6515--CARTO PRIME Upgrade by Biosense Webster. THIS IS NOT A REQUEST FOR QUOTE

SOW CARTO PRIME by Biosense Webster 2 STATEMENT OF WORK (SOW) MEDICINE SERVICE/ CARDIOLOGY DIVISON DEPARTMENT OF VETERANS AFFAIRS CORPORAL MICHAEL J CRESCENZ VA MEDICAL CENTER 3900 WOODLAND AVE, PHILADELPHIA, PA 19104 GENERAL DESCRIPTION: The Cardiac Electrophysiology Laboratory of Michael J Crescenz Medical Center is under the Cardiology Division of the Medicine Service line, directed by Dr. Andrew Epstein. The Cardiac Electrophysiology Physicians are licensed and credentialed to provide care to patients undergoing cardiac ablation procedures for management of arrhythmias. The equipment specific to this request is called the CARTO PRIME Cardiac Mapping System by Biosense Webster. The CARTO PRIME Cardiac Mapping System by Biosense Webster is used for diagnostic and therapeutic electrophysiology procedures for diagnosing and treating cardiac arrhythmias. The system, when connected to catheters placed in the heart, provides an electro-anatomical map of the hearts electrical system to find and isolate accessory cardiac electrical pathways that cause abnormal cardiac rhythms. This system enables the operator (Electrophysiologist) to isolate the location of the accessory pathway and provide radiofrequency energy to the site to ablate the pathway while preserving surrounding healthy cardiac tissue. This upgrade will enhance the operator s ability to diagnose complex arrhythmias, provide parallel mapping (helpful with dual pathway arrhythmias), provide dynamic displays of arrhythmia voltage and activation fast anatomical mapping without connecting a therapeutic catheter. SUPPLIES/SERVICES The CARTO PRIME is for use in the cardiac electrophysiology laboratory during electrophysiologic testing and ablation procedures. The CARTO 3 Mapping System is currently used in the Electrophysiology Laboratory. This request is for an upgrade to the latest software and some hardware refresh. SCHEDULE OF ITEMS Item description of QTY/Unit/No. Supplies/Services Item # Description UOM QTY KT5400222FG CARTO PRIME Mapping System to Include: Carto Prime Module Kit CARTO Finder Module Coherent Mapping Parallel Mapping and Map Replay LAT Hybrid EA 2 KT400170 CARTO Ripple Mapping EA 2 VSPEPU1 VISTATAG SURPOINT Module Kit EA 2 C3PASO PASO Module EA 2 KT5400165 FAM Dx Expansion Pack EA 2 DELIVERY Corporal Michael J. Crescenz Veterans Affairs Medical Center Philadelphia 3900 Woodland Avenue Philadelphia, PA 19104 30 Days from time of order. Anything other, please notify us. SALIENT CHARACTERISTICS CMCVAMC requests to upgrade our existing CARTO3 Mapping System to enhance procedural safety and efficacy for diagnostic and therapeutic electrophysiology procedures for the treatment of complex cardiac arrhythmias. Hardware and software should include: Coherent Mapping- to simplify the diagnosis of scar-related complex atrial arrhythmia by applying physiological constraints on LAT information. Improves accuracy of ablation site identification. CARTOFINDER Module- conveniently identifies repetitive focal and rotational region of interest in adjunction with current atrial fibrillation workflow. LAT Hybrid- Improves location accuracy compared with standard PVC mapping by associating the PVC location information to its corresponding normal sinus rhythm location. Parallel Mapping and Map Replay- Efficiency gain of mapping multiple arrhythmias prospectively or retrospectively. Upgrade must integrate with existing CARTO3 system and integrate with the existing hardware utilized in the Electrophysiology Laboratory (GE Cardiolab and Siemens SC2000). V7 CARTO PRIME Module Kit Dell T5820 Workstation Coherent Mapping May simplify the diagnosis of scar-related complex atrial arrhythmia. LAT Hybrid Increased Premature Ventricular Contraction (PVC) mapping location accuracy. CARTOFINDER Module Identifies repetitive focal and rotational activation patterns in irregular atrial arrhythmias. Parallel Mapping & Map Replay Enhances mapping efficiency by enabling the ability to map multiple arrhythmias simultaneously (Parallel Mapping) or retrospectively (Map Replay) using the same catheter location. CARTOSEG Module CT Segmentation Module that provides detailed anatomic 3D image integration in the CARTO3 System and highlights discrete anatomic structures. Semi-automatically segments all four chambers of the heart, aorta, coronary sinus, coronary arteries, and esophagus. VISITAG SURPOINT Module Customized Module settings to include Built-in algorithm and standard workflow Catheter stability parameters for accurate RF delivery Anatomical presets for tissue variability Integration with CARTO3 System Continuous real-time progress display Easy access to information associated with ablation locations Color coded visibility of ablation strategy progress FAM Dx Expansion Pack (for CARTO3 v6 base software) Enabled catheter visualization Point acquisition Fast Anatomical Mapping without first connecting an ablation catheter STATEMENT OF WORK (SOW) Project Scope The Corporal Michael J. Crescenz Veterans Affairs Medical Center (CMCVAMC) is looking to purchase and expand our electrophysiology program using advanced tools that will integrate with our currently used technology (GE CardioLab, Siemens ARTIS Q X-Ray, Bloom 2 Stimulator and Siemens SC2000 Ultrasound). The purchase must include end-user training for electrophysiology staff and physicians. All hardware, software components must be compatible with CARTO3 and CARTO PRIME. Delivery Location CMCVAMC Philadelphia 3900 Woodland Avenue Philadelphia PA, 19104 Warranty and Support Warranty of the equipment must be provided for a minimum of one year upon receipt, acceptance of equipment. The warranty must cover all hardware and software components of the system. Warranty and support should include a 4-hour call back response during normal business hours of 7:30AM- 4:30 PM Monday thru Friday (except holidays). Any service reports sent to all appropriate points of contact. The vendor shall provide and install all manufacturer recommended software upgrades and changes included in the cost of the system during the warranty/contract period. The vendor shall provide two (2) sets of user manuals and technical manuals to VA Biomedical Engineering and site end user. Repairs or services that are performed during normal working hours should be covered by warranty/contract. Installation All work and installation shall be coordinated with the department Nurse Manager, site Biomedical Engineering team and the Contracting Officer Representative (COR) and a phasing and work-schedule shall be provided. All work is to be executed as to not interfere or interfere as little as possible with normal functions of the Medical Center and department. The contractor shall keep work, storage and staging areas clean and neat. Testing The contractor shall verify to Biomedical Engineering and Electrophysiology Staff that the system meets all requirements through demonstration and validation. The contractor shall have no access to VA sensitive information during testing. Training The contractor shall be responsible for providing on-site user training for the equipment. Each session of end-user training is to be scheduled at the CMC VAMC discretion and training shall have a one-year window. Work Hours Normal business hours are 7:30 AM to 4:30 PM Monday thru Friday excluding Federal Holidays. Work completed outside this time must be requested through Facility Biomedical Engineering. PERIOD OF PERFORMANCE Single procurement. No base or option period of performance. MISCELLANEOUS INFORMATION: Payment Net 30 days. POC INFORMATION: For any additional information contact Jill Neill, Nurse Manager Medicine- Cardiology, +1 (555) 000-0000 x203233 or Vera Taylor, Administrative Officer, Medicine Business office, +1 (555) 000-0000 x206317. Instructions The information identified above is intended to be descriptive, of the brand name CARTO PRIME Cardiac Mapping System by Biosense Webster 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. 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