Achieva Release 2.6.1

Transcription

1 Magnetic Resonance Achieva Release Intera Release and 12.6 series Instructions for Use English/US

2 Royal Philips Electronics N.V All right are reserved. Reproduction in whole or in part is prohibited without the prior written consent of the copyright holder. Philips Medical Systems Nederland B.V. reserves the right to make changes in specifications and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequences resulting from the use of this publication. Printed in The Netherlands /781*2008/4 P.

3 Contents 1 Introduction to the IFU About the system About this manual Intended use Compatibility Compliance Training Other manuals Installation instructions Equipment classification Safety Definition: IEC operating modes General safety directions Safety awareness Adequate training Intended use & compatibility Maintenance, faults and modifications Safety devices Cleaning MR equipment and MR rooms Magnetic safety Static magnetic field Controlled Access Area Access to Controlled Access Area Magnet EMERGENCY STOP button Mobile telephones & similar products Specific Absorption Rate (SAR) Operating modes Clothing and environmental conditions High SAR scanning ACHIEVA/INTERA 0-1

4 2.6 Gradient field strength (gradient output) Gradient output PNS levels Defining a scan Electrical safety Explosion safety Mechanical safety Tabletop movement in the event of an electrical power failure Manual override switch Vertical tabletop movement Fire safety Safety with liquid helium Safety with helium gas Laser light radiation safety (light visor) Emergency procedures Image quality Intrinsic artifacts Extrinsic artifacts Fluids in phantoms Phantoms for 1.5T systems Phantoms for 3.0T systems Spectroscopy phantoms Liquid in Gradient System Safety directions concerning a routine MR examination Screening prior to MR examination Contra-indications Communication Acoustic noise protection Patient clothing and positioning Total body scanning ECG/VCG RF receive coils Endo-cavitary coil for 1.5T systems Endo coil with disposable probe Coil and cable positioning ACHIEVA/INTERA

5 Moving the patient into the magnet bore Monitoring Stereotactic Localization Device BOLD imaging package Imaging Techniques Data export Spectroscopy On Planscan and Review planscan Network safety, security and privacy Important messages and indications PhysioTrak patient monitor Third party equipment Symbols on the system System overview System components Panels Patient support control panel Control panel at the rear of the magnet Coil and sensor sockets Connection panel Patient/operator Intercom Safety devices System Operation System logon Screen organization Basic viewing Advanced Viewing Extended MR WorkSpace Keyboard Keyboard overlay Stop Scan (F12) Workflow Preparation for scanning ACHIEVA/INTERA 0-3

6 4.5.1 Non-magnetic equipment Information towards patient Special cases Entering Patient data New patient Patient positioning Run / Create an ExamCard Viewing images Storage and Transfer of Patient Data Exit system software Shutdown the computer System start up and switch-off System start up System switch off User account administration Help system, User documentation, Instructions for Use and Technical description Accessing from the application software Accessing from the Windows Start menu Language settings Hospital/Institution name setting Using USB memory devices LOTS/TO remote assistance Workflow Remote Software Installation (RSI) Maintenance Planned maintenance User routine checks program Weekly magnet check Topping up liquid helium Periodic image quality test (PIQT) Anti-virus updates Cleaning and disinfection ACHIEVA/INTERA

7 5.4.1 Cleaning Disinfection Product disposal About product disposal Passing the product on to another user Final disposal of the product China RoHS declaration table Appendices Error procedures Scan not possible Computer malfunction Logging Security and Privacy features implemented Other Security and Privacy features addressed Network firewall configuration Cross reference index... I-1 ACHIEVA/INTERA 0-5

8 0-6 ACHIEVA/INTERA

9 1 Instructions for Use 1 Introduction to the IFU 1.1 About the system General Achieva and Intera systems are Philips new generation Magnetic Resonance Imaging systems. Principle of operation Philips Achieva and Intera 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. 1.2 About this manual This manual describes the following systems: Achieva 3.0T, Achieva 1.5T and Achieva XR of Release 2.6.1; new installations and upgrades. Intera systems upgraded to release (freewave) or release All information and procedures in this manual apply to the above-mentioned systems, unless explicitly stated otherwise. NOTE 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. This manual is intended to assist users and operators in safe and effective operation of the equipment described. The user is considered to be the body with authority over the equipment; operators are those persons who actually handle the equipment. Before attempting to operate the equipment, you must read, note and strictly observe all DANGER notices and safety markings on the systems. ACHIEVA/INTERA 1-1

10 Before attempting to operate the equipment, you must read this manual 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. WARNING CAUTION NOTE NOTE 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. Cautions are directions which if not followed could cause damage to the equipment described in this manual and/or any other equipment or goods, and/or cause environmental pollution. Notes are intended to highlight unusual points as an aid to an operator. Within this manual, 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. Apart from this manual, 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 scanner. The Technical Description can be accessed from the Windows Start Menu. It does not describe upgraded systems. 1.3 Intended use The Philips Magnetic Resonance equipment is intended to be used only for the purposes for which it was designed. It must be operated in accordance with the safety procedures and operating instructions given in this manual. However, nothing stated in this manual reduces users' and operators' responsibilities for sound clinical judgement and best clinical procedure. Uses of the equipment for purposes other than those intended and expressly stated by the manufacturer, as well as incorrect use, incorrect operation, or modifications made to the system without explicit approval from Philips, may relieve the manufacturer (or his agent) from all or some responsibilities for resultant non-compliance, damage or injury. This includes the operation of non compliant 3rd party equipment in the vicinity of the MR scanner, which may influence the operation of the scanner. The Philips Achieva and Intera may only 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 1-2 ACHIEVA/INTERA

11 1 indicated by the manufacturer, must be fulfilled and a preventive maintenance program for both the system and siting requirements must be operational. Philips Achieva and Intera MR systems are indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MR scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis. Only during specific studies the patient can control or influence the progress of the study, e.g. by breath hold studies or via synchronization of the study to the heart rate or the respiratory cycle. For some studies the use of contrast agents can be essential. In addition Philips Achieva and Intera MR systems provide capabilities to perform interventional non critical cardiac and vascular procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user. All patients, with the exception of contra-indicated patients as defined in chapter 2 Safety can be submitted to an MR study on the Philips Achieva or Intera, given the dimensional limitations of the system. Screening of the patient is essential following the safety paragraphs of this Instructions for Use. During an MR examination energy is transferred to the patient in the form of Radio Frequent radiation, switching magnetic fields and acoustic noise. The energy levels as well as the level of the static magnetic field are controlled following international safety standards. For a static magnetic field at values over 2T, patients may experience effects such as dizziness, vertigo and a metallic taste in the mouth. Use and operation of this equipment is subject to the law in the jurisdiction(s) in which the equipment is being used. Both users and operators must only use and operate the equipment in such ways as do not conflict with applicable laws or 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 this manual. ACHIEVA/INTERA 1-3

12 WARNING 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 Equipment described in this manual 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 Achieva and Intera by Philips Healthcare. Changes and/or additions to the equipment 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 equipment 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 equipment, maintenance by persons not appropriately qualified and/or using unapproved spare parts carries serious risks of damage to the equipment and of personal injury. Specific technical information needed to enable testing of the proper operation of peripheral equipment is described in the Technical Description. 1.5 Compliance The Philips Achieva and Intera comply with relevant international and national standards and laws. Information on compliance will be supplied on request by your local PMS representative. The Philips Achieva and Intera 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. The Philips Achieva and Intera are not AP (Anaesthetic-Proof) or APG (Anaesthetic-Proof Category G) tested. 1-4 ACHIEVA/INTERA

13 1 1.6 Training Operators of the Philips Achieva and Intera must have received adequate training on its safe and effective use before attempting to operate the equipment described in this manual. Training requirements for this type of device will vary from country to country. It is for users 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 equipment, please contact your local Philips Healthcare representative. 1.7 Other manuals This manual describes the Achieva and Intera. However, certain other pieces of equipment may be used with the system, and each may have its own manual. On the Achieva and Intera you can also access a Help system. This Help system gives you basic and advanced scanning information. The Intera and Achieva software has also a context sensitive Help functionality. This functionality will lead you directly to the related topic of the Help system. 1.8 Installation instructions The installation instructions for Achieva and Intera Systems is supplied by Philips Healthcare in separate documentation. The installation must be performed by appropriately trained personnel. Philips Healthcare can only accept responsibility for basic safety, reliability and performance, if: qualified personnel carry out assembly operations, extensions, readjustments or repairs, the electrical installation of the technical room complies with the appropriate requirements, and the Inter Achieva system is used in accordance with the Instructions for Use. ACHIEVA/INTERA 1-5

14 WARNING This equipment/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. 1.9 Equipment classification EQUIPMENT CLASSIFICATION Classification according to IEC According to the type of protection against electrical shock: According to the degree of protection against harmful ingress of water: According to the methods of sterilization or disinfection: According to the mode of operation: Class I equipment. Ordinary equipment (enclosed equipment without protection against ingress of water). Non sterilizable. Use of Liquid surface disinfectants only. Continuous operation. 1-6 ACHIEVA/INTERA

15 2 Safety 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 equipment for any examination Definition: IEC operating modes Three operating modes are defined by IEC In the following sections, it is referred to these operating modes. Therefore they are briefly explained below. Normal operating mode: In the normal operating mode no physiological stress factors are to be expected. It is recommended that all patients receive routine monitoring. First level controlled operating mode: In the first level controlled operating mode some conditions may cause physiological stress to patients. Particular caution must be taken for patients at risk by adding medical supervision in addition to routine monitoring. Second level controlled operating mode: The second level controlled operating mode can not be entered on the system. The scan protocol indirectly determines the operating mode. NOTES IEC is the MR Safety standard published by the International Electrotechnical Commission. Achieva and Intera conform to the 2nd edition of this IEC standard (published in 2002). ACHIEVA/INTERA 2-1

