36C24819Q1383-002.docx

STATEMENT OF NEED

GENERAL: James A. Haley Veterans’ Hospital, Medical Services, 13000 Bruce B. Downs Blvd, Tampa, Florida 33612, has a requirement for Workmate Claris. The Cath Lab has a requirement for a new Electrophysiology (EP) medical recording system for mapping purposes. The system is needed for mapping fidelity critical to the success of cardiac ablation surgical procedures. The system we are currently using to perform these procedures needs a new work station to have it functioning at the level required for mapping.

BACKGROUND: The current mapping system is old and outdated. It is currently used to identify areas of the heart that need treatment to stop patient’s arrhythmias. We tailor therapies based on mapping information. As this technology advances, we fall further behind and risk providing less than the standard of care in these procedures.

PURPOSE: The EP medical recording system is responsible for acquisition and processing of the cardiac signals that physicians use during procedures for the diagnosis and treatment of cardiac arrhythmias. The current system is past its life expectancy.

A new updated system will improve patient safety by providing the physician with a clear diagnostic understanding of the patient.

The mapping system will be utilized for ablation surgical procedures completed by EP Cardiology in the Catherization Lab.

SCOPE: James A Haley is requesting contractors provide brand name or equal equipment that meets or exceed the physical, functional and performance of the listed salient characteristics in this section. The equipment feature is essential to the technical requirements to meet the need of the government.

PHYSICAL CHARACTERISTICS: Equipment must have the physical characteristics to enable the government to perform the capabilities:

· Advanced Display Workstation

· Network Connection to Hospital System

· Integrated cardiac stimulator control software

· Ablation Data Interface (RF & Cryo)

· Amplifier with ClearWave Technology

· Up to 448 Channel Display capability

· 56 Intracardiac Electrode Inputs

· 12 Surface ECG Channels

· Cardiac Stimulator

· Integrated EP-4 Four Channel Cardiac Stimulator

· Physiologic Pressure Monitoring

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

· Carts

· 1) Primary Workstation Cart - 48"

· 1) Bedside Slave Cart - 24"

· Warranty for WorkMate

· 1 Year Warranty on Hardware and Software Upgrades

· 90 Day Warranty on Cables and Batteries

EnSite Contact Force Module

· EnSite Contact Force Module v1.0

· TactiSys Quartz

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

Ampere Generator Kit

· Specifications:

*RF Output Power: 1 to 100 W adjustable in steps of 1 W *Impedance Range: Measures 50 Ω to 300 Ω in steps of 1 Ω *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

EnSite Precision Cardiac Mapping System

· 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

· EnSite Precision Module – hardware

· EnSite PrecisionTM Module -software

· EnSite™ AutoMap

· EnSite™ AutoMark

· System contains Instructions For Use (IFU).

· Service Coverage: Includes initial one year manufacturers warranty

· Anti Fatigue Mat

Workmate Image Sync Intracardiac (ICE) Echocardiography images 3D Mapping systems

FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Electrophysiological recording and monitoring system that capture, display, store and retrieve surface and intracardiac electrical signals during electrophysiological studies. Software provides data acquisition and analysis, interval posting and instant data retrieval with waveform markers and intervals displayed.

SOFTWARE: Contractor must be responsible for the complete software system integration and installation to the current VA system to include all fees, permits, and work required to accomplish the installation.

TRAINING: Contractor is to provide a one-time training at installation of equipment (if applicable). Government will not require additional training.

PLACE OF PERFORMANCE: James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL 33612.

WARRANTY OF EQUIPMENT: Contractor must provide manufacturer(s) warranty on all provided supplies.

DELIVERY SCHEDULE: All items to be delivered and installed within 5 days of purchase order receipt.

FOB destination.

pRICE/COST SCHEDULE

Brand Name or Equal Integrated Electrophysiology System, WorkMate Claris Recording System 56 with EP-4 Cardiac Stimulator Upgrade: Remove Existing and Install New

MANUFACTURER PART NUMBER (MPN): H700123

Brand Name or Equal Integrated Electrophysiology System, WorkMate Claris Recording System 56 with EP-4 Cardiac Stimulator

MANUFACTURER PART NUMBER (MPN): H700123

Brand Name or Equal EnSite Contact Force Module: EnSite Contact Force Module v1.0, TactiSys Quartz

MANUFACTURER PART NUMBER (MPN): CFK3000

Brand Name or Equal EnSite Precision Cardiac Mapping System: 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, EnSite Precision Module – hardware, EnSite Precision Module -software, EnSite AutoMap, EnSite AutoMark System contains Instructions For Use (IFU).

Service Coverage: Includes initial one year warranty Anti Fatigue Mat

MANUFACTURER PART NUMBER (MPN): PRECISION SYS

Brand Name or Equal Cool Point Irrigation Pump: 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

MANUFACTURER PART NUMBER (MPN): 89003

Brand Name or Equal Ampere Generator Kit: RF Output Power: 1 to 100 W adjustable in steps of 1 W Impedance Range: Measures 50 O to 300 O in steps of 1 O, 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

MANUFACTURER PART NUMBER (MPN): H700494

Brand Name or Equal Workmate Image Sync: Intracardiac (ICE) Echocardiography images 3D Mapping systems, includes 2 Port DVI Video Splitter (part number 100066677), 6 ft DVI-D Single Link cable (part number 100016650)

MANUFACTURER PART NUMBER (MPN): H700116

DELIVERY SCHEDULE

13000 BRUCE B. DOWNS

SCI

TAMPA, FL 33612