Insight where it matters. Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

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1 Insight where it matters Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

2 Performing complex interventions with confi dence has always required a clear view of vessel morphology. Now this clear view also comes with a host of effi ciency and clinical performance enhancements. Introducing the next generation of Allura Xper FD20/10 and FD20/20 biplane systems. With integrated Live 3D guidance these represent some of the most advanced systems available, offering excellent insight for increased confi dence and decision-making during complex interventions. The Allura FD20/10 and Allura Xper FD20/20 offer a choice of systems to match the needs of your practice. 2 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

3 Contents 4 A system that stands apart 6 Xper provides excellent customization to meet your needs Xper Module 6 Xper in the examination room On-Screen Display Xper Geometry Module Xper Imaging Module 7 Xper in the control room Xper Viewing Console Xper Review Module 8 The image quality you want with low X-ray dose Dynamic Flat Detector 2K Digital Imaging Chain Xres* MRC tube SpectraBeam fi ltration Monitors MultiVision video switch* Fluoro storage* Xper Beam Shaping 9 Rotational Angio* Xper DICOM Image Interface Biplane continuous autopush* RIS/CIS DICOM Interface* Xper MultiSwitch* 9 Features that enhance workflow 12 Technical information Geometry C-arm Stand Double C-arc 15 Table swivel* 16 Ceiling Suspended Radiation Shield* Table Mounted Radiation Shield* Examination Light* Optional accessories 18 Technical information - User Interface Xper User Interface in the examination room 19 Xper Module Xper Geometry Module 20 Xper Imaging Module Xper User Interface in the control room Xper Review Module 21 Xper data monitor Scheduling 22 Technical information - User Interface Options Xper review monitor Second Xper Imaging Module Second Xper Geometry Module Contrast Injectors 23 Technical information - Integration Xper MultiSwitch Lab Reporting* 24 Technical information - Additional Communication Options Biplane continuous autopush DICOM Print Intercom RIS/CIS DICOM Interface Standard Line Rate Video Output 25 Technical information - Image Detection Dynamic Flat Detector Fluoroscopy Grid-switched pulsed fl uoroscopy 26 Double wedge fi lters Biplane trace-subtract fl uoroscopy SmartMask* Subtracted Bolus Chase Digital acquisition Storage Capacity 27 Technical information - X-ray Generation X-ray generator Xper Beam Shaping MRC-GS X-ray tubes MRC-GS 0407 X-ray tube for frontal plane 28 MRC-GS 0508 X-ray tube for lateral plane SpectraBeam Anatomical fi lters X-ray On indicator light X-ray dose information in the examination report 29 Technical information - Viewing 2k display* MultiVision* PhysioViewing* 30 Technical information - Additional Options Rotational Angio* Integrated Allura 3D-RA* 31 Dynamic 3D Roadmap XperCT* 32 XperGuide* StentBoost* Allura 3D-CA* CT TrueView* 33 EP navigator* 33 Quantitative Analysis Packages* Vascular Quantifi cation software package Clinically validated software packages for quantitive cardiac analysis are: Full Autocal CO 2 View Trace* 34 Technical information - Dimensions FD20/10 and 20/20 35 Technical information - Room Layout Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 3

4 A system that stands apart Complex procedures and new devices make image quality more important than ever. The Allura Xper biplane incorporates the unique 2k x 2k imaging chain for accurate visualization of the very small details so you can make confi dent decisions. The powerful MRC tubes ensure uninterrupted operation, while Xres delivers real-time noise reduction to optimize image quality during interventions. And importantly, the Philips low X-ray dose program ensures maximized image quality at the lowest possible X-ray dose for the patient. The Allura Xper biplane systems offer a broad range of unique Live 3D guidance tools for both vascular and non-vascular procedures. These include XperGuide for needle-guided interventions, such as vertebroplasties, and Dynamic 3D Roadmap for enhanced navigation and coil delivery. In addition, excellent 3D clinical insight is provided with high speed Allura 3D-RA for visualization of vessel morphology and XperCT that provides you with soft tissue imaging right in your own angio suite. These groundbreaking tools have all been developed in close cooperation with our worldwide clinical network. This ensures superb imaging performance, instant availability of results, seamless integration, and full tableside control - all for better clinical insight and enhanced navigation. Moreover, you can deploy any of these tools quickly and effi ciently, since they are fully integrated into the Allura Xper workfl ow. The intuitive Xper user interface makes it even easier to perform a procedure. And, thanks to the innovative Xper Settings, the system can be set up according to 4 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

5 your preferences. The system remembers your personal settings and implements them automatically. This enables you to fully focus on your patient, not the system. Effi ciency is further enhanced with the Xper Workspace. It is a customizable solution that brings together all the information you need, where you need it, helping you to manage and improve your procedures and departmental effi ciency. For example, you can view and control CT and MR images at tableside, or speed up workfl ow by post-processing cases in the control room, while your patients are treated in the exam room. The Allura Xper FD20/10 and FD20/20 systems set new standards in clinical performance, ease of use, and workfl ow effi ciency. Quite simply, they are the next generation in interventional imaging. Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 5

6 Xper provides excellent customization to meet your needs The Allura Xper FD20 biplane systems feature Xper technology, which is designed to enhance your personal and departmental effi ciency. Xper settings provide an advanced level of customization so users can create an interventional lab that directly meets individual needs and preferences The Xper User Interface provides intuitive system controls and all relevant functionality at the tableside to enhance ease of use Xper Integration provides bi-directional information exchange Xper Module Available in both the examination and control room, the Xper Module communicates user preferences for acquisition settings, automatic position control, processing, and quantitative analysis. It also provides controls for the integrated 3D interventional tools and ViewForum for multimodality viewing. Xper in the examination room On-Screen Display The On-Screen Display on the reference monitor provides information that includes X-ray indication, radiographic parameters, rotation and angulation stand positions, Source Image Distance, Air Kerma (both rate and accumulated X-ray dose), frame speed, and fl uoroscopy mode. On the examination monitor, the On-Screen Display contains the user interface of the Xper Viewpad, which is used to execute functions including run and image selection, review speed, active fi le selection, and digital zoom. Xper Geometry Module To make operation as convenient as possible, the Xper Geometry Module can be positioned on all sides of the patient table, while keeping positioning (angulation, rotation) logical and intuitive. It controls tabletop fl oat, table height, pivot lock, Source Image Distance, stand positioning, and optionally, tilt and cradle functionality. Xper Imaging Module Like the Xper Geometry Module, the Xper Imaging Module can be positioned at all sides of the patient table, while retaining intuitive button operation. The Xper Imaging Module allows the user to activate shutter and wedge positioning, fl uoroscopy mode as defi ned via Xper settings, roadmapping functionality, detector fi eld size, and storage of fluoroscopy images. Shutters and wedges can be positioned on Last Image Hold for additional X-ray dose saving. Both Xper Modules have a removable protection bar that prevents unintended activation of the system. 6 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