16 The levels of exposure at which the Normal Operating Mode is left and First level controlled operation mode is entered are specified in IEC 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. 2.2 General safety directions Safety awareness WARNING Do not use the Achieva or Intera 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. NOTE In some countries legislation may exist covering occupational limits for exposure to EMF (Electro Magnetic Fields) Adequate training WARNING Do not use the system for any application until you have received adequate and proper training in its safe and effective operation. Training is needed for physicians and operators to operate the MR equipment safely and effectively. This training shall include emergency procedures related to emergency medical procedures, access to the controlled access area, the handling of emergency field shut down unit, procedures in case of fire and the emergency actions in the event of a quench. 2-2 ACHIEVA/INTERA

17 If you are unsure of your ability to operate this equipment safely and effectively DO NOT USE IT. Operation of this equipment without proper and adequate training could lead to fatal or serious personal injury and to clinical misdiagnosis. For information about training, please refer to Section 1.6 Training of this manual Intended use & compatibility WARNINGS NOTES Do not use the Achieva or Intera for any purpose other than those for which it is intended. Do not use the Achieva or Intera with any equipment/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. 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 Maintenance, faults and modifications WARNINGS Do not use the Achieva or Intera 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. ACHIEVA/INTERA 2-3

18 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 scanner. Sharp edges may cause injury to patient s skin. Changes to the Achieva or Intera 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. 2-4 ACHIEVA/INTERA

19 2.2.5 Safety devices WARNING Never attempt to remove, modify, over-ride or frustrate any safety device on the equipment or examination room. See also section 3.3 Safety devices. Interfering with safety devices could lead to fatal or other serious personal injury Cleaning MR equipment and MR rooms WARNINGS Flammable or potentially explosive disinfecting sprays must not be used. The resultant vapour could ignite, causing fatal or other serious personal injury and/or damage to equipment. Also refer to section 2.8 Explosion safety. Objects made of iron or other magnetic materials must not be brought into the Controlled Access Area such as vacuum cleaners, pocket knifes and keys. To avoid cross-infection always clean/disinfect the tabletop, RF coils and cables after examination of (injured) patients where contamination of the tabletop, RF coils and cables may have occurred, see chapter 5.4 Cleaning and disinfection. NOTE For detailed instructions on cleaning Endo-cavitary coils see section Endocavitary coil for 1.5T systems and section Endo coil with disposable probe ACHIEVA/INTERA 2-5

20 2.3 Magnetic safety NOTE In some countries, legislation may exist prohibiting very high magnetic fields (>2T) for routine clinical use Static magnetic field For the static magnetic field, the following operating mode limits apply as described in IEC Field strength IEC Operating mode Safety measures 1.5T Normal operating mode Routine patient monitoring 3.0T First level controlled operating mode Routine patient monitoring Particular caution for patients at risk WARNING 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 Controlled Access Area In the Controlled Access Area the stray field will exceed 0.5 mt (= 5 Gauss). 0.5 mt is exceeded up to the following distances from the magnet centre: Field strength X direction Y direction Z-direction 1.5T 2.4 m 2.4 m 3.8 m Achieva XR 1.5T 2.7 m 2.7 m 4.3 m 3.0T and Achieva XR 3.0T 3.1 m 3.1 m 5.0 m 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 2.24 Symbols on the system. 2-6 ACHIEVA/INTERA

21 6 m 6 m 6 m 5 m 4 m 0,5 mt (5 Gauss) 5 m 4 m 0,5 mt (5 Gauss) 5 m 4 m 0,5 mt (5 Gauss) 2 3 m 3 m 3 m 2 m 2 m 2 m 4 m 3 m 2 m 2 m 3 m 4 m 4 m 3 m 2 m 2 m 3 m 4 m 4 m 3 m 2 m 2 m 3 m 4 m 2 m 2 m 2 m 3 m 3 m 3 m 4 m 4 m 4 m 5 m 6 m 1.5T systems Figure m 5 m XR 1.5T systems 3.0T systems 6 m 6 m Top view with 0.5 mt (5 Gauss) lines for 1.5T, XR 1.5T and 3.0 T systems Access to Controlled Access Area WARNINGS 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. Persons fitted with metallic implants or electrically, magnetically, or mechanically activated implants (such as cardiac pacemakers) must not be allowed to enter the Controlled Access Area. The magnetic and electromagnetic fields produced by the MR equipment can exert strong forces on these devices or interfere with their operation. ACHIEVA/INTERA 2-7

22 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. NOTE 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 Magnet EMERGENCY STOP button Design Red button with text EMERGENCY STOP Location Emergency stop buttons: are located: in the examination room outside the examination room Purpose For immediate removal of the magnetic field (within 20 seconds). Operation of this button will de-energize the magnet. Reason for use ONLY use in case of emergency: Objects are attracted by the magnet, causing injury to patient or personnel. Fire or some other unexpected event occurs that demands immediate action and entry into the examination room by emergency personnel. In any other situation that requires immediate removal of the magnetic field as opposed to the normal, controlled ramp-down of the magnetic field. 2-8 ACHIEVA/INTERA

23 Limitation Warning label 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. It is therefore very expensive. 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. 2 Pressing an Emergency Stop button will initiate a quench of the magnet within a few seconds. The system will then make a loud noise caused by the rapid relief of helium gas through the quench pipe. This loud noise is proof that the magnet has actually quenched and that the magnet field has decreased to less than 10mT. This will take approximately 20 seconds. WARNING It is the responsibility of the hospital to establish emergency procedures in case there is a need for an emergency stop of the magnet. 2.4 Mobile telephones & similar products Philips MR systems comply with the requirements of applicable EMC standards. Other electronic equipment exceeding the limits defined in such EMC standards, such as certain mobile telephones, could, under unusual circumstances, affect the operation of the system. WARNING Radio frequency transmitting devices (such as mobile telephones) must not be allowed into the examination room - even if switched off. Such devices could exceed EMC radiation standards and, under unusual conditions, interfere with the proper functioning of the system. This could, in extreme cases, lead to fatal or other serious personal injury or to clinical misdiagnosis. ACHIEVA/INTERA 2-9

24 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 Head SAR Local torso SAR Local extremities SAR the SAR averaged over the total mass of the patient. (4 W/kg) the SAR averaged over the mass of the patients head. (3.2 W/kg) the SAR averaged over any 10g of tissue of the patient. (10 W/kg) the SAR averaged over any 10g of extremity tissue of the patient. (20 W/kg) 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: SAR / limiting SAR type: x % / x W/kg Whole body / level: y W/kg / n 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) Operating modes The system recognizes three operating modes (section 2.1 'Definition: IEC operating modes'): 2-10 ACHIEVA/INTERA

25 IEC Operating mode SAR limits Safety measures 2 Level 0 (Normal) Whole body SAR less than or equal to 2 W/kg Head SAR less than or equal to 3.2W/kg Local torso SAR less than or equal to 10W/kg Local extremities SAR less than or equal to 20W/kg Routine patient monitoring Level I (First level controlled) Whole body SAR greater-than or equal to 2 W/kg and less than or equal to 4 W/kg Head SAR less than or equal to 3.2W/kg Local torso SAR less than or equal to 10W/kg Local extremities SAR less than or equal to 20W/kg Routine patient monitoring Particular caution for patients at risk Level II (Second level controlled) Whole body SAR greater-than 4 W/kg Head SAR greater-than 3.2W/kg Local torso SAR greater-than10w/kg Local extremities SAR greater-than 20W/kg The system is limited. Level II cannot be reached. More information about Level I When level 1 is reached a warning message is given and medical supervision of the patient is required. If the patient's condition cannot be monitored, or the risk is too high, the scan parameters must be changed to give a SAR in level 0 range. If the risk is acceptable, the scan can be started. NOTE This message may be combined with the message warning that a certain gradient output level may be exceeded. See section 2.6 Gradient field strength (gradient output). Particular caution for patients at risk In addition to routine monitoring, particular caution must be exercised for patients who are sensitive to temperature increases or to RF energy, e.g.: Patients at risk of cardiac arrest Pregnant women Patients susceptible to seizures, or claustrophobic reactions Decompensated cardiac patients and febrile patients Patients with impaired ability to perspire ACHIEVA/INTERA 2-11

26 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) WARNING The whole body SAR limits are only valid for room temperatures not greater than 24 o C 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 24 o C. 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 Clothing and environmental conditions Increased ambient temperature and humidity hinder the body s ability to get rid of excess heat. Likewise, heavy clothing hinders heat dissipation. Ensure that: Ambient temperature does not exceed 24 o C or 75 o F Relative humidity does not exceed 60% WARNINGS Avoid bringing metal parts close to the magnet. Interaction with RF signal may result in excessive heating of these metal parts which may lead to burn injuries. Severe perspiration of the patient may result in excessive heating and ultimately in burn injuries. Any added insulation (such as blankets) should be removed. Blankets may prevent satisfactory dissipation of body heat. Make sure that the ventilation system is working fine. Patient core temperature rise can be decreased by adequate ventilation of the patient space ACHIEVA/INTERA

27 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, scanning in high SAR mode may result in perspiration of the patient. 2 WARNINGS 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. NOTE 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. 2.6 Gradient field strength (gradient output) The use of fast switching and high gradients may lead to peripheral nerve stimulation (PNS) during the scan. The location and nature of the PNS differs for each individual. PNS can cause a tingling sensation or superficial twitching. NOTE Too high gradient output may even cause cardiac nerve stimulation. Literature indicates that threshold levels for cardiac stimulation are much higher than for peripheral nerve stimulation. Peripheral nerve stimulation is possible. Cardiac stimulation for all stimulus durations is virtually impossible Gradient output During the scan definition, the gradient output is calculated for this scan (PNS) and compared with mean threshold level. This mean threshold PNS is defined as the onset of sensation, and refers to the level at which 50% of the people start to experience PNS. The expected PNS level is displayed on the info page and expressed as a percentage of the mean threshold level for PNS as calculated by the system for the sequence prepared for the patient. ACHIEVA/INTERA 2-13

