22-006511

Submitted by fratecm on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Nox A1s Sleep System
Contracting Office
National Institute of Mental Health (NIMH)

Contact Points

Primary Contract Specialist

Cheryl
Leone
cleone@mail.nih.gov

Secondary Contracting Officer

Dionne
Draper
dionne.draper@nih.gov
NAICS Code Number
621512
Diagnostic Imaging Centers
Small Business Size Standard
$16,500,000
Delivery of Goods
November 01, or 4-8 weeks post ARO
Competition Status
Brand Name Only
Vendor Name
Nox Medical, LLC
Address
6485 Shiloh Rd., Building B, Suite 500
Alpharetta, GA 30005
Single-Sole Source Determination
Brand-name or Items peculiar to one manufacturer:

The Nox system is the only ambulatory sleep system that has data on the reliability and validity of polysomnography in outpatient and home settings. Both we and our collaborators at the Metabolics Research Unit at the NIH Clinical Center have purchased core NOX polysomnography systems for use in Clinical Center studies. Therefore, we have to acquire the ambulatory sleep units from NOX in order to employ the same technology and maintain reliability across the two settings.
Background/Description of Requirement

The Genetic Epidemiology Research Branch (GERB) in collaboration with the Energy Metabolism Section at the NIDDK, is investigating the role of circadian regulations of mood and behavior in both animals and humans, and has important medical applications specifically for sleep and mood disorders.  Unfortunately, in humans, little is known regarding the chronophysiology of basic behaviors such as eating, activity, and sleep. The Energy Metabolism Section has been focused on measuring eating, activity, and metabolic rates in human studies. Sleep measurements using classical sleep labs are limited due to their unnatural setting and cumbersome equipment, wiring, and restrictions. These factors limit the ability to study patients who are especially more sensitive to them, such as bipolar disorders.  The NOX A1 system developed by NOX Medical is a small, lightweight, wearable, wireless, untethered full polysomnography (PSG) sleep system that is uniquely designed to measure sleep for both inpatient (laboratory) and outpatient (home) settings.

Signal Specifications:

13x Unipolar Channels

Touch proof connector DIN 42-802, ±8mV input range AC < 1 μVrms noise, 90 Hz BW, 256 kHz Sampling rate

4x Bipolar Channels

Key hole connector, ±350mV input range DC or AC < 1 μVrms noise, 90 Hz BW, 256 kHz Sampling rate

2x RIP Channels

Thorax and Abdomen Respiratory Inductance Plethysmography

1x Flow/Pressure Channel

>60 cmH2O input pressure range, DC-90 Hz, <1 mmH2O noise

1x Sound Channel

8kHz sampling, Internal 3.6 kHz bandwidth, 24-bit ADC

3x Activity/Position Channel

Internal 3 axis, ±2 g

1x Wireless Interface

Bluetooth® V2.0 wireless interface for external devices

1x Ambient Light

1Hz

Performance Specifications:

 

Storage Capacity

1 GB

Recording Time

Up to 12 hours

PC Communications

USB 2.0 hi-speed

Physical Specifications:

Power Source

One 1.5V AA battery during recording; Host PC USB during data download

Battery Type

Nickel-metal hydride rechargeable (NiMH), Lithium

Device Dimension

82 mm W x 63 mm H x 21 mm D (3.23 in W x 2.48 in H x 0.83 in D)

Weight

132 grams (0.29 pounds)

Display

Type OLED-Dimensions 19 x 35 mm (0.75 x 1.38 in), resolution 128 x 64 dots

Battery Cover

Tamper proof and locked

USB 2.0 Connection

USB-Mini type B

 

NoxA1 unique features:

  • 256 kHz Sampling Rate -  A very high frequency sampling rate of 256 kHz  (256,000 samples per second) provides clean and accurate signals with advanced noise reduction and anti-aliasing.  Other systems sample much lower with most around only 256 Hz.

 

  • 32 bit signal processing – Other systems provide 16 or 24 bit signal processing.

 

  • Continuous Calibrated RIP belt technology – The Nox A1 system calibrates the thorax and abdominal every 30 seconds to provide accurate chest volume and movement as well as calculating and displaying flow and summation channel data. 

 

  • Integrated microphone – The unique built in microphone records patient and ambient room noises and can analyze and report decibel levels of snoring.

 

  • Flow Volume Loops – The A1 system and the Noxturnal software can provide flow volume loops and Konno-Meade loops from ambulatory sleep study recording or in real-time during attended acquisition studies.  The flow volume loops can be played back for each breath during analysis post recording.

 

  • Built-in Actigraphy – The built in actigraph and five way body position sensor are used to report body position and monitor the patients movements.  The Noxturnal software automatically identifies and marks the actigraph movement time to eliminate portions of data in the reporting of respiratory indices, if desired.  

 

  • Wireless Bluetooth Nonin WristOx oximeter – for accurate data and patient comfort.  

 

  • Ambient Light Meter – light sensor provides light’s on / light’s off information for unattended sleep testing.

 

  • Wireless Bluetooth enabled interface -  Wiresless data collecton from  various external, EtCO2 monitors.

 

  • Built-in Differential Pressure Transcuder – Allows for differential pressure signal recordings without the need for a separate pneumotach.

 

Quantity: One (1) Nox A1 Polysomnography (PSG) System with Wrist Ox2, Nox C1 Kit, and Nox A1 Starter Sensor Kit (Adult), Licensing and three-days onsite training

Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.