D-CSS_Attach1_Purchase_Description.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1. Statement of Need and Purpose:

The National Institute of Mental Health (NIMH) needs a brand-name or equal NIRScout X+ Core System unit and accessories.

2. Background Information and Objective:

Individuals with neurodevelopmental disorders/ intellectual disability (ID) are more likely to experience pain due to associated medical conditions. However, communication deficits in ID will frequently interfere with pain assessment as verbal inability to report pain, its intensity, and its nature are often present. To understand the genotype/ phenotype relationships in individuals with neurodevelopmental disorders/ intellectual disability relating to pain, non-invasive methods like functional near-infrared spectroscopy (fNIRS) can be used. The Brain Vision fNIRS system will be used to investigate the neurologic response to noxious stimulus in individuals with neurodevelopmental disorders/ intellectual disability. fNIRS records brain hemodynamic function in response to nociceptive stimuli, without requiring self-report.

Caretakers and clinicians caring for individuals with ID often report patterns of behaviors suggestive of altered pain sensitivity/response in individuals with intellectual disability.

While verbal description is one of several behaviors to express pain, inability to verbally communicate does not negate the possibility that a human is experiencing pain.

However, communication deficits in ID individuals will frequently interfere with pain assessment as verbal inability to report pain, its intensity, and its nature are often present. Therefore, understanding the nociceptive response in ID individuals may lead to the identification of individuals with altered nociception and pain sensitivity. fNIRS is a non-invasive method and do not require as much cooperation as other neuroimaging studies, which make them suitable to study nociception in individuals with ID.

fNIRS have been used in studies of pain sensitivity and pain response and have been shown to detect changes in somatosensory cortices in response to evoked pain in healthy individuals and in populations with chronic pain conditions. NIMH will be using the fNIRS system to characterize brain activation patterns in response to innocuous and noxious stimulation in individuals with ID (ages, 8-30 years), compared with the brain activation pattern observed in healthy controls.

3. Generic Name of Product:

functional near-infrared spectroscopy (fNIRS) system

4. Purchase Description:

Item Number 1 Product’s Brand Name: NIRScout X+ Core System Unit

ATTACHMENT 1

Manufacturer: NIRx Medical Technologies, LLC Catalog Number: NSXP-CORE Quantity: One (1)

Item Number 2 Product’s Brand Name: Source drivers for Laser source leads Manufacturer: NIRx Medical Technologies, LLC Catalog Number: ELEC-LAS-08 Quantity: One (1)

Item Number 3 Product’s Brand Name: 3x Avalanche Photodiode (APD) detector cards Manufacturer: NIRx Medical Technologies, LLC Catalog Number: ELEC-APD-12 Quantity: One (1)

Item Number 4 Product’s Brand Name: 2-wavelength laser module Manufacturer: NIRx Medical Technologies, LLC Catalog Number: LAS-2W-8 Quantity: One (1)

Item Number 5 Product’s Brand Name: Bundle of 4x laser source fibers Manufacturer: NIRx Medical Technologies, LLC Catalog Number: SRC-FBO-LAS-LOW Quantity: Two (2)

Item Number 6 Product’s Brand Name: Bundle of 4x detector fibers Manufacturer: NIRx Medical Technologies, LLC Catalog Number: DET-FBO-LOW Quantity: Three (3)

Item Number 7 Product’s Brand Name: Complete Cap Kit 16x16 Manufacturer: NIRx Medical Technologies, LLC Catalog Number: CP-KIT-1616-MRI-C Quantity: Two (2)

Item Number 8 Product’s Brand Name: 128-position NIRScap Manufacturer: NIRx Medical Technologies, LLC Catalog Number: CP-128-128S Quantity: Four (4)

Item Number 9 Product’s Brand Name: Bundle set of 8x short-channel detectors Manufacturer: NIRx Medical Technologies, LLC Catalog Number: DET-SHRT-SET Quantity: Four (4)

Item Number 10 Product’s Brand Name: Parallel port replicator Manufacturer: NIRx Medical Technologies, LLC Catalog Number: ACC-LPT-REP Quantity: One (1)

Item Number 11 Product’s Brand Name: 5-hour online remote installation and training for fNIRS Manufacturer: NIRx Medical Technologies, LLC Catalog Number: INST-TRN-R Quantity: One (1)

5. Salient characteristics: The salient physical, functional, or performance characteristics that “equal” products must meet are as follows:

Item Number 1

• Functional near-infrared spectroscopy (fNIRS) platform able to measure hemodynamic neuroactivation via oxy-, deoxy-, and total hemoglobin changes in the cerebral cortex.