28 PNS/level x % / n PNS levels x % = The predicted PNS value is expressed as a percentage of the mean threshold level for PNS. n = Operating mode ( Normal or level I ) The system recognizes three PNS levels, corresponding to the operating modes (Section 2.1 Definition: IEC operating modes ): IEC Operating mode Level 0 (Normal) Level I (First level controlled) Level II (Second level controlled) Gradient output The gradient output is less than or equal to 80% of the mean threshold level The gradient output is greater than 80% but less than or equal to 100% of the mean threshold level The gradient output is greater than 100% of the mean threshold level Safety measures Routine patient monitoring Routine patient monitoring Particular caution for patients at risk The system is limited to a maximum gradient output of 100% of the mean threshold level. Level II cannot be reached More information about Level 0 In level 0 the probability of PNS is very low. More information about Level I When Level I is reached (predicted gradient output exceeds 80% of the mean threshold level) a warning message is displayed: Potential Peripheral Nerve Stimulation in scan(s) <numbers>. Medical supervision of the patient is required. Click Proceed to confirm. 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 ACHIEVA/INTERA

29 NOTE 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 Operating modes for patients at risk. 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 Defining a scan The potential for peripheral nerve stimulation depends on the maximum gradient strength, slew rate and timing of the scan. When defining a scan, the parameter PNS mode is used to control the maximum allowed gradient output. The actual gradient output is displayed on the info page and is dependent on other parameters. Three levels are available: "low": the maximum allowed gradient output will be limited to 60% of the mean threshold level, i.e. the system will always operate in normal operating mode and the probability of PNS is very low. "moderate": the maximum allowed gradient output will be limited to 80% of the mean threshold level, i.e. the system will always operate in normal operating mode. The probability of PNS is low and if experienced it is mostly not painful. ACHIEVA/INTERA 2-15

30 "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. 2.7 Electrical safety Philips MR systems may be operated on a permanent 24-hour basis without adversely affecting its safety or performance. WARNINGS 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 shortcircuits 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. 2.8 Explosion safety This equipment must not be used in the presence of explosive gases or vapours, such as certain anaesthetic gases. Use of electrical equipment in an environment for which it was not designed can lead to fire or explosion. WARNINGS Flammable or potentially explosive disinfecting sprays must not be used ACHIEVA/INTERA

31 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 with air, oxygen or nitrous oxide is not allowed at the system. The Philips Achieva and Intera are not AP (Anaesthetic-Proof) or APG (Anaesthetic-Proof Category G) tested Mechanical safety WARNINGS 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 Tabletop movement in the event of an electrical power failure In the event of an electrical power failure, all tabletop movement will be blocked. 1 Press the red TableTop Release button (TTR) located at each side of the patient support to free the In/Out tabletop movement. The tabletop can then be moved manually. All motor driven tabletop movement will be interrupted. 2 When electric power is re-established press the same TTR button again to re-enable motorized movement. The motor driven vertical and horizontal movements are interrupted when the sensor plate beneath the magnet aperture is pressed 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 under the TTR buttons at the magnet end of the patient support. ACHIEVA/INTERA 2-17

32 TTR button Manual override switch Figure 2.2 TTR button and manual override switch Manual mode Vertical tabletop movement If vertical tabletop movement is not functioning properly the patient support switches automatically into 'manual mode': The LED at the manual mode button of the Patient Support control panel flashes. Move the tabletop manually out of the system into its end position. The patient support is reset and the LED stops flashing. Press the manual mode to switch to motorized movement again: vertical movement of the tabletop is re-enable Fire safety In the event of a fire in the examination room: Press the magnet Emergency stop button (section Magnet EMERGENCY STOP button ) to rapidly remove the magnetic field before bringing fire-extinguishers into the examination room. General safety measures in the event of fire All operators of this medical electrical equipment should be fully aware of and trained in the use of fire extinguishers and other fire-fighting equipment, and in local fire procedures. Fire extinguishers should be provided for both electrical and non-electrical fires. Fire regulations for the type of medical area being used should be fully applied, observed and enforced ACHIEVA/INTERA

33 The fire precautions stated in this section should be discussed with the local fire department and fire emergency precaution procedures should be established. 2 WARNINGS NOTE It is the responsibility of the hospital to establish emergency procedures in case there is a need for an emergency stop of the magnet. For electrical or chemical fires only use extinguishers that are specifically labelled as suitable. Using water or other liquids can lead to serious or fatal injury. Attempt to isolate the equipment from electrical supplies before fighting the fire. This will reduce the risk of electric shocks. MR safe (non-magnetic) fire extinguishers are commercially available and can be used. If your system is a 3.0T system assure yourself that the fire extinguishers are also compatible with this field strength. The most restrictive local rules must be complied with. Choose fire extinguishers that best suits your site and that mixing up with MR unsafe extinguishers is not possible Safety with liquid helium WARNINGS Under no circumstances should a liquid helium container be brought into the magnet area unless it is known to be made of non-magnetic material or the magnet is not energized. It is extremely dangerous for patients, personnel and equipment to bring any magnetic or ferrous metal objects into the examination room. Special non-magnetic containers are available from liquid helium suppliers and must always be specified and appropriately labeled. Under no circumstances should liquid helium be transferred into the magnet prior to installation of the helium venting system. ACHIEVA/INTERA 2-19

34 Filling with liquid helium WARNINGS Filling with liquid helium. Filling with liquid helium should be carried out by trained and authorized persons. See section Topping up 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 Safety with helium gas Properties of helium gas: Odorless Non-flammable Non-poisonous On evaporation of liquid helium a cold mist is formed. Helium gas rises in air. Normal operating conditions Under normal operating conditions a small amount of helium gas is evaporated by the boil-off of the liquid helium in the magnet. Philips MR systems are equipped with a helium venting system, which vents the helium gas from the magnet to the outside of the building under normal operation and emergency switch-off conditions (quench). High concentration of helium gas High concentrations of helium gas in the examination room can lead to suffocation, as it dilutes the oxygen in the air. A large amount of helium gas is evaporated when the magnet Emergency stop button is used for immediate removal of the magnetic field, or during a spontaneous quench of the magnet ACHIEVA/INTERA

35 WARNINGS 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 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. An oxygen detector with audible alarm may be used as a warning device. Do not switch-off the air conditioning or air circulation in the room if helium has leaked into the examination room (this is an automatic procedure triggered by a smoke detection alarm for detection of fire) but maintain air circulation and ventilation Laser light radiation safety (light visor) Philips MR systems have a laser type light visor system. The light visor should only be used under supervision of medical trained personnel, who are acquainted with hazards implied by the use of laser light. It is the user s responsibility to meet local safety regulations. WARNINGS 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. ACHIEVA/INTERA 2-21

36 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 LASER WARNING SYMBOL At the laser aperture (outside front cover) LABEL LASER APERTURE 2.14 Emergency procedures WARNING It is required for the hospital to establish emergency procedures for the following situations: emergency medical procedures. unauthorized people entering the controlled access area ACHIEVA/INTERA

37 the need for an emergency field shut down. fire precautions in case of a quench of the magnet. 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 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 2 WARNING Electronic or other metallic emergency equipment must not be brought into the examination room. TTR button (on each side of the patient support) 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. ACHIEVA/INTERA 2-23

38 2.15 Image quality WARNING 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 Intrinsic artifacts MR technical capabilities and patient physiology e.g. magnet homogeneity gradient linearity truncation aliasing motion flow chemical shift susceptibilities may result in artifacts which appear in the image. These artifacts and methods of correcting or mitigating such effects (e.g. changing bandwidth, gradient moment nulling, pre-saturation, etc.) are described in the online help system Extrinsic artifacts Magnetic objects or non-magnetic metallic objects such as jewelry, hairpins, buttons, prosthetics will disturb the RF signal or will influence the homogeneity of the magnet field and will interfere with the imaging capabilities of the system. This may lead to clinical misdiagnosis. WARNING 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) ACHIEVA/INTERA

39 2.16 Fluids in phantoms WARNING 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 Phantoms for 1.5T systems Fluid in Body 400 mm and Head 200 mm phantoms Personal protection Eyes: safety goggles Constituents in weight % water percent % sulfuric acid % copper(ii)sulphate Toxicity LD-50: 300 mg/kg (ORL-RAT, copper (II) sulfate) LD-50: 2.14 mg/kg (ORL-RAT, sulfuric acid) 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. Fluid in Bottle phantoms Personal protection Eyes: safety goggles Constituents in weight % water percent 0.005% sulfuric acid 0.077% copper(ii)sulphate 0.2% sodium chloride 0.001% dialkyl-1-dimethyl ammonium chloride Toxicity LD-50: 300 mg/kg (ORL-RAT, copper (II) sulfate). LD-50: 2.14 mg/kg (ORL-RAT, sulfuric acid). LD-50: 3 g/kg (ORL-RAT, sodium chloride). ACHIEVA/INTERA 2-25

40 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 Phantoms for 3.0T systems Fluid in Head 200 mm phantom Personal protection Eyes: safety goggles Constituents in weight % water percent % sulfuric acid % copper(ii)sulphate Toxicity LD-50: 300 mg/kg (ORL-RAT, copper (II) sulfate) LD-50: 2.14 mg/kg (ORL-RAT, sulfuric acid) 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. Fluid in 400 mm Body phantom and Bottle phantoms Personal protection Eyes: safety goggles Constituents in weight 100% mineral oil percent Toxicity LD-50: 2000 mg/kg. 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: Wash with soap and water. Eyes: Rinse for a long time with plenty of water ACHIEVA/INTERA

41 Spectroscopy phantoms Proton Phantoms 2 Fluid in proton sphere phantoms A Personal protection Eyes: safety goggles Constituents 5 ml/l 98% acetate (CH 3 COOH) 10 ml/l 80% ethanol (CH 3 CH 2 OH) 8 ml/l 98% Phosphorus acid (H 3 PO 4 ) 1 ml/l 1% arquad solution mg/l CuSO 4 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 Fluid in phosphorus sphere phantoms B Personal protection Eyes: safety goggles Constituents 30 g/l Methyl phosphonic acid P(OH) 2 O(CH 3 ) 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. Fluid in phosphorus disk phantoms A Personal protection Eyes: safety goggles Constituents 300 mm H 3 PO 4 (phosphor acid) solution ACHIEVA/INTERA 2-27

