Attachment B Statement of Need-.pdf

Attachment B 36C24821Q1289

STATEMENT OF NEED

Ensite X Upgrade

Brand Name or Equal

Background:

The North Florida/South Georgia Veterans Health System has a brand name or equal requirement to upgrade existing equipment currently in-use at the Malcom Randall VA Medical

Center, 1601 S.W. Archer Road Gainesville, FL 32608.

Objective:

Purchase the Ensite X Mapping System to upgrade the current system which is not compliant with VA operating system, past end of life, and behind software editions to provide state of the art care for our cardiac patients.

Salient Characteristics:

The Ensite X Upgrade key features:

• Ensite X Mapping system version 1.1 software with upgraded software and hardware that provides improvement to our current Ensite 3-D mapping technology from signals to diagnosis in cardiac arrythmias.

• Ensite X EP System:

o Provides information on the electrical activity of the heart and displays catheter location during EP procedures.

o Provide a catheter navigation and mapping system that will display the 3-D position of general and sensor EP catheters.

o Display the cardiac electrical activity as waveform tracings and dynamic 3-D maps of the heart chambers.

o Includes:

▪ Ensite X Amplifier

▪ Ensite X Display Workstation

• Ensite X Amplifier:

o Accepts signals from catheters and electrodes that are attached to the patient.

o Accepts signals from Ensite X SurfaceLink module, Ensite X 20-pin and 80-pin catheter input module, Ensite X Field Frame, and four (4) patient reference sensors.

o Provides signals that care converted to a digital format and sends them to the display workstation for processing and display.

o Ensite X SurfaceLink Module:

▪ Able to connect the Ensite X surface electrodes, system reference surface electrode, and ECG electrodes to the Ensite x Amplifier.

o Ensite X Field Frame:

▪ Creates the magnetic tracking field during an Ensite EP procedure.

o Ensite X Catheter Input Module:

▪ Allows for connection of standard diagnostic catheters to the Ensite X

Amplifier

▪ 20-pin and 80-pin modules o Four (4) Ensite Patient Reference Sensors:

▪ Provides sensors with cables

▪ One (1) anterior and three (3) posterior o Ensite X ECG Cable:

▪ Connects the standard ECG electrodes to the Ensite X Amplifier o Medical Grade Isolation Transformer:

▪ Allows the system components to be connected to a line power through the isolation transformer.

▪ Only Ensite X Amplifier cart should be connected to this isolation transformer.

• Ensite X Display Workstation:

o Includes – workstation (computer), monitors, medical grade isolation transformer, and optional printer o Ensite X Workstation:

▪ Provides the system software that displays data from the Ensite x Amplifier.

▪ Includes – keyboard and mouse o Monitors:

▪ Used to display procedures information.

o Medical Grade Isolation Transformer:

▪ Allows the system components to be connected to a line power through the isolation transformer.

▪ Only Ensite X Workstation should be connected to this isolation transformer.

• Ensite X Contact Force Module:

o Provides contact force data that is viewed on the Ensite mapping system.

o Allows for easy set up and enhanced workflow.

o Requirement:

▪ Ensite Display Workstation 5 or higher

▪ Ensite Precision Mapping Module o Includes:

▪ Ensite Contact Force Module v1.0

▪ TactiSys Quartz

• Ampere Generator Kit:

o Includes – generator and footswitch with 2.5m cable o Designed to provide better efficiency and control during radiofrequency (RF) ablation procedures with user control for power and temperature modes and minimal noise interference.

o Power control modes:

▪ Safire BLU Duo ablation catheters

▪ Therapy Cool Path Duo ablation catheters o Able to monitor real-time temperature and impedance data o Provides:

▪ Color LCD screen

▪ Power, temperature, impedance, and duration push-button controls

▪ User presets

▪ Bedside control with footswitch o Temperature guard mode:

▪ TempGuard mode – ability to select maximum temperature for programmed variation of power.

o Power Ramp-up feature that provides management of procedure needs through user-configured variables.

o Auto flow feature that provides controlled irrigation flow rates.

o Controlled RF delivery with automatic RF shutoff parameters.

o Integrates with:

▪ Ensite Mapping System

▪ Cool Point Irrigation Pump

▪ LS Pro Bard EP Recording System

• Ampere remote control with 15m fiber cord

• Cool Point Irrigation Pump:

o Designed to provide a cooling to the ablation catheter and site to prevent burning and further cardiac tissue damage.