• Concurrent fNIRS + fMRI and fNIRS + TMS may be conducted utilizing low-profile fiber-optic probes.

• Measures both topographic and tomographic NIRS data from the entire cortex yielding 3-D depth-discriminating neuroactivation

• Up to 64x Laser-2 (or 32x laser-4) illuminators or 64 LED-2 illuminators

• Up to 32x detectors

• Chassis (4x source bays, 8x laser module bays, 8x detector bays, 8-bit trigger input/output, 100Hz sampling rate max)

• Static calibration phantom

• dual-arm articulating assembly (up to 6x fiber bundles, 4x active bundles)

• Recording software which provides real-time multi-event block average views;

activation shown in 2D, 3D, and MNI displays; automated hardware diagnostics;

SDK for BCI/neurofeedback applications; automatic calibration and signal quality display; unique gain settings for each source-detector pair; 3D optode position registration; programmable source-illumination pattern; hyper-scanning to allow multi-subject experiments; and raw data recorded which can be analyzed in any environment

• Maximum data channel streams: 2048 (up to 4096 in tandem configuration)

• Source illumination type: Hybrid Choice: LED + Laser Sources

• Source wavelengths: LED is 760nm & 850nm; Laser is 685nm, 780nm, 808nm, 830nm

• Key measurement features: Time multiplexing and 10^9 dynamic gain state switching

• Detector Dynamic Range & Sensitivity: dynamic Range of 90 dBopt; sensitivity of SiPD: <1.0 pW; and APD of 0.05 pW

• Maximum Functional Resolution: 5mm - 30mm, depending on optode spacing

• Headgear is fully-customizable and fits all age ranges

• Multi-modal compatibility: EEG, tDCS, eye-tracking, motion-tracking with module:

fMRI, TMS

• Hyperscanning configuration: Up to 4 separate bi-lateral 16-source/8-detector arrays for four subjects

• Phase and spectroscopic technique: Single phase, continuous wave

Item Number 2

• 1x hybrid source driver card

• Powers up to 8x 2-wavelength or 4x 4-wavelength lasers; or 8x 2-wavelength

LEDs

Item Number 3

• Connects up to 12x detector leads.

Item Number 4

• 8x source lead connections (or 2x bundles) for chassis

• 1x hybrid/LED laser driver

• 1x laser module bay in system chassis.

Item Number 5

• MRI-compatible low-profile tip (up to 10m long)

Item Number 6

• Low-profile tip

• MRI-, MEG-, and TMS-compatible.

• Up to 10m long

Item Number 7

• Four oval-cut, adult head caps size 54, 56, 58, and 60cm head circumference, shower cap, holders, tops, links, cable trees and accessories for 16 sources and 16 detectors compatible with fNIRS-fMRI recordings.

Item Number 8

• 128x unpopulated 'slits' for NIRS in 10-5 layout

• NIRS positions require grommets and probes for measurements

• Numbered and colored labels

• Labeled 'standard' EEG landmarks

• Size 50, 52cm (x2)

Item Number 9

• Specialized ring grommets that secure spring-loaded and low-profile grommets

• Splits a single detector into 8 short channels that may be placed anywhere on a single cap

• Interface for any detector probe tip

Item Number 10

• 1 x parallel port (DB25) input

• 1x SMB input (BNC adapter for SMB)

• 4 x parallel port outputs

• Ideal for multi- modal integration (NIRS, EEG, tDCS, fMRI, etc.)

• 3m USB cable for power

• Cedrus C-Pod adapter.

Item Number 11

• Online and remote system installation and training including cap preparation, experimental design, and system software

6. Quantity: See paragraph 4. above.

7. Delivery Date: Within (60) after receipt of order (ARO).

Delivery shall be made to the following address:

Neurodevelopmental & Behavioral Phenotyping Service (NBPS) National Institute of Mental Health 10 Center Drive Bld. 10, Rm 1C250 Bethesda, MD 20892

8. Warranty: The Contractor shall warrant that all equipment will be free from defects from the date of installation, inspection by the Government, and acceptance. The Contractor shall provide: Standard Support and Product Warranty. 3 years on all system base units and core hardware; 1 year on NIRScaps (1-year warranty) and probes; 30-day return on consumables.