7 Xper in the control room Xper Viewing Console The Xper Viewing Console comprises a color data monitor for patient data and system information management, including radiographic parameters and review monitors. The intuitive review monitors, one for each plane, enable effi cient review of exams and control of image processing and Quantitative analysis programs. The Xper data and Xper review monitors use a shared screen and the mouse can be moved over the three monitors. All areas of exam workfl ow have been greatly optimized with Xper technology, from scheduling to archiving. The system is completely set up and prepared for the procedure just by selecting patient and clinical application. Closing the examination will automatically archive the images and exam patient data to the user s preferred destination, while the next procedure is started. Examination management is task oriented and includes exam Scheduling, Preparation, Acquisition, Reviewing, Reporting, and Archiving. The various windows allow real multi-tasking for better lab effi ciency. Xper Review Module The Xper Review Module provides direct control of key viewing functions, like fi le and run cycle, contrast, brightness, edge enhancement, and viewing speed (tagarno wheel) to further enhance workfl ow effi ciency. Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 7

8 The image quality you want with low X-ray dose The Allura Xper FD20/10 and FD20/20 feature advanced algorithms, next generation fl at detectors, and Philips renowned 2k imaging chain to ensure superb image quality at a low patient X-ray dose. Dynamic Flat Detector Philips' 14-bit virtually distortion-free dynamic fl at detectors include a large 30 x 40 cm fl at detector on the frontal and a 20 x 20 cm or a 30 x 40 cm detector on the lateral plane. These detectors together with a compact detector design optimize image coverage and patient access in neuro-vascular procedures. The fl at detectors have high resolution and high DQE for better image quality. Furthermore, a refresh light is included that provides temporal virtually artifact-free imaging by blanking the detector and thereby eliminating image ghosting during dynamic studies. MRC tube The Allura Xper FD20/10 and FD20/20 are equipped with the legendary high power MRC Grid Switched tubes. The tubes' exceptional design provide long life and allow them to withstand high continuous loads and maximize heat dissipation. This enables them to provide virtually unlimited series lengths. SpectraBeam filtration The MRC tube works in tandem with SpectraBeam fi ltration to allow increased X-ray output with better fi ltration of soft radiation. SpectraBeam offers three levels of fi ltration - up to one mm Cu equivalent - to reduce patient X-ray dose, while maintaining image quality. The fi ltration level can be programmed via Xper settings. The fl uoroscopy mode can be selected at tableside. 2K Digital Imaging Chain The Allura Xper platform includes a ground breaking 2k digital imaging chain. This innovative imaging chain is designed to process up to 2048 x 2048 pixels as acquired by the fl at detectors to increase detail resolution. Full resolution acquisition is also available in biplane mode. Furthermore the 2k imaging chain can be completed with an additional 2k display for evaluating clinical images with for evaluating clinical images in native resolution. The Allura Xper biplane systems set a new standard in image quality for neuro-vascular applications. Xres* Xres is Philips real-time image processing algorithm. Xres was developed by the Philips Research Laboratories and has been applied in several Philips products, e.g. Ultrasound and MRI. This image processing algorithm provides 1 billion calculations per frame and is applied to each clinical image real-time. Xres provides excellent image quality through enhanced contrast and sharpness. It exploits the benefi ts of the fully digital detector to reduce noise in non subtracted fl uoroscopy and trace substract fl uoroscopy for neuro-vascular studies. Each user can customize Xres via Xper settings for the preferred image quality settings. Monitors The LCD progressive display monitors are virtually fl icker-free to prevent physician eyestrain. In the control room the 19-inch LCD color monitor and two 18-inch LCD black and white monitors are standard. In the exam room four 18- inch LCD black and white monitors are standard. For each plane it provides the live monitors and the reference monitors. MultiVision video switch* MultiVision allows images from different image sources to be viewed on the LCD color monitor in the exam room, eliminating the need for multiple monitors. Fluoro storage Xper Fluoro storage captures up to the last 20 seconds of fl uoroscopy. Fluoroscopy runs (up to 600 images) can then be stored, processed, and archived like regular run exposures. Xper Beam Shaping Xper Beam Shaping allows the wedges and shutters to be positioned without using X-ray radiation. * optional 8 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

9 Features that enhance workfl ow Rotational Angio* Rotational Angio, performed on the frontal stand, saves time, contrast medium, and X-ray dose by creating real-time 3D impressions of complex vasculature with multiple projections and just one contrast injection. The rotational scans can be processed automatically for an instant 3D reconstruction. The combination of advanced integration features with Xper settings, which personalize image archiving and printing, make the Allura Xper FD20 biplane systems an excellent workfl ow-friendly system. Now your department can run the way you want it to, with effi ciency-enhancers that give you more time for patient care. Xper DICOM Image Interface The Xper DICOM Image Interface provides fast export of clinical images in DICOM XA Multi Frame or DICOM Secondary Capture. Images can be sent in different formats to any DICOM-compatible device, and can be sent to several destinations, as configured via Xper settings. In addition, with DICOM Query/Retrieve, older DICOM studies can be uploaded into the system. Biplane continuous autopush* The biplane continuous autopush option, allows uninterrupted image transfer in the background during procedures, so that you do not have to wait for the system after each case or delay archiving until the day ends. RIS/CIS DICOM Interface* This RIS/CIS DICOM interface option uses DICOM Worklist Management and Modality Performed Procedure Step standards to enable two-way communication between the system and a local information system. Xper MultiSwitch* The Allura Xper FD20/10 and Allura Xper FD20/20 can be integrated with a broad range of solutions in the control room. The Xper Viewing Console can be shared with external IT systems for workfl ow effi ciency and space saving. The Xper Viewing Console with Xper MultiSwitch provides access to PC based applications, such as PACS and the 3D interventional tool. Furthermore a web based browser application is provided to access Radiology and Cardiology Information Systems (RIS, CIS). * optional Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 9

10 Floor mounted C-arm stand FD20 Flat detector High output MRC Lateral Arc with Xper Access X-ray tube 10 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

11 Flexible monitor ceiling suspension with height adjustment 18-inch LCD monitors Xper Module with Xper Viewpad attached Xper data monitor (LCD) Xper review monitors (LCD) Xper Geometry and Imaging Modules Xper table Xper Review Module Optional Xper Module Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 11

12 Technical information Geometry The geometry of the Allura Xper FD20 biplane systems is designed for fast and fl exible imaging. The combined fl oor mounted C-arm stand with the ceiling suspended double C-arm in lateral plane, forms a perfect match. It gives you unlimited projection capability, while the compact size provides excellent patient access and frees up working space for staff and equipment. In addition, The Allura Xper FD20 biplane systems are equipped with a dedicated patient support table and highly fl exible, ceiling-suspended LCD monitors. Frontal and lateral stand C-arm Stand The compact fl oor mounted C-arm stand provides you with considerable advantages in accessing patients. The fully motorized C-arm can be positioned at the head end and at both sides of the table. All projections can be achieved with minimal effort. Specifi cations: L-arm rotation is motorized and manual over 180 with snap positions at 90, 0, 90 to allow patient access from three sides of the table C-arm rotation: - In head-end position: 120 LAO, 185 RAO - In side position: 90 LAO, 90 RAO C-arm rotation speed: - up to 25 /s C-arm angulation: - In head-end position: 90 cranial, 90 caudal - In side position: 185 cranial, 120 caudal - Full angulation capability, restricted only by patient position C-arm angulation speed: - up to 18 /s Iso-center to fl oor: cm Focal spot to iso-center: 81 cm Source Image Distance: cm C-arm depth: 90 cm Motorized fl at detector movement including source image distance and Xper Access - Xper Access allows re-positioning of the fl at detector from portrait to landscape. Rotation of the fl at detector is performed in 3 seconds Collision safety control: BodyGuard patient protection system Double C-arc Double C-arc Philips unique ceiling-mounted, double C-arc can be independently rotated and angulated to provide full caudal and cranial angulations for all oblique positions. The C-arc is moved via a precision motorized drive. The counterbalanced fl at detector allows for precise motorized and fast manual movements. The C-arc is easily parked by moving it manually along the ceiling rails. Motorized parking is also available with an autostop in 12 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

