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Statement of Need for the EnSite Precision Mapping System. Advanced electrophysiology mapping system creates non-fluoroscopic 3D images of the heart chamber(s) through the use of either EnSite NavX Vi... Statement of Need for the EnSite Precision Mapping System. Advanced electrophysiology mapping system creates non-fluoroscopic 3D images of the heart chamber(s) through the use of either EnSite NavX Visualization and Navigation Technology or the non-contact EnSite Array catheter. System provides diagnostic tools which represent the anatomy of the cardiac chamber and electro-anatomical information (e.g. activation maps, voltage maps, CFAE maps, fractionation maps) as well as tracks the real-time location of electrophysiology catheters within the cardiac structure. System also assists in recording the location of ablation lesions as applied by an ablation generator. VA Pittsburgh Electrophysiology Lab Requirements: Display Workstation with 32 GB RAM, 3.4 GHz dual six-core processors, and Quadro K2200 Graphics running most current version of operating system software. EnSite Amplifier Subsystem, magnetic unit, field frame, mapping software for 3D electroanatomical map creation and additional modules (listed below), RF generator, RF generator remote control, fiber optic light unit for contact force catheter, irrigation pump, fiber optic cables, serial cables, DVI cables, CAT5 cables, power supply units, color inkjet printer, physician and staff training. System contains Instructions For Use (IFU). Service Coverage: Includes initial one-year manufacturer s warranty SJM Connect Remote Access for real time technical support through a secure broadband connection. EnSite X EP System The EnSite X EP System is a catheter navigation and mapping system capable of displaying the 3-dimensional (3-D) position of conventional and Sensor-Enabled electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these 3-D maps are based on the anatomy of the patient s own cardiac chamber. 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 Contact Force Module Contains: EnSite Contact Force Module v1.0 TactiSys Quartz Allows contact force data to be viewed on the EnSite Velocity Cardiac Mapping System. Key benefits include an intuitive display of contact force data, easier set-up and an enhanced workflow. o Requires EnSite Velocity System Display Workstation 5 (DWS5) or higher. o Requires EnSite Precision Mapping Module part number H700386 to already be installed. Ampere Generator Kit User controlled Power or Temperature modes. Power Control mode for: - Safire BLU Duo Ablation Catheters - Therapy Cool Path Duo Ablation Catheters - Future irrigated ablation catheters *Monitor real-time temperature and impedance data on the color LCD screen *Power, temperature, impedance and duration push-button controls *Increased lab efficiency through user presets *Easy bedside physician control with included Footswitch Solutions designed to reduce risk *Select maximum temperature for automatic modulation of power with the TempGuard mode *Manage procedural needs through user-configured variable Power Ramp-Up *Control irrigation flow rates with the Auto Flow feature *Enhanced control of RF delivery with Automatic RF shutoff parameters *Ampere RF generator integrates with our EnSite Velocity System, WorkMate Claris System, Cool Point Irrigation Pump and all other Abbott Laboratories Inc., standard and irrigated ablation catheters. The Ampere software is also upgradable via USB connection. Includes generator and footswitch with 2.5 m cable. Specifications *RF Output Power: 1 to 100 W adjustable in steps of 1 W *Impedance Range: Measures 50 to 300 in steps of 1 *Target Temperature: 15° C to 80° C adjustable in steps of 1° C *RF Delivery Time: 1 to 999 seconds adjustable in steps of 1 second *Control Modes: Temperature; Power *Energy Delivery Modes: Independent; Sequential; Simultaneous *Operating Parameters: Values are digitally displayed on the Ampere Generator front panel *Generator Dimensions: 266.7mm H x 360.68mm W x 363.22mm D (10.5 H x 14.2 W x14.3 D) *Generator Weight: 9.98 kg (22.0 lbs) *Supply Voltage: 100-240 VAC, 50/60 Hz *Safety Class: Class I; Type CF according to IEC 60601-1 Ampere Remote Control (includes 15m fiber cord) Cool Point Irrigation Pump o Includes: Pump, power cord, pole clamp, 1779 communications (connecting) cable, tubing set (1 each) and operator s manual. Communication cable for