Salient Characteristics.pdf

Brand Name Worksheet (“Salient Characteristics”)

8/7/2024

Brand Name Item: Interacoustics Eclipse EP25 ASSR/VEMP

Essential/significant physical, functional, or performance characteristics.

Tests: ECOG, ABR, MLR, LLR, MMN, P300, ASSR AC/BC; cVEMP/oVEMP.

Transducers: Insert phones, bone conduction oscillator.

EP features: auto peak picking; Baysian weighting; objective waveform analysis (FMP, residual noise, waveform reproducibility); BB amd NB CE Chirps.

Auditory Steady State Response(ASSR)/ Auditory Brainstem Response (ABR) Equipment o Recording window is 980 ms or higher o Capabilities:

EcochG

ABR

MLR

ALR

MMN/P300

eABR o Internal medically approved power supply o Soft attenuator o Integrated database and report generator o Includes automatic test sequence and norm data o Integrated patient communication and impedance check o Correlation calculation o Network version o Bayesian weighting o Stochastic stimuli rate o Fmp calculation o Residual noise calculation.

Vestibular evoked myogenic potential (VEMP) testing module o Recording window is 150 ms or higher o Capabilities:

cVEMP / oVEMP

EMG controlled stimulus/recording

EMG scaling (rectification)

Patient EMG monitor/tone

Accessories: starter supplies (electrodes; skin prep materials).

a) Compatibility – Compatible module with NOAH, the VA standard module for Audiology, Win 10

b) Industry Standard – Yes

c) Purpose – AEP, ASSR, VEMP & OAE testing

d) Governing Body or Organization – Veterans Health Administration

1) Complete generic identification – Recorders: Physio: Evoked Potential: Auditory

2) Applicable model/make/catalog number – 8531285

3) Manufacturer name – Interacoustics

Brand Name Item: Interacoustics EyeSeeCam vHIT 3rd Gen

Essential/significant physical, functional, or performance characteristics.

Tests: VOR of lateral, RALP, & LARP canals, SHIMP, spontaneous nystagmus.

Software: 3rd generation VE525 software.

Hardware: printer, lightweight monocular video goggles w/ high speed USB camera, inertial measurement unit, built‐in laser calibration lights.

Comprehensive ‐ assess presence of spontaneous nystagmus and VOR function of all six semicircular canals with confidence

Easy ‐ guides are provided to help the clinician generate accurate head impulses

Reliable – extremely lightweight, superior goggle design to reduce slippage

Flexible – can test the left or right eye

Accurate – measures instantaneous gain and velocity regression

Comprehensive – displays overt and covert saccades, gain and 3D graphics

Has the capability to record and 2 playback videos.

a) Compatibility – Compatible module with NOAH, the VA standard module for Audiology

b) Industry Standard – Yes

c) Purpose – Video Head Impluse Test

4) Complete generic identification – Videonystagmographs

5) Applicable model/make/catalog number – 8525982

6) Manufacturer name – Interacoustics

Brand Name Item: Interacoustics Titan V4 Clinical Middle Ear Analyzer/

DPOAE/TEOAE/WBT Clinical

Essential/significant physical, functional, or performance characteristics.

Software: Titan Suite w/ IMP/multiple probe tones/Wide Band Tympanometry; DPOAE/TEOAE.

Tests: 226, 678, 800, 1KHz (Y,B,G) tymps; WB tymp; WB absorbance; ipsi & contra reflexes; patulous ET; ETF

(intact TM); reflex decay; reflex latency; screening and dx DPOAE/TEOAE.

Transducers: probe extension cable (IMP, OAE); IP30 contra phone.

Accessories: charging stand; 2 rechargeable lithium batteries; eartip kit; test cavities; USB cable; carrying case.

Features: PC‐controlled or standalone; auto & manual pump control; pressurized OAE test; DP I/O growth test; 3D tympanometry; WB absorbance; ME resonance.

PC printing from Titan Suite

a) Compatibility – Compatible module with NOAH, the VA standard module for Audiology

b) Industry Standard – Yes

c) Purpose – Perform standard tympanometry, acoustic reflex, and reflex decay and latency tests

7) Complete generic identification – Analyzers: Physio: Middle Ear

8) Applicable model/make/catalog number – 8531247

9) Manufacturer name – Interacoustics

Brand Name Item: OtoAccess

Essential/significant physical, functional, or performance characteristics.

Compatible with chair, caloric irrigator, vendor license upgrade, Auditory Steady State Response(ASSR)/

Auditory Brainstem Response (ABR) Equipment, VEMP module, and Vendor Vestibulo‐ocular reflex (VOR) module

Standardized database across VANCHCS, end user/clinical user knows how to use the system no matter what location they are at

a) Compatibility – See above

b) Industry Standard – Yes

c) Purpose – Vendor proprietary database for audiology computer

1) Complete generic identification – Vendor proprietary database for audiology computer

2) Applicable model/make/catalog number – 8517470

3) Manufacturer name – Interacoustics

Brand Name Item: Aqua Stim

Essential/significant physical, functional, or performance characteristics.