42 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. Fluid in phosphorus disk phantoms B Personal protection Eyes: safety goggles Constituents 300 mm H 3 PO 2 (phosphoric acid) solution 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 Liquid in Gradient System Gradient amplifier Constituents Distilled water 50% Dowtherm SR1 9 (dyed pink) 50%, consisting of: - Ethylene glycol CAS# (>95%) - Dipothassium Phosphate CAS# (<3%) - Water CAS# (<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 ACHIEVA/INTERA

43 Gradient amplifier First aid Skin contact: Immediately remove contaminated clothing and rinse the skin with plenty of water. Eyes: Rinse for a long time with plenty of water. 2 Gradient coil coolant Constituents Distilled water (approximately 30 l) Inhibitor, AZ8104 from Betz Dearborn (6ml) - Sodium Hydroxide =5% - Sodium, 4(of 5)- Methyl-1H-Benzotriazole = 3% - 1H-Benzotriazole, C-Chloro-C-Methyl, Sodium Salt =20% Biocide, Spectrus NX 1164 from Betz Dearborn (2.7 ml) - 3(2H)-Isothiazolone, 5-Chloro-2-Methyl <=3.0% - Magnesium nitrate =5% 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 coil cooling system needs topping up. Contact your local Customer Support representative. First aid Skin contact: Immediately remove contaminated clothing and rinse the skin with plenty of water. Eyes: Rinse for a long time with plenty of water Safety directions concerning a routine MR examination Screening prior to MR examination Screening of patients prior to MR examination is necessary. This is especially important for those who could be at risk due to their occupation, past medical history, present medical condition or the physical environment of the MR equipment. Particular caution must be exercised for the following classes of patients: Patients for whom MR examinations are contra-indicated, see section Contra-indications. ACHIEVA/INTERA 2-29

44 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. WARNING If in doubt, do not scan. Contact the referring doctor. Obtain a sample of the material in question if necessary, and seek advice from the manufacturers 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. Implants of magnetic material Examples: - Intracranial aneurysm clips - Other surgical clips and staples - Artificial cardiac valves - Joint prostheses Contra-indication depends on the amount of ferromagnetic material and the possibility of heating and/or movement. A Charnley-Muller hip-prosthesis f.i. presents no risk. - Limb prostheses containing ferromagnetic materials WARNING Most metallic implants are only tested for field strengths up to 1.5T. For 3.0T systems extra care is necessary. Metal splinters 2-30 ACHIEVA/INTERA

45 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 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. 2 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). Spine stabilizing devices There is a risk to patients who require stabilization of the spine with a halovest or other similar device e.g. bracelets or prostheses, because the RF interaction with the conductive metal parts of such devices could cause electrical arcing or undue local heating. 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. Permanent (tattoo) eye-liner and facial make-up Facial make-up may contain ferromagnetic particles that could penetrate the tissues around the eye. It may also cause a "heating" effect. Sweaters with conductive wires All clothing containing metallic thread or parts and all other metallic objects must be removed from the patient. High RF levels can be harmful to certain patients. Other contra-indications may be specified by local regulations. ACHIEVA/INTERA 2-31

46 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 equipment. 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. WARNING CAUTION Wearing damp clothing may result in excessive local heating. 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 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 ACHIEVA/INTERA

47 NOTE 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 Acoustic noise protection Earplugs, headphones or some other form of hearing protection must be worn by the patient during scanning. Without hearing protection, noise levels may be high enough to cause discomfort or result in temporary or even permanent loss of hearing. WARNINGS 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. 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 newborns, infants and young children and to elderly. The sound level in the control area must comply with local regulations concerning exposure to noise at work. NOTE It is advised to apply SofTone to reduce the noise level. ACHIEVA/INTERA 2-33

48 The A-weighted RMS sound pressure levels, L aeq, 1h, are measured while using the MR equipment 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 Patient clothing and positioning For high SAR scanning patients must be dressed in light clothing (e.g. light pajamas, nightshirt or T-shirt). any added insulation (such as blankets) should be removed. Blankets may prevent satisfactory dissipation of body heat. WARNINGS Patient s clothing must not allow skin-to-skin contact. Care must be taken to avoid current loops: place insulating material (e.g. foam rubber, preferably thicker then 0.5 cm) between and outside the patient's legs to prevent skin-to-skin contact. There is a risk of burning due to generation of high current loops if the legs/arms are allowed to touch. Ensure that the patient does not form a loop with any body parts. For breast coils in particular, patients are imaged lying prone with both arms extended above the head (superman). Do not allow patients to touch any part of the right hand or arm to any part of the left hand or arm. The loop formed by doing so could cause an RF burn at the point of contact. Be sure to inctruct the patient accordingly and check the patient's position immediately before the scan ACHIEVA/INTERA

49 Total body scanning For total body scanning the special Total body tabletop must be installed onto the (regular) tabletop. 2 WARNINGS 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 ECG/VCG WARNINGS The ECG/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. Never reposition or reuse ECG electrodes. Repositioning or reuse may result in a heating effect, as a result of high skin resistance. Always use new electrodes. Do not use ECG electrodes after they have reached their expiration date. ACHIEVA/INTERA 2-35

50 Do not use pediatric ECG electrodes on adults and vice versa as this may result in skin burns. Do not place the VCG battery module direct 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 module 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. NOTE For correct positioning of the electrodes see the system help or the Application Guides. ECG/VCG cable heating Figure 2.3 ECG/VCG cable: Location where heating can occur Under some circumstances the combined use of SENSE Cardiac coil and the ECG/VCG cable can cause local heating of the ECG/VCG cable. See Figure 2.3 for location where heating can occur. Heating only occurs in cases where a loop has been formed in the cable of the SENSE coil next to the ECG/VCG cable. WARNING Strictly follow the instructions below to avoid local ECG/VCG cable heating and the risk of skin burns: DO NOT position the VCG cable and the cable of the SENSE Cardiac coil next to each other. Place the coil cable on one side of the patient and the VCG cable on the other side of the patient. Keep a distance of at least 20 cm between both cables, see Figure 2.4. Make sure that no loops have been formed in the cables when they are connected to the Patient Support Control Panel ACHIEVA/INTERA

51 2 Figure 2.4 LEFT: CORRECT cable positioning: Coil cable and ECG/VCG cable positioned on different sides of the patient RIGHT: INCORRECT cable positioning: Coil cable looped parallel to the ECG/VCG cable 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. WARNINGS 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 scanner. 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. ACHIEVA/INTERA 2-37

52 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 Endo-cavitary coil for 1.5T systems WARNINGS 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 ACHIEVA/INTERA

53 NOTE 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. 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. Structure 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 Cleaning and disinfection WARNINGS Do not sterilize any part of the Endo-cavitary coils. Always close the air valve during cleaning to prevent ingress of liquid. It is important to clean the coil thoroughly before disinfection. ACHIEVA/INTERA 2-39

54 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. 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. For disinfection, the following high level disinfectants can be used: Cidex OPA, see Steranios 2% NG, see Based on material compatibility testing these agents have been found to be chemically compatible with the coil Endo coil with disposable probe Endo coils with disposable probes are available for 1.5T and 3.0T systems. WARNINGS NOTE 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. For USA only: the user should refer to the FDA March 29, 1991 Medical Alert on latex product ACHIEVA/INTERA

55 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. 2 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. Positioning and routing The coil can only be connected after the patient is positioned head-first into the isocenter. Route the cable of the coil and the preamplifier box between the patient s legs parallel to the axis of the bore. The cable of the probe may not touch the patient and the bore. Route the preamplifier cable underneath the patient s leg to the side. 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. ACHIEVA/INTERA 2-41

56 WARNING Emergency Patient Removal: Stop the scan, disconnect the probe from Endo-coil Interface Device, and remove the patient from the examination room. After the patient is removed, deflate the balloon and remove probe. Cleaning and disinfection Discard the probe in a hazard waste container. Clean the interface device after each use with one of the following solutions: - distilled water, mild dish detergent. - 10% bleach/90% distilled water solution. - hydrogen peroxide. - isopropyl alcohol. - formula Lysol disinfectant. - methylated spirits (90% ethanol, 9.5% methanol,.5% pyridine) Coil and cable positioning Risk factors The MR system dissipates energy from various sources. This can lead to a temperature rise of components surrounding the patient such as cables and RF coils. Usually the end temperature does not exceed body temperature. In these situations there is no concern regarding patient safety. The most important source of energy is the RF energy emitted by the transmit coil. Safety issues on the direct deposition of RF energy into the patient are described in section 2.5 Specific Absorption Rate (SAR). When electrical cables are close to the patient (e.g. RF coil cables) or connected to the patient by electrodes (e.g. ECG cables), care must be taken to avoid situations of components heating up to high end temperatures. WARNINGS 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 ACHIEVA/INTERA

57 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. 2 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. 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. NOTE 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. WARNING 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 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). ACHIEVA/INTERA 2-43

58 Figure 2.5 LEFT: CORRECT cable distance: Distance of SENSE Flex-S coil cables to patient s body greater than 2 cm using the standard accessory set RIGHT: INCORRECT cable distance: Coil cable directly on patient s body WARNINGS Never scan with the SENSE Head Coil positioned more than 5 centimeters offcenter. 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 (if used as positioning aid also the head coil) 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. Heating of the Interface Box (RF cable trap) WARNINGS 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 ACHIEVA/INTERA

59 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. 2 Total Neuro studies 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 Moving the patient into the magnet bore WARNINGS NOTES 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. 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 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. ACHIEVA/INTERA 2-45

60 These patients are unable to sense excessive local heating, excessive sound or peripheral nerve stimulation and are unable to alert the operator Stereotactic Localization Device Cleaning, disinfection and sterilizing Cleaning Before disinfection or sterilizing, all blood or otherwise contaminated parts of the device must be cleaned mechanically. Special attention must be paid to the holes in the needle guides and the upper compression plate. Disinfection After cleaning the compression plate must be disinfected with a locally approved disinfectant (e.g. Sekosept or Hemosol). Please carefully read the instructions of the manufacturer. Sterilizing (metal needle-guide) After cleaning the metal needle-guide must be steam-sterilized: o C. WARNING: Before first use, the metal needle guides must be sterilized and the compression plates disinfected 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 protocols/paradigms by means of a galvanic separated trigger pulse generated by the functional imaging pulse sequence. WARNINGS 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 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 ACHIEVA/INTERA

