Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF MAY 08, 2021 SAM #7098
SOLICITATION NOTICE

65 -- EnSite X EP System (Brand name only) This is not a request for quote

Notice Date

5/6/2021 5:20:49 PM
 

Notice Type

Presolicitation
 

NAICS

334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
 

Contracting Office

244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
 

ZIP Code

15215
 

Solicitation Number

36C24421Q0667
 

Response Due

5/14/2021 12:00:00 PM
 

Archive Date

08/12/2021
 

Point of Contact

Allan Tabliago, Contract Specialist, Phone: 215-823-5800 x203443
 

E-Mail Address

allan.tabliago@va.gov
(allan.tabliago@va.gov)
 

Awardee

null
 

Description

THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. No solicitation exists. Therefore, do not request a copy of a solicitation. See Instructions on page 7. Ensite X EP�System INTRODUCTION/BACKGROUND: 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. OBJECTIVE: The VA Pittsburgh Healthcare System, (646) Pittsburgh, Pennsylvania, hereby referred to as the VAMC Pittsburgh (646), is seeking the acquisition of one (1) Ensite X EP System. MAJOR REQUIREMENTS: The Contractor/ Vendor must complete the following tasks to meet the needs of this acquisition: Line No.� � � � � � � � � �Order No.� � � � � � � � � � � � � � � � � � � � � Product Description� � � � � � � � � � � � � � �� � � � � � � � � � � � � � � � � � � � � � � � Qty 0001� � � � � � � � � � � � �ENSITE-SYSTEM-01� � � � � � � � � � � � �EnSite X EP System� � � � � � � � � � � � � � � � � � � � � � � �� � � � � � � � � � � � � � � � � �1 0002� � � � � � � � � � � � �CFK3000� � � � � � � � � � � � � � � � � � � �� � �EnSite Contact Force Module� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 1 0003� � � � � � � � � � � � �H700494� � � � � � � � � � � � � � � � � � � � � � �Ampere Generator Kit� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � ��1 0004� � � � � � � � � � � � �H700490� � � � � � � � � � � � � � � � � � � � � � �Ampere Remote Control (includes 15m fiber cord)� � � � � � � � � � � � � � � � � �1 0005� � � � � � � � � � � � �89003� � � � � � � � � � � � � � � � � � � � � � � � �Cool Point Irrigation Pump� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �1 0006� � � � � � � � � � � � �H701336� � � � � � � � � � � � � � � � � � � � � � �ViewMate� Ultrasound Imaging Console with Battery� � � � � � � � � � � � � � �1 0007� � � � � � � � � � � � �H701554� � � � � � � � � � � � � � � � � � � � � � �P4-1C Trans-thoracic Transducer� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �1 0008� � � � � � � � � � � � �H702084� � � � � � � � � � � � � � � � � � � � � � �P-8-3 Trans-esophageal (TEE) Transducer� � � � � � � � � � � � � � � � � � � � � � � 1 0009� � � � � � � � � � � � �H702488� � � � � � � � � � � � � � � � � � � � � � �L8-3 Linear Transducer� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � �1 (2) Salient Characteristics 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. The Government and the Contractor understand and agree that the services to be delivered under this contract by the Contractor to the Government are non-personal services and the parties recognize and agree that no employer-employee or master-servant relationships exist or will exist under the contract between the Government and the Contractor s employees. POINT OF CONTACT (POC): The identified POC and technical representative for this acquisition is: Name: Joseph Falcona Phone Number: 412-360-1077 Email: joseph.falcona@va.gov ""No Government personnel, other than the Contracting Officer, have the authority to change or alter these requirements. The COR shall clarify technical points or supply relevant technical information, but no requirements in this scope of work may be altered as a sole result of such verbal clarification."" REPORTS/DELIVERABLES: Delivery confirmation of equipment and commodities will be made through the Logistics Department of the VAMC Pittsburgh (646). This will include documentation of receipt and assignment of a facility based EE number for identification and tracking purposes. Delivery confirmation of non-equipment/ commodities acquisitions is the responsibility of the receiving Facility and/ or Service. Request for Information Instructions The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 334510 (size standard of 1250 employees). Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If not, can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers. Does your company exceed 500 employees; Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied; Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; Obtained an individual or class waiver? If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontract work and completion of job. Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes? Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. Please provide your DUNS number. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to allan.tabliago@va.gov no later than, 03:00 PM Eastern Standard Time (EST) on May 14, 2021. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, Allan Tabliago. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. If a solicitation is issued, information will be posted on the beta.sam web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Officer at allan.tabliago@va.gov. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. GSA has determined unit prices to be fair and reasonable FAR subpart 8.404(d) End of Document
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/c1950e72e3b147f8ad7ce34db75bd89e/view)
 

Place of Performance

Address: VA Pittsburgh HCS Univeristy Dr C, Pittsburgh 15240, USA

Zip Code: 15240

Country: USA
 

Record

SN05994337-F 20210508/210506230118 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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