm a password.
A CHIEVA 4-29
5 (a) click |Approve| to confirm a Takeover session or
(b) click |View only| to confirm a Viewonly session.
When the Remote connection is active the background color of the ‘VNC’
icon in the tray of your Windows taskbar changes from white to black.
For a Fixed Duration the service engineer has to enter a password. After the
password has been confirmed the box minimizes to the |Stop| button. With
this button you can stop the session. The button always stays on top and can
(a) (b) be placed anywhere on the screen.
The remaining session time is displayed in the header of the button.
N OT E Error messages may appear on the screen when the password is not entered correctly.
These messages are for the remote user only.
Stopping a session
The local user can stop a Remote Desktop session at all times:
• Click the red |Stop| button to stop the session.
A confirmation box appears on the screen:
‘Are you sure you want to stop the remote session’.
• Click |OK| to confirm. The session is stopped.
When finishing a Single Windows Session the local user as well as the remote
user can close the session.
N OT E The start/stop of every Remote Desktop session is logged by your system. The Remote
Service Network logs who has been the remote user.
4-30 A CHIEVA
4.19 Remote Software Installation (RSI)
The Remote Software Installation application (RSI) detects software updates
or fixes which are uploaded to your system and ready to install.
This application is started automatically at logon of your system.
When new updates or fixes are available, a flashing RSI icon will appear in
the tray of your Windows taskbar. The taskbar is shown automatically.
Hide the taskbar again by clicking on an arbitrary application.
1 Click on the |RSI| icon.
The MR software Installation dialog appears.
A CHIEVA 4-31
N OT E S • The ‘Install All’ button is not available to operators:
Installation of updates and fixes can only be performed by the hospital
administrator or MR service engineers.
• The operator should inform the hospital administrator or MR service engineers
when updates or fixes are available.
• A Warning is displayed in the dialog when patient data will be deleted at installing
of updates and fixes:
‘Patient database will be deleted. Archive the patient database before installation‘.
Installation
Installation of updates and fixes can only be done by the hospital
administrator or MR service engineers.
1 Logon as hospital administrator.
N OT E If necessary contact your local Philips service representative for logon details.
After installations the system has to be rebooted and a dialog will appear.
5 Confirm to reboot the system or cancel.
4-32 A CHIEVA
After successful installation all updates and fixes will be deleted and the status
is set to ‘Installed’.
The Release and Application Notes remain on the system and in the RSI
dialog.
N OT E Please contact your local Philips service representative if an installation was
unsuccessful.
A system restore may be required.
A CHIEVA 4-33
4-34 A CHIEVA
5 Maintenance
Planned maintenance and user routine are necessary to keep the system
operating safely, effectively and reliably.
A CHIEVA 5-1
Miscellaneous checks
• Check the function of the red Emergency stop buttons on both Patient
Support Control Panels, see chapter 3. When pressed, the button is lit red.
Press the resume button to exit the stop mode.
When a failure occurs the following message appears on the console:
Possible failure of STOP button at magnet. Please call Philips Service.
• Inspect coils for damage to coverings and connectors.
• Check the ink cartridge for correct printing and replace it if necessary.
5-2 A CHIEVA
Position the (200mm) head phantom with the holder/load segment arranged
transversely:
1 In basic viewing click on the |System Performance Test| icon in the packages
area.
2 Click on the ‘PIQT’ icon or select |File| followed by |Perform PIQT| on the
main menu bar.
The PIQT windows opens.
3 Follow the instructions on the PIQT window.
4 Click |Proceed| to start the scans.|
The PIQT procedure will run automatically making survey scans, making
PIQT scans and evaluating the results.
5 Click |Cancel| to return to the main menu.
WA R N I N G S • Never use cleaning equipment that contains ferromagnetic material, e.g. pails made
of metal, spray aerosols.
• Never allow water or other liquids to enter the system.
These may cause electrical short-circuits or metal corrosion.
A CHIEVA 5-3
• Never clean electrical parts, such as the Patient Support Control Panel and
connectors, with a damp or wet cloth unless the system or system parts are
switched off.
• Never use the following products for cleaning and disinfection purposes: Ether,
White Spirit, Turpentine, Trichlorethylene, Iodine and products based on Phenol.
These products cause damage to the system.
5.3.1 Cleaning
Enamelled parts and aluminum surfaces
• Clean with damp cloth and mild detergent. Wipe dry with a woolen cloth.
• Never use abrasive cleaning agents on the tabletop and never use corrosive
cleaning agents, solvents, abrasive detergents or abrasive polishes.
• If you are not sure about the properties of a cleaning agent, do not use it.
Chrome parts
• Clean by rubbing down with a dry woolen cloth.
• Never use abrasive polishes, but a non-abrasive wax.
Operator’s console
• Clean the display screen and the keyboard with a soft cloth.
• Never use aggressive detergents or alcohol.