13 the isocenter. The compact fl at detector and the design of the ceiling mounting create maximum fl oor space and superb accessibility around the patient. The Allura Xper FD20/10 can be mounted with the lateral detector on doctor or nurse side for dedicated neuro-vascular or mixed cardio-vascular use, respectively. The Allura Xper FD20/20 is provided with the lateral detector on the doctor s side. Specifi cations: Ceiling suspended double C-arc Motor-driven rotation angles: - 27 RAO to 115 RAO or 0 LAO to 90 LAO for the Allura Xper FD20/10-27 RAO to 115 RAO for the Allura Xper FD20/20 Motor-driven angulation: 45 cranial to 45 caudal, possible at any rotation angle Rotation speed: 8 /s Isocenter to fl oor: cm Focal spot to isocenter: 76.5 cm Focal spot to fl at detector: cm, manual and motorized movement Manual or motorized longitudinal movement for parking or positioning - Autostop in Isocenter - Two speed control to accurately position the beam longitudinally in the region of interest: 6 cm/s inside working area with neuro fi ne positioning 12 cm/s outside working area Nominal ceiling height: 297 cm Collision protection - Automatic Power Safety Control and additional slip clutch control for fl at detector movement - Proximity switches for all other movements in sequence or selected individually. The projection sequence parameters include rotation, angulation, SID, and orientation of the detector. Reference-driven positioning: Single plane or biplane projection derived from the images displayed on the reference monitors. BodyGuard Patient Protection BodyGuard enables the use of high-speed rotation and angulation. It uses "'non-contact" proximity sensors to detect the position of the patient or objects. The combination of C-arm geometry and exclusive BodyGuard sensing achieves a level of control that is not possible with conventional high-speed motorized C-arm confi gurations. The conventional stands use a pre-set one-size-fi ts-all program, resulting in a so-called safety envelope that is too large to be practical. With BodyGuard s continual capacitive sensing, the system adapts to individual patient size. The system slows down or stops moving when a patient or object gets too close. BodyGuard has an override button to allow full gantry positioning control at all times. In addition, BodyGuard utilizes motor current sensing (the electronic equivalent of a slip clutch) to safeguard all stand movements. The counterbalanced fl at detector on the lateral arc incorporates a mechanical slip clutch, to control motorized and manual movements and uses proximity switches to safeguard other movements. Automatic Position Controller Automatic Position Controller (APC) functionality is accessed through the Xper Module at the patient tableside. The APC provides two modes of operation: Preset Position Sequence: The projection sequence can be defi ned by Xper Settings for every clinical procedure. Every procedure can contain up to 10 different stand positions. Positions can be recalled BodyGuard Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 13

14 Xper table The Xper table is a dedicated cardiovascular table with a free-fl oating tabletop. This table has very high patient loadability and can make a large longitudinal fl oating movement. new stand position. As a result, the region of interest is always centered. As the table tilts, the X-ray beam automatically coordinates to the movement. Specifi cation: Radio translucent carbon fi ber tabletop Tabletop length: 319 cm Tabletop width: 50 cm Motorized height movement: From cm Tabletop metal free overhang: 125 cm Free fl oat at 0 degrees Longitudinal fl oat: 120 cm Transverse fl oat: 36 cm Maximum allowable patient weight: 250 kg (550 lbs) with additional force of 500 N (50 kg/110 lbs) allowed in case of CPR. CPR can be performed while the tabletop is in any longitudinal position Pivot over 270 degrees* 7 cm slow recovery foam patient mattress for optimum patient comfort Comfortable, infl atable patient mattress The Xper Module, Xper Imaging, and Xper Geometry Modules can be positioned on three sides of the patient support Cables incorporated in the table to allow maximum operational fl exibility Table automatic positioning Xper table - tilt Specifi cations: Maximum tilt range: -17º (head-down) to +17º (head-up). Tilt speed: 2 degrees/second Automatic safeguarding system with manual override Panning range in tilted plane: equal to standard panning range Xper table - cradle Table tilt* The optional isocentric tilt enhances the accuracy and effi ciency of gravity-oriented procedures. It is ideal for interventional, myelography, phlebography, and head down procedures because it provides more precise imaging of contrast medium, blood, or objects in the body. As the table tilts, the X-ray beam automatically coordinates to the movement to keep the region of interest in the isocenter of rotation and angulation of the stand. If the longitudinal position of the stand changes, the tilt isocenter is changed to match with the Table cradle* In addition to the Syncratilt functionality this option enables you to tilt the tabletop in a cradle movement. This allows optimal positioning of the patient for instance, for more invasive or guided puncture procedures. Specifi cation: Isocentric cradle Maximum cradle range: -15º to +15º for the full tilt range Cradle speed: 3 degrees/second * optional 14 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

15 Table Automatic Position Controller* The tabletop position can be adjusted to the pre-defi ned default position to save time and X-ray dose at the start of an exam or for setting up the system for rotation scans. It also offers store and recall functionality of the height, longitudinal, and lateral position of the tabletop. This allows you to return to your exact previous position, without using X-ray dose. Pan handle* The pan handle is a tabletop float control extension, which can be attached to any side of the table. This additional pan handle works in a master/slave confi guration. Pivot* The table-based pivot option is designed for angiographic and interventional procedures of the upper peripherals. It provides enhanced table access for e.g. patient transfer. This option enables the table to pivot around its vertical axes. The pivot range moves from -90 to +180 (or -180 to +90 ) with locked positions at 0, -13, and +13 (to facilitate arm angiography) and -90, +90, and 180. Table swivel* The swivel option allows total body coverage without the need to change the patient s position on the table. Ergonomic pan handle Monitor Ceiling Suspension The Monitor Ceiling Suspension enables you to freely rotate and adjust the height of two, four, or six monitors. Monitors rotate freely on the ceiling suspension over a range of 350 Suspension moves transversely over a distance of 300 cm (118.1 in.) and longitudinally over a distance of 330 cm (129.9 in.) Allows motorized height adjustment over a maximum range of 32 cm. Table swivel Specifi cations: 80 cm translocation of the whole patient support assembly in the direction of the fl oor-mounted C-arm Pivot of tablebase allows rotation of the table base over a range of 90 to the right side and 90 to the left side of the patient. Monitor Ceiling Suspension * optional Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 15

