Product Specifications
Intended use
Integrity™ V500 is indicated for auditory evoked response testing as an aid in detecting hearing loss and lesions in the auditory pathway. Integrity™ V500 is a prescription device.
The labeling, instructions and user operations are designed for trained professionals.
System
Portable PC-based, consisting of hardware and computer software, and configured in a carrying case.
Software specifications
Modules (test modalities)
ABR B Auditory Brainstem Response (diagnostic and threshold)
ASABR A Automated Screening ABR (future release)
ECochG C Electrocochleography
DPOAE D Distortion Product Otoacoustic Emission
TEOAE T Transient Evoked Otoacoustic Emission
ASSR S Auditory Steady State Response (future release)
Computer software architecture (Graphic User Interface, GUI)
Seven tab-selectable, common for all software modules (test modalities), user-friendly,and easy-to-navigate functional screens:
Patient’s spreadsheet-style data entry, for patient demographic information
Planner spreadsheet-style data entry, for scheduling appointments
Protocol password-protected, for setting protocol parameters
Test SQL-based, for running tests and on-line viewing results
System for system settings and fully secure data backup, restore, and merging
from multiple Integrity™ units
Database SQL-based, secured, password-protected, spreadsheet-style data sorting and query, viewing and off-line analysis of test results, typing reports, printing
results and reports, and exporting data to statistical software
About Software identification and Customer Support information
Module-specific specifications
ABR – diagnostic and threshold estimation
Stimulation: Air (AC) and bone conduction (BC), ipsi- and contralateral
Stimuli: Click 100 µs and tone bursts 0.5, 1, 2, 3, and 4 kHz
Calibration: dB pe SPL and nHL for AC, dB pe FL and dB nHL for BC
Tone-burst windowing: Blackman, rectangular, and linear
Stimulus rate: 7.1 to 95.0 per second with 0.1/s step
Stimulus polarity: Condensation (C), Rarefaction (R), Alternating (C & R averaged),
Alternating Split (C & R displayed separately)
Recording traces: Average (A+B), A and B, and A-B
Recording window: From -1 to 0-30 ms
Digital filters: Adjustable, high-pass 30-300 Hz and low-pass 1000-3000 Hz
Measured variables: Real-time Wave I, II, III, IV, V latencies, I-III, III-V, I-V interpeak
intervals, Wave I and V amplitudes, V/I amplitude ratio, and latency-specific
Correlation Coefficient
Latency norms: Newborn to adults (UCLA, Vanderbilt, and Boys Town)
ASABR – automated screening ABR (future release)
Stimulus: Air-conducted click 100 µs, 35 dB nHL, rate 37.7 per second
Screening criteria: Statistic-based (variance ratio), not template-based
ECochG
Stimuli: Click 100 µs, 80-100 dB nHL (135 dB pe SPL)
Recording: Gold-foiled ABR electrode (TipTrode™)
Measured variables: Baseline, SP, and AP latencies and amplitudes,
and SP/AP amplitude ratio
TEOAE – diagnostic and automated screening
Stimuli: Click 80 and 120 µs, 60-85 dB pe SPL, linear and non-linear
Measured variables: Signal, noise, and SNR in 1-kHz, 1, 1/2, 1/4, 1/6-oct bands
Pass-refer criteria: Multiple, flexible, user-selectable
DPOAE – diagnostic and automated screening
Stimuli: f2 frequencies 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.2, 3.5, 4, 4.5, 5, 5.5, 6, 7, and
8 kHz; levels 40-75 dB SPL; f2/f1 ratio 1.2 and 1.22 (f2> f1)
System Noise and System DP: ≤-10 dB SPL at 75/75 dB SPL stimulus
Measured variables: Signal, noise, and SNR at f2 frequencies
Pass-refer criteria: Multiple, flexible, user-selectable
ASSR (future release)