Cabinet
• Clean with a soft cloth dampened with mild detergent and water. Repeat
with water only and wipe dry with a cloth.
Suitable products: Alcohol (Ethyl, Isopropyl), Aquasonic Gel, Betadine,
Cidex and other, ammonia-based cleaners (Windex).
5-4 A CHIEVA
Patient accessories and surface coils
• Clean with a damp cloth and mild detergent (preferably liquid soap based,
rather than antiseptics). Wipe dry with a cloth.
Patient support
• Clean tabletop and mattress daily in accordance with the general hygiene
regulations; pay special attention to the cleaning of the tracks of the
tabletop wheels to keep the tabletop rolling smoothly.
The mains supply may be kept switched on when cleaning the tabletop.
• Clean the patient accessories after use with a damp cloth and mild
detergent (preferably liquid soap based rather than antiseptic) followed by
drying with a cloth. Do not immerse the accessories in liquid.
Printer
• Clean the exterior with a lint-free cloth moistened with isopropyl alcohol.
• Clean the paper paths and the paper handling mechanism.
5
5.3.2 Disinfection
All parts of the system can be disinfected by wiping with a cloth dampened
with a suitable agent.
A CHIEVA 5-5
• Disinfect the equipment in the way recommended above.
• Ensure that all traces of the vapor have dispersed before switching the
equipment on again.
5-6 A CHIEVA
6 Product disposal
For advice and information, contact your local Philips Healthcare Customer
Support Organization first, or otherwise PMS at the address below.
A CHIEVA 6-1
6.2 Passing the product on to another user
If this product passes to another user, it must be in its complete state,
including all product support documentation.
Make the new user aware of the support services that Philips Healthcare
provides for installing, commissioning and maintaining the product.
Before passing on the product or taking it out of service, all patient data must
be (backed up elsewhere if necessary, and) unrecoverable deleted on the
product.
It must be remembered by all existing users that passing on medical electrical
products to new users may create serious technical, medical and legal (e.g. on
privacy) risks. Such risks can arise even if the product is given away. Existing
users are strongly advised to seek advice from their local Philips Healthcare
representative before committing themselves to passing on any product.
Alternatively, contact the manufacturer.
Once the product has been passed on to a new user, a previous user may still
receive important safety-related information, such as bulletins and field
change orders. In many jurisdictions, there is a clear duty on the previous
user to communicate such safety-related information to new users. Previous
users who are not able or prepared to do this should inform Philips
Healthcare about the new user, so that PMS can provide the new user with
safety-related information.
6-2 A CHIEVA
Special attention should be paid to:
• Cooling fluids
• Phantom fluids
• Batteries
• Helium
N OT E Lithium battery cells used in the host computer, identified by CRxxxxx, contain
perchlorate material, special handling may apply.
See www.dtsc.ca.gov/hazardouswaste/perchlorate/index.cfm.
A CHIEVA 6-3
6.5 Toxic or hazardous substances and elements
REACH Declaration
REACH requires Philips Healthcare (PH) to provide chemical content
information for Substances of Very High Concern (SVHC) if they are
present above 0.1% of the product weight.
Components with electric or electronic equipment may contain phthalates
above the threshold (for example, bis(2-ethyl(hexyl)phthalate),
CAS nr.: 117-81-7).
The SVHC list is updated on a regular basis.
Please refer to the following Philips REACH website for the most up-to-date
list of products containing SVHC above the threshold:
http://www.philips.com/about/sustainability/reach.page
6-4 A CHIEVA
7 Appendices
A CHIEVA 7-1
7.2 Logging
Logging is a tool, which helps the Customer Support engineers analyze
operational problems. Logging can be accessed via the Windows start menu
1 Select |system| -> |show taskbar| or press the ‘windows’ key on your keyboard
to show the windows taskbar.
2 Click |Start| -> |MR User| -> |Diagnostics| -> |Logging Application UI|.
The logging application will be opened.
Access control
Intended to restrict access to the system to authorized users only:
• customizable on/off, a user log-on/log-off procedure is required to gain
access to the system.
• access to the system is granted according to a customizable list of
authorized users.
Audit trail
Required to log user activities which are information-security critical:
• applies to logging-on, reading and/or modifying clinical information.
• requires that means be provided for auto-backup on a hospital server, e.g.
the use of an external standard 'Syslog' server.
7-2 A CHIEVA
• uses standard Transport Layer Security Protocol
• the user can decide at installation to use encryption on a per node basis
(this may result in reduced performance).
Computer systems cannot be guaranteed to be safe in an insecure network.
The user should provide some level of network protection e.g. installing
firewalls. (section 2.20 ‘Network safety, security and privacy’).
Implementation
In order to meet the requirements described above, the system implements
the solution defined by the Integrating the Healthcare Enterprise (IHE) year
4 Basic Security profile.
• The Basic Security Integration Profile establishes security measures which,
together with the Security Policy and Procedures of the Enterprise, provide
patient information confidentiality, data integrity and user accountability.
