6515--Zeiss Tivato 700

TOGUS VA MEDICAL CENTER

STATEMENT OF WORK

ZEISS TIVATO 700

Introduction

The VA Maine HCS requires delivery, installation and training of (1) Tivato 700 Premium Microscope Package with accessories for the Operating room at Togus VA Medical Center located at 1 VA Center, Augusta, ME 04330.

Background

The VA Maine Operating room is looking to replace the current microscope that is over 10 years old, at end of life, and has no maintenance contract connected to it. It can be used as a backup microscope for the Ortho Spine service should anything happen to the scope used by them. Microscope equipment of this caliber is purchased not leased and the newer Tivato 700 will provide the Operating room with the most advanced features in order to provide the best care for our veterans. Technology in surgical microscopes has advanced in the last 10+ years, incorporating 4K videography, and both infrared and fluorescence options. All of this allows the surgeon to work more precisely and safely. Purchasing this microscope now allows the facility and our Perioperative Services to care for possibly hundreds of Veterans who wish to stay within our System for ENT care and procedures.

Scope (Provide an overview of the PWS emphasizing the most important aspects of your https://vaww.aams.ecms.va.gov/AAMS_Production/Desktop/DTMain.aspxrequirement and defining the boundaries of the contractor s performance responsibilities).

The Tivato 700 Microscope has a Workflow-Enhancing Visualization that enables you to have state-of-the-art modalities at your fingertips. The ZEISS TIVATO 700 enables effortless use of advanced surgical visualization modalities and delivers superb image clarity for every procedure. Inside the OR, you can broadcast the procedure every step of the way in brilliant detail with the integrated 4K camera technology, while the large external monitor allows for easy viewing by your entire team. This microscope contains the newest in surgical microscope technology, which will help ensure that we provide Veterans with the best opportunity for high-quality, safe, and efficient care. It is equipped with a camera and can connect to a monitor for viewing by room staff, so all can see and anticipate case needs.

Model No.

Description

QTY.

000000-2235-392-01PREMIU

CARL ZEISS MEDITEC, INC. | TIVATO 700 PREMIUM PACKAGE

1

000000-2235-392-90EYEP10

Eyepiece 10x for all tubes

1

000000-2235-392-20COLRFO

CARL ZEISS MEDITEC, INC. | COOBSERVATION LEFT/RIGHT WITH STERO-COOBSERVER, FOLDABLE TUBE AND 2X EYEPIECES

1

000000-2235-392-20COFFFO

CARL ZEISS MEDITEC, INC. | COOBSERVATION FACE-TO-FACE STEREO-BRIDGE WITH FOLDABLE TUBE AND 2X EYEPIECES. SUPPORTS ASSISTANCE IN SPINE/P&R SURGERY

1

000000-2235-392-30YE560H

CARL ZEISS MEDITEC, INC. | PREPARES TIVATO 700 FOR FLUORESCEIN SODIUM INDUCED FLUORESCENCE VISUALIZATION. INCLUDES ONE FLUORESCENCE TARGET YELLOW 560

1

000000-2235-392-30IR800H

CARL ZEISS MEDITEC, INC. | INFRARED 800 PREPARATION PREPARES TIVATO® 700 FOR ICG BASED VASCULAR FLUORESCENCE VISUALIZATION. INCLUDES ONE FLUORESCENCE TARGET INFRARED 800

1

000000-2235-392-50NAVIMO

CARL ZEISS MEDITEC, INC. | NAVIGATION INTERFACE MODULE

1

000000-2235-392-50LANPOR

CARL ZEISS MEDITEC, INC. | LAN INTERFACE

1

000000-2235-392-10HFCFWL

Foot Control Panel Wireless Enables movement of the system with the foot to reduce workflow interruption. Includes wireless 14 Fct FCP WL, with 6m back-up cable

1

000000-2235-392-60TRSBOX

CARL ZEISS MEDITEC, INC. | SHIPPING CRATE (NO SOLID WOOD) | 1/E

1

This is the standard of care outside the VA and with essential features as;

Achieve enhanced visualization during your workflow

New treatment modalities, enhanced visualization, and brilliant broadcasting of procedure in the operating room the surgical landscape is changing at a rapid pace. Without the best tools and most intuitive technologies, your workflow can be disrupted inside and outside of the operating room (OR).

Workflow-Enhancing Visualization enables you to have state-of-the-art modalities at your fingertips. The ZEISS TIVATO 700 enables effortless use of advanced surgical visualization modalities and delivers superb image clarity for every procedure.

Visualization enhanced. Experience our fluorescence options. Leveraging brilliant apochromatic optics from ZEISS, now venture into new fields including the use of intra-operative fluorescence 2 options. Assess patency of vessels joined by anastomosis with ZEISS INFRARED 800. Go even further with ZEISS YELLOW 560 to visualize fluorescence-stained structures for additional clinical applications.

Visualize with 4K. Inside the OR, you can broadcast the procedure every step of the way in brilliant detail with the integrated 4K camera technology, while the large external monitor allows for easy

viewing by your entire team.

Stability reimagined.

Avoid unwanted vibrations during procedures after the repositioning of the visualization system and during small movements. Experience the innovative Active Vibration Damping, strengthened by robotic movements, to streamline your surgical workflow.

Ultimate Reach & Flexibility

Gives you and your team the freedom to handle every OR situation with confidence. ZEISS TIVATO 700 offers excellent overhead clearance to work under the arm of the visualization system in every setup. Position the base as your space allows and still operate comfortably with Ultimate Reach. When working with long instruments, rely on the large working distance of 200 625 mm to ensure continuous focus. Prepare the device with ease for daily use with convenient features like AutoBalance and AutoDrape®.

Applicable Directives (List all documents referenced in the next section 5.0, Performance Requirements, with which the contractor will have to comply in performance of the contract effort. If only portions of a given document apply, specifically identify the applicable portions).

The system must meet the manufacturer s specifications and be designed and implemented within the vendors 510K system design as an FDA regulated medical device/system.

Performance Requirements (Identify what the contractor is required to do (major tasks and subtasks).

The vendor will ship, install, Calibrate, and provide On-Site Training. The vendor also includes a 12-month warranty starting from the completion of the assembly and instillation date.

Deliverables (List all data required to manage or monitor contractor performance).

This project will include all and any peripheral items to ensure a fully functional system. (misc. hardware or req. hardware upgrades, network switches, video cards, KVM switches, cabling, mouse, keyboards etc.) to ensure the functionality of the final product. Carl Zeiss Meditec provides a 12-Month standard warranty on all microscopes, parts, labor, commencing on the date of instillation.