61 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 Imaging Techniques General WARNING 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. WARNINGS When using SENSE, do NOT plan with foldover. 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 must consist of several averages. ACHIEVA/INTERA 2-47

62 Before starting the reference scan, the patient must be instructed to hold a full inspiration for seconds and to continue with free breathing afterwards (the reference scan is divided into four breath holds, only the first breath hold must be on full inspiration). 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. NOTE Both SENSE reduction factors will decrease the actually encoded FOV in P and S direction, respectively. This implies increased k-space steps. Geometry compensation WARNING 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 WARNING 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. 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 fibertract settings include signal-threshold, FA values and curvature of the fibertract. WARNING 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 ACHIEVA/INTERA

63 WARNING 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 arterialinput-function. 2 WARNING 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. Diffusion WARNING For ADC measurements the FOV must be positioned in the isocenter of the magnet to avoid misinterpretations due to incorrect ADC calculations. Q-flow WARNINGS For Q-Flow measurements the FOV must be positioned in the isocenter of the magnet to avoid misinterpretations due to incorrect Q-Flow calculations. ACHIEVA/INTERA 2-49

64 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 NOTE 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 WARNING 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 IView Bold WARNING Misinterpretation of the results of the IviewBold technique is possible due to several causes on the system for which operator attention and training is required. 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 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 ACHIEVA/INTERA

65 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. 2 NOTE Attention is needed for operator instructions displayed on the viewing screen Data export WARNING To limit the output size, Export2Office uses storage formats with lossy compression. This compression can result in loss of detail important for diagnoses Spectroscopy WARNINGS CAUTION 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. 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. Do not use the coils in an unloaded situation. When the load (normally the patient) is removed from the coil, or vice versa, the voltages may damage the capacitors of the spectroscopy coils. WARNING 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 ACHIEVA/INTERA 2-51

66 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. The PlanScan Metabolite and Shifted Metabolite boxes displayed during scan set-up, can be used to determine which voxels lie in the overlap region for two metabolites of interest, both in-plane (for 2D and 3D CSI) and in the slice direction for 3D CSI. Choosing higher bandwidth RF pulses (such as the "sharp" excitation pulse) can help to minimize the mismatch. An alternate for 2D CSI is to use spin-echo slice localization (plus multiple REST slabs if necessary) instead of PRESS or STEAM volume localization, this method eliminates in-plane chemical shift displacement and associated peak ratio distortions, and is recommended for 3.0T. Another approach for 3.0T is "overprescription", using a set of high bandwidth REST pulses (power level 3 or 4) applied with negative gap values to saturate signal from non-overlapping regions, effectively redefining the actual localized volume. Whatever the technique, it should be noted that SpectroView does not apply any correction factors for chemical shift displacement On Planscan and Review planscan Since the actual contents of processed data in multi voxel experiments can be changed by the order of processing and the actual commands used, the following must be taken into account: Double volume The planscan and review planscan show the correct volume numbers only after postprocessing with the available postprocessing batch DOUBLE.scom 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 ACHIEVA/INTERA

67 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. 2 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." Additional security and privacy information can be found on the Philips product security web site at Important messages and indications Important messages and indications are displayed in the language of the user interface. The table below displays the english messages and their translation. ACHIEVA/INTERA 2-53

68 Messages English Medical supervision of the patient is required High SAR in scan(s): SAR value(s): Reduce by lowering the 'SAR mode' High db/dt in scan(s) Potential peripheral nerve stimulation in scan(s) SAR High B1 in scan(s) Change SAR mode to moderate Change SAR mode to low Examinations modified in presentation mode are no longer compatible with their original L (as abbreviation for Left) R (as abbreviation for Right) A (as abbreviation for Anterior) P (as abbreviation for Posterior) H (as abbreviation for Head) F (as abbreviation for Feet) Stop Scan Proceed Cancel 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. PPNS. Some of the following scans may possibly cause Peripheral Nerve Stimulation. PPNS can be reduced by lowering the PNS mode. Allow system-controlled tabletop movement? The patient support is moving under remote control. (Language) 2-54 ACHIEVA/INTERA

69 Messages English Patient support is under manual control, slice position may be incorrect. Image geometries do not match. Fused images are not guaranteed to be correct. Stacks are of incorrect sizes. Perform a single axis MPR before loading the dataset in Mobiview for better results. (Language) PhysioTrak patient monitor The operator should read and thoroughly understand these instructions completely before attempting to operate the MRI Patient Monitor. EQUIPMENT CLASSIFICATION Classification according to IEC According to the type of protection against electrical shock: According to the degree of protection against electrical shock: According to the degree of protection against harmful ingress of water: According to the methods of sterilization or disinfection: According to the mode of operation: Class I equipment. Type CF (defibrillator-proof) equipment. Ordinary equipment (enclosed equipment without protection against ingress of water). Non sterilizable. Use of Liquid surface disinfectants only. Continuous operation. WARNING The Equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. An explosion hazard exists in this situation. ACHIEVA/INTERA 2-55

70 General precautions for the MRI Patient Monitor The accuracy of the measurements can be affected by the position of the patient, the patient s physiological condition, and other factors. Always consult a physician for interpretation of measurements made by this monitor. If any system failure occurs (e.g. an unexplained continuous audible alarm) remove the monitor from use, and refer it to qualified service personnel. When an X appears in the Alarm Bell symbol, the audible alarm tone will not sound for any reason. Perform operational checkout before each use. If monitor fails to function properly, refer to qualified service personnel. For safe and accurate operation, use only recommended MRI approved patient cable, lead wires, cuffs, hoses, sensors, tubing, etc. When the trolley is docked the batteries are automatically charged. When the trolley is undocked and a Battery Low indication occurs, connect the trolley to the Charging Unit for continued operation. Failure to do this can lead to interruption of monitoring and/or damage to the batteries of the monitor. The system may not conform to all performance specifications if stored or used outside the environmental specifications. Do not apply any unnecessary pressure to the screen area of the monitor. Severe pressure applied to this portion of the monitor could result in damage or failure of this screen. All equipment not complying with IEC should be placed outside the patient environment. Only connect IEC compliant equipment to this monitor. To avoid potentially hazardous leakage currents, always check the summation of leakage currents when several items of equipment are interconnected. For proper equipment maintenance, perform the service procedures at the recommended intervals as described in the monitor s service instructions. Single use devices should never be reused. Always route the sensor cables carefully to avoid patient injury during tabletop movement ACHIEVA/INTERA

71 Electrical Safety precautions To avoid an electrical hazard, never immerse the unit in any fluid or attempt to clean it with liquid cleaning agents. Ensure that the trolley is undocked and not connected to the Charging unit before performing cleaning or maintenance. Shock hazard exists if operated without chassis cover. Refer servicing to qualified service personnel only. For continued protection against fire hazard, replace fuses with same type and rating only. If the integrity of the earth conductor of the AC mains power cable is in doubt, operate the monitor on internal battery power until proper earth connection is confirmed. Avoid use of electrical power extension cords. Electrical power cords may create a safety hazard by compromising the grounding integrity of the monitor. If monitor becomes accidentally wet during use, discontinue operation of the monitor until all affected components have been cleaned and permitted to dry completely. Contact your local representative if additional information is required. This monitor and its listed accessories may be safely powered by the voltages / ~ having a frequency of 50 or 60 Hz. 2 MRI Use Precautions Certain components of this device will be affected by the magnetic and RF fields present in your MRI system. Confer with the Philips service engineer to identify the proper placement and use areas for the PhysioTrak. The MRI Patient Monitor is specially designed not to interfere with MRI operations and may be used inside the MRI Magnet Room in any location outside the 1000 Gauss (0.1T) field line of the MRI system. When brought closer than the 1000 Gauss (0.1T) line, the monitor may fail to operate. When brought closer than the Gauss (1.0T) line, damage may result. ECG precautions An inoperative ECG monitor is indicated by absence of an ECG waveform and a simultaneous Lead Fail alarm. ACHIEVA/INTERA 2-57

72 Heart rate values may be adversely affected by cardiac arrhythmia, or by operation of electrical stimulators. For other ECG related precautions refer to the onscreen help. Non Invasive Blood Pressure (NIBP) precautions Always use recommended NIBP cuffs and hoses. Avoid compression or restriction of NIBP cuff hose. Always select the right menu for neonates. A too high pressure of the cuff may restrict the blood flow in the arm of the neonate. For other NIBP related precautions refer to the onscreen help. SpO2 precautions The numeric measurement values are updated every 1second on the monitor display. The pulse oximeter feature in this monitor is designed to display functional SpO2 values. The pulse oximeter pulsatile waveform is not proportional to the pulse volume, but adjusts the waveform amplitude as needed for proper viewing. All monitor alarms are categorized as medium priority, unless otherwise specified. For other SpO2 related precautions refer to the onscreen help. Precautions This monitor is equipped with a demonstration mode which displays simulated electronic patient data for training or demonstration purposes. Do not attach a patient to the monitor whenever this simulation is present on the monitor display ( SIMULATION can also be seen in the screen center). Failure to properly monitor the patient could result. The patient connector inputs for all parameters are protected against the use of a defibrillator by internal circuitry, when the recommended patient cables or accessories are used. This monitor uses rechargeable batteries which contain lead, which must be recycled, or disposed of properly. For proper disposal methods, contact your local Philips Healthcare representative or distributor ACHIEVA/INTERA

73 User responsibility This product will perform in conformity with the description contained in these instructions and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This product must be checked and calibrated periodically. A malfunctioning product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary refer unit to qualified service personnel. This product or any of its parts should not be repaired other than in accordance with written instructions provided by the manufacturer, or altered without written approval of Philips Healthcare. The user of the 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 authorized service personnel. Using these instructions. Whenever the various options are discussed, XXX is used to indicate a variable setting. It is required that every operator read these instructions completely, including any patient information in sections about monitoring features the operators monitor does not have, before attempting to operate the MRI Patient Monitor. Precautions (listed earlier in this section) cover of wide ranges of information crucial to the safe monitoring of patients. It is required that every operator read the PRECAUTIONS completely, including the Precautions associated with monitoring features that the operators monitor does not have, before attempting to operate the MRI Patient Monitor. 2 WARNINGS MRI Patient Monitor Electrical shock hazard: Turn off monitor and ensure that the trolley is undocked and not connected to the Charging unit before cleaning. Do not immerse the monitor in any water or liquid for any reason. Do not apply excessive pressure to the monitor display screen. The MRI Patient Monitor contains Magnetic Material. This monitor must be located, outside the 1000 Gauss (0.1T) Magnetic Field Lines of the MRI System. To ensure proper monitor operation, a System Cold Start is required after a program update/upgrade. ACHIEVA/INTERA 2-59

74 Always check that the Alarm Tone setting is appropriate for each particular patient. Alarm Sound volume is adjustable for suitability to various clinical environments (where background noise may range from relatively quiet to noisy). Always verify that the user/attendant of this monitor can hear the Alarm Sound above the ambient noise (particularly during MRI Scanning). The MRI Patient Monitor will not alarm unless it is connected. Always verify proper operation of the entire PhysioTrak System before performing any patient monitoring. The Simulation Mode will display real looking waveforms which are computer generated. The monitor will not monitor patients while in the Simulation Mode. Do not activate the Simulation Mode when this monitor is connected to a patient. The patient's blood pressure determinations are not continuous. The blood pressure determinations are only updated immediately after a blood pressure measurement is taken. When using the MRI Patient Monitor to monitor critical situations, set the Automatic Reading mode to a short period for more frequent updating of the blood pressure determinations. When set to the shortest of the automatic intervals, the constant measurements can cause blood pooling in the limb, and blood pooling in the limb may artificially increase the value of the blood pressure determinations. Alarm Limits can be set to a wide range including Off. It is the responsibility of the operator of this monitor to ensure that Alarm Limit values appropriate to each particular patient are established and set. Alarm Sound may be set to OFF. When the Alarm Sound is off the letter "X" will appear in the bell shaped Alarm Status Symbol. Alarm Sound should only be turned off when performing tasks which may cause false alarms to sound (such as changing ECG Leads, SpO2 Probes, etc.). All batteries must be removed prior to shipping the monitor for any reason. CAUTIONS Patient Monitor The AC Power Adaptor is used inside the Magnet Room. It must be kept outside the 1000 Gauss (0.1T) Field Line of the MRI System. Consult with your Philips service engineer for the exact location of the Field Line. Power can not be interrupted while the PCMCIA card is reprogramming your monitor. Do not turn power off to the monitor during the Load or Verification process. If power is turned off the monitor will have to be returned to Philips Healthcare Service for internal programming. Be careful that the tubing remains clear of any tabletop moving mechanisms which may kink or cut the tubing ACHIEVA/INTERA

75 Always inspect patient tubing after attachment to the monitor following the patient circuit s manufacturer s recommendations Third party equipment 2 WARNINGS 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 Achieva or Intera system, e.g. to higher gradients, do not use third party equipment approved for use with the Achieva/Intera 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 Achieva/Intera 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. ACHIEVA/INTERA 2-61

76 Auxiliary devices labeled as MR conditional may only be used in combination with Philips MR scanners when the conditions specified in the manufacturer s instructions for use are fulfilled. 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. NOTE For description and further Instructions for Use on compatibility test protocols, see the Technical Description of the system. MR compatibility labels on third party equipment The compatibility of third party equipment in combination with the MR scanners is regulated via special warning labels (see below). These warning signs indicate whether the third party equipment is MR safe, MR unsafe or MR conditional. When the equipment is marked as MR conditional these conditions must be described in the Instructions for use of this equipment. Warning label Category MR safe MR conditional 2-62 ACHIEVA/INTERA

77 Warning label Category MR unsafe 2 ACHIEVA/INTERA 2-63

78 2.24 Symbols on the system The following symbols are used with the system: General symbols Meaning Attention, consult manual (Instructions for use) Type B applied part (IEC ) Type BF applied part (IEC ) Prohibition symbols Meaning Active implants, metallic implants prohibited Metal body implants prohibited Mechanical watches prohibited Loose ferromagnetic objects prohibited Magnetic media prohibited (credit cards, diskettes, magnetic tapes) 2-64 ACHIEVA/INTERA

79 Warning symbols Meaning Strong magnetic field 2 High frequency electromagnetic field Medical symbols Meaning ECG Peripheral pulse/blood pressure Disposal symbol Meaning Dispose of in accordance with your local regulation. Environmental symbol Meaning 50 The environment-friendly use period of this product is 50 years. (according to People's Republic of China Electronics Industry Standard SJ/T ) NOTE For laser light safety symbols and labels see section 2.13 Laser light radiation safety (light visor). ACHIEVA/INTERA 2-65

80 2-66 ACHIEVA/INTERA

81 3 System overview 3.1 System components 3 Interactive display (optional) Patient support control panel Magnet Tabletop Magnet bore Patient support Figure 3.1 System components Magnet and magnet bore During the MR examination the patient is positioned in the magnet bore. Philips MR imaging systems are available with different magnetic field strengths. Gradient system The gradient coils in the system provide the relative small magnetic field variations needed for the localization of the weak relaxation signal emitted by the human body. Philips MR imaging systems are available with different gradient field strengths. Tabletop and patient support The patient lies on a tabletop which is carried by the patient support. The tabletop can be moved longitudinally to transport the patient into the magnet. It can also be moved vertically for convenient patient transfer. ACHIEVA/INTERA 3-1

82 Patient support control panel This panel comprises buttons and knobs for light visor, tabletop movement, patient communication/music and connection sockets for the RF coils and physiology sensors. 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 23 inch 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, - DVD recorder (optional: MOD recorder), a DVD provides high-capacity storage of images. NOTE The DVD recorder is compatible with Philips DVD+RW 4-speed media only. 3.2 Panels Network The network facility can be used to exchange images and Data with other systems (RIS, PACS). Radio frequency system RF coils The transmit coil transmits the RF pulses into the patient. The receive coil receives the MR relaxation signals subsequently emitted by the patient. RF transmitter The RF transmitter generates the RF pulses. RF receiver and spectrometer They analyze the MR signals emitted by the patient. NOTE This section describes the panels on the Achieva and Intera system. 3-2 ACHIEVA/INTERA

83 For description of panels on Gyroscan NT systems upgraded to the current release please refer to the Instructions for Use originally delivered with your system Patient support control panel The Patient Support Control Panel on the front of the magnet can be located either on the left or right side of the magnet bore. 3 Figure 3.2 Patient Support Control Panel on ACHIEVA systems and INTERA systems with FreeWave upgrade. Figure 3.3 Patient Support Control Panel on INTERA systems ACHIEVA/INTERA 3-3

84 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. Tumble switch Operating the 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. NOTE 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. Stop Manual mode Light visor Stop Pressing the Stop button will stop the tabletop movement. This can be reset using the Manual button. The Stop button has a ridge around it to prevent it from being pressed by accident. 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. Stop, Manual mode and Light visor buttons NOTES 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. 3-4 ACHIEVA/INTERA

85 Travel to scanplane button Bore illumination Ventilator Talk Travel to scanplane 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. Travel to scanplane (TTS) With the TTS button, TTS mode can be toggled on and off. TTS Mode In TTS mode the patient reference point is moved to the isocenter. The tabletop movement will follow the movement of the tumble switch, giving the operator the freedom to move the patient reference point to the isocenter and away from the isocenter. TTS Mode - LED In TTS mode the direction of movement to the isocenter is indicated by the LED next to the TTS button which illuminates. When tabletop movement is away from the isocenter in TTS mode, the LED 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. Bore illumination The bore lights can be adjusted to three levels: off, low light and full light. 15 minutes after the tabletop is fully out of the magnet, the lights will 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. 3 Bore illumination, Ventilator and Talk buttons NOTE Ventilation air is not sterile. ACHIEVA/INTERA 3-5

86 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. NOTES 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. Stop scan Start scan Music volume Music volume This knob can be used to adjust the volume of music for the patient. Start scan This green button can be used to start a scan in the examination room. Music volume, Start scan and Stop scan buttons NOTE 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. 3-6 ACHIEVA/INTERA

87 NOTE Pressing the Stop scan button twice will also stop reconstruction. If pressed only once, reconstruction will continue if enough data is available Control panel at the rear of the magnet At the back of the magnet another small control panel is located with a limited number of functions. Start scan 3 Stop scan Figure 3.4 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 Coil and sensor sockets The coil connection sockets are located on the Patient Support Control Panel. Talk Manual mode ACHIEVA/INTERA 3-7

88 ACHIEVA systems and INTERA systems with FreeWave upgrade Peripheral pulse sensor VCG Respiratory sensor Receive coils Spectroscopy and Transmit/receive coils Receive coils Figure 3.5 Sockets on the Patient Support Control Panel of Achieva systems Coil connector adapter For connecting Synergy/SENSE and surface coils with a previous type connector a special connector adapter is provided. 3-8 ACHIEVA/INTERA

89 Intera systems 31P spectroscopy coil Surface coil Synergy coils 1H spectroscopy coil Surface coil 3 Figure 3.6 Coil sockets on Patient Support Control Panel of Intera systems Connection panel ACHIEVA systems and INTERA systems with FreeWave upgrade Nurse call Head phone Figure 3.7 Connection panel on Patient support 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). ACHIEVA/INTERA 3-9

90 Intera systems Head phone Peripheral puls sensor ECG/VCG Respiratory sensor Nurse call Figure 3.8 Connection panel on Patient support 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 Patient/operator Intercom Microphone Listen volume Talk volume Speaker Talk push button Nurse call LED Patient music On/Off Listen On/Off Figure 3.9 Patient/operator intercom 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 ACHIEVA/INTERA