16 Ceiling Suspended Radiation Shield* The ceiling suspended radiation shield protects against scatter radiation to the eyes and the upper body of the physician and staff. The shield is mounted on the ceiling monitor carriage with a two-section suspension arm to allow free positioning of the shield. It can be used in combination with the table mounted lower body radiation shield. Examination Light* An examination light enables the optimal visualization of the examination region under daylight conditions. This light intensity is 30,000 Lux. The hand grip is removable and can be sterilized for use with a disposable cover. Examination light Ceiling suspended radiation shield Table Mounted Radiation Shield* The table mounted radiation shield provides additional protection of physician and staff against scatter radiation. The shield consists of two protective parts: a lower shield and an upper shield. The shield is specially designed for use with the Xper patient table. Table mounted radiation shield Specifi cations: Can be mounted on either the right or left table accessory rails Can be pulled into the required working position and parked underneath the tabletop to facilitate patient preparation The upper shield can be positioned upright for optimal protection or can be folded down to allow free access to the patient Optional accessories Peripheral X-ray fi lter Cath arm support (adjustable) Ratchet compressor Pulse cath arm support Table mounted radiation shield MCS bracket ceiling radiation shield Ceiling mounted radiation shield Drip stand Arm support Mattress Neuro Mattress Set of arm supports Table clamp Patient straps Head support Set hand grips & clamps Cerebral fi lter Neuro wedge Cable holders (15 pieces) Add-on OP-rail * optional 16 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

17 Rotation angle of the Lateral Arc up to 25º through the horizon for optimal positioning Independent or combined positioning of both planes in biplane use Free positioning of the Frontal stand in monoplane use Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 17

18 Technical information - User Interface Xper User Interface in the examination room The Allura Xper FD20 biplane systems feature Xper technology, which is designed to enhance your personal and departmental effi ciency. Xper settings provide an advanced level of customization so users can create an interventional lab that directly meets individual needs and preferences The Xper User Interface provides intuitive system controls and all relevant functionality at the tableside to enhance ease of use Xper Integration provides bidirectional information exchange In the examination room, the Xper User Interface comprises the On-Screen Display, the Xper Module, and the Xper Imaging and Geometry Modules. The On-Screen Display is on the left side of the reference monitors. The following system information is displayed: X-ray indicator X-ray tube temperature for each channel Radiographic parameters: kv, ma, ms Rotation and angulation parameters of each stand Source Image Distance per plane Table height Detector fi eld size of each plane General system messages Selected frame speed Fluoroscopy mode Integrated fl uoroscopy time Air Kerma (both rate and accumulated X-ray dose) X-ray dose area product (both rate and accumulated X-ray dose) Stopwatch Graphical bars for body zone specifi c X-ray dose-rate and accumulated Air Kerma levels, in relations to the 2 Gy threshold for cardiac procedures The On-Screen Display on the live monitors in the examination room contains the Xper ViewPad, which stores the pre-programmed function settings. The Xper ViewPad controls the following: Run and image selection Exam and run cycle Review speed Run and exam overview Active exam folder selection Flagging image and run for storage Subtraction and image mask selection Digital zoom Storing reference run or image to reference monitors Select reference monitors for review and/or processing of previous run exposures 18 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

19 Xper Module The Xper Module can be positioned both at the tableside and in the control room. Up to two Xper Modules can be connected to the system. The Xper Module contains the following functionality: Acquisition setting Selection of preprogrammed procedures and acquisition parameters. Procedures are programmed in the Xper settings. This is also where the specifi c Xper procedure for the Allura 3D-RA / Allura 3D-CA / StentBoost and XperCT option(s) can be selected. Automatic Position Control (APC)* A sequence of up to 10 single plane or biplane projections per clinical procedure can be preprogrammed via Xper settings and selected via the APC. Via APC, the geometry can also be steered to the projection as displayed on the reference monitors or the optional Allura 3D-RA color monitor. Image Processing parameters, like contrast, brightness, edge enhancement, subtraction, zoom, pixelshift, landmarking, and image invert can be adjusted. Quantitative Analysis (QA), optional If QA packages are available on the system, the analysis can be performed on the Xper Module. Optional interventional tools, like Allura 3D-RA, Allura 3D-CA, Dynamic 3D Roadmap, StentBoost, CT TrueView, XperCT and XperGuide allow control of interventional tools via the Xper module in the examination room during the exam. ViewForum and Xcelera on Xper Module Integrates ViewForum multimodality review application and/or the Xcelera network application in the Allura Xper system. It allows operation of these viewers via the Xper Module in the examination room during examination. Hemo on Xper Module* Integrates Xper IM Physiomonitoring with the Allura Xper system. It allows the physician and procedure staff to perform a complete hemodynamic study from tableside. An additional Xper Module can be connected in the control room. The functionality of this Xper Module is equivalent to the functionality of the Xper Module connected in the examination room. When multiple Xper Modules are connected to the system, the Xper Modules operate independently. Images and movies can be exported in a PC compatible format via the USB interface on the Xper Module. Xper Geometry Module The Xper Geometry Module can be positioned at all sides of the patient table. The module adjusts to the position to retain the intuitive button operation. The Xper Geometry Module provides the following functionality: Tabletop fl oat Table height position Table tilt angle (if the tilt option is selected) Table cradle angle (if the cradle option is selected) Source Image Distance selection per plane Frontal plane fl at detector portrait/landscape position Stand positioning per plane Biplane rotation Longitudinal movement of the lateral stand along the ceiling Frontal stand rotation in an axis perpendicular to the floor Store and recall of two scratch stand positions, including source image distance and detector orientation Emergency stop button Accept button of the Automatic Positioning Control Geometry reset button, which resets stand and table to a default starting position Xper Module Xper Geometry Module * optional Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 19

20 Xper Imaging Module The Xper Imaging Module can also be positioned at all sides of the patient table, while retaining intuitive button operation. The Xper Imaging Module provides the following functionality: Fluoroscopy mode selection as defi ned via Xper settings Shutters and wedge positioning per plane Manual or automatic wedge operation for each plane, including positioning on the displayed image without radiation Xper fl uoro storage to record up to the last twenty seconds of fl uoroscopy* Selection of the detector fi eld size per plane Selection of shutter setting per plane Reset of the fl uoroscopy buzzer Selection of Fluoro Trace subtract function Selection of SmartMask function (optional) Toggle button to select the required channel for adjustments Xper User Interface in the control room In the control room, the Xper User Interface comprises an Xper Review Module, three LCD monitors, a keyboard and a mouse. The monitors are shared screens: the color screen is the data monitor; the two black and white screens are the review monitors. Both the Xper Geometry and Imaging Modules have a removable protection bar that prevents unintended activation of system. Xper Imaging Module Xper Review Module Xper Review Module The Xper Review Module is a review station for basic viewing needs. The most prominent functions can be controlled by the push of a button. The Xper Review Module comprises the following functionality: Power on/off of the system Tagarno wheel to control the review of a patient exam Exam and run cycle Adjustment of contrast, brightness, and edge enhancement Exam, run, and image stepping Run and exam overview Basic review functionality as image invert and digital zoom Go to original settings Reset fl uoroscopy timer and switch X-ray on/off * optional 20 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