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).

o Compatible with Cool Point Tubing Set

• Security and Compliance o Software version 1.1 o Linux operating system o HIPPA compliant

• Compatibility:

o Must be compatible with current systems – Cryoablation, LS Pro Bard EP

Recording System, and Vivid IQ Ultrasound

• Standard one-year manufacturer’s warranty to begin after install of equipment

• Clinical and technical specialists available for support and training

• Clinical Training:

o Include 2 days of on-site training from one of the clinical representatives to staff o Include on-site Biomedical Engineering training for Biomedical Specialist

General Requirements

(1) Installation:

a. Contractor shall provide a dedicated project manager who coordinates go-live, pre-installation preparation calls, pre-install check-list, scheduling of service installation and clinical applications training, single point of contact for go-live support, and project closure meeting to confirm successful go-live and transition to service.

b. The Contractor shall install the Ensite X Upgrade: should be under two (2) business days to install.

c. The Contractor shall provide a system Installation Plan (IP) to the Contracting

Officer Representative (COR) and Contracting Officer (CO) for approval prior to the start of work. The COR shall approve the IP and return to the contractor. The

IP shall include estimated timeline of start and completion and estimate unexpected delays/lead time.

d. System configuration/implementation (e.g. configuring most of the database install/hardware, synchronizing other equipment to new system, setting up custom templates) shall occur prior to installation at least two (2) weeks in advance due to the nature of the recovery environment.

(2) Test and Acceptance: Contractor shall test all equipment after installation. The

Government will accept equipment once installation and successful testing has been completed and approved.

(3) Training and Simulation:

a. Includes 2 days of on-site staff training by clinical representative

(4) Warranty/Service Contract: All equipment and materials shall come with a standard one-year manufacturer’s warranty. Warranty shall begin after installation of equipment and completion of tests.

(5) Contractor(s) quoting Brand Name shall provide written documentation of authorized distributor/reseller of the Ensite X Mapping System Upgrade.

Contractor Qualifications/Certifications

The Contractor shall be responsible for the following:

• Contractor shall stage all equipment for installation.

• Contractor shall provide qualified personnel to install cable, monitors, system components, or accessories.

• Contractor shall be responsible for all system/software testing after installation and prior to Government acceptance.

• Contractor is responsible for securing all materials, equipment and tools while on

Government property or in the Government facility. The Government is not liable for any lost or stolen items that are not properly secured.

• Contractor shall mount all hardware, displays, racks, switches, etc. necessary to complete installation.

• Contractor shall provide and install Ensite X Upgrade.

Government Responsibilities

The Government will provide the following:

(1) Provide site access and escorts through work areas as needed

(2) Provide primary electrical power

(3) Provide adequate space for the system equipment

(4) Ensure power and data ports are active

(5) Identify and provide representatives for walk through and sign off of installation when complete.

Scheduling and Hours of Work

• All work in areas involved shall be scheduled with the CO and COR.

• Work shall be scheduled for proper execution to completion of this contract.

• Hours of work: Work to be accomplished Monday through Friday from 0800-1630, or on weekends, as required to minimize to disruption to the hospital.

• Work to be performed n the Cardiology Cath Lab.

• The 11 holidays observed by the Federal Government, are New Year’s Day, Juneteenth, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas or any other day specifically declared by the President of the United States to be a national holiday.

Delivery:

• Any equipment to be delivered shall be coordinated with the CO and COR prior to delivery. All deliveries will be Monday – Friday (Excluding National Holidays), 8am –

4:30pm:

o Malcom Randall VA Medical Center – Warehouse or Designated location given at time of award.

1601 S.W. Archer Road Gainesville, FL 32608

Attn: Jamie Dillard