6515--621-23-3-091-0172 - Brand Name or Equal to Ensite X EP System and Accessories

The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 9 is issuing this synopsis as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for procurement of equipment and services identified below to support a new program of electrophysiology ablation procedures to aid in JHQVAMC s diagnosis and treatment of the spectrum of cardiac arrhythmias.

Additional information regarding the requirement may be added throughout the active period of this notice. The result of this market research will contribute to determining the method of acquisition.

The applicable North American Industry Classification System (NAICS) code assigned to this acquisition is 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing, with a Small Business size standard of 1250 employees.

There is no solicitation at this time. This request for capability information does not constitute a request for proposals, quotes, bids, etc. Submission of any information in response to this market survey is purely voluntary. The government assumes no financial responsibility for any costs incurred.

Background:

The James H. Quillen Veteran Affairs Medical Center (JHQVAMC) currently has one cardiac catheterization lab. Until May 2015, the facility utilized community care for all Interventional Cardiology procedures; an interventional cardiologist was added, and now only high risk percutaneous coronary intervention (PCI)s are sent to outside facilities. The Cardiac Catheterization Lab (CCL) now performs radial diagnostic cardiac catheterization, radial percutaneous coronary interventions for low to intermediate risk PCIs, , Instantaneous Flow Reserve, Fractional Flow Reserve (FFR), Optical Coherence Tomography (OCT) and high definition Intravascular Ultrasound (IVUS), BIV-ICD implantations, ICD implantations (single and dual chamber devices), single and dual chamber pacemakers, Micra leadless pacemakers, loop recorder implantations, peripherals angiography, and aortic valve studies. Pre and post procedure holding and recovery area suites inside the current lab area are utilized for pre and post procedure care.

We propose to initiate a new program of electrophysiology ablation procedures at the above-named facility. The program would add a variety of diagnostic services (electrophysiology studies and ablations for cardiac arrhythmias) that would aid in our diagnosis and treatment of the spectrum of cardiac arrhythmias.

These services will be carried out in a dedicated electrophysiology laboratory located on the 2nd floor of building 200 adjacent to our current diagnostic/interventional cardiac catheterization lab. The procedure area is a large area with a control room for monitoring the procedures. It will be composed of state-of-the-art equipment that will integrate seamlessly into our current cardiac catheterization lab imaging suite and data repository. The equipment consists of table, a biplane C-arm which is the X-ray source for the procedure, power columns, and swing-arm booms. The imaging equipment has the capability of a typical catheterization lab offering superb image quality with digital imaging enhancement to provide X-ray images with minimization of radiation exposure to patients and staff. There will be the capability to administer general anesthesia in the room for anesthesia support to be utilized on a periodic basis. The current cardiac catheterization lab prep and recovery area will be redesigned to support a large volume of patients to minimize impact on staffing in other areas of the facility.

Requirement: Government s basis of design to meet this requirement is from Abbott Laboratories Inc. (ALI) at https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x.html. The following is a general breakdown of the requirement:

EQUIPMENT/PRODUCTS/SOFTWARE:

QTY: 1 | EnSite X EP System - Service Coverage: Includes initial one year manufacturer s warranty

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. Various software expansion modules and warranties are available.

Subcomponents:

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-DF16)

Service Coverage: Includes initial one-year manufacturer s warranty

SJM Connect Remote Access for real time technical support through a secure

broadband connection.

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.

Accessories:

Qty: 1 | 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.

Requires EnSite Velocity System Display Workstation 5 (DWS5) or higher.

Requires EnSite Precision Mapping Module part number H700386 to already be installed.

Qty: 1 | Ampere Generator Kit-

Increased efficiency and control

*Designed for improved efficiency and decreased noise interference

*User controlled Power or Temperature modes

*New Power Control mode for:

Safire BLU Duo Ablation Catheters

Therapy Cool Path Duo Ablation Catheters

Future irrigated ablation catheters Easy to use standard options

*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

For example, auto-shut off is adjustable for impedance that changes by more than 10 ohms over 5 seconds

Seamless integration for the EP Lab

*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

Qty: 1 | Ampere Remote Control (includes 15m fiber cord)

Qty: 1 | Cool Point Irrigation Pump

Cool Point Irrigation Pump 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). Cool Point Tubing Set (sold individually).

