Biosense webster carto 3 system

Added: Sep 01, 2017 12:01 pm STATEMENT OF WORK (SOW)

as of 27/Nov/2016





1. Contracting Officer s Representative (COR).



Name:

Roman Wynnyckyj

Section:

Medicine Service Cardiology Section

Address:

1501 San Pedro Drive SE, Albuquerque, NM 87108

Phone Number:

(505) 767-6003

Fax Number:

(505) 256-2803

E-Mail Address:

Roman.Wynnyckyj@va.gov





2. Contract Title. We are requesting to replace our current Cath Lab Cardiac Mapping system with a CARTO 3 System.



3. Background.

Our current Cardiac Mapping system is a St. Jude ENSITE Velosity system that past its end of life two years ago. The current system uses an old platform and does not have any available updates or upgrades. We are living on borrowed time, as the unit can malfunction or cease working at any time.



4. Scope.



Cardiac Mapping Systems are used by our Electrophysiologist Cardiologists to map the electro-conductivity of the heart. This allows for precise placement of ablation catheters that are able to cauterize aberrant electronic impulses that can cause arrhythmias and stop the heart from beating.



Clearly, the more precise and accurate the system, the better the outcome for our Veteran patients. Our current system is outdated, past its useful life and has no available updates or upgrades. The system we are seeking is more accurate, has better placement, is safer, decreases our fluoroscopy time and uses less expensive supply costs.



This system will be housed in our Cardiology Cath Lab and will be used on inpatient and outpatients to map and/or ablate aberrant electronic impulses.









5. Specific Tasks.



The replacement system needs include:

Allow for the selection, visualization and management of ablation parameters

Work with ThermoCool SmartTouch Irrigated Ablation Catheters

Allow for importation of pre-acquired MRI and CT images direct from scanners or from radiology workstations and provide a semi-automated image segmentation.

Allow for catheter icon registration to pre-acquired MRI and CT images.

Allow for the integration of real time intra-cardiac echo in an integrated and a side-by-side manner on the system screen.

Be compatible with Biosense Webster SoundStar 10F and 8F and GE and Siemans 10F and 8F AcuNav catheters.

Enable automatic detection of CFAE (Complex Fractional Atrial Electrogram) sites by analyzing individual signals from endocardial locations.

Insure the analysis is based on a series of advanced user defined parameters applied to the acquired signals.

Insure the analysis provides a consistent method to quantify and characterize complex fractional signals.

Provide rapid acquisition of mapping points based on physician standards.

Capability to continuously acquire MEM points, indicators of tissue proximity of MEM-enabled catheters, advanced electrogram annotation algorithms, and advanced map integrity algorithms.

Provide detailed electrogram recording and review for the duration of each case with the ability to add points from any time in the case to a map.

Be able to review catheter placement for any acquired point and edit maps with data from review tools.

Allow the user to automate pace mapping for ventricular tachycardia cases and integrate the results into the system s maps.

Access catheter position stability, time at location and range of movement.

Evaluate temperature and time.

Focus users on ablation strategy.

Evaluate ablation parameters during and after ablation.

Customize parameters by procedure type.

Control influencing factors associated with user input.

Evaluate specific parameters to determine adequacy and gaps.

Display essential data at each application to assess progress.

Increase safety at high-risk anatomical locations.

Index and visualize parameters of RF lesion formation.

Indicate when minimum and maximum time RF delivery has been maintained.

System quote should include appropriate workstations, carts and training for BioMed and cardiology staff.







6. Performance Monitoring



System performance will be monitored by our BioMed staff, our Cardiology Cath Lab Cardiologists, Cardiology staff, and COR.

7. Security Requirements

Although this system is capable interfacing with our CPRS/VISTA system, our intent is to use it as a stand-alone system for mapping electrical conductivity and /or ablating aberrant nodes in the heart. We will use printed reports or CDs rather than direct input into CPRS/VISTA. Please see 6550 and 6500.6 for details of this system. The C&A requirements do not apply, and that a Security Accreditation Package is not required



8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).



This requirement is for equipment not services.



9. Other Pertinent Information or Special Considerations.



Quoted price includes training for all appropriate staff.





a. Identification of Possible Follow-on Work.



No follow-on work identified at this time.





b. Identification of Potential Conflicts of Interest (COI).



No known conflicts of interest have been identified at this time.





c. Identification of Non-Disclosure Requirements.



N/A





d. Packaging, Packing and Shipping Instructions.



N/A



e. Inspection and Acceptance Criteria.



Acceptance of the equipment identified in this requirement will be performed by our Warehouse, BioMed and Cardiology staff.

10. Risk Control

Risk using this equipment is reduced as the amount of radiation exposure with Fluoroscopy is reduced.

11. Place of Performance.



Use of the requested equipment will be limited to the NMVAHCS in Albuquerque, NM 87108.