Product Specifications (Generation 2) Intended Use TM Integrity V500 System is intended to aid in detecting hearing loss and lesions in the auditory pathway. It is a prescription device with labelling, instructions and user operations designed for trained professionals. System Summary Main Hardware Components: Computer Interface Portable laptop with Windows 7/8 64-bit and Integrity V500 software. TM VivoLink Wireless interface module A81 electrode-mounted in-situ differential bio-amplifier Amplitrode A82 dual-channel electrode-mounted in-situ differential bioamplifier AEP Transducers ER-3A-800 insert earphones (included with ABR) B71W bone-conductor (included with ABR) H-800 EP Headphones (option) OAE Probes P81-GP custom probe for general use (option) P81-UG smaller probe suitable for newborns, infants (option) Software Modules: ABR B ASSR A DPOAE D ECochG C TEOAE T 40 Hz ERP F Auditory Brainstem Response Auditory Steady-State Response Distortion Product Otoacoustic Emissions Electrocochleography Transient Evoked Otoacoustic Emissions 40 Hertz Event-Related Potential Output from Software (reports): Customizable PDF, file export Test Module Specifications ABR – diagnostic & threshold estimation Stimulation: Air-conduction (AC), Bone-conduction (BC), and Supraaural headphones Stimuli: Click 100 μs, Toneburst 0.5, 1, 2, 3, 4 kHz, Broadband chirp Calibration: AC: dB pe SPL, dB nHL BC: dB pe FL, dB nHL Toneburst windowing: Blackman, Rectangular, Linear Stimulus intensity: Click: 0-99 dB nHL Toneburst: 0.5 kHz: 0-105, 1 kHz: 0-104, 2 kHz: 0-99, 3 kHz: 0-97, 4 kHz: 0-95 dB nHL Chirp: 0-111 dB nHL Stimulus rate: 1.0 to 99.0 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), buffers A & B and difference (A-B) Recording window: From 0 to 120 ms Digital filters: Adjustable, High-pass 30-300 Hz, Low-pass: 300-3000 Hz Measured variables: Real-time Wave: I, II, III, IV, V latencies Interpeak invervals: