Making the difference with Live Image Guidance

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Surgery BV Pulsera Making the difference with Live Image Guidance BV Pulsera mobile C-arm system specifications K e yb e n e fi t s Powerful system with choice of 9" or 12" image intensifier to perform a wide range of routine and challenging applications Ortho Plus applies extra X-ray power to visualize challenging regions of interest with normal or obese patients Single user vascular workflow - tap the footswitch once to perform Subtraction, Trace, or Roadmap Pulsed exposure mode visualizes fast moving anatomy with outstanding image quality for a virtually unlimited amount of time The BV Pulsera mobile C-arm solution provides the power and superb visualizations to support a variety of challenging interventions. From open to minimally invasive, from Abdominal Aortic Aneurysms (AAA) to pacemaker implants. From spinal to hip surgery. This counter-balanced system can be positioned quickly and easily. It provides the extra power to image obese patients or technically difficult projections. Compact Mobile View Station with exceptional viewing flexibility

Contents 1 System overview 4 2 Image detection 6 2.1 Image intensifier 6 3 X-ray generation 7 3.1 X-ray generator 7 3.2 X-ray tube 8 3.3 X-ray collimation 9 4 Workflow 10 4.1 C-arm stand 10 4.2 Mobile View Station 10 4.3 Connectivity 10 4.4 Handheld remote control 11 4.5 Touchscreen Examination monitor 11 4.6 DICOM and IHE 11 4.7 Stand monitor 11 5 Imaging 12 5.1 SmartVision 12 5.2 DoseWise 12 5.3 Automatic Programmed Fluoroscopy 13 programs 5.4 Real-time processing functions 13 5.5 Post processing functions 13 5.6 Mobile View Station monitors 13 6 Options 14 7 Geometry 15 7.1 C-arm stand 15 7.2 Mobile View Station 15 8 Service 16 9 Dimensions 18 9.1 C-arm stand 18 9.2 Mobile View Station 19 2

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1 System overview The BV Pulsera is a counterbalanced mobile C-arm system. Its C-arm stand has a compact foot and rear-wheel steering for easy maneuverability and positioning. The intelligent design of the Mobile View Station supports easy transport and set-up, ergonomic viewing and full connectivity capabilities. 2 4 1 3 4

1 Easy workflow Automatic Programmed Fluoroscopy (APF) programs are fine-tuned for each clinical application to enable high quality visualizations 4 2 Image intensifier 1K 2 high resolution imaging chain 9" or 12" triple-mode image intensifier 9/7/5" (23/17/13 cm) 12/9/7" (31/23/17 cm) 3 High power X-ray tank 15 kw rotating anode power for demanding procedures Excellent heat management for lengthy interventional procedures Monoblock architecture delivers sharp defined pulses 5 6 4 Monitors C-arm stand: 12 stand monitor (optional) Mobile View Station: 19 color LCD Contrast ratio >500:1 (optional: HiBri >700:1) Convenient touchscreen user interface (optional) Flexible monitor positioning: stepless height adjustment and 180 rotation Foldable for easy transport and storage 5 Archiving and documentation Fully integrated DICOM solution (optional) Medical DVD recorder (optional) Printer (optional) USB image storage 6 Connectivity Video-in to display external video signals such as ultrasound or endoscopy displayed on reference monitor Digital video out (optional) and analog video out (standard) to display BV Pulsera images on separate monitors (such as ceiling suspended monitors) 5

2 Image detection Designed to handle a variety of routine and complex procedures, this surgical imaging system is compact, flexible and easy to move. Choose either a 9" or 12" triple-mode image intensifier, to match your applicational requirements. 2.1 Image intensifier The BV Pulsera comes with a 9" or 12" image intensifier and can go wherever you need it - surgery, intensive care and the emergency room. Specification Image intensifier type Triple-mode 9" HRC / Triple-mode 12" Nominal II formats 31, 23, and 17 cm (12", 9", and 7") 23, 17, and 13 cm (9", 7", and 5") Entrance screen Cesium Iodine Grid type Circular, carbon fiber; 60 lines/cm Ratio = 1:10 SID = 100 cm TV camera type CCD; high-resolution 1k 2 Image rotation Digital, live and on LIH Image reversal Yes Mirror up/down Digital, live and on LIH Mirror left/right Digital, live and on LIH Automatic anatomical measuring field Yes with BodySmart 6