21 Xper data monitor The Xper data monitor is a 19-inch LCD color monitor. It is part of a shared screen with the review monitors. A standard keyboard and mouse control the user interface. The data monitor is intended as the patient data interface. Workfl ow is divided into Scheduling, Preparation, Acquisition, Review, Report, and Archive. System information is displayed on the bottom of the data monitor: Stopwatch and Time System guidance information Dose Area Product and Air Kerma per plane (both rate and accumulated X-ray dose) Frame speed settings, fl uoroscopy mode, and accumulated fl uoroscopy time Exposure and fl uoroscopy settings as Voltage (kv), Current (ma) and pulse time (ms) Stand position information, including rotation, angulation, and source image distance per plane Scheduling On the scheduling page, new patient data can be added manually or loaded from the RIS or CIS via DICOM Work List Management. Patients can be listed and selected per date, physician, or intervention type. Older DICOM patient studies can be uploaded with the DICOM Query/Retrieve function. Patient management protocols are exceptionally flexible and allow for multiple exams to be selected under one patient identification number, so that new exams can be appended to an earlier patient file. Furthermore, each patient folder can contain multiple examinations to allow for split billing and split administrative purposes. Each examination contains multiple files, such as acquisition, reference and print files. Patient information can also be sent from the modality to the information systems with DICOM Modality Performance Procedure Step. Preparation The preparation page provides the room and patient preparation preferences of each individual physician, eliminating the need for hard copy protocols. Physicians preferences are programmed in the Xper settings and the information resides permanently in the system unless a change is made. Acquisition The acquisition page contains information on the current selected exam. The page shows a full overview of all acquired runs. The history fi le of the patient can be reviewed by the push of a button. Xper data monitor Review The review page lets you review the following information from patients: Previous exams Exams from other imaging modalities Report For systems with the Lab Reporting option, the report page lets you create a patient report. The report contains information on patient X-ray dose, written text from the intervention, and appended clinical images. It can be printed or sent out electronically by . Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 21

22 Technical information - User Interface Options Archive Clinical studies can be archived to a CD with the optional ViewForum workstation, Xcelera DICOM recorder or to a PACS. The archiving process - including multiple destinations, archive formats, and background transfer- can be completely automated and customized with Xper settings. Video invert Zoom and pan image View trace Pixel shift Electronic shutters Toggle switch physio Copy images/runs Second Xper Imaging Module Extension of the imaging controls with a second module in the control room, in a master-slave confi guration. Second Xper Geometry Module Extension of the geometry controls with a second module in the control room, in a master-slave confi guration. Xper review monitor Contrast Injectors The following contrast injectors are optimized for use with the Allura Xper systems: Liebel-Flarsheim: Angiomat Illumena Medrad: Mark V ProVis, Avanta Acist: Voyager Xper review monitor The Xper review monitors are two 18-inch black and white LCD monitors with a shared interface with the color data monitor. The graphical user interface on the black and white monitors have the following features: Step through exam, run, or images Exam and run overview Image processing features such as contrast, brightness, and edge enhancement Flagging of runs or images for transfer Image annotation Automatic printing* Quantitative Analysis Packages* Subtraction Move or renew mask Landmarking (increase/decrease of degree of subtraction) * optional 22 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

23 Technical information - Integration The Xper DICOM Image Interface enables the export of clinical images to a destination such as ViewForum, Xcelera DICOM Recorder, EasyAccess Modality or any third party PACS. The system exports clinical studies in DICOM XA Multi Frame or DICOM Secondary Capture. The Xper DICOM Image Interface speeds image transfer through its fast Ethernet link, making images available on-line within seconds. The archiving process can be confi gured via Xper settings Image archiving is done in the background during or after the procedure The images can be archived automatically in background with the continuous autopush option The export format can be confi gured to a 512 2, , or 2k 2 (unprocessed) matrix The Xper DICOM Image Interface can distribute the examination images to multiple destinations for archiving and reviewing purposes The Xper DICOM Image Interface provides DICOM Store and DICOM Store Commitment Services The Query/Retrieve function allows older DICOM studies to be uploaded in the system Xper MultiSwitch Xper MultiSwitch enables the Xper workspot in the control room to be shared with other applications that are loaded on separate PC modalities. The MultiSwitch option enables you to switch to the color LCD data monitor, keyboard and mouse normally connected to the Allura Xper system. This saves signifi cant space in the control room by enabling only one monitor and keyboard to be used for multiple applications, like Allura 3D-RA, XperCT, ViewForum and Xcelera DICOM Recorder. In addition the Xper data monitor can be switched to Radiology Information Systems through the web based browser application (HTML) or X-window (Exceed). It makes full use of the available RIS facilities, and existing support for automatic handling of logistic tasks (for example automatic tracking, purchasing of supplies, and billing). Lab Reporting* The Lab Reporting option allows the clinical user to generate and print a report in modality stand-alone situations. The user can incorporate free text and clinical images and X-ray dose information. It is possible to print the report or send it via . Part of the report is generated automatically from administrative data (e.g. patient/exam data, hospital name), and part with acquired data (e.g. run-log, X-ray dose information, and event-log). * optional Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 23

24 Technical information - Additional Communication Options Biplane continuous autopush The biplane continuous autopush option provides an additional image processor board dedicated to archiving, to minimize interruptions that are caused by other functions that require the image processor, such as patient review. Using this option speeds up archiving and the availability of clinical images for reviewing at other PACS destinations. DICOM Print DICOM Print provides an interface to any DICOM Printer. It provides Print Preview, Print Compose, Print Manual Overrides, Print Job submission, and Print Job management via automated printing protocols. Standard Line Rate Video Output The standard line rate video output option is 625 (525) lines, 50 (60) Hz. video output unit. This option is available as a monoplane (frontal) or biplane version. This option is required to connect a medical DVD/VCR or an additional TV monitor. This option provides automatic start/stop of a medical DVD/VCR and replay on the live monitors of the video signal synchronous to generation of X-ray during fl uoroscopy and exposure. Intercom Remote Intercom is used for communication between the examination and control room. RIS/CIS DICOM Interface This interface option enables two-way communication between the system, a local Information System (CIS or RIS) or hemodynamic system. The interface uses the DICOM Worklist Management and Modality Performed Procedure Step standards. If a hospital has an information system, it is possible to receive patient and examination (request) information and to report examination results. This option provides the following benefi ts: Eliminates the need to retype patient information on the system Helps to reduce errors in typing patient name or registration number, which ensures consistency of information throughout the department to prevent problems in archive clusters Provides information to and from the information system about the acquired images and radiation dose Upon request from the system, the complete worklist with all relevant patient and examination data is returned to the system. 24 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

