Attachment B Statement of Need- EEG.pdf

Attachment

36C24823Q1563

Statement of Need

Background:

The Malcom Randall VA Medical Center has a unique & specific requirement to expand the Clinical Neurophysiology Diagnostic Department throughout the North Florida/South Georgia VA Healthcare System: A service/maintenance agreement is not required. EEG Sleep

Acquisition Desktop System.

Salient Characteristic:

The offerors equipment shall meet or exceed the following characteristics for the required EEG

LTM/Sleep Acquisition System: Offerors system shall be compatible with the Natus System currently in place throughout the North Florida/South Georgia VA Medical Center. EEG System shall be compatible in form, fit and complete functionality.

• Each EEG System should include:

• 510(k) Clearance

• UL 60601-1 Medical Electrical Safety Standard

• Persyst 14 EEG Review and Analysis Software

• EEG/Sleep Acquisition Desktop with IP PTZ HD Color/BW Camera on ErgoJust Cart

• Minimum 24-inch FP Monitor Resolution of 1024 x 768 panel

• Medical Grade UPS with Isolation – 110V ErgoJust Cart

• EMU40EX with Natus Base:

• NeuroWorks 9x Acquisition Software with Spike / Event and High- Resolution Video

• Extended Video Monitoring Controllers

• LED Photic Stimulator:

• An arm-mounted light assembly

• A light source

• Intensity control

• Test button

• Trigger-in receptacle for a cable from a headbox

Generate photic flashes in the range of 0.5Hz to 60Hz

• EMU40 External Battery Pack, USB Power Adapter, USB Power Cable, EMU40EX

Power Cable

• Encrypted Computer Hard Drive

• On-site Installation and Training

The Quantum amplifier system is designed for the acquisition of EEG data from both scalp and intracranial contacts and features the following:

128 channels and can be cascaded up to 256 AC channels

64-channel breakout with maximum 64 AC channels

Signal quality with up to 16 kHz sampling rate

Integrated software controlled digital switch matrix

Integrated pulse oximeter

16 DC inputs

Data Stream Wizard to speed up clinical workflow when reviewing high sampling data:

The ErgoJust cart provides a portable workstation at the point of care at any hospital room:

• Mounting brackets for amplifier base units

• Acquisition computer with NeuroWorks/SleepWorks software

• Computer Monitor

• HD Color/BW various resolution camera

• IR light and microphone

• Photic stimulator

• Isolation transformer (ISO) or uninterruptible power supply (UPS)

The EMU40EX connects to the base unit, and should have the following components:

• For scalp and diagnostic studies with wireless capabilities

• 40 AC channels, 4 DC channels, SpO2

• Bandwidth is 0.1 Hz to 400 Hz

• 1 kHz sampling rate

• Bluetooth wireless technology with on-board memory for live monitoring

• Lightweight, patient wearable breakout box

The Battery Pack for EMU40EX Breakout Box is a portable power source consisting of the following four parts and is intended for use with EMU40EX Breakout Box only:

• Battery pack

• USB Power Adapter

• USB Power Cable

• EMU40EX Power Cable

The Brain Monitor connects to the base unit, and should have the following components:

• For scalp and diagnostic studies

• Up to 64 referential, up to 12 differential, 16 DC channels

• 4 kHz sampling rate

• On-board impedance check

The C& A requirements do not apply, and a security accreditation package is not required.

Software is specific to the EEG Operation system

• CPA Persyst Comprehensive Monitoring Package to provide continuous monitoring for acquisition of EEG data.

• Windows® 10 and 7 compatible

• Live streaming and recording of video EEG to a server

• Cerebrum - centralized software update management

• User customizable personal workspaces

• Built-in HIPAA compliant role-based security with Active Directory integration

• Variety of analysis tools o Natus spike and event detection o Stellate event detection o Persyst® event detection and trending o Natus QEEG trending o Frequency analysis tool o Advanced Trending options

• Physiologic Monitoring Integration options

• IP streaming cameras and amplifiers

• Single or dual stream Full HD 1080p video

• Enterprise level MS SQL Server database

• Automated discovery of amplifiers and cameras using DHCP

• Support for hard drive encryption

• EEG/Sleep combo software package

• SDK for direct EEG data access for research

• Data-stream Wizard with two data streams for efficient clinical and research workflow

• Citrix® Ready partner

Used to apply photic flashes to the patient during neurophysiology studies. The photic stimulator assembly connects to the base unit cart and should \ consist of the following components:

• An arm-mounted light assembly

• A light source

• Intensity control

• Test button

• Trigger-in receptacle for a cable from a headbox

• Generate photic flashes in the range of 0.5Hz to 60Hz

The base unit can be powered by 100-120 V, 220-240 V, 50/60 Hz

Operating (in use): Temperature should be 60 to 90˚F (15.6 to 32.2 ˚C).

Non-Operating (in storage): Temperature should be 0 to 132˚F (17.7 to 55˚C).

Delivery:

• Vendor shall deliver equipment to the warehouse no later than 30-days from the date of award to the place of performance indicated below.

• Monday – Friday (Excluding National Holidays), 8am – 4:30pm:

WARRANTY OF EQUIPMENT: Offeror shall provide all manufacturer(s) warranty and any extended warranties information for all offered equipment and accessories.