FUNCTIONAL/PERFORMANCE/SPECIFCATION
Description & Salient Characteristics:
The Fargo VA Health Care Systems is needing to purchase one (1) new EEG and upgrade one (1) EEG for the hospital located at 2101 N. Elm St. Fargo ND 58102. This is a brand name only requirement. The brand name component is Nihon Kohden EEG-1260
1. Introduction of Required Specifications:
1.1.1 Purpose: The purpose of this statement of requirements is to outline the tasks and responsibilities of the awarded contractor in relation to provisions, installation, integration and implementation of equipment for a complete EEG system at the Fargo VAMC, Fargo, ND.
1.1.2 Contractor must provide all necessary tools, equipment/hardware, software, licenses, installation, maintenance, warranty, and training in accordance with this SOW.
1.1.3 Primary Goals: This procurement is to procure one (1) complete EEG system including equipment, accessories, and software and upgrading ONE (1) to most current operating system.
1.1.4 Equipment: All equipment must be new, state of the art, and not recertified nor refurbished. All equipment must be compliant with current VA requirements for allowable operating system platforms.
1.1.5 Industry Standards: Unless otherwise stated, all equipment must be held to current industry standards for such equipment as present within the current market for EEG system equipment, supplies, and related services.
1.1.6 Contractor must meet all minimum requirements contained in section 1.3.
1.2 Definitions:
1.2.1 EEG System: An EEG system is equipment used to test and detect abnormalities in patient brain waves, and/or electrical activity.
1.2.2 Clinical acceptance: Initial Clinical use means the delivered equipment as determined by the Government performs the basic intended clinical function of the system in a safe manner for the purpose for which it was designed, with most or all system functionality, allowing the equipment to be used clinically. This begins the initial Contractor warranty period.
1.2.3 Warranty: Equipment has one year of parts and depot support. Supply items are warranted for 90 days from the date of shipment. The products are warranted to be free from material defects in workmanship or material under normal use and service for the warranty period.
1.3 Equipment Minimum Requirements:
1.3.1 BRAND NAME: Neurofax EEG-1260 (NEW EEG SYSTEM)
Neurofax-1260 PC with NeuroWorkBench data management software
Photic Control Unit with LS-703A Flash Lamp Assembly and stand
Photic stimulation control unit
Photic flash lamp assembly
24 Flat screen high resolution monitor (1900x1200)
Sound bar for 24 monitor
Hight adjustable cart with installation kit
IP Camera mount
Two-port NIC Card, for use with SFF and tower PC's
Hospital grade UPS (420VA)
Complete review suite for multi-user environment (Citrix, VMWare, Terminal services, ect)
Software for remote access sold per PC
Digital Video Software MPEG4 with USB dongle
Sony HD Camera with pan, tilt, zoom, IP streaming supporting 1080P
Microphone system, ceiling or surface mount. Microphone power provided by camera
VARIO I2 Illuminator with 3 angle OP
VARIO IR Remote control
1.3.2 BRAND NAME: Neurofax EEG-1260 (UPGRADE EEG)
Neurofax-1260 PC with NeuroWorkBench data management software
Two-port NIC Card, for use with SFF and tower PC's
Software for remote access sold per PC
Hight adjustable cart with installation kit
IP Camera mount
Hospital grade UPS (420VA)
Digital Video Software MPEG4 with USB dongle
Sony HD Camera with pan, tilt, zoom, IP streaming supporting 1080P
Microphone system, ceiling or surface mount. Microphone power provided by camera
VARIO I2 Illuminator with 3 angle OP
24 flat widescreen high resolution monitor with soundbar
1.3.3 BRAND NAME Air EEG Amplifier:
64 channel air EEG telemetry unit, main unit, battery pack, and connection cables, event marker, mini flat 64 channel junction box, and pouch for telemetry unit.