the Cool Point Irrigation Pump (included with pump). ViewMate Ultrasound Imaging Console with Battery P4-1C Trans-thoracic Transducer Phased Array (4-1 MHz) transducer designed to address Adult Echocardiography, Trans-cranial and Abdominal Vascular Imaging. The transducer offers fourteen frequencies within 2D and M-Mode, Tissue Harmonics, Color/Power, PW Doppler, Compound Harmonics, and Compound Imaging. Up to 30 cm penetration. Advanced, fully featured ultrasound system optimized for 64-element phased array intra-cardiac echo (ICE) visualization. System works with the ViewFlex family of ICE catheters. The ViewMate System includes the SmartCart and SmartCart battery for operation without plugging into AC power. Software: Cold Boot-up time, approximately 30 seconds Modes: 2D/B, M, Color Doppler (CD), Power Doppler, Pulse Wave (PW), Continuous Wave (CW), AUX CW, ECG, TEE and Tissue Harmonics Auto Opt with ZST Instantly equalizes tissue gain and brightness. ZST automatically compensates for differences in sound speed propagation from patient echo information. Hardware: SmartCart battery allows up to 1.5 hours of operation without plugging into AC power Connects up to 3 transducers simultaneously Interface module for ICE Multifunction USB port, Wireless ready, Digital video Minimum 120 GB Hard Drive Storage on SmartCart 19 color, high resolution LCD display mounted on articulating arm of SmartCart LED display for customizable image mode menus HDMI/DVI digital video output Integrated DICOM viewing software Customized, durable baskets to carry supplies P-8-3 Trans-esophageal (TEE) Transducer Multi-plane phased array transducer with imaging modes for M-Mode, Color Doppler, PW, TDI (tissue Doppler imaging) and CW imaging. The transducer offers three 2D frequencies, two color Doppler frequencies and one spectral Doppler frequency. The intended application is for adult imaging. Requires SmartCart and Echocardiography Option. L8-3 Linear Transducer Linear Array (8-3 MHz) transducer designed for peripheral vascular imaging. The transducer offers ten frequencies including three frequencies for 2D and M-Mode, two for Tissue Harmonics, one for Compound Harmonics, and two each for Color/Power and PW Doppler.

Inactive

Statement of Need for the EnSite Precision Mapping System. Advanced electrophysiology mapping system creates non-fluoroscopic 3D images of the heart chamber(s) through the use of either EnSite NavX Vi... Statement of Need for the EnSite Precision Mapping System. Advanced electrophysiology mapping system creates non-fluoroscopic 3D images of the heart chamber(s) through the use of either EnSite NavX Visualization and Navigation Technology or the non-contact EnSite Array catheter. System provides diagnostic tools which represent the anatomy of the cardiac chamber and electro-anatomical information (e.g. activation maps, voltage maps, CFAE maps, fractionation maps) as well as tracks the real-time location of electrophysiology catheters within the cardiac structure. System also assists in recording the location of ablation lesions as applied by an ablation generator. VA Pittsburgh Electrophysiology Lab Requirements: Display Workstation with 32 GB RAM, 3.4 GHz dual six-core processors, and Quadro K2200 Graphics running most current version of operating system software. EnSite Amplifier Subsystem, magnetic unit, field frame, mapping software for 3D electroanatomical map creation and additional modules (listed below), RF generator, RF generator remote control, fiber optic light unit for contact force catheter, irrigation pump, fiber optic cables, serial cables, DVI cables, CAT5 cables, power supply units, color inkjet printer, physician and staff training. System contains Instructions For Use (IFU). Service Coverage: Includes initial one-year manufacturer s warranty SJM Connect Remote Access for real time technical support through a secure broadband connection. EnSite X EP System The EnSite X EP System is a catheter navigation and mapping system capable of displaying the 3-dimensional (3-D) position of conventional and Sensor-Enabled electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as dynamic 3-D isopotential maps of the cardiac chamber. The contoured surfaces of these 3-D maps are based on the anatomy of the patient s own cardiac chamber. 