Qty: 1 | SensiThermTM Multi Esophageal System Monitor

The SensiThermTM Multi Esophageal Monitoring System is composed of SensiThermTM Multi Esophageal Monitor and SensiThermTM Multi Esophageal Probe (sold separately) and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms.

Included:

One Patient Cable (ST-PTCBL)

One Power Supply (ST-PWRADPT)

One Equipotential Cable (ST-EQCBL)

One Power Cord (ST-JPNCBL) System contains Instructions for Use (IFU).

Service Coverage: Includes initial one year manufacturer s warranty

NOTE: The SensiThermTM Multi Esophageal Probe must be used in conjunction with the SensiThermTM Multi Esophageal Monitor and is sold separately.

Qty: 1 | Medinbox Mobile Configuration

The mobile configuration MedinboxTM System is an integrated audio/visual live collaboration system for EP labs that facilitates live engagement and collaboration for procedural support, service support, and/or community engagement for EP procedures. The MedinboxTM system can integrate multiple overhead screens; including but not limited to fluoroscopy, ICE, electro- anatomical mapping, and EP recording, and combines it with a live audio and video feed into a single remote-accessed and capable of remote-controlled two- way communication display via commonly used business conferencing software.

Mobile Configuration MedinboxTM System

MedinboxTM Core Box contains the hardware/software suite enabling up to six audio/video inputs + rover and camera input, processing, and signal output on a wheel-mounted platform for ease of placement, movement, and access.

MedinboxTM Audio Box & Headsets provides five headsets and a fixed charging station for storage and charging of headsets.

Boom Mounted Camera attached to the mobile corebox via boom mounted camera for optimally positioned, UHD, live-video streaming.

Keyboard & Mouse enabling accessory user interface with the Medinbox system.

Touchscreen Monitor providing interactive, customizable display and user interface for the Medinbox system.

Cabling and Connections supporting the full system of corebox, audiobox, camera connections, and power supply. Includes DVI video converters and adaptors, splitters, and connectors and accessory device connectors such as keyboard, mouse, and touchscreen display.

Includes initial one (1) year of MedinboxTM System software license. Additional years sold separately.

Service Coverage: Includes initial one year manufacturer s warranty

Information Sought: (Interest & Capability)

Qty: 1 | SensiThermTM Cable Holder

Qty: 1 | SensiThermTM Mapping System Adapter Cable

Qty: 1 | WorkMate Claris Recording System 120 with EP-4 Cardiac Stimulator

High-performance electrophysiology recording system for collecting, displaying and storing data from multiple sources within the electrophysiology (EP) lab.

Signal Clarity - Unique ClearWave signal acquisition technology enables diagnosis with amplified confidence. With fast post-pacing recovery, high sample rates, and low baseline ablation noise, the electrograms displayed on the high-resolution WorkMate Claris System assist with fast and accurate diagnosis.

Enhanced Integration - Seamless connections among multiple IT systems and platforms are designed to increase operator efficiency without sacrificing patient care.

Increased Efficiency - Key user interface and hardware design improvements enable both current users and those new to the WorkMate Claris System to quickly become proficient with its setup and operation.

TECHNICAL DESCRIPTION

Advanced Display Workstation

DVD-RW Drive

Mouse, Custom Keyboard

Basic Image Capture System (2 Black & White Inputs)

Network Connection to Hospital System

Inbound/Outbound Data Interface

Allows the WorkMate Claris System to connect to an external data source, archival of signals to a hospital file server

Display of Signal FFT Data

Ablation Data Interface (RF & Cryo)

Integrated cardiac stimulator control software

Amplifier with ClearWave Technology

Up to 448 Channel Display capability

120 Intracardiac Electrode Inputs

4 Analog Input Channels

4 Analog Output Channels

4 Physiologic Input Channels

12 Surface ECG Channels

Catheter Interface Module(s)

Miscellaneous

(4) 24 High Resolution 16:9 aspect ratio Widescreen Monitors

(1) Color Printer

WorkMate Claris 12 Lead ECG Cable

Cables

(1) Anti Fatigue Mat

Cardiac Stimulator

Integrated EP-4 Four Channel Cardiac Stimulator

Stimulator Touch Screen Control

Physiologic Pressure Monitoring

(1) Pressure Transducer Cable (Up to 4 pressure Channels)

Carts

(1) Primary Workstation Cart - 48"

(1) Bedside Slave Cart - 24"

Warranty Information for WorkMate Claris only

Service Coverage: Includes initial one year manufacturer s warranty

90 Day Warranty on Cables and Batteries

Qty: 1 | WorkMate Scribe Module

Nurses Workstation for Efficient and Comprehensive Patient Data Management allows a secondary user to simultaneously monitor the patient s vital signs, record patient monitoring and charting information, and perform signal analysis all independent of the primary WorkMate Claris System workstation.

