D-Attachment-PURCHASE DESCRIPTION MRI compatible Two Way Noise Cancellation System.pdf

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

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: The purpose of this requirement is to acquire an OptoACTIVE MRI-compatible Two Way Noise Cancellation System for use in NIA’s new Siemens 7T Magnetom Terra MRI scanner. This system provides both passive protection against the acoustic noise produced by the scanner and active noise cancellation for enhanced comfort and ability for the patient to communicate with the MRI operator during scanning.

2. Background Information and Objective: While MRI scanners afford a unique ability to characterize the anatomy, function and metabolism of tissues in living subjects, MRI scanning generates very loud acoustic noise. This noise is not only hazardous to the participant’s hearing but also interferes with functional MRI (fMRI) experiments and other physiological measurements sensitive to acoustic stimulation and related stress. At 3 Tesla, protection against acoustic noise requires that the participant wear both earplugs and a headset. MRI-compatible noise cancellation technology, based on optoacoustic coupling, has been developed in an effort to further attenuate acoustic noise during scanning. For several years, the National Institute on Aging (NIA) has used an earlier version of the OptoACTIVE MRI-compatible Two Way Noise Cancellation System with great success on its Philips 3T MRI scanner. With the upcoming addition of a Siemens 7T Magnetom Terra MRI scanner, the need for thin active noise cancellation headphones is still greater given the tighter head coils associated with this high-field MRI instrument. Since our purchase for the 3T MRI scanner, OptoAcoustics, Ltd. has made considerable improvements in their unique MRI-compatible noise cancellation technology and the NIA intends to utilize this technology to provide optimum attenuation of acoustic noise for participants undergoing scanning at 7 Tesla.

3. Generic Name of Product: MRI-compatible Two Way Noise Cancellation System.

4. Purchase Description:

OptoACTIVE Two Way Noise Cancellation fMRI Communication System PART#

700A0221 (QTY=1)

Headset OptoACTIVE-III Concha PART# 700A0225 (QTY=1)

Customized Concha Multipad PART# 700A0231 (QTY=1)

Hygienic Pop Screens (Pack 100 pieces) PART# 501A0039 (QTY=1)

Hygienic Earpad covers Pack 50 pieces (Disposables) (QTY=1)

5. Salient characteristics

a. System shall permit two-way communication between a subject undergoing head-first MRI scanning on a 7 Tesla Siemens Magnetom Terra X scanner.

b. System shall utilize opto-acoustic technology for coupling of sound into and out of the patient headset. - This is needed to completely eliminate the use of electrical wiring within the MRI magnet room. Such wiring can produce image artifacts and may burn the patient. Equipment containing no electrically conductive materials is intrinsically MRI-safe at any field strength.

c. System shall utilize noise-cancellation technology for active attenuation of acoustic noise generated by the MRI scanner during examinations. – This is needed to protect the patient’s hearing, for patient comfort and to minimize potential artifacts in functional MRI (fMRI) and other physiological measurements due to exposure of the patient to loud noise.

d. System shall be compatible with Siemens Magnetom Terra X MRI electronics and software to permit synchronization of noise-cancellation module with MRI pulse sequence. – The noise-cancellation feature works by “learning” the sound produced by a given MRI sequence and then playing out an “equal but opposite” audio waveform. This results in noise cancellation only if the audio system is exactly synchronized with the MRI scanner.

e. System shall be tested and approved for use at 7 Tesla. – Most MRI scanners operate at a magnetic field strength of 3 Tesla or below, so most “MRI-compatible” equipment is tested only to a maximum of 3 Tesla. As magnetic field strength increases, the danger of interaction with ferromagnetic parts and the production of image artifacts increases greatly, so special testing at 7 Tesla is essential. Equipment certified for use at 3 Tesla will not necessarily be safe and effective at 7 Tesla.

f. The system shall be capable of operating without noise-cancellation when performing MRI scans that do not support synchronization with the MRI scanner.

– As described above, the noise-cancellation feature relies on the MRI scanner to transmit one or more synchronization logic pulses. This requires that the MRI pulse sequence is programmed to generate these logic pulses. Typically, fMRI sequences have this feature built in while some other sequences do not.

g. Patient headset shall fit within the following MRI head coils: Nova Medical 8Tx/32Rx multi-transmit array; RAPID MR 1H/31P and 1H/23Na multi-nuclear head coils Nova Medical 1Tx/32Rx array coil. – These are the head coils that will be supplied with the Siemens 7 Tesla Magnetom Terra X MRI scanner.

h. That portion of each headset ear pad that extends beyond the patient’s head shall be no more than ½” (12.7 mm) thick. – This specification is needed to ensure that the headset will fit comfortably on patients with large heads in the above head coils.

i. System shall include control console at MRI operator’s station to adjust volumes and noise-cancellation parameters.

j. Control console at MRI operator’s station shall include microphone for MRI operator to communicate with patient and a push-button switch to enable and disable this microphone.

k. Patient headset shall include opto-acoustic microphone for communication with MRI operator. This microphone shall be coupled to the MRI operator’s console via opto-acoustic technology.

l. Patient microphone shall be removable. System shall remain capable of noise-cancellation and one-way communication from MRI operator to patient with patient microphone detached.

6. Quantity: See Purchase Description for quantity

7. Delivery Date: 4/1/2024

8. Period of Performance: Not applicable

9. Option(s): None