Atch.3_Requirements List FA282325Q0080.pdf

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Recorder Physiologic Evoked Potential Auditory (ABR) Equipment
Solicitation number
FA282325Q0080
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This document is a Request for Quote (RFQ) for a Recorder, Physiologic, Evoked Potential, Auditory (ABR) system, solicitation number FA2823-25-Q-0080 issued on 28 August 2025. The requirements specify a comprehensive prescription-grade auditory diagnostic system intended for professional clinical use, capable of performing assessments across all human age groups. The system must support multiple diagnostic test modalities including ABR, ASSR, ECochG, 40 Hz Event-Related Potentials, TEOAE, and DPOAE, with advanced hardware and software capabilities.

Key technical requirements include a wireless data acquisition unit with 30 ft transmission range, electrode-mounted preamplifiers, a dedicated laptop with Windows 10/11, and included accessories like insert earphones and OAE probes. Software features encompass adaptive processing, noise-tolerant acquisition, confidence graphs, and automated threshold estimation. The system must support testing in noisy clinical environments, enable tele-audiology applications, operate for at least 6 hours per battery charge, and provide extensive measurement capabilities such as stimulus levels up to 111 dB nHL, adjustable filters, and measurement of latencies, interpeak intervals, amplitude ratios, and correlation coefficients.

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Atch.3_RFQ FA2823-25-Q-0080 28 Aug. 2025

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Requirements List Recorder, Physiologic, Evoked Potential, Auditory (ABR)

1. General Requirements

• The system shall be a prescription-grade auditory diagnostic system intended for professional clinical use.

• The system shall be capable of performing comprehensive auditory assessments across the human lifespan, from neonates through adults.

2. Test Modalities

The system shall include the following diagnostic test capabilities:

• ABR (Auditory Brainstem Response)

• ASSR (Auditory Steady-State Response)

• ECochG (Electrocochleography)

• 40 Hz Event-Related Potentials

• TEOAE (Transient Evoked Otoacoustic Emissions)

• DPOAE (Distortion Product Otoacoustic Emissions)

3. Hardware Requirements

• The system shall include a wireless data acquisition unit with a minimum 30 ft transmission range.

• The system shall include electrode-mounted preamplifiers for in-situ amplification.

• The system shall support both single-channel and dual-channel electrode configurations.

• The system shall include a dedicated laptop with Windows 10/11 and ABR software preinstalled.

• The system shall include:

o Insert earphones o Bone conductor o OAE probes o ECochG electrode ear tip cable

Atch.3_RFQ FA2823-25-Q-0080 28 Aug. 2025

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4. Software Requirements

• The system software shall provide adaptive processing with Kalman-weighted averaging.

• The software shall allow noise-tolerant acquisition without discarding sweeps.

• The software shall provide confidence graphs, waveform repeatability displays, latency-intensity plots, Wave V Norms, and waveform smoothing.

• The system shall allow simultaneous multi-frequency ASSR with automated threshold estimation.

5. Performance Requirements

• The system shall allow click stimuli up to 99 dB nHL, tonebursts up to 105 dB nHL, and chirps up to 111 dB nHL.

• The system shall support adjustable filters:

o High-pass: 30–300 Hz o Low-pass: 300–3000 Hz

• The system shall provide a recording window of 0–120 ms.

• The system shall measure:

o Latencies (I–V) o Interpeak intervals o Amplitude ratios o Correlation coefficients

6. Clinical & Operational Requirements

• The system shall enable sedated and non-sedated ABR testing in infants and children.

• The system shall be able to be used in noisy clinical environments (e.g., NICU, OR) without requiring a shielded sound booth.

• The system shall support tele-audiology applications via wireless operation.

• The system shall be battery powered with at least 6 hours of operation per charge.

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