6515--EnSite X EP System

STATEMENT OF NEED GENERAL: James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, Florida 33612, has a requirement for hardware and software upgrades to its Abbott Laboratories, Inc. EnSite X EP cardiology mapping system. These upgrades will provide the Cath Lab with the latest and greatest technology for providing physicians efficient and accurate catheter placements during procedures. BACKGROUND: The James A Haley VA Medical Center currently owns and uses the Abbott Laboratories, Inc. EnSite X EP system for cardiology mapping of catheters in Cath Lab procedures. The equipment requires updates in order to keep up with changes in technology in the field. PURPOSE: The upgrades to the EnSite X EP system helps enhance patient care by improving the technology used by Cath Lab personnel to accurately and efficiently map the patient s heart for pinpoint precision of catheter insertion. This makes for increased patient safety as well as faster recoveries. Also, with the ever-changing technology, catheters in the future will become less and less compatible with the system if no upgrades are received. A failure to upgrade could cause potential delays in patient care and could force the facility to send patients elsewhere. SCOPE: James A Haley is requesting contractors provide brand name equipment and software upgrades that meets or exceed the physical, functional and performance of the listed salient characteristics in this section. The equipment feature is essential to the technical requirements to meet the need of the government. PHYSICAL CHARACTERISTICS AND FUNCTIONS: EnSite X Amplifier The EnSite X EP System Amplifier accepts signals from EnSite X SurfaceLink Module, EnSite X 20 pin and 80 pin Catheter Input Modules, the EnSite X Field Frame, and four (4) Patient Reference Sensors. The devices accept signals from catheters and electrodes attached to the patient and pass these signals to the EnSite X Amplifier. The EnSite X Amplifier converts these signals to a digital format and sends them to the DWS for processing and display. EnSite X EP System Field Frame. The Field Frame generates the magnetic tracking field during an EnSite X EP System procedure. EnSite X EP System SurfaceLink Module. Connects the EnSite X surface electrodes, system reference surface electrode, and ECG electrodes to the EnSite X Amplifier. EnSite X EP System Catheter Input Modules. 20 pin and 80 pin modules allow for connection of standard diagnostic catheters to the EnSite X Amplifier. Four (4) EnSite X EP System Patient Reference Sensors, one anterior (PRS-A) and three posterior (PRS-P) sensors with cables. EnSite X EP System ECG cable. Connects standard ECG electrodes to the EnSite X Amplifier. Medical Grade Isolation Transformer. When using the Amplifier Cart, the system components connected to line power through the isolation transformer. Only components on the Amplifier Cart should be connected to this isolation transformer. EnSite X Display Workstation (DWS) The DWS consists of the workstation (computer), monitors, medical grade isolation transformer, and optional printer: EnSite X EP System Workstation. The workstation contains the system software displaying data from the EnSite X Amplifier. Attached to the workstation are a keyboard and mouse for user input. Monitors. Monitors are used to display patient information. One monitor is placed near the workstation and keyboard for system operation. Medical Grade Isolation Transformer. All system components on the DWS cart are connected to line power through the isolation transformer. Only components of the DWS should be connected to this isolation transformer. EnSite LiveView Dynamic Display : EnSite LiveView Dynamic Display is a feature allowing mapping data to be visualized in real time during an EnSite X EP System study. The following devices are required to use EnSite LiveView Dynamic Display and are sold separately: Advisor HD Grid Mapping Catheter, Sensor Enabled Software Entitlement Kit (model H702519) ; Advisor HD Grid Mapping Catheter, Sensor Enabled (model D-AVHD-DF1 Advanced Mapping Software License : Advanced Mapping Software License is a set of mapping features that introduces the following new functionality: EnSite OT Near Field Detection Algorithm A new detection method placing the detection time at the peak frequency (sharpest point) of the signal. Peak Frequency maps A new map type based on the peak frequency (sharpness) of the map point signal. Emphasis maps A new map visualization tool where areas of interest are emphasized on the map by darkening areas on the map that do not meet user-defined criteria. Included EnSite OT license features: Omnipolar waveforms A calculated waveform of the optimal bipole (maximum voltage) independent of catheter orientation. Omnipolar waveforms are calculated from the bipoles of triangular three-electrode groupings, or cliques, on the Advisor HD Grid Mapping Catheter, Sensor Enabled . Activation Vectors A mapping feature where arrows representing activation direction, calculated from EnSite OT waveforms, are overlaid on the map. Included EnSite X EP System Wave Speed license feature: Wave Speed maps A new map type showing the apparent speed at which the depolarization wave travel through the cardiac tissue. SOFTWARE: Contractor will provide all software upgrades associated with the requested equipment/modules. Computer will run Windows 10 OS. TRAINING: Contractor is to provide a one-time training at installation of equipment (if applicable). Government will not require additional training. WARRANTY OF EQUIPMENT: Government requirement for standard manufacturer industry warranty term. Government does not accept extended warranty, which requires advance payment. DELIVERY SCHEDULE: All items to be delivered and installed within 30 days of receipt of purchase order, and no later than 9/31/2023. PLACE OF Delivery: James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd. Bldg 1, Tampa, Florida 33612, between 8:00AM to 4:30PM. Delivery during the Holiday will not be accepted.