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 Contact Force Module Contains: EnSite Contact Force Module v1.0 TactiSys Quartz Allows contact force data to be viewed on the EnSite Velocity Cardiac Mapping System. Key benefits include an intuitive display of contact force data, easier set-up and an enhanced workflow. o Requires EnSite Velocity System Display Workstation 5 (DWS5) or higher. o Requires EnSite Precision Mapping Module part number H700386 to already be installed. Ampere Generator Kit User controlled Power or Temperature modes. Power Control mode for: - Safire BLU Duo Ablation Catheters - Therapy Cool Path Duo Ablation Catheters - Future irrigated ablation catheters *Monitor real-time temperature and impedance data on the color LCD screen *Power, temperature, impedance and duration push-button controls *Increased lab efficiency through user presets *Easy bedside physician control with included Footswitch Solutions designed to reduce risk *Select maximum temperature for automatic modulation of power with the TempGuard mode *Manage procedural needs through user-configured variable Power Ramp-Up *Control irrigation flow rates with the Auto Flow feature *Enhanced control of RF delivery with Automatic RF shutoff parameters *Ampere RF generator integrates with our EnSite Velocity System, WorkMate Claris System, Cool Point Irrigation Pump and all other Abbott Laboratories Inc., standard and irrigated ablation catheters. The Ampere software is also upgradable via USB connection. Includes generator and footswitch with 2.5 m cable. Specifications *RF Output Power: 1 to 100 W adjustable in steps of 1 W *Impedance Range: Measures 50 to 300 in steps of 1 *Target Temperature: 15° C to 80° C adjustable in steps of 1° C *RF Delivery Time: 1 to 999 seconds adjustable in steps of 1 second *Control Modes: Temperature; Power *Energy Delivery Modes: Independent; Sequential; Simultaneous *Operating Parameters: Values are digitally displayed on the Ampere Generator front panel *Generator Dimensions: 266.7mm H x 360.68mm W x 363.22mm D (10.5 H x 14.2 W x14.3 D) *Generator Weight: 9.98 kg (22.0 lbs) *Supply Voltage: 100-240 VAC, 50/60 Hz *Safety Class: Class I; Type CF according to IEC 60601-1 Ampere Remote Control (includes 15m fiber cord) Cool Point Irrigation Pump o Includes: Pump, power cord, pole clamp, 1779 communications (connecting) cable, tubing set (1 each) and operator s manual. Communication cable for the Cool Point Irrigation Pump (included with pump). ViewMate Ultrasound Imaging Console with Battery P4-1C Trans-thoracic Transducer Phased Array (4-1 MHz) transducer designed to address Adult Echocardiography, Trans-cranial and Abdominal Vascular Imaging. The transducer offers fourteen frequencies within 2D and M-Mode, Tissue Harmonics, Color/Power, PW Doppler, Compound Harmonics, and Compound Imaging. Up to 30 cm penetration. Advanced, fully featured ultrasound system optimized for 64-element phased array intra-cardiac echo (ICE) visualization. System works with the ViewFlex family of ICE catheters. The ViewMate System includes the SmartCart and SmartCart battery for operation without plugging into AC power. Software: Cold Boot-up time, approximately 30 seconds Modes: 2D/B, M, Color Doppler (CD), Power Doppler, Pulse Wave (PW), Continuous Wave (CW), AUX CW, ECG, TEE and Tissue Harmonics Auto Opt with ZST Instantly equalizes tissue gain and brightness. ZST automatically compensates for differences in sound speed propagation from patient echo information. Hardware: SmartCart battery allows up to 1.5 hours of operation without plugging into AC power Connects up to 3 transducers simultaneously Interface module for ICE Multifunction USB port, Wireless ready, Digital video Minimum 120 GB Hard Drive Storage on SmartCart 19 color, high resolution LCD display mounted on articulating arm of SmartCart LED display for customizable image mode menus HDMI/DVI digital video output Integrated DICOM viewing software Customized, durable baskets to carry supplies P-8-3 Trans-esophageal (TEE) Transducer Multi-plane phased array transducer with imaging modes for M-Mode, Color Doppler, PW, TDI (tissue Doppler imaging) and CW imaging. The transducer offers three 2D frequencies, two color Doppler frequencies and one spectral Doppler frequency. The intended application is for adult imaging. Requires SmartCart and Echocardiography Option. L8-3 Linear Transducer Linear Array (8-3 MHz) transducer designed for peripheral vascular imaging. The transducer offers ten frequencies including three frequencies for 2D and M-Mode, two for Tissue Harmonics, one for Compound Harmonics, and two each for Color/Power and PW Doppler.