6525--Ensite PrecisionT Cardiac Mapping System

Sources Sought The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Business Manufacturers, other Small Businesses interested and capable of providing items requested, as well as any large businesses. The results from this source sought notice will be used to determine set-aside. The intended contract is a firm-fixed price supply purchase. The SBA Non-Manufacturer Rule is applicable however, there is a possible SBA class waiver for the NAICS/PSC for this potential acquisition. The Department of Veterans Affairs, NCO20 is looking for BRAND NAME or EQUAL sources of the following: MFG PN Item Qty Precision SYS EnSite PrecisionTM Cardiac Mapping System 1 CFK3000 EnSite Contact Force Module 1 H700494 Ampere Generator Kit 1 H700490 Ampere Remote Control (includes 15m fiber cord) 1 89003 Cool Point Irrigation Pump 1 H700124 WorkMate Claris Recording System 120 with EP-4 Cardiac Stimulator 1 H700147 WorkMate Unity HL-7 Module 1 H700148 WorkMate Unity DICOM Module 1 H700144 WorkMate Unity Review Module 1 AM904 EnSiteTM Precision Assurance Premium Service Plan 1 TQ-EXW EnSite Contact Force Module Extended Warranty Plan 1 AMPERE-1YR Ampere Generator Kit Extended Warranty Plan 1 IBI-CPOINT 1YR Cool Point Irrigation Pump Extended Warranty Plan 1 WMC901 WorkMate Claris Recording System Assurance Plus Service Plan 1 EP-4-SC-FS EP-4 Cardiac Stimulator Extended Warranty Plan 1 Salient Characteristics: Brand Name Item: EnSite PrecisionTM Cardiac Mapping System St Jude 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) 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. This is an electrophysiology system including software and monitoring equipment to allow for display, recording, and analysis of heart electrical activity during intracardiac catheter-based evaluation and treatment of patients with abnormal heart rhythms. The equipment must meet the minimum of the following: EnSite PrecisionTM Cardiac Mapping System: Must be able to create non-fluoroscopic 3D images of the heart chambers. Must provide diagnostic tools which represent the anatomy of the cardiac chamber and electro-anatomical information as well as track the real-time location of electrophysiology catheters within the cardiac structure. Must be able to assist with recording the location of ablation lesions as applied by an ablation generator. Must include display workstation 32 GB RAM 3.4 GHz dual six-core processors Quadro K2200 Graphics running most current version of operating system software. Must include amplifier subsystem. Must be able to create 3D cardiac chamber models from CT/MR datasets for display on the system. Must be able to incorporate a real time model with a segmented CT or MR model to facilitate navigation within the segmented geometry. Must include software features that integrate the recording system with the EP system to consolidate patient and clinical information and reduce the duplicate steps in the workflow. Must be able to import CT/MR/3D rotational angiography cardiac datasets from the PACS server to the EP system. Must be able to export segmented 3D models back to the PACS server. Must be able to back up the velocity system data to the PACS server. Must allow review of case data from the velocity system or a remote workstation. Must allow the user to create high density maps with any catheter and collect date with no point limit. Must allow for automated lesion marker guidance based on user-defined criteria. Must include Instruction for Use (IFU). Must include 1-year warranty. Must include an anti-fatigue mat. Must allow for remote access for real time technical support through the secure network. Must include a contact force module that allows contact force data to be viewed on the cardiac mapping system. Ampere Generator Kit: Must be designed for improved efficiency and decreased noise interference Must include user-controlled power or temperature modes for: Multiple types of ablation catheters. Future irrigated ablation catheters. Must be able to monitor real-time temperature and impedance data on the color LCD screen. Must have presets. Must have a bedside physician control with footswitch to reduce risk. Must be able to select maximum temperature for automatic modulation of power. Must be able to manage procedural needs through user-configured variable power ramp-up. Must be able to control irrigation flow rates. Must be able to control RF delivery with automatic RF shutoff parameters. Must have seamless integration for the EP lab. Must be able to upgrade the software. Must include the generator and footswitch. 