Product Specifications

(Generation 2)

Intended Use
TM
Integrity V500 System is intended to aid in detecting hearing loss and lesions in the ECochG – diagnostic
auditory pathway. It is a prescription device with labelling, instructions and user Stimulation: Air-conduction (AC)
operations designed for trained professionals. Stimuli: Click 100 μs, 0-99 dB nHL
Recording: Gold-foiled ABR electrode (TipTrode™)
System Summary Measured variables: Baseline, SP & AP latencies & amplitudes,
Main Hardware Components: SP/AP amplitude ratio
Computer Interface Portable laptop with Windows 7/8 64-bit and Integrity V500 TEOAE – diagnostic & automated screening
software. Stimuli: Click 80, 120 μs, 60-85 dB pe SPL, linear, non-linear
TM
VivoLink Wireless interface module Measured variables: Signal, noise, SNR in 1-kHz, 1, 1/2, 1/4, 1/6-oct bands
Amplitrode A81 electrode-mounted in-situ differential bio-amplifier Pass-refer criteria: Multiple, flexible, user-selectable
A82 dual-channel electrode-mounted in-situ differential bio-
amplifier 40 Hz ERP – threshold estimation
AEP Transducers ER-3A-800 insert earphones (included with ABR) Stimulation: Air-conduction (AC) and Supra-aural headphones
B71W bone-conductor (included with ABR) Stimuli: 0-105 dB nHL, Chirp stimuli with center frequency
H-800 EP Headphones (option) 0.5, 1, 2, 4 kHz
OAE Probes P81-GP custom probe for general use (option) Recording traces: Average (A+B), buffers A & B & difference (A-B)
P81-UG smaller probe suitable for newborns, infants (option) Recording window: 125 ms
Measured variable: interpeak latency (ms)
Software Modules:
ABR B Auditory Brainstem Response Hardware Specifications
ASSR A Auditory Steady-State Response Computer Dual-core laptop with built-in Bluetooth adapter, minimum
DPOAE D Distortion Product Otoacoustic Emissions 3 USB ports, 15” color, 1366x768 resolution; or equivalent.
TM
ECochG C Electrocochleography VivoLink
TEOAE T Transient Evoked Otoacoustic Emissions Sampling rate: 38,400 samples per second (sps) for windows <30ms
40 Hz ERP F 40 Hertz Event-Related Potential A/D & D/A resolution: 24 bit
Built-in: 4 snaps for parking Amplitrode, power switch, 3 LED
Output from Software (reports): indicators for power level, impedance match and wireless
Customizable PDF, file export ON
Software notch filters: 50 Hz, 60 Hz, or switched OFF
Test Module Specifications Patient isolation: Radio-frequency, spread-spectrum wireless
ABR – diagnostic & threshold estimation RF transmission: hopping, 2,402 to 2,480 MHz, emitted power < 3 dBm,
Stimulation: Air-conduction (AC), Bone-conduction (BC), and Supra- connection range 30 feet (10 meters)
aural headphones Dimensions: L 7.1” (18cm) x W 3.6” (9.1cm) x H 1.2” (3.2cm)
Stimuli: Click 100 μs, Toneburst 0.5, 1, 2, 3, 4 kHz, Broadband chirp Weight: 0.8 lb (363g) with battery pack
Calibration: AC: dB pe SPL, dB nHL Batteries: Vivosonic rechargeable battery pack
BC: dB pe FL, dB nHL Amplitrode
Toneburst windowing: Blackman, Rectangular, Linear Nominal gain: 7,600
Stimulus intensity: Click: 0-99 dB nHL Frequency band: 30-3000 Hz
Toneburst: 0.5 kHz: 0-105, 1 kHz: 0-104, 2 kHz: 0-99, Input impedance: 1.5 MΩ at 60Hz
3 kHz: 0-97, 4 kHz: 0-95 dB nHL Noise level: 15 nV/root (Hz) at 100 Hz
Chirp: 0-111 dB nHL Common mode >120 dB at 60 & 50 Hz (>130 dB typical)
Stimulus rate: 1.0 to 99.0 per second with 0.1/s step rejection ratio:
Stimulus polarity: Condensation (C), Rarefaction (R), Alternating (C & R Electrodes: Snap type, Neuroline 72000-S, NeuroPlus Electrode