25 Technical information - Image Detection The Allura Xper FD20 biplane systems are equipped with next generation dynamic fl at detectors, whose compact size easily handle complex projections. Image quality and X-ray dose reduction are further enhanced by Xres image processing. Fluoroscopy Three fl uoro modes are available at tableside and these can be programmed via Xper settings, each with a different composition of X-ray dose rate, digital processing and fi lter settings. Dynamic Flat Detector Philips next generation dynamic fl at detector provides excellent image quality at a low patient X-ray dose. The Allura Xper FD20/10 combines the FD20 detector on the frontal plane with an FD10 detector on the lateral plane. The Allura Xper FD20/20 comes with the FD20 detector on both the frontal and the lateral plane. Specifi cations for the FD20 detector: Size of detector housing: 42 x 52 cm Maximum fi eld of view: - 30 x 38 cm for the frontal FD20 detector - 30 x 30 cm for the lateral FD20 detector Image matrix: 2480 x 1920 pixels at 14 bits depth Detector zoom fields: 30 x 30 cm, 26 x 26 cm, 22 x 22 cm, 19 x 19 cm, 16 x 16 cm and 13.5 x 13.5 cm, 11 x 11 cm square formats Pixel size: 154 μm x 154 μm Detection quantum effi ciency DQE (0) > 73% Digital output: up to 2k 2 at 14 bit depth resolution Specifi cations for the lateral FD10 detector: Size of detector housing: 28 x 28 cm Maximum fi eld of view: 18 x 18 cm Image matrix: 1024 x 1024 pixels at 14 bit depth Detector zoom fi elds: 14.5 x 14.5 cm, 11 x 11 cm square format Pixel size: 184 μm x 184 μm Detection Quantum Effi ciency DQE (0) of 75% Digital output: 1k 2 at 14-bit depth resolution Specifi cations: SpectraBeam fi lters for MRC-GS tubes: 0.2, 0.5, and 1.0 mm Cu-eq pediatric fi lter Fluoroscopy image processing: Recursive fi ltering, Localized Contrast-adaptive Contour enhancement, SPIRIT fi lters and Xres algorithm Pulsed X-ray modes with a Fast Fluoro Reset function, which quickly returns the system to Fluoroscopy if there is an unexpected system reset Pulse rates: system-customized at 3.75, 7.5, 15 and 30 pulses per second in monoplane and Allura Xper FD20/10 biplane mode Pulse rates Allura Xper FD20/20 in biplane mode: system-customized at 3.125, 6.25 and 12.5 pulses per second Frame grabbing of static fl uoroscopy images or Xper fl uoro storage to store up to the last 20 seconds of fl uoroscopy for reference or archiving Grid-switched pulsed fluoroscopy Pulsed fl uoroscopy can reduce X-ray dose and enhance X-ray image quality. Conventional pulsed fl uoroscopy, however, has a ramp-up and trail effect of soft radiation that does not contribute to image quality, leading to unnecessary dose exposure for patients and staff. With Philips unique grid-switched pulsed fl uoroscopy, this effect is eliminated, leading to a signifi cant reduction in dose compared with conventional pulsed fl uoroscopy. systems allow you to take full advantage of the tubes of the Allura Xper systems have capabilities, allowing you to take full advantage of the dose reduction capabilities of the system. Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 25

26 Double wedge filters Double wedge fi lters provide optimum image quality in all projections. The wedge fi lters facilitate that optimal exposure and hence optimal image quality is maintained (with minimal patient entrance X-ray dose). Biplane trace-subtract fluoroscopy Biplane trace-subtract fl uoroscopy provides top quality reference images for accurate positioning of a catheter, guidewire or other interventional devices. The peak bolus is automatically traced over the area in view when contrast is administered under fl uoroscopy. The resulting image shows a vascular structure as if it were completely fi lled, this is the reference image or roadmap. The roadmap image can be faded in/out for optimal viewing. Subsequent fl uoroscopy shows the progress of the intervention over this reference image. A run exposure can be performed without losing the roadmap image, saving contrast and X-ray dose. The subtracted fl uoroscopy can be re-masked to compensate for motion. SmartMask* SmartMask simplifi es Roadmapping procedures by overlaying the fl uoroscopy image with a selected reference image on the live monitor. The reference image can be faded in/out for optimal viewing. Biplane Dual Fluoroscopy* The Biplane Dual Fluoroscopy mode allows monoplane or biplane digitally processed fl uoroscopy in parallel with trace subtract fl uoroscopy, providing a non subtracted reference fl uoro image for complex interventions. The subtracted fl uoro image will be displayed on the live monitor(s), while the non-subtracted image is displayed on the reference monitor(s). The dual fl uoroscopy option comes with live digital zoom capabilities providing additional magnifi cation of the region of interest. With the additional dual fl uoroscopy monitors*, you can simultaneously display trace subtract fl uoroscopy, non-subtracted fl uoroscopy and reference images. Subtracted Bolus Chase Bolus Chase provides more flexibility for imaging lower peripheral vasculature imaging via Xper Access. Xper Access allows re-positioning of the frontal detector from portrait to landscape for ideal image coverage. Routine examinations can be performed quickly and confidently with Bolus Chase. A hand-held speed controller is used to constantly match table speed to the speed of the contrast run-off, displayed in real-time on the monitor screen. After the contrast run the memorized speed profi le can be used to acquire mask images in order to allow subtraction with high accuracy. The result is effi cient, accurate run-off studies that that limits the need for repeat exposures. Bolus Chase gives fast, accurate results for increased patient throughput and enhanced patient management. Automated exposure control and precise speed control assure high quality images and excellent subtraction studies with 2k image resolution. Digital acquisition The Allura Xper FD20 biplane systems can be customized with a virtually unlimited number of acquisition programs for digital angiography and digital subtraction angiography. Image resolution is up to 2048 x 2048 pixels for vascular imaging. Acquistion speeds in single and biplane mode are: 0.5 to 6 fps standard 15 and 30 fps, optional 60 fps is optionally available in monoplane and biplane mode for the Allura Xper FD20/10 and in monoplane mode for the Allura Xper FD20/20 Storage Capacity The Allura Xper FD20/10 has a standard storage capacity of 100,000 images at matrix. This capacity is divided equally per channel. Optionally, the storage capacity can be extended to a total of 200,000 images at matrix (100,000 images per channel). * optional 26 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

27 Technical information - X-ray Generation X-ray generator The X-ray generator is optimized for the latest cardiovascular needs. Specifi cations: Microprocessor-controlled, 100 kw high frequency converter generator Quartz-controlled power-switch, with a minimum switching time of 1 ms Voltage range: 40 to 125 kv Maximum current: 1250 ma at 80 kv Maximum continuous power: 2.5 kw for 0.5h, 2 kw for 8h Nominal power (highest electrical power): 100 kw (1000 ma at 100 kv) The settings for X-ray generation control can be selected on the Xper Module. Xper Beam Shaping Xper Beam Shaping provides virtual collimation of the shutters and wedges on the last X-ray image, eliminating additional X-ray dose during collimation changes. MRC-GS X-ray tubes The Allura Xper FD20 biplane systems are provided with the legendary high power MRC-GS tubes. In the last seven years, Philips has installed more than 5000 MRC X-ray tubes with customers around the world. Data shows that on average, the MRC X-ray tube lasts signifi cantly longer than conventional tubes. The powerful MRC tubes allow very high heat dissipation, enabling SpectraBeam fi ltration to reduce patient X-ray dose. MRC-GS X-ray tube MRC-GS 0407 X-ray tube for frontal plane Specifi cations: 0.4/0.7 mm nominal focal spot values with maximal 30 and 65 kw loadability Grid Switching at pulsed fl uoroscopy Fluoro power for 10 minutes: 4500 W Max. anode heat dissipation 11,000 W Fluoro power for 20 minutes: 3500 W Max. heat dissipation of assembly: 3500 W SpectraBeam dose management Oil-cooled X-ray tube with thermal safety switch Direct anode oil coding system with 200 mm anode diameter Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 27