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 Must include remote control. Must include a minimum one-year warranty. Cool Point Irrigation Pump: Must include pump, power cord, pole clamp, connecting cable, tubing set, operator s manual. Must include a minimum one-year warranty. Workmate Claris Recording System with EP-4 Cardiac Simulator: Must be a high-performance electrophysiology recording system for collecting, displaying and storing data from multiple sources withing the lab. Must have fast post-pacing recovery, high sample rates, and low baseline ablation noise so fast and accurate diagnoses can be determined. Must have seamless connections among multiple systems and platforms to increase operator efficiency without sacrificing patient care. Workstation: DVD-RW Drive Mouse, custom keyboard Basic image capture system Network connection to hospital system Inbound/outbound data interface Display of signal FFT data Ablation data interface Integrated cardiac simulator control software Amplifier: 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 Miscellaneous: (4) 24 high resolution 16:9 aspect ratio widescreen monitors (1) color printer 12 lead ECG cables All necessary cables (1) Anti fatigue mat Cardiac Simulator Integrated EP-4 four channel cardiac stimulator Stimulator touch screen control Physiological Pressure monitoring (1) pressure transducer cable (up to 4 pressure channels) Carts (1) primary workstation cart 48 (1) bedside slave cart 24 Warranty Service coverage: initial one-year manufacturer warranty 90-day warranty on cables and batteries Workmate Unity HL-7 Module: Ability to seamlessly store and retrieve patient and procedure data on a PACS, hospital file server or other HL-7 compliant systems within the hospital. HL-7 Module Need to be able to query hospital information systems using HL-7 interface for patient demographic data to eliminate manual data entry time and reduce the potential for errors At the end of the study, must be able to transmit HL-7 encoded reports to the electronic medical records or any HL-7 compliant system Workmate Unity DICOM Module: Must be able to store and retrieve procedure data onto a PACS to reduce time spent saving cases onto external media, such as DVDs, and archiving the external media in accordance with VA Puget Sound policies Workmate Unity Review Module: Must be able to review archived patient data Note: Entire system needs to work with Siemens Cath lab equipment at VA Puget Sound HCS. EnSite Assurance Premium Service Plan: Provide Software Upgrades / Revisions. Annual Preventive Maintenance. On-Site Service, Priority Response (within two business days). Shipping: Priority next business day. 24/7/365 Telephone Technical Support. Remote System Diagnostics and Maintenance (as applicable). Loaner Systems / Components / Modules (as needed during service/repair of Covered Product). Technical User Training Course Credits (as applicable). 10% Parts and Services Discount. Hardware Upgrades / Revision released during the term of service coverage. Software Expansion Modules released during the term of service coverage. Extended Warranty Specifics: Term of Plan: 1 year effective upon expiration of initial year of manufacturer s warranty. Shipping: Standard next business day afternoon. 24/7/365 Telephone Technical Support. Loaner Systems / Components / Modules (as needed during service/repair of covered product). (End Salient Characteristics) Potential contractors shall provide, at a minimum, the following information to contact@example.gov. 1) Company name, address, and point of contact, phone number, e-mail address, and DUNS. 2) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing. To be considered a small business your company must have fewer than 1250 employees. This notice is to determine the marketplace for this specific requirement. Please check one of the following: [ ] yes [ ] no Service Disabled Veteran Owned Small Business (SDVOSB) [ ] yes [ ] no Veteran Owned Small Business (VOSB) [ ] yes [ ] no Small Business Manufacturers [ ] yes [ ] no All other Small Business (SB) [ ] yes [ ] no Other than Small Business 3) The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM). 4) Any Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. 5) If not a manufacturer, only authorized representatives/providers/distributors of the manufacturer will be considered. Equipment must be new, no used or refurbished equipment accepted. Please provide a proof of authorized dealer or reseller letter from manufacturer. 6) This is a brand name or equal sources sought. As such, the salient characteristics reflect the physical, functional, or performance characteristics that equal products must meet to satisfy the Government s needs. To be considered for any potential solicitation, offers of equal products, including equal products of the brand name manufacturer, must: (a) Meet the salient physical, functional, or performance characteristic specified in this sources sought; clearly identify the item by Brand name, if any and make/model number. (b) Include descriptive literature such as illustrations, drawings, or a clear reference to descriptive data or information available that identifies that the equal item meets or exceeds the salient characteristics required by the Government. (c) Please provide a courtesy quote in response to this request to evaluate price reasonableness for any set-aside determination. Responses are due by 03/03/2020 10:00 AM EST, to the Point of Contact. Shipping Address: Seattle VA Medical Center 1660 S. Columbian Way Seattle, WA 98108 Point of Contact: Robert Hamilton Contracting Officer contact@example.gov