3 X-ray generation The rotating anode technology and 15 kw generator of the BV Pulsera provide the power to see through virtually any normal or obese patient and visualize fine details in steep projections. 3.1 X-ray generator BV Pulsera uses a Monoblock concept with the hightension transformer in the X-ray tank. This means pulses do not have to be transmitted over high voltage cables, which can result in ramping up and trailing down effects, due to the electrical impedance of the cables. The BV Pulsera Monoblock generator produces immediate pulse rise so all radiation is in the useful spectrum. The result is excellent quality images with less soft radiation and long fluoro times. Monoblock Without monoblock ma ma imaging pulse time ramping imaging pulse trailing time The BV Pulsera Monoblock concept decreases blurring and soft radiation X-ray generator type Max. generator output Max. X-ray tube voltage Max. X-ray tube current Specification Monoblock 80 khz high-frequency generator microprocessor controlled 15 kw 120 kv 125 ma 7

3.2 X-ray tube BV Pulsera has a rotating anode and high power generator with excellent heat management to perform demanding interventional procedures. An integrated beam filter helps to reduce patient skin dose 1. Automatic Programmed Fluoroscopy (APF) provides provide consistent image quality for every examination. Tube type Nominal X-ray tube voltage Nominal focal spot values Maximum anode heat content Maximum heat dissipation Cooling method Inherent filtration Additional filtration Specification Rotating anode X-ray tube 120 kv 0.3 IEC and 0.6 IEC 311 khu 73 khu/min Active oil-circulation cooling 1.0 mm Al eq. 3.0 mm Al eq. + 0.1 mm Cu Operating values Continuous Fluoroscopy kv range ma range for Low Dose Fluoroscopy mode ma range for High Definition Fluoroscopy mode 40-120 kv 0.10-8.33 ma (up to 10 ma during Auto High Penetration) 0.24-20 ma Operating values Half Dose Fluoroscopy kv range ma range Pulse width Pulse rate 40-120 kv 0.4-12 ma 11-37 ms 12.5 pps Operating values Quarter Dose Fluoroscopy kv range ma range Pulse width Pulse rate 40-120 kv 0.4-12 ma 11-37 ms 6.25 pps Rating values Pulsed Exposure kv range ma range Pulse width Pulse rate 40-110 kv 2.0-60 ma 8.0, 9.5 and 11.1 ms 3, 5, 8 pps (optional 15, 30 pps) Operating values Digital Exposure kv range ma range Pulse width 40-110 kv 1.5-75 ma 120-440 ms 8 1. Compared to conventional filtration of 3 millimeters aluminium as required by IEC 60601-2-43, 2010.

3.3 X-ray collimation Collimation reduces exposure dose by reducing the radiated surface and enhances image quality. BV Pulsera makes collimation easy. Its full lead (assymetric) shutters can be rotated and moved independently, and the unique Philips Automatic Shutter Positioning (ASP) feature automatically positions shutters for high image quality at the touch of a button. You can position shutters or adjust the iris on the last X-ray image (Last Image Hold), eliminating additional X-ray dose during collimation. Iris collimation Independently movable lead shutters Additional beam filter Near focus collimation Anode Specification Shutters Two independent lead shutters with steel wedge: shutters can be coupled for rotation and translation, or moved individually for asymmetric collimation Automatic Shutter Postioning Automatic shutter placement based on image content Shutter material 3 mm Pb Wedge material 0.2 to 2.5 mm stainless steel Adjustment Stepless Rotation 360 Minimal iris diameter < 50 mm on II entrance Position indication On screen and also on LIH without radiation At a touch of a button, Automatic Shutter Positioning (ASP) places shutters in the optimal position Iris collimation 9