For more information see the DICOM Conformance Statement.
Field Service
Field Service is used to enable the following configuration items based on
information supplied by the hospital:
• authentication and encryption
• time synchronization
• configuration of the 'Syslog' server
• configuration of any other programs, e.g. tools used to install certificates.
Certificates
Certificate requests should be handled by the hospital. The hospital should 7
decide on a procedure to create the Certificate request and import the
certificates.
The hospital should also define the types of certificates required, for example:
• the certificate of the machine itself
• the certificates of the machines it chooses to trust
• the certificate of the Certificate Authority (CA).
Certificates should always be signed by someone else, i.e. no self-signed are
allowed. However, the signer of the certificate need not be present on the
system. Self-signed certificates are the certificates required by the Integrating
the Healthcare Enterprise (IHE).
The following should also be specified:
A CHIEVA 7-3
• the location of the certificates (local machine)
• the location of the tools for certificate installation.
Certificates should be used between nodes to enable them to validate the
identity of each other.
It is the responsibility of the Healthcare Enterprise (HE) to define the
maximum validity period of certificates in its security policy.
Backup procedure
It is not the intended use of the system to permanently store (sensitive)
personal information. Information should be exported to a storage device as
soon as possible.
Automatic logoff
An auto-logoff feature is not implemented since it contradicts the intended
use of the system. A configurable screen save function with password
protection is available.
7-4 A CHIEVA
Cross reference index
A
F
Administration 4-2
FiberTrak 2-53
Ambient Ring 3-6
Fire safety 2-18
B
G
BOLD imaging 2-51
Geometry compensation 2-52
C H
Check Magnet weekly 5-2
Hardcopy 4-3, 4-7, 4-8
Cleaning 2-5, 5-3, 5-4
Hearing protection 2-33
Clothing 2-34
Helium 2-19, 2-20, 5-2
Compatibility 2-3
High SAR scanning 2-34
Contra-indications 2-30
Controlled Access Area 2-6, 2-7
Current loops 2-34 I
Image quality 2-24
D Implants 2-7
Important messages 2-58
Data export 2-55
Insulin pumps 2-30
Diffusion 2-54
intercom 3-15
Disinfection 5-5
IView Bold 2-54 I
E
K
Emergencies 4-11
Keyboard overlay 4-10
Emergency 2-22
k-t Blast 2-52
Emergency procedures 2-22
Emergency stop 3-7
Endo-cavitary coil 2-39
A CHIEVA I-1
L Q
Language 4-23 Q-flow 2-54
Laser light visor 2-21
Light visor 2-21
Light visor button 3-4, 3-10 R
Logging 7-2 Risk factors 2-43
M S
Main menu 4-6 SameScan 2-54
Maintenance 5-1 SAR 2-10, 2-13
Manual mode button 3-7, 3-10 Scan button 4-4, 4-9
Manual Override switch 2-18 Scan impossible 7-1
Metal splinters 2-31 Screening 2-29
MobiView 2-54 Security and Privacy 7-2
Select 4-13
SENSE 2-51
N Spectroscopy 2-55
NeuroPerfusion tool 2-53 Start scan button 3-5, 3-12
Nurse call 3-15 Static magnetic field 2-6
Stereotactic Localization Device 2-47
Stop scan button 3-5, 3-12
O Stop table button 3-10
Operating modes 2-1, 2-10 Storage and Transfer of Patient Data 4-17
Storage devices 4-17
P
Pan 4-16 T
Phantoms 2-25 TableTop Release button (TTR) 2-23
Phosphorus phantoms 2-27 Talk button 3-6, 3-11
Physiology 4-4, 4-9 Third party equipment 2-61
Physiology display system 3-3 Tool bar 4-8
Physiology signals 4-4 Topping up liquid helium 5-2
Pictorial index 4-8 Total body scanning 2-36
PIQT 5-2 Training 2-2
PNS 2-14 Travel to scan plane mode 4-13
Product disposal 6-1 Travel to scanplane button 3-4, 3-10
Proton Phantoms 2-27
I-2 A CHIEVA
V
View button 4-3
Viewing togglebutton 4-3, 4-8
W
Warning 5-5, 6-2
Windowing 4-16
Z
Zoom 4-16
A CHIEVA I-3
I-4 A CHIEVA
Philips Healthcare is part of
Royal Philips Electronics
This Medical Device meets the provisions of the transposition of
www.philips.com/healthcare the Medical Device Directive 93/42/EEC within the country of
healthcare@philips.com origin of the Notified Body concerned with the device.
Manufacturing address Philips Medical Systems Nederland B.V. reserves the right to
Philips Medical Systems Nederland B.V. make changes to both this Instructions for Use and to the
Veenpluis 4-6 product it describes. Product specifications are subject to change
5684 PC Best without notice. Nothing contained within this Instructions for
The Netherlands Use is intended as an offer, warranty, promise or contractual
condition, and must not be taken as such