Stimuli: AM, FM, mixed AM and FM, single-ear and simultaneous R&L ears,
single-frequency and multiple frequency modes, carrier frequencies 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 6, and 8 kHz
Hardware specifications
VivoLink™ – wireless interface module
Gain: User-selectable, 0, 10, 20, and 40 dB (post-Amplitrode®)
Sampling rate: 38,400 samples per second (sps)
A/D and D/A resolution: 24 bit
Built-in: 1-cc Cavity for OAE Probe, 3 snaps for parking Amplitrode®, power switch,
3 LED indicators for power ON, impedance match, and wireless ON
Notch filters: User-selectable 50 Hz, 60 Hz, or switched OFF
Patient isolation: Radio-frequency, spread-spectrum wireless
RF transmission: hopping, 2,402 to 2,480 MHz, emitted power <1.02 mW,
connection range 30 feet (10 meters)
Connectors: ER3-A (R&L) insert earphones, B-71 bone conductor, OAE Probe, Amplitrode®
Physical: 0.8 lb (350g) weight, 7.2” (18cm) L x 3.65” (9.1cm) W x 1.2” (3cm) H
Batteries: 4 AA NiMH (rechargeable) or Alkaline (non-rechargeable)
Amplitrode® – electrode-mounted in-situ differential bio-amplifier
Gain: 15,000
Frequency band: 30-3000 Hz
Input impedance: 1.5 MΩ at 60Hz
Noise level: 8 nV/root (Hz) at 100 Hz
Common Mode
Rejection Rate: ≥115 dB at 60 and 50 Hz
Electrodes: Snap type, Neuroline 720 00-S or equivalent
OAE Probe
Design: Common for DPOAE and TEOAE, 2 microphones, 2 receivers
Easy cleaning: Mini-brush, disinfecting wipes. No detachable parts.
Configurations
AEP Kit: Notebook computer with Integrity™ software, VivoLink™, Amplitrode®, ER-3A-ABR insert phones (10 Ω), B-71 bone conductor with calibration on CD-ROM, ER3-06 Eartip Adapter, starter ear tip set, starter Neuroline 720 00-S electrode set, disinfecting wipes, prep gel or pads, Bluetooth® dongle, ER-28S Cables and gold-foiled ear tips, Charger and 8 AA NiMH batteries, User’s Manual, carrying case
OAE Kit: Notebook computer with Integrity™ software, VivoLink™, Probe with calibration on
built-in EEPROM, Starter Ear Tip Set, disinfecting wipes, software, Bluetooth® dongle, Charger and 8 AA NiMH batteries, User’s Manual, carrying case
Notebook computer: 15” screen, 1024x768 resolution, and min 3 USB ports
Optional devices: Printer, cart
Warranty
One-year warranty on parts and labor. Extended warranty available
Intellectual property
U.S. Patent Nos. 6,463,411, 6,778,955, 7,206,625, and 7,286,983. Other patents pending in the US and other countries. Integrity and VivoLink are trademarks, and Amplitrode is a registered trade mark of Vivosonic Inc. Bluetooth is a registered trade mark of Bluetooth SIG
Regulatory clearances
Canada: Health Canada Medical Device Licence 67609. Industry Canada IC 6273A-V50
United States: FDA 510(k) K043396. FCC Part 15 Product ID TVZ-V50
European Union: CE Registration DE/CA09/0170/1207 to 1212, ETSI EN 300 328 V1.6.1 (2004-07)
Reimbursement (US)
CPT Coding:
92584 Electrocochleography
92585 Auditory evoked potentials for evoked response audiometry
92586 Limited auditory evoked potentials
92587 Evoked otoacoustic emissions; limited
92588 Evoked otoacoustic emissions, comprehensive or diagnostic evaluation
ICD-9 Diagnoses Codes:
380.00-380.89 Disorders of the external ear
381.00-381.89 Nonsuppurative otitis media and Eustachian tube disorders
382.00-382.9 Suppurative and unspecified otitis media
383.00-383.9 Mastoiditis and related conditions
384.00-384.9 Other disorders of tympanic membrane
385.00-385.9 Other disorders of middle ear and mastoid
386.00-386.9 Vertiginous syndromes and other disorders of vestibular system
387.0-387.9 Otosclerosis
388.00-388.8 Other disorders of the ear
389.00-389.8 Hearing loss
780.4 Dizziness and giddiness