Enhanced Lab Staff Efficiency

Enter patient data via the WorkMate Scribe Module during the procedure at the same time as the WorkMate Claris System operator without the need for an additional centralized IT server.

Monitor and chart patient data remotely, enabling the WorkMate Claris System operator to remain focused on the diagnostic procedure.

Seamlessly exchange procedure data, including EP signals, with the WorkMate Claris System during the case.

Enable the physician and staff to enter procedure data concurrently for speed and efficiency, reducing post-procedure data entry, improving lab turnover and providing faster case throughput.

Track medications, dosage, log times and quantities used during the procedure for maintenance of a unified chronological log.

Chart patient care notes, and enter ACT and sedation information at specific user-defined intervals at the patient s bedside for ease and convenience.

QTY: 1 | ViewMate Ultrasound System

The ViewMate Ultrasound System is a fully featured imaging platform. Optimized for a 64-element phased array intra-cardiac echo (ICE) visualization, the system is compatible with the ViewFlex family of ICE catheters. Equipped with ZONE Sonography® Technology (ZST), the ViewMate Ultrasound System uses a software-driven approach to acoustic data acquisition and image formation that breaks the barriers of conventional ultrasound imaging.

Software:

Modes: 2D/B, M, Color Doppler (CD), Power Doppler, Pulse Wave (PW), Continuous Wave (CW), AUX CW

Auto Opt with ZST instantly equalizes image gain and optimized sound speed compensation

Total Recall Imaging (TRI)- enabling retrospective processing

Cardiac calculations packages

Configurable cybersecurity options

DICOM networking includes Verify, Store, Print, and Basic Modality Worklist Query service classes

Hardware:

19 color, high resolution LCD display mounted on articulating arm

OLED display for customizable mode menus

Interface Module for ICE

Rechargeable battery allows up to 1.5 hours of operation without plugging into AC power

Connect up to 3 transducers simultaneously

Multifunction USB port, Wireless ready

Minimum 120 GB Hard Drive Storage

HDMI/DVI digital video output

Accessories:

Customized, durable baskets to carry supplies

3 Lead ECG connection

Operator s manual and quick reference guide

Service Coverage: Includes initial one year manufacturer s warranty

Qty: 1 | 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.

Service Coverage: Includes initial one year manufacturer s warranty

Qty: 1 | 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.

Service Coverage: Includes initial one year manufacturer s warranty

SERVICES:

Initial Installation

On-site Training

Extended Warranty plans for all above products/software/equipment providing for the following:

Parts & labor Coverage

Hardware & Software Upgrades/Revisions

Annual Preventative Maintenance

On-Site Service, Priority Response within 2-business days.

Priority Shipping of loaner/repaired/replaced items next business day morning

24/7/365 Telephone and email customer technical & service support

Remote Diagnostics and maintenance as-needed basis

Loaner systems / components / modules as needed during service/repair of covered product

If your organization has the potential capacity to meet this requirement, please provide the following information:

organization name, address, email address, website address, telephone number, and business size and type of ownership for the organization;

Note: If you are not sure of your business size, give an approximate number of employees and/or annual revenue.

tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated to deliver technical capability, address the administrative and management structure of such arrangements.

Brochures and/or spec documents, internet links of Product and Service capability that meets or exceeds the ALI products and services described above.

The government will evaluate market information to ascertain potential market capacity to:

provide product and services consistent in scope and scale with those described in this notice and otherwise anticipated;

secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements;

Meet or exceed the basis of design described previously herein.

.

Based on the responses to this sources sought notice/market research, this requirement may be sole sourced, set aside for small businesses, procured through full and open competition, or another method that meets Federal Acquisition policies. The government will not provide feedback or evaluations to companies regarding their submissions in response to this notice.

Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this sources sought notice by the end/close date of this notice. All responses and/or questions and comments under this notice must be emailed to sascha.hertslet@va.gov.