28 MRC-GS 0508 X-ray tube for lateral plane Specifi cations: 0.5/0.8 mm nominal focal spot values with maximal 45 and 85 kw loadability Grid Switching at pulsed fl uoroscopy Max. anode heat dissipation 11,000 W Anode heat dissipation in continuous mode: 3200 W Fluoro power for 10 minutes: 4500 W Fluoro power for 20 minutes: 3500 W Max. heat dissipation of assembly: 3500 W SpectraBeam dose management Oil-cooled X-ray tube with thermal safety switch Direct anode oil cooling system with 200 mm anode diameter SpectraBeam The combination of SpectraBeam with the MRC-GS tubes increases X-ray output with better fi ltration of soft radiation. This reduces patient X-ray dose for cardiac and vascular applications, while maintaining the same excellent image quality. Specifi cations: Copper fi lters: 0.2, 0.5, and 1.0 mm copper equivalent The fi lters can be programmed via Xper settings The fl uoroscopy mode can be selected at tableside Anatomical filters Filters designed to compensate for large absorption differences in the object. There are special fi lters for cerebral angiography and lower peripheral angiography. X-ray On indicator light It is important that everyone in the examination room- or just entering it, knows when the X-ray is being applied so that they can take the necessary precautions. The Allura Xper systems have an integrated X-ray On indicator light located above the LCD monitors, that is clearly visible from virtually anywhere in the room. X-ray dose information in the examination report An X-ray dose report can be printed (in background) at the end of each examination at the touch of a button. This includes data, such as patient demographics, cumulative fl uoroscopy time, cumulative fl uoroscopy, acquisition and total examination X-ray dose, the amount of runs and X-ray parameters. Examination report data can be provided through the RIS/CIS DICOM two-way interface, to the RIS/CIS (MPPS protocol). SpectraBeam minimizes soft radiation with unique beam fi ltration 28 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

29 Technical information - Viewing Specifi cations Color LCD monitor: 19-inch Color LCD display Native format 1280 x 1024 SXGA Wide viewing angle (approximately 160 ) Controlled brightness (200 Cd/m 2 ) with ambient light dependent brightness control On screen display of control functions operated via push buttons Ceiling suspended LCD monitors in the exam room LCD monitors in the control room The system is delivered standard with four black and white 18-inch LCD monitors in the examination room. A 19-inch LCD color monitor and two 18-inch black and white LCD monitors are standard in the control room. Specifi cations Monochrome LCD monitor: 18-inch monochrome LCD display with a native format of 1280 x 1024 SXGA 10 bit grey-scale resolution with grey-scale correction Wide viewing angle (approximately 160º) High brightness (max 600 Cd/m 2, default 500 Cd/m 2 ) with ambient light dependent brightness control On screen display of control functions operated via push buttons Examination room LCDs include protection screen and motorized height adjustment * optional 2k display* The 2k display is an additional high quality display for viewing clinical images in full resolution as acquired. The 2k display can be configured in the control or exam room. It provides high resolution clinical information and displays both acquisition and fluoroscopy images. In the control room the 2k display is configured as a slave of the review monitor. In the exam room the display is configured as a slave of the exam monitor. The main characteristics of the monitor are: 21 inch monochrome TFT-LCD display Native format 2560 x 2048 matrix Wide viewing angle Brightness; max 700 cd/m 2 Contrast ratio 600:1 On screen display Weight 8.6 kg Dimensions 495(W)x425(H)x108(D)mm MultiVision* The MultiVision video switch is the integrated video switch for high quality Progressive Display video sources on the color LCD monitor. It can switch either black and white or color signals, with up to four inputs to one output. MultiVision enables an extra color monitor in the ceiling suspension in the examination room to be shared between the system and other sources, such as a DICOM viewer, ViewForum, Allura 3D-RA interventional tool, etc. The switch is controlled via the acquisition menu on the Xper Module. PhysioViewing* PhysioViewing provides acquisition, storage and display of ECG signals on the Allura Xper systems. Four physiological data signals can be acquired and stored. One signal can be displayed during review of images. Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 29

30 Technical information - Additional Options Rotational Angio* Rotational Angiography acquires a range of projections with just one contrast injection to create real-time, 3D impressions of complex vasculature and coronary arteries. A contrast run can be followed up with a mask run to allow image/run subtraction. Rotational Angiography can save considerable time and contrast, while providing the image detail required for diagnostic and therapeutic decisions. A rotational scan is possible both in the head and side positions. The high speed acquisition reduces the amount of contrast medium, while the wide rotation range provides a complete evaluation of the anatomy. The stand s excellent stability enables precise positioning and high reproducibility, resulting in high quality images that are required for Allura 3D-RA and XperCT. Specifi cations: C-arm in head position - Maximum rotation speed: 55 /s - Maximum rotation angle: 305 C-arm in side position - Maximum rotation speed: 30 /s - Maximum rotation angle: 180 Frame speeds: 15, 30 and 60 fps Users can designate speed, as well as a start and end position, through Xper settings The clinical images from the rotational scan are sent automatically to the 3D interventional tool* for reconstruction. Integrated Allura 3D-RA* The integrated 3D solution extends the interventional capabilities of the 3D applications. To achieve this the 3D imaging channel has been integrated into the X-ray system and operates in parallel with the 2D X-ray imaging chain providing a breakthrough in performance. The integrated 3D solution offers: Real-time Allura 3D-RA reconstruction: this allows instant availability of the 3D reconstruction immediately after the exposure run 3D Follow C-arc: when the position of the C-arc (not using X-ray) is changed, the 3D volume will automatically follow the position of the C-arc, so the 2D view and 3D volume are always aligned 3D Automatic Position Control: when the user selects an optimal working position from the 3D volume, the C-arc automatically steers itself to the selected position Worklow automation: the complete 3D process is fully automated. Acquired images are reconstructed automatically and the volume appears instantly on the monitor. No user action is required Allura 3D-RA on Xper Module: with the Xper Module the physician has all 3D functionality available at tableside. There is no need for the physician to leave the examination room Allura 3D-RA is designed to provide three dimensional images of brain and peripheral vessels to facilitate endovascular interventions in neuro and vascular radiology. Allura 3D-RA assists in decision making for treatment strategy in endovascular procedures, neuro or vascular surgery or even radiotherapy. Allura 3D-RA reduces the number of digital subtracted angiography acquisitions and fl uoroscopy time needed to perform an examination. This means less X-Ray dose for both patient and staff and a reduced quantity of contrast medium, leading to reduced procedure costs. Image acquisition is performed with the Rotational Angio feature of the Allura Xper FD20 biplane systems with the flexibility to position the frontal C-arm in either head or side position. Rotational angiography * optional 30 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