91 NOTES Listen On/Off Button and LED This button switches the Listen function on and off. It will not respond if the talk channel is open. The LED illuminates when the Listen function is on. Patient Music On/Off knob and LED This button switches the patient s music on and off. It will not respond if the talk channel is open. The LED is illuminated if the music is on. If the headset is not in use, it should be unplugged. If left connected, the headset microphone will remain active while not at the patient. Optimal communication will not be possible. With the headset unplugged, the system will switch to the room speakers and the magnet microphone. Nurse call LED When the pinchball of the nurse call is pressed more than once within 4 s or for more than 1.5 s, the LED will flash and a buzzer will sound to draw the attention of the personnel. Pressing the Talk button will turn the LED off. Talk Volume knob This knob is used to adjust the talk volume. Listen Volume knob This knob is used to adjust the listen volume. Music or speech for the pneumatic headset (option) Pressing the Talk button on the Patient Support Control Panel connects the magnet microphone to the patient headset and switches off the music speakers in the examination room. This allows easy communication with the patient. 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. 3 ACHIEVA/INTERA 3-11

92 3.3 Safety devices The following devices on the equipment and examination room are considered to be 'saferty devices' and should therefore never be removed, modified, over-ridden or frustated: Quench button Table top release button Fingerswitch plate Nurse call Stop buttons on PICU and keyboard RF door switch Quench pipe inside and outside the examination room RF examination room configuration Patient ventilation 3-12 ACHIEVA/INTERA

93 4 System Operation Help System with User Documentation on-line This chapter describes the most important functions with respect to system operation. The complete set of documentation is available on-line and can be viewed on the system. For more information on how to access the Help System, refer to section 4.14 Help system, User documentation, Instructions for Use and Technical description 4.1 System logon 4 1 Type in Username and Password. 2 Confirm by clicking OK or pressing the Return key. The system software will start NOTE Initial settings of username and password are "MRuser" and "Philips". After first logon a different password must be entered of at least seven characters. 4.2 Screen organization Basic viewing The screen is divided into image area and control area. Image area is to display images, the results of analysis functions (e.g. graphs), messages, queries, prompts and temporary control information. ACHIEVA/INTERA 4-1

94 Control area Scan button and Advanced Viewing button Main Menu Examination for viewing Image Information Panel Packages Viewing Tools Scan Button Physiology display Scan Control Panel Figure 4.1 Control panel Main menu Clicking on one of the main menu items, the following submenus appear: Figure 4.2 Main Menu Patient New Exam... Function 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 ACHIEVA/INTERA

95 System Advanced Viewing Queue manager Print Job Control HC Protocols Screen Capture Advanced Tools Autopush to DICOM node Bumping Policy FPR utility Show Taskbar Exit... Function Switches the system to the advanced viewing mode Displays a panel with list of background processes. Displays the printer dialog panel Displays the HC dialog panel Creates a secondary capture Selects Text suppression, Service and Research functions, Develop Utilities or Delayed Reconstruction. Sends an examination automatically to a DICOM node (when connected) To set the bumping policy Opens the Field Problem Report utility Shows the Windows taskbar To exit the system software 4 Help User Documentation About Help Topics Function Displays the User Documentation window Displays system name, release number, software options etc.. Opens the Help system. Image information panel (3 lines) Clicking in the Image information panel displays an extended image information panel for the current image. For more information see the help system (clicking F1). View button Switches the system to View mode. All viewing functions are available. The full screen is reserved for viewing and post-processing. Viewing toggle button Switches the system to the Advanced Viewing Environment. The Advanced Viewing Environment provides a set of advanced post-processing packages. ACHIEVA/INTERA 4-3

96 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 ACHIEVA/INTERA

97 Scan control panel Preset procedure name Scan progress bar (% executed) Button Autoview Start scan Stop scan Function To display the latest reconstructed image of the current scan. To start the next scan or scan list. To stop the current scan Advanced Viewing 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. The screen is divided into image area and control area. 4 Image area is to display images, the results of analysis functions (e.g. graphs), messages, queries, prompts and temporary control information. ACHIEVA/INTERA 4-5

98 Control area Examination for viewing Basic viewing button ExamCard and Postprocessing status button Main Menu Tool bar Image information area Pictorial index Scan Button Physiology display Scan progress bar Stop scan button Figure 4.3 Advanced Viewing Control Area Main menu Clicking on one of the main menu items, the following submenus appear: Session Switch to viewing Switch to acquisition Function Switches back to the basic viewing screen. Switches to the acquisition screen. Case <case name> Function To Select a case. 4-6 ACHIEVA/INTERA

99 Views Tile Stack Apply Link Current link Add to link Remove from link Unlink all Function To arrange all selected series in a tiled layout. To arrange all selected series in a stack layout. Applies a link between a selected views. The views of the link are highlighted. Adds the selected view to the current link. Removes the selected view from the current link. To remove all links. Tool Screen Capture as... Screen Capture Function Make a screen capture and saves it. Make a screen capture. 4 Analysis ImageView QFlow IView Bold Basic T1 Perfusion MobiView PicturePlus SpectroView ImageAlgebra VolumeView Neuro Perfusion FiberTrak Diffusion Diffusion Registration Function Opens the ImageView package. Opens the QFlow package. Opens the IView Bold package. Opens the Basic T1 Perfusion package. Opens the MobiView package. Opens the PicturePlus package. Opens the SpectroView package. Opens the ImageAlgebra package. Opens the Volume View package. Opens the Neuro Perfusion package. Opens the FiberTrak package. Opens the Diffusion package. Automatically performs a registered diffusion dataset. Help Help Topics User Documentation Function Opens the Help system. Displays the User Documentation window ACHIEVA/INTERA 4-7

100 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. 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. Viewing toggle button Switches the system back to the basic viewing mode. Examination information and tool tip panel Extended examination information appears as a tool tip when positioning the cursor on the examination information panel. For more information see the help system (pressing F1 ). ExamCard and Postprocessing status button Toggle between current ExamCard and Pictorial index. Pictorial index A representative image per series is displayed in the pictorial index. 4-8 ACHIEVA/INTERA

101 Scan button Switches the system to scan mode. Physiology signal Displays the physiology signals. Scan progress bar Scanset progress bar Stop Scan button To stop the current scan. 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 Extended MR WorkSpace For Extended MR Workspace systems the Advanced Viewing environment is combined with a ViewForum application. For detailed description of the Extended MR Workspace please refer to its Instructions for Use Analysis 4 Switch button Switch to the ViewForum environment Click the Switch button to leave the MR environment and to open the Extended MR Workspace application. ACHIEVA/INTERA 4-9

102 4.3 Keyboard Keyboard overlay A special overlay explains the function of all function keys on your keyboard in the system application software Stop Scan (F12) Pressing F12 (Stop Scan) on your key board will stop the current scan. Pressing F12 will stop the scan immediately, the reconstruction commences if enough data is available. Pressing F12 a second time will stop the reconstruction. If tabletop movement is initiated by the TTS function, pressing F12 will abort tabletop movement. 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. Step With ExamCard More information 1 Patient preparation In general in this chapter For detailed description see Help system Patient preparation 2 Enter patient data Workflow in this chapter For detailed description see Help system Entering Patient data 3 Patient positioning In general in this chapter For detailed description see Help system Patient preparation 4 Run / Create the ExamCard Workflow in this chapter For detailed description see Help system Run an ExamCard 4-10 ACHIEVA/INTERA

103 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 4.5 Preparation for scanning 4 WARNING Before using the system, it is essential that you read and familiarize yourself with all Warnings and Cautions given in chapter 2 Safety Non-magnetic equipment The following equipment should be available: a non-magnetic trolley and wheelchair lockers with a non-magnetic key for patient's valuables Information towards patient Explain the examination. Advise patients to go to the toilet before the examination Special cases Emergencies If a patient's condition becomes critical, remove the patient as quickly as possible from the MR room so that emergency aid can be given promptly and without risk to patient or staff. MR staff should be trained to cope with an emergency situations. For information on emergency procedures, see section 2.14 Emergency procedures. ACHIEVA/INTERA 4-11

104 4.6 Entering Patient data 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. 4.7 Patient positioning WARNING CAUTION NOTE Before using the system, it is essential that you read and familiarize yourself with all Warnings and Cautions given in chapter 2 Safety. Do not extensively move the patient support. If the patient support is moved up and down very often in a short period of time with a patient load, a thermal protection could be activated and the vertical movement could stop. After cooling down the movement can be restarted. For choosing coils see online help system. 1 Move the tabletop into the parking position: Under motor control: Press the tumble switch down to the Out/down position and hold it there until the tabletop automatically stops in the parking position. 2 Lower the tabletop to the appropriate height by pressing the tumble switch down to the Out/down position and holding it there until the appropriate height is reached. 3 Place the coil on the tabletop. 4 Position the patient on the tabletop with the help of the appropriate patient accessories ACHIEVA/INTERA

105 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. Acoustic noise protection 8 Earplugs, head phones or some other form of hearing protection must be worn by the patient during scanning, see section Acoustic noise protection. 4 To center by means of the light visor WARNING Instruct the patient not to stare into the laser beam. Direct laser light may cause irreversible damage to the eyes. 9 Press the light visor button once to switch on the light visor beams. 10 Raise the tumble switch to the Up/In position and hold it until the area of anatomical interest lies within the illuminated cross. 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. ACHIEVA/INTERA 4-13

106 4.8 Run / Create an ExamCard 1 Select either Philips procedures or Hospital procedures. Philips procedures Hospital procedures All preset procedures delivered by Philips. All user defined preset 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. offcenter 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 ACHIEVA/INTERA

107 The values of the Offcenter 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. Outer circle Center Outer circle Figure 4.4 Planning volume, stack or slab. 4 Resume the ExamCard 14 Click Start scan to resume the ExamCard. All of the items within the ExamCard will be performed now. Save the ExamCard NOTE ExamCards can be saved only when the write protection is unselected. In ExamCards environment select the Hospital tab, right click on this tab and unselect write protected. 15 Select the anatomy / subanatomy folder where the ExamCard has to be saved in. Double click on the desired anatomy folder. Double click on the desired subanatomy folder. 16 Select the Current ExamCard by clicking on the Header. 17 Drag the ExamCard into the open folder. 4.9 Viewing images 1 Click on the Viewing button to enter viewing mode. 2 Select a scan by means of the horizontal scan scrollbar in the viewing tools. ACHIEVA/INTERA 4-15