averaged), Alternating Split (C & R displayed separately) A10040, NeuroPlus Electrode A10041
Recording traces: Average (A+B), buffers A & B and difference (A-B) OAE Probe Options
Recording window: From 0 to 120 ms P81-GP probe: General use. 2 microphones, 2 receivers. No detachable
Digital filters: Adjustable, High-pass 30-300 Hz, Low-pass: 300-3000 Hz parts. Easy to clean with mini-brush and disinfecting wipes.
Measured variables: Real-time Wave: I, II, III, IV, V latencies P81-UG probe: General use and suitable for newborns and infants.
Interpeak invervals: I-III, III-V, I-V 1 microphone, 2 receivers, test cavity.
Amplitudes: Wave I & V, V/I amplitude ratio Warranty
Latency-specific Correlation Coefficient One year warranty on most new parts and labor (excluding mishandling or misuse).
Latency norms: Newborn to adults Amplitrode - 180 days. Battery packs – 120 days.
Masking: White noise, 0-90 dB HL
Quality System
ASSR – threshold estimation Meets the requirements of ISO 13485, FDA 21 CFR Part 820, Medical Devices
Stimulation: Air-conduction (AC) and Supra-aural headphones Directive 93/42/EEC (CE marking approval).
Stimulus 0.5, 1, 2, 4 kHz
frequencies: Set up to 4 simultaneous frequencies per ear. Regulatory Compliance
Stimulus intensity: 0 to 95 dB nHL Canada: Health Canada Medical Device Licence 67609.
Set maximum, minimum and initial levels. TÜV SÜD 81763. Industry Canada ID 1520A-LMX9838.
Modulation 40 Hz and 80 Hz families European Union: CE Registration DE/CA09/0170/1207Ä1 to 1212Ä1, 3157
frequency rates: ETSI EN 300 328 V1.8.1.
Modulation type: Modified chirp United States: FDA 510(k) K043396. TÜV SÜD 81763. FCC Part 15, FCC
Threshold search Automated method using two user-definable search ID ED9LMX9838.
method: resolution steps. Users can monitor and adjust settings. Other countries: Please enquire.
Maximum search time: User-definable Configurations
ASSR detection: Automated Full-featured Laptop computer, VivoLink, A81, A82, ER-3A-800, B71W,
Conversion factors: User-definable conversion from ASSR to behavioral Integrity ER3-60 electrode eartip cable with connector, tip adapters,
Report: Estimated audiogram, ASSR gram ABR/ECochG: battery pack charging kit, carrying case, shoulder straps,
starter kit of disposables and consumables, Integrity V500
DPOAE – diagnostic & automated screening ABR/ECochG software, Integrity V500 User’s Manual
Stimuli: f2 frequencies: 0.5, 0.75, 1, 1.5, 2, 2.5, (PDF), Integrity V500 Quick Reference. Optional: printer
3, 3.2, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 kHz
levels: 40-75 dB SPL Optional: ASSR module, DPOAE/TEOAE module with OAE
f2/f1 ratio: 1.2 & 1.22 (f2> f1) Probe and test cavity, 40 Hz ERP, supra-aural headphones.
System noise & ≤-10 dB SPL at 75/75 dB SPL stimulus
system DP:
Measured variables: Signal, noise, SNR at f2 frequencies
Pass-refer criteria: Multiple, flexible, user-selectable

North America: 1.877.255.7685 Intl: 1.416.231.9997 Fax: 416.231.2289 E-mail: [email protected]

Integrity, VivoLink and Aurix are trademarks of Vivosonic Inc. Amplitrode is a registered trademark of Vivosonic Inc. U.S. Patent Nos.
120-5525 Eglinton Ave. W. 6,778,955, 7,206,625, 7,286,983, 7,548,774 and 8,484,270 . Other patents pending in the U.S. and other countries. FDA, FCC
Toronto, ON M9C 5K5 Cleared, Health Canada Licensed, CE Marked. Document No. D-11419 Version 2, 05-Mar-2015.