Lithium Ion battery
Connection cable for 32 channel to telemetry unit
External event marker with cable for connection to telemetry unit (2.2 feet)
Photic cable connection kit
Event / DC Cable for telemetry unit
Adapter Plate Main unit
Channel mount basket
Mini input box for amplifier
Pouch for all 32-channel mini input boxes with shoulder strap
WLAN assessment of facility to ensure if clinical workflow and technical performance requirements are met (if required)
1.3.4 BRAND NAME : Vital EEG Headset:
Must be wireless.
Must allow for setup and acquisition of data within five minutes.
Must be compatible with the rest of EEG equipment and software being procured.
1.3.5 BRAND NAME Ambulatory EEG
Trackit video collection system, color camera, built-in IR and auto switching to B&W capability, rolling case and handle
Persyst ambulatory pack for review stations only
Trackit Plus software
1.3.6 Review PC's
Replacement PC's for system being offered
1.3.7 Implementation, Configuration, and Training
Installation and termination per unit
IT Systems configuration and implementation / remote configuration
Biomedical training
Additional product training up to 16 hours (if required)
1.3.8 Persyst Upgrades
Out-of-Maintenance Persyst (CPA-I) acquisition Upgrade
Out-of-Maintenance Persyst (CPR) review upgrade
1.3.9 Implementation, Configuration, and Training
Installation and termination per unit
IT System configuration and implementation
Travel for configuration and training
Additional product training
1.4 Installation Considerations:
1.4.1 IT systems configuration and implementation for two days, including travel time, configuration and training for 20 units with additional product training up to 16 hours during a single site visit.
1.4.2 Contractor must comply with all VA mandated and local permitted/safety requirements.
1.4.3 Contractor will dispose of all boxes, trash and debris resulting from installation IAW hospital policy.
1.4.4 Remote Access: The contractor will ensure they understand and implement the IT security requirements for system interconnection documents required per the Memorandum of Understanding or Interconnection Agreement (MOU-ISA). The standard operating procedure (SOP) and a template for a MOU-ISA are located on the Information Protection Risk Management (IPRM) Portal and can be provided to the contractor. The facility will work with the contractor to establish a MOU-ISA for this requirement/equipment.
1.4.5 Installation and clinical resources scheduling dates will be established with the contractor, if applicable. Delivery dates for equipment will be confirmed prior to award and incorporated into documentation.
1.4.6 Technical and clinical assessment of facilities WLAN network to determine if clinical workflow and technical performance requirements are met. Minimum 1,500 square feet. If hospital's WLAN does not meet contractor's air/EEG system requirements, remediation will be recommended. Remediation may require the hospital to upgrade existing network which could require a modification and/or additional funding.
1.4.7 Facility will sponsor and submit necessary paperwork thru appropriate channels in order for equipment contained in this contract to obtain TRM and/or RMF and/or any other necessary cybersecurity approvals.
1.4.8 Facility will sponsor and submit necessary paperwork thru appropriate channels in order for equipment contained in this contract to obtain AVHE certification/approval.
Support Features:
1.5.1 Telephone Support: Must include 24x7x365 Unlimited Telephone Support, 24x7 Go-Live Clinical Support by Telephone per Department, 24x7 Ongoing Clinical Support by Telephone per Department for the life of the system. This support must be at no additional cost to the Government.
1.6 Warranty:
1.6.1 Equipment Warranty: Equipment has one year of parts and depot support. Supply items are warranted for 90 days from the date of shipment. The products are warranted to be free from material defects in workmanship or material under normal use and service for the warranty period.
1.7 Exclusions:
1.7.1 Asbestos testing or abatement is not the responsibility of the Contractor.
1.7.2 The contractor will not work in a bio-hazardous, radioactive, toxic, or other high-risk environment.
1.7.3 The Contractor will not provide structural, mechanical, conduit installation or electrical drawings.
1.7.4 The facility is responsible for hanging any devises on the wall/ceiling that require drilling behind sheetrock.
1.7.5 The facility is responsible to repair-patch and/or paint any walls or ceilings effected by installation or deinstallation of equipment.
1.7.6 The facility is responsible for any new network or cabling required for the installation of the system.
End Statement of Work