110V

Water flow rate: 250cc/30 seconds

Water temperature: 30ºC and 44ºC

Water fill and heat cycle: Each irrigation

Temperature stability: ± 1ºC

Flow accurracy: ± 15 ml/irrigation

Accuracy of tip: ± 1ºC

Irrigation time: 30 seconds

Stand‐alone or PC USB Interface

Micromedical’s Spectrum software control

Handle freatures LED’s to illuminate ear; pushbutton switch; disposable tips

External water tank

a) Compatibility – Compatible module with NOAH, the VA standard module for Audiology

b) Industry Standard – Yes

d) Purpose – Caloric water irrigator

e) Governing Body or Organization – Veterans Health Administration

4) Complete generic identification – STIMULATORS: CALORIC: VESTIBULAR FUNCTION

5) Applicable model/make/catalog number – 8534226

6) Manufacturer name – Interacoustics

Brand Name Item: Air Fx

Essential/significant physical, functional, or performance characteristics.

110V

Air flow rate: 8 ‐ 12 liters / minute

Air temperature range: Cool 20° C to 30° C (change in 1° C increments)

Stability: +/‐ 0.5° C, +/‐ 0.5 liters/min

Accuracy: +/‐ 0.5° C Quiet: 49 dB sound at 1 meter

Programmable: start temperature and irrigation duration

Time to temperature: < 3 minutes Warm 40° C to 50° C

Otoscope speculums: 2.75 mm and 4.25 mm (single use) uses audio and visual cues

LCD display front‐panel buttons

Lighted otoscope with magnifying lens and push button start

Audible and visual cues produced to assist during testing

Operate manually or via the VisualEyes software USB interface

a) Compatibility – Compatible module with NOAH, the VA standard module for Audiology

b) Industry Standard – Yes

c) Purpose – Caloric air irrigators

7) Complete generic identification – STIMULATORS: CALORIC: VESTIBULAR FUNCTION

8) Applicable model/make/catalog number – 8531357

9) Manufacturer name – Interacoustics

Brand Name Item: Interacoustics Orion Reclining Rotational Vestibular Chair and

Visual Eyes 525 3rd Generation VNG System

Essential/significant physical, functional, or performance characteristics.

Tests: gaze, random saccade, pursuit, OPK, Dix‐Hallpike, positional, caloric, ocular counter roll, saccadometry, SHA, step velocity, Visual VOR, VOR suppression

Software: 3rd generation VE525 software.

Hardware: small form factor PC; widescreen monitor, printer; binocular video goggles w/ USB cameras, RF remote control, room camera w/ mic, ISO transformer, equipment cart.

Features: real time test analysis, customized test protocols, multiple pupil tracking algorithms, one‐click eye centering, eye movement video recordings

Modern touch‐enabled user interface

Four button RF Remote to start and stop recording, turn on fixation light and center both eyes on computer screen

TV screen to display large eye images for ease of testing and patient review

Real time analysis of nystagmus measures patient's nystagmus response as data is collected

Time line scrolls to show location in raw data

Color‐coded nystagmus beats to quickly highlight patient's response

Fixation light is automatically enabled during the caloric tests when the patient's response begins to decay

Patient Interview recording for documenting patient's case history, patient observation recording for documenting patient testing procedures or for clinical training sessions maximum velocity of 200 deg/ sec acceleration up to 200 deg/ sec2 patients up to 350 lbs

Test battery o Sinusoidal harmonic acceleration (SHA) from 0.01 Hz to 0.64 Hz o Step velocity test up to 200 deg/sec o VOR suppression test from 0.01 Hz to 0.64 Hz o Visual VOR using the included large screen monitor

Comes with 50 inch compatible TV, TV wall mount, HDMI cable, power extension cables and wire moldings

a) Compatibility – software integrates either the Air Fx air caloric irrigator or Aqua Stim water caloric irrigator for computer controlled caloric stimulations, Compatible module with NOAH, the VA standard module for Audiology

b) Industry Standard – Yes

d) Purpose – Complete VNG solution for balance assessment

e) Governing Body or Organization – Veterans Health Administration

10) Complete generic identification – Videonystagmographs

11) Applicable model/make/catalog number – 8526809(VNG Chair/Visual Eyes), 1000683 (TV), 1000684 (TV Mount)

12) Manufacturer name – Interacoustics

Per VAAR 811.104 and 811.105, I certify the following regarding the above information:

The salient characteristics listed above are essential to the Government’s requirements.

To my knowledge, the restrictions listed above will not limit the acquisition to an item peculiar to one manufacture.