4Wo r k fl o w The BV Pulsera combines intelligent, ergonomic design with workflow-friendly features. From transport to setup to operation, the BV Pulsera is a system built for the way you want to work. 4.1 C-arm stand Smooth, form fitting handles and responsive movements make the C-arm easy to transport and position. Its easy steering and lightweight design allow it to be quickly moved through crowded hallways and into position in the OR. The intuitive user interface is designed so that trained staff can easily operate the BV Pulsera. Controls are laid out in a logical fashion with a minimum of functions and menus to streamline operations. For more procedure control at table side, the remote control and footswitch can be added as an option. 4.2 Mobile View Station The compact Mobile View Station (MVS) fits perfectly in the surgical workflow. Its intelligent design supports easy system set up and fast transportation. To provide ergonomic viewing for different medical staff, the MVS can be placed close to the operating table. The height and angles of the monitors can be adjusted to comfortable viewing positions. The smooth, sealed controls simplify cleaning. 4.3 Connectivity Analog video out (left Examination monitor). Digital video out (optional) displays left and right images on separate monitors (such as ceiling suspended monitors). Video in allows you to conveniently display external video signals such as endoscopy or ultrasound on the right Reference monitor, so all the information you need is in one place. USB storage provides a convenient way to store images for use in reports or presentations. Analog video out Digital Video out (optional) Video in USB storage Specification 1 BNC connector left monitor 2 DVI connectors left and right monitor S-Video bmp format Enter patient demographics and connect to PACS/RIS/HIS conveniently using the handy touchscreen. For ergonomic viewing, the LCD monitors can be rotated 180 and adjusted in height (23 cm/9"). For easy transport and storage, simply fold the monitors and move them to their lowest position. 10

Optional 4.6 DICOM and IHE BV Pulsera can be equipped with the Philips Integrated DICOM solution, which transfers images from the BV Pulsera onto the hospital network in a Seconary Capture DICOM SC or a DICOM XA format. The Basic DICOM package supports DICOM Print and DICOM Store. You can quickly display previous images on the fly during a procedure using the remote control. 4.4 Handheld remote control The remote control unit is a handheld infrared keypad used to control the main image handling functions. For sterile operation, it can be used in a transparent sterile plastic cover. The functions include: Run loop Overview run/exam Retrieve previous image/run Retrieve next image/run Park image on Reference monitor Retrieve image from Reference monitor Protect image/release image SmartMask Fluoroscopy mode selection II-format selection Subtraction on/off Image grab The advanced DICOM/IHE package (optional) supports: Modality Worklist Management Modality Performed Procedure Step Storage Commit Full compliance to the IHE Scheduled Workflow integration profile as an Acquisition Modality Actor The BV Pulsera supports DICOM Structured Dose Reporting Query/Retrieve (ViewForum option) 4.7 Stand monitor In a busy operating room, monitors are positioned for optimal viewing by the surgeon. BV Pulsera gives visual control to the operator by providing an extra 12 LCD monitor on the C-arm. The extra stand monitor can be rotated and tilted to the angle needed for the operator to follow the procedure, all without compromising the view of the surgeon. The extra monitor displays the live image, enabling accurate positioning of the C-arm. 4.5 Examination monitor The touchscreen on the Examination monitor of the Mobile View Station makes it easy to access the system s graphical user interface. It s all at your fingertips. You can intuitively set up an exam, postprocess images, or export a case to PACS. Because Philips uses advanced infra-red technology in the touchscreen, it delivers the same image quality as non-touchscreen monitors. Stand monitor can be rotated and tilted to improve the viewing position 11

5 Imaging The BV Pulsera offers you a combination of advanced imaging technologies across the imaging chain that result in high quality image using efficient X-ray dose. 5.1 SmartVision Unique BodySmart software allows free positioning of the anatomy, even at the edge of the image detector. BodySmart detects the anatomy and adjusts the technique and image processing to produce high quality images. Automatic Shutter Positioning (ASP) positions shutters around the anatomy of interest for excellent image quality at the touch of a button. Users can enhance the contrast and brightness automatically in real time, or adjust them manually for the preferred Image quality. Unique dynamic movement detection reduces motion artifacts. Millions of calculations are made every second to apply the appropriate level of noise reduction to every pixel in the image. Less noise reduction is applied to dynamic structures to reduce motion artifacts. More integration is applied to static structures to produce high quality images that are virtually free of noise. 5.2 DoseWise Efficient beam filters with an additional 0.1 mm of copper and 1 mm of aluminum increase the quality of the X-ray beam, allowing a 40% reduction in skin entrance dose rate compared to the minimum filtering required by international standards.* - Pulsed fluoro modes ( 1 /2 or 1 /4 pulse rate) to reduce X-ray exposure dose. Collimation: - Shutters and image orientation on Last Image Hold without applying radiation - Real lead asymmetrical shutters - Independent shutter positioning Dose reporting, dose display and an alert when exceeding a pre-defined procedure dose-level contribute to an increased dose awareness BodySmart automatically identifies the anatomy anywhere in the image and adjusts the settings to produce high quality images. intensity Patient Entrance dose Detector dose without + 0.1mm Cu with energy kev Additional beam filter reduces soft radiation that does not contribute to the image intensity without + 0.1mm Cu with * IEC 60601-2-43: 2010 specifies minimum filtering of 3 mm aluminum. Data was obtained from non-clinical testing using PMMA phantoms. energy kev 12

5.3 Automatic Programmed Fluoroscopy programs The Automatic Programmed Fluoroscopy (APF) programs apply pre-set application-specific fluoroscopy settings to obtain a high quality image for the anatomy of interest. Within each program there are different X-ray modes available (depending on region): Low Dose Fluoroscopy Fluoroscopy High Definition Fluoroscopy Pulsed exposure mode to produce high quality images of virtually every patient Digital exposure, for extra-sharp, single snapshot images 5.4 Real time processing functions 360 digital rotation, mirror left/right and up/ down without radiation (Automatic) contrast and brightness Dynamic noise reduction (Adaptive temporal recursive noise reduction) Adaptive 2D edge enhancement White compression Image disk storage: 2,000/10,000/20,000 images 5.5 Post processing functions 360 digital rotation, mirror left/right and up/ down Contrast and brightness Annotation (for a single image or all images in an examination) Video invert Zoom and roam (factor 2x real-time magnification, freely movable to any section of an image) Measurement (to quantify lengths and angles in images) Electronic shutters Digital zoom that can be easily moved over the image 5.6 Mobile View Station monitors Two 19" Color LCD monitors for diagnostic image quality display. Specification Resolution 1280 x 1024 pixels Contrast ratio >500:1 >700:1 (optional 19" High Brightness monitor) Viewing angle 170 in horizontal and vertical direction Touchscreen (optional for left monitor) Offers easy access to postprocessing of acquired images, patient demographics as well as PACS 13

6 Options Tank laser aiming device II laser aiming device Medical DVD Recorder Video Paper printer Video Paper/transparency printer Multi modality workstation (ViewForum option) ViewForum options Vascular package Advanced Vascular package Ortho plus Cardiac package Stand monitor Specification Laser projects a crosshair towards the image intensifier, indicating the center of the X-ray beam and enabling alignment of the C-arm without X-ray Positioning device for use at the image intensifier side Recording of static and dynamic live fluoroscopy on a DVD (up to 2 hours) Thermal printer to print video images from the Examination (left) monitor onto paper during or after examinations. Thermal printer to print video images from the Examination (left) monitor onto paper or transparencies during or after examinations. Intuitive multi-purpose platform for retrieving and handling images from different modalities. Allows comparison of pre-operative images side-by-side with live fluoroscopy images. MIP/MPR maximum intensity projection singles out high intensity areas for optimized 2D projection of a 3D volume DVD DICOM Store record DICOM images onto a DVD Subtracted fluoroscopy mode Trace-mode shows opacification of the vessels in real time Roadmap images support catheter guidance Remask lets you reselect the best image in a run as a new mask image SmartMask uses previously acquired mask images for roadmapping to support efficient use of X-ray dose and contrast medium Landmarking provides a non-subtracted background for anatomical reference Real-time pixel shift compensates for movement artifacts Subtraction on/off simplifies the orientation for subtracted images during roadmap procedures View Trace creates a trace image in post-processing CO2 mode for subtraction, trace white and roadmap with SmartMask Pulsed exposure at a maximum pulse rate of 15 pps, with max. 60 ma All vascular package features Extra examination type to obtain low noise images in dense patients 12.5 pps, with max. 60mA Three dedicated APF sets for cardiac procedures, advanced pacemaker placements, and electrophysiology Pulsed exposure at 8, 15 and 30 pps, with max. 60 ma 12" LCD monitor on C-arm stand 14

7 Geometry The BV Pulsera consists of a mobile C-arm stand with monitor for image acquisition and a Mobile View Station with two LCD monitors for image processing, review, archiving and display. 7.1 C-arm stand Specification Longitudinal movement 20 cm (7.9") Panning movement (swivel) ± 10 Vertical movement Motorized 49 cm (+43 cm / -6 cm) (19.3", +16.9", -2.4") Rotation ± 180, with safety stop at ± 135 Angulation +90, -25 Extended angulation (optional) +90, -45 for increased projection flexibility Source to Image Distance 98 cm (38.7") Free space within C-arm 77 cm (30.3") C-arm depth 61 cm (24.0") Lowest lateral working position 102 cm (40.2") Brakes for all movements Yes, manual Steering Rear wheel Parallel movement Dedicated parallel movement via rear wheel control Cable deflectors Yes C-arm stand weight 9": 310 kg (683 lbs) 12": 305 kg (672 lbs) C-arm stand length 196 cm (77.2") C-arm stand width 81 cm (31.9") C-arm stand height 9": 173 cm (68.2") 12": 182 cm (71.7") 7.2 Mobile View Station Specification Mobile view station depth 70 cm (27.6") Mobile view station width 94 cm (37.1") 70 cm (27.6") monitors folded Mobile view station height Max height is 185 cm or higher (72.8 )* Weight (including options) 195 kg or lower (313 lbs)* Monitor rotation 180 Monitor height movement 23 cm (9") BV Pulsera and MVS movements * depending on configuration 15

8 Service Count on us as your patients count on you Staying on top of today s complex and ever changing healthcare environment is challenging enough. The last thing you need to be concerned with is keeping your care systems up and running smoothly. At Philips, we work as one with your teams. We share their dedication to solve issues before they start and their drive to keep going day and night until the job is done. With us taking care of your systems you can focus on what really matters delivering better care, to more people, at lower cost. Together we can create a healthier future. Services a full lifecycle solution The success of your organization depends on people. Philips Services are designed with that in mind creating healing environments, developing your staff, improving your organization s performance, and increasing patient satisfaction. Rely on us. The resources, training, and support we offer, enable you to focus on what s most important - your patients. Philips provides a full lifecycle solution designed around your patients, your people, and your organization. We help you succeed in every phase of system ownership, from planning to start-up, through peak usage and renewal. Planning Understand how and when the right equipment and services contribute to enhanced patient care and economics. Start-up Make the most of your system as quickly as possible. Peak Usage Extract maximum utility out of your system day to day. Renewal We ll help you make smart decisions on upgrading or transitioning to a new system. First-rate care Philips global service network, our highly qualified service engineers, the individual attention of our service technicians, and the international availability of spare parts combine to provide our seamless service support. 16

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90 9 Dimensions 8.1 C-arm stand 45 (option) 25 532 (20.9") 752-1242 (29.6" - 48.9") 2": 385 (15.2") 1020-1510 (40.2" - 59.4") 607 (23.9") 200 (7.9") 1016 (40.0") 430 (16.9") 803 (31.6") 60 (2.4") 672 (26.4") 1226-1426 (48.3" - 56.1") 176 (6.9") 9": 297 (11.7") 12": 385 (15.2") 45 (17.5") 770 (30.3") 118 (4.6") 9": 1732-2222 (68.2" - 87.5") 12": 1822-2312 (71.7" - 91.0") 389 (15.3") All dimensions are in millimeters (inches) 18

8.2 Mobile View Station 594 mm (23.4") max 281 mm (11.1") or lower* Max 1850 mm (72.8") or higher* min 1650 mm or lower (64.9")* 1048 mm (41.3") 90 180 943 mm or lower (37.1")* 90 701 mm (27.6") max 702 mm (27.6) or lower* * depending on configuration 19

2017 Koninklijke Philips N.V. All rights reserved. Specifications are subject to change without notice. Trademarks are the property of Koninklijke Philips N.V. (Royal Philips) or their respective owners. 4522 991 19161 * JAN 2017 How to reach us Please visit www.philips.com/healthcare www.philips.com/bvpulsera healthcare@philips.com