108 Windowing Change window level Change window width Hold down middle mouse button and move mouse: upwards = darker; downwards = brighter to the right = less contrast; to the left = more contrast If window copy is On, subsequent images or all images are windowed, if window copy is 'No', only the current image is windowed. Zoom Hold down the middle + right mouse buttons and move mouse: Zooming in upwards (Maximum zoom factor is 8) Zooming out downwards (Minimum zoom factor is 0.5) 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) For information on Post-processing and Hardcopy see the help system ACHIEVA/INTERA

109 4.10 Storage and Transfer of Patient Data NOTE The export to (removable) media offers the option to "suppress patient data" in order to protect the privacy of the patient(s). General procedure of data transfer 1 Select Patient on the main menu bar and select Administration to open the administration window 2 Select the data to be transferred using one of the available tools. 3 Select a node in the required destination field. 4 Start the transfer by clicking on the icon of the destination. 5 Answer the questions in the pop-up dialogue boxes and click Proceed. 6 Select system and Queue Manager to view the progress or to stop the transfer or press the button with the hour glass. 4 Destination - Storage devices Storage device Local patient database DVD DICOM Network Node PACS Disk files Description Currently stored patients. Local DICOM nodes DVD s. Remote (DICOM) patient databases, location listed in scroll list. Remote DICOM archive, location listed in scroll list Local DICOM directory NOTE The MR system is not designed to be an archive. Always use external systems for patient data archiving 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. ACHIEVA/INTERA 4-17

110 Shutdown the computer The computer can be shut directly or indirectly. System shutdown with start menu 1 Press the start menu button ( Windows button) on your keyboard. 2 Select Shutdown. The Shutdown window is displayed. 3 Click on one of the following options: Log Off Shutdown Restart Cancel Exits the system software, see also section 4.11 Exit system software Shuts down the System Restarts the system Cancels the shutdown procedure Computer shutdown from system Software 1 Exit the system software as described. This will display the logon screen. 2 Press Ctrl + Alt + Del buttons The logon dialog box is displayed 3 Click Shutdown. The dialog box It is safe to turn off your computer is displayed System start up and switch-off CAUTION NOTE 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. It is advised to leave the system running and to only switch off the computer. The RF amplifiers and LCC (Liquid Cooling Cabinet) will switch into standby mode after approximately two hours of inactivity. Power consumption is then minimum ACHIEVA/INTERA

111 System start up This procedure has to be followed if the system has been switched off. 1 Switch on the system on the IMDU (Integrated Mains Distribution Unit). 2 Switch on the computer in the operator s console. 3 When the logon screen appears on the monitor press Ctrl+Alt+Delete keys on the keyboard. The logon dialog box is displayed. NOTE Log in: 4 Type in Username and Password and confirm by clicking OK or pressing the Return key. The system software will start Initial settings of username and password are "MRuser" and "Philips". After first logon a different password must be entered of at least seven characters System switch off To switch off the system 1 Shutdown the computer in the operator s console. 2 After the computer has been shutdown you can switch off the system on the IMDU (Integrated Mains Distribution Unit). WARNINGS With 3.0T systems the RMMU (Remote Magnet Monitoring Unit) and the LCC (Liquid Cooling Cabinet) remain powered. Danger of an electric shock. With 1.5T systems the LCC (Liquid Cooling Cabinet) remains powered. Danger of an electric shock. The RMMU (Remote Magnet Monitoring Unit) is switched off. Important considerations WARNING Once energized, the magnetic field of the superconductive magnet is always ON, even when the system is switched off. ACHIEVA/INTERA 4-19

112 CAUTIONS DO NOT SWITCH OFF Do not switch the system off when the computer in the Operator's Console is still ON. This may damage the software! About computer and display in operator's console CAUTIONS It is strongly recommended to keep the computer running permanently. It is sufficient to exit the system software and to switch off display without using Shutdown. In this way the system will remain available for remote servicing and will run scheduled tasks. Only switch off if the system has hanged up. Never exit the system software while a background process (such as hard copy, DVD recording or Network) is still running. It is advisable to switch off the display unit on the Operator's Console at night User account administration About user accounts The general user account "MRuser" can be applied by different system operators, but does not provide a personified logging of the actions done by each operator. Personified user accounts on the system provide the logging of the actions done by each individual user may be required by legislation, for example HIPAA. Each of these individual users has the same permissions and rights as the general system user. User accounts should be managed by the System administrator. New user account To make a new user account 1 Logon with username HospitalAdmin (not case sensitive). 2 Password: Hospital (case sensitive) at first logon. You have to replace and confirm the initial password Hospital by another password of minimum 7 characters. The system does not start, but a restricted Windows environment is opened ACHIEVA/INTERA

113 3 Select Extra MR systems management --> User management. The MR User Manager panel is displayed. 4 Select User --> New User 5 Enter a personal username. 6 Enter and confirm a password of minimum 7 characters for the new user. To edit a user account 1 Open the MR User Manager panel. 2 Right click on a user in the list. 3 You can: Change its 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 the user account Help system, User documentation, Instructions for Use and Technical description Accessing from the application software The Help system of the application software and the user documentation can be viewed in the configured application language. Context sensitive Help 1 Move the cursor on a field you want information about. 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. ACHIEVA/INTERA 4-21

114 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 Accessing from the Windows Start menu All provided documents can be accessed from the Windows start menu: 1 from the application select system -> show task bar or press the windows key on your keyboard to show the windows task bar. 2 Select Start -> User documentation. 3 Scroll to the required language and select the document you want to view: For the available user interface languages (see section 4.15 Language settings ) you can directly select: - Help (CHM), help system, - Help (PDF), user documentation viewed with the Adobe Reader, - Instructions for Use (PDF), viewed with the Adobe Reader, - Technical description (PDF), viewed with the Adobe Reader. For all other language you can select the Instructions for Use (PDF), viewed with the Adobe Reader. DICOM Conformance Statement The DICOM conformance statement can be selected from the Windows start menu by selecting Start -> User documentation -> DICOM Conformance Statement.PDF Language settings The application software and the Windows operating system can be set to the following languages: 4-22 ACHIEVA/INTERA

115 English Simplified Chinese (PRC) Danish Dutch French German Greek Italian Japanese Norwegian Spanish Swedish Changing the language setting 1 Select system -> show task bar or press the windows key on your keyboard to show the Windows task bar. 2 Select Start -> Settings -> Control panel. 3 Double click on the Regional and Languages Options Icon The Regional and language Options window is displayed. 4 Select the Language tab. 4 WARNING Do not change any settings on other tabs. 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. After logon the language setting will have changed. ACHIEVA/INTERA 4-23

116 4.16 Hospital/Institution name setting The hospital or institution name can be changed: 1 Select system -> show task bar or press the windows key on your keyboard to show the Windows task bar. 2 Select Start -> MR User -> MR System. The MR System Properties window is displayed. 3 Select a name from the scroll list or enter a new name and click Apply. NOTE A new name entered will be added to the scroll list. 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 Using USB memory devices USB memory devices are recognized by the system and can be used for exchanging data. The operating system automatically assigns a drive letter to the device. CAUTION NOTE Do not remove the USB memory device without using the "Safely Remove Hardware" option. Removing the device without using this option can cause the operating system to get instable or to crash. The USB memory device may contain confidential and/or personal information. Take appropriate measures to protect this information. Using "Safely Remove Hardware" option. 1 Select system -> show task bar or press the windows key on your keyboard to show the Windows task bar. 2 left click once on the Safely Remove Hardware icon in the lower right Task Bar and select Safely remove USB Mass Storage Device - Drive (<drive letter>:). 3 You can safely remove your USB memory device when the Safe To Remove Hardware message appears ACHIEVA/INTERA

117 4.18 LOTS/TO remote assistance This section describes the Look Over The Shoulder and Take Over (LOTS/TO) 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 LOTS/TO functionality enables service engineers (remote user) to access your system: LOTS: remote viewing of the scanner desktop. TO: remote control of the scanner desktop. In a Single Windows Session (LOTS or TO) you allow the remote user to view your system or control your system for one session only. After a session is stopped or after a log-off or reboot of your system the remote connection has to be re-enabled by the local user. 4 In Fixed Duration (TO 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. WARNING 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. NOTE When starting a LOTS/TO 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. ACHIEVA/INTERA 4-25

118 WARNINGS During a single windows Take Over 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 LOTS/TO 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 TO session. During a TO 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 TO session is running. Remember that scanning is only possible when the door of the examination room is closed Workflow Contact your Philips customer support in case of a system failure or problem. The service engineer may want to view your scanner desktop while you are scanning or access it to remotely service your system. NOTE 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 LOTS/TO application. A dialog box appears displaying the following text: 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 4-26 ACHIEVA/INTERA

119 (a) (b) 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 allow the remote user to access your system, and click OK. The application is active and a VNC icon is displayed in the tray of your 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. 4 NOTE The password has to be entered by the remote user. 4 Inform the service engineer that the application is active. The service engineer will start up the remote connection and a VNC server acceptance box appears on the screen. ACHIEVA/INTERA 4-27

120 (a) (b) 5 (a) click Accept to confirm a TO session or (b) click View only to confirm a LOTS 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 be placed anywhere on the screen. The remaining session time is displayed in the header of the button. NOTE 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 LOTS or TO 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. NOTE The start/stop of every LOTS/TO session is logged by your system. The Remote Service Network logs who has been the remote user 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 ACHIEVA/INTERA

121 In the Installation dialog the following is listed: Updates and fixes list. - Name, name of the update or fix. - Release notes, name of the Release Notes. - Application notes, name of the Application Notes, if available. - Patient data deleted?, the value is yes when patient data is deleted before installation of the update or fix. - Installation time, displays the estimated installation time of the update or fix. - Status, displays the status of the update or fix (ready for installation, or installed). Buttons. - Open Release Notes, to view the Release Notes. - Open Application Notes, to view the application Notes. - Install All, to install all listed updates and fixes. - Close, to close the installation dialog. 4 NOTES 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. 2 Click on the row of the update of fix of which information is needed. 3 Click the Open Release Notes or Open Application Notes button to open the required document. ACHIEVA/INTERA 4-29