SOW_Neurosurgery Microscope.pdf

STATEMENT OF WORK

Leica ARveo 8 Microscope

Veterans Affairs Health Care System Oklahoma City, Oklahoma

1. General: Currently, the Oklahoma City Veterans Affairs Health Care System (herein after referred to as OKC VAHCS) Surgery Service requires a Leica ARveo 8 neurosurgery microscope system and various accessories, used to enhance visualization during neurosurgical procedures, using augmented reality florescence, IGS systems, and endoscopic image injections.

2. Delivery Location: Oklahoma City Veterans Affairs Health Care System, 921 N.E.

13th St. Oklahoma City, Ok 73104

3. Delivery Times: Delivery times shall be Monday through Friday from 07:00 to 16:00 (7:00AM to 4:00PM).

4. Definitions/Acronyms

4.1. OKC VAHCS: Oklahoma City Veterans Affairs Health Care System

5. Scope: The Contractor will provide the necessary equipment and accompanying software to the OKC VAHCS for one (1) Leica ARveo 8 neurosurgical microscope, including accessories and attachments. This requirement is for a comprehensive and whole solution. The Contractor is required to be an expert in the field of surgical microscope systems, specifically within the field of neurosurgery. As such, the Contractor is required to include any items not specifically listed in the pricing schedule but is necessary to enable the equipment or accompanying software to function. Examples include installation expenses, VA staff training, equipment mounts, display charts, cables, connectors, plugs, and special equipment wiring requirements. The company will be responsible for replacing any machines that malfunction, break, or are not adequately operating at no additional cost to the VA within the first 12 months of purchase. The company will work with OKC VAHCS Biomedical Engineering Department to coordinate any preventive maintenance or replacement of any machine.

6. Training for VA Employees: Comprehensive training or VA staff is required.

Examples include: Physicians, Nurses, Surgical Technicians, and Biomedical Engineers.

7. Specifications:

7.1. Below are salient characteristics for the Brand Name or Equal requirement:

7.1.1. Must be capable of treating the following:

• Provide visualization for surgical cases, specifically for neurosurgeons

7.1.2. Must be capable of performing or have the following:

• Optics

7.1.2..1. Provides maximum resolution and depth of field simultaneously

7.1.2..2. System which provides coaxial light with narrow angle of illumination to light beam path and brighten up shadowed areas in the field of view, while retaining depth perception

7.1.2..3. Surgeon-opposite co-observer has independent fine focus 7.1.2..4. Real-time visualization of vascular perfusion

• Stand 7.1.2..1. Provides dual 400 watt xenon bulbs with two independent power supply boards providing higher safety and lower risk of failure, allowing uninterrupted continuation of surgery if one bulb fails or in the case of a board failure

7.1.2..2. Compatible with any and all existing endoscopes 7.1.2..3. Integrated luxmeter that provides real-time objective light data so that intensity can be measured directly form the bulb output

7.1.2..4. Provides additional arm reach for surgeon’s comfort, stability, and vibration absorption

7.1.2..5. Provides independently controlled cameras, as well as manual working distance and magnification controls allowing the surgeon to continue to operate in the case of power loss

7.1.2..6. Allows for easy one-step intra-operative balancing for surgeon

7.1.3. Must meet the following:

• Optics

7.1.3..1. Angled optics binoculars are standard for maximum comfort and personalization:

• 30-50 and 0-18- rotatable binoculars

• Full 360-degree rotation of all binoculars which allows surgeon to maintain straight, ergonomic posture, regardless of the tilt of the optics carrier

• Wide field 8.3x, 10x, or 12.5x eyepieces

• Viewing options include: stereo side assistant for left/right, 0-180 binoculars for ‘straight’ co-observer, as well as angled and adjustable tube

• Stand 7.1.3..1. Surgeon controlled robotics when paired with navigation

(Brainlab) 7.1.3..2. All metal construction (not plastic) for reliable longevity 7.1.3..3. Interfaces with Medtronic Stealth and Brainlab, including robotic alignment 7.1.3..4. DICOM interface available 7.1.3..5. Optimizes light intensity relative to eh working distance, reducing the risk of patient burns

• Camera

7.1.3..1. Includes 3 cameras providing HD video in 1080i and 1080p 7.1.3..2. Video can be exported by SDI and/or DVI 7.1.3..3. Recorder provides:

• HD video

• 3D camera is available

• High efficiency video compression

• 1 TB storage

• Ultra-quick video and still image transfer to surgeon’s preferred storage device

• 5 hour case transfers in about 30 seconds

• Videos can be recorded in 3D with an optional 3D license that can be purchased

8. Security Requirements: The contractor will have no access to patient records or areas of the hospital. The A&A requirements do not apply, and a Security Accreditation Package is not required.

8. Security Requirements: The contractor will have no access to patient records or areas of the hospital. The A&A requirements do not apply, and a Security Accreditation Package is not required.