31 The Allura 3D-RA interventional tool itself gives you access to a wide range of innovative functions including: Reconstructive Zooming Technique, SpineView, CalciView, a complete measuring package that includes automated vessel analysis, the unique computer assisted aneurysm analysis, virtual Stenting, catheter tip shape simulation and automatic voxel shift. The 3D roadmap will remain if the user changes the C-arm position, the source image distance and/or the Field of View of the fl at detector. The 3D volume will also automatically follow the orientation of the C-arc in real time, providing the fl exibility to choose the optimal position of the C-arc. The clinical potential for this technology is signifi cant for applications, such as catheter navigation and monitoring coil delivery. It helps to reduce procedure time, X-Ray dosage and contrast usage. XperCT* XperCT provides CT-like imaging capabilities in the interventional suite without transporting the patient. This opens up a new area of clinical applications that aid interventions. Applications include the evaluation of soft tissue information before and immediately after the intervention, as well as detection of bleeding areas and calcifi cations. In addition XperCT provides high quality bone images to support spinal procedures. Allura 3D-RA Dynamic 3D Roadmap Dynamic 3D Roadmap is adding unique functionality to the integrated 3D product by providing a sustainable 3D roadmap to support interventional procedures. The Dynamic 3D Roadmap option matches the real-time 2D fluoro images with the 3D reconstruction of the vessel tree, so that the advancement of the guide wire, catheter and coils on the 3D volume is visible in real-time, on one monitor. The imaging process is fully automated in the Xper system. The XperCT 3D volume is displayed automatically without any user interaction. The 3D volume can be viewed in the control room and in the examination room. Slice view is performed to visualize the soft tissue and to scroll through the volume. Slice thickness and window width/window level can be varied upon user need. XperCT can be controlled via the Xper module at tableside. * optional Dynamic 3D Roadmap XperCT Philips Allura Xper FD20/10 and Allura FD20/20 Functional description 31

32 In addition the XperCT volume can be matched with Allura 3D-RA. This view combines soft tissue information with high-resolution vessel information. The optimal view can be chosen with the orientation of the 3D volume: the C-arc follows automatically. XperGuide* XperGuide supports percutaneous needle interventions with Live 3D Guidance. It brings percutaneous needle interventions back to the interventional suite. XperGuide is a navigation tool to support the physician during these interventions. The physician can use XperGuide in a wide range of clinical procedures, ranging from biopsies and drainages to RF ablations. XperGuide is based on an XperCT dataset. With XperGuide virtual needle paths are created on an XperCT dataset. This volumetric dataset can be viewed in any slice direction. A wide range of gantry positions can be used to defi ne the needle path. XperGuide automatically calculates the optimal gantry projections for viewing needle insertion and progress monitoring. The calculated virtual needle paths can be viewed on the XperCT slices, to verify if this path is feasible. XperGuide is fully controlled from table side. Pressing the foot paddle to acquire fl uoro images, will automatically activate the XperGuide matching functionality. The live 2D image is projected over XperCT volume and is automatically displayed on the Monitor Ceiling Suspension. The gantry can be positioned in the predefi ned gantry positions or controlled manually. The XperCT or XperGuide images will follow the gantry projections. StentBoost* StentBoost is a simple, quick, and cost-effective tool to enhance visualization of stents in the coronary arteries. It shows the stent in relation to the vessel wall. StentBoost uses markers on the balloon or stent delivery catheter to better visualize objects in the direct environment of the markers. it enhances: Stent positioning in lesions and bifurcations Stent deployment Stent-in-stent placement Assessment of stent artifacts (like fractures) Allura 3D-CA* Allura 3D-CA creates a 3D model of 2D coronary artery images. It can help improve diagnosis by providing: Optimal insight into the structure of the coronary tree Enhanced assessment of lesions and bifurcations Insight into the optimal working angles Enhance interventional preparation: Select the right stent length Select optimal view of lesion or bifurcation with 'TrueView' map Enhance interventional execution: Work with optimal viewing angles of lesions and/or bifurcations Place the right stent with the right length in the right place CT TrueView* CT TrueView connects the Cath lab to the CT room. It provides all the benefi ts of Allura 3D-CA based on a CT diagnostic image XperGuide * optional 32 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

33 CT TrueView offers: Optimal C-arc positioning on Philips CT datasets to minimize foreshortening when assessing lesions or bifurcations Full integration with Philips' products. This option is available in the extended Brilliance workspot in the CT Room and it can be controlled from tableside or from the control room. It is an easy to use user interface on the Extended Brilliance Workspot and interventional hardware EP navigator* EP navigator shows the catheter and the 3D anatomy in real-time in one image, allowing electrophysiologists to instantly confi rm the position of any catheter or lead with respect to detailed 3D cardiac anatomy in the EP intervention lab. This information can support the electrophysiologist in performing complex EP procedures with greater confi dence, in a more intuitive way. During the procedure, EP navigator helps the electrophysiologist: Guide mapping procedures more effectively Get to ablation points that are diffi cult to reach more confi dently Perform complex procedures when you don t have access to mapping Clinically validated software packages for quantitive cardiac analysis are: (Biplane) Left Ventricular Quantifi cation software package Right Ventricular Quantifi cation software package Coronary Quantifi cation software package Full Autocal The Full Autocal option can be used in conjunction with the quantitative analysis packages. When the object to be analyzed (e.g., Left Ventricle, Vessel Segment) is placed in the isocenter, full autocal avoids the need to: Acquire an additional image series containing a sphere or grid for calibration purposes, or Calibrate manually on a calibration object (e.g., catheter) displayed in the image or image series to be analyzed CO 2 View Trace* Software package enabling tracing (stacking) of images acquired with CO 2 injections. This package can be used during post-processing, next to View Trace images acquired with iodine injections. Quantitative Analysis Packages* Vascular Quantification software package The clinically validated analytical software for vascular quantitative analysis provides: Vessel diameter and stenotic index. A program that allows vessel size to be manually measured and the degree of stenosis to be calculated Automated Vessel Analysis. A program that uses contour detection to calculate vessel dimensions and subsequently analyses stenoses Calibration routines to enter the scale into the programs (based on the size of a catheter visible in the image) * optional Customer Services Philips Customer Services support you in every season of system ownership from Planning through Start-up, Peak Usage and Renewal by helping you simplify your operations in ways that let you spend more time focusing on what s most important: the needs of your patients. Philips Customer Services is service that works for you in all the seasons of ownership.

34 Technical information - Dimensions FD20/10 and 20/ dotted line = dimensions FD20 on lateral arc all dimensions in mm 34 Philips Allura Xper FD20/10 and Allura FD20/20 Functional description

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