Evaluation: Philips Azurion FlexMove Ceiling-Mounted Angiography System for Hybrid OR Applications
December 29, 2017 | Evaluations & Guidance
Preview
- Angiography systems use x-rays to allow visualization of the vasculature to aid in the assessment of potential conditions and to provide guidance during interventional procedures. A hybrid OR is a surgical suite equipped with a dedicated imaging system, integrated patient table, and tableside controls to enable physician-controlled intraoperative imaging. Hybrid ORs can accommodate both minimally invasive and open surgical procedures. These suites typically include angiography, CT, and/or MR imaging equipment.
- This type of room allows percutaneous procedures to be performed before, during, or after an open surgical procedure, without the need to move the patient from the OR table.
- Clinical applications include vascular, cardiovascular, thoracic, spine, and neurologic procedures.
- Procedures include endovascular aneurysm repair (EVAR), transcatheter aortic valve implantation or replacement (TAVI or TAVR), and peripheral vascular procedures.
- The most common type of hybrid OR is an endovascular suite with an advanced angiography system.
- The Azurion FlexMove features a ceiling-mounted C-arm. Overhead rails installed in the ceiling enable the C-arm to be positioned on all sides of the surgical table; or the C-arm can be rotated and shifted away from the table for parking or conversion to open procedures.
- The Azurion FlexMove hybrid OR system is not indicated for any supplementary uses.
- Major system components and capabilities:
- Angiography system
- X-ray generator: The 100 kW high-frequency Certeray generator supplies the current and voltage necessary to produce x-rays.
- X-ray tube: The MRC-GS 0407 is an oil-cooled x-ray tube featuring two focal spot sizes (0.4 and 0.7 mm nominal values). Focal spots are not automatically switched, but are instead automatically selected based on the procedure type.
- Collimator: Constructed of lead shutters (blades) and located on the x-ray tube housing, the collimator shapes the x-ray field to the patient's anatomy to reduce dose. The collimator on this system has SpectraBeam filters (with copper equivalence) and grid-switched pulsed fluoroscopy. The beam has three levels of copper equivalent filtration, 0.2, 0.5, and 1.0 mm.
- Detector: The Azurion detector is a dynamic flat detector with a bit depth of 16 bits, maximum field of view of 48 cm (19 in) diagonally, and image matrix of 2480 × 1920 pixels. It produces a digital image readout. It has seven zoom fields that range from 42 cm down to 15 cm (42, 37, 31, 27, 22, 19, 15 cm diagonal square formats).
- Antiscatter grid: Mounted on the detector, the grid reduces the amount of scattered radiation that reaches the detector, improving image contrast. The Azurion FlexMove includes a removable grid.
- C-arm: The C-arm houses the x-ray tube and detector. The wide-bore design has a maximum source-to-image distance (SID) of 123.5 cm.
- Gantry/stand: The gantry is the structure to which the C-arm is mounted. For the Azurion FlexMove, the gantry is a ceiling-mounted L-arm that travels on an overhead rail system.
- The ceiling-mounted gantry, which includes FlexMove to allow longitudinal and traversal travel, facilitates positioning the C-arm anywhere around the patient table. The L-arm of the gantry and the C-arm move independently of each other.
- Electrical cords and cables are routed through the ceiling rail housings.
- An unlimited number of preprogrammed positions can be saved tableside for procedure setup or parking.
- The gantry can be manually moved with a push-and-hold button on the side of the unit.
- Patient table: The standard Azurion FlexMove patient table is height-adjustable with a free-floating tabletop. Specifications of the standard table are:
- Height (minimum to maximum): 74.5 to 102.5 cm (29.3 to 40.4 in)
- Length: 319 cm (125.6 in); width: 50 cm (19.7 in)
- Longitudinal float: 120 cm (47.2 in); lateral float: 36 cm (14.2 in)
- Maximum table load: 325 kg (715 lb); maximum patient weight: 275 kg (606.3 lb) plus 500 N additional force maximum at full tabletop extension in case of CPR.
- Third-party tables from Maquet and Trumpf are compatible with the system. However, the Trumpf table is not available in North America.
- Surgical display(s): The Azurion FlexMove comes standard with a two-fold monitor ceiling suspension (MCS) and one 27-inch full HD widescreen monitor. Philips options include two-fold, four-fold, and six-fold MCSs, each designed for 27-inch widescreen monitors, with a rotation range of 350 degrees. Additional options from Philips include single or dual 8 megapixel 58-inch FlexVision displays. Dual 58-inch displays can be switched on separately from the angiography system to display OR protocols or for procedures in which angiography imaging is not used. Third-party MCSs are also compatible with the Azurion FlexMove.
- Exam room user interface:
- There are three components that together provide full tableside control of the system. Each component is a separate module that can be attached to the table, boom, or cart. Frequently used commands are accessible in multiple locations. Users can enter protocols for an unlimited number of system presets. The components of the exam room user interface are:
- Control Module: The Control Module is used to control the geometry of the system components and imaging settings. Adjustment to system components include C-arm position, tabletop motion (tilt, cradle, swivel, pivot, and height), and SID and other stand adjustments. Each table positioning control is designed with a unique shape to enable adjustments in position without the need to look down at the console. Imaging controls include field size, fluoro flavors (acquisition settings), image storage, collimation, shutters, and wedges.
- Touch Screen Module (TSM): The TSM is unique to Philips. The TSM is a 12-inch touchpad that controls acquisition parameters, image postprocessing, quantitative analysis, and interventional tools. The TSM is fully customizable and enables full control of the system and integrated equipment such as ultrasound. ProcedureCards and Applications (Apps) are used to access the available tools and features. *Figure 2.Sample screenshot from the Philips Touch Screen Module, or TSM. (Image courtesy of Philips.)* ---
- Review Module: The Review Module includes settings for reviewing acquisitions, activating/deactivating geometry locks, and enabling and disabling x-rays.
- Seamless Mouse Over: Available with FlexVision Pro and the 58-inch FlexVision display, a tableside mouse can be used to select images and zoom or rotate for assessment. In addition to flexible screen layouts, this feature can control up to 11 external sources, including third-party systems.
- There are three components that together provide full tableside control of the system. Each component is a separate module that can be attached to the table, boom, or cart. Frequently used commands are accessible in multiple locations. Users can enter protocols for an unlimited number of system presets. The components of the exam room user interface are:
- Control room user interface: Workspot includes components of the exam room user interface, an acquisition monitor, and a review monitor.
- Workstation user interface: FlexSpots includes the components of the exam room user interface and either one or two monitors.
- Interoperability/third-party integration capabilities: (1) Philips Integrated Lab Solutions (IGT) collaborates with manufacturers of all devices, including surgical tables, injectors, booms, power, accessories (head rests, arm rests, etc.), ultrasound, intravascular imaging, robotics, electrophysiology, and others. The level of integration is on a per-project basis. Public plug-and-play interfaces are available that third-party manufacturers can connect to so that their information can be displayed on the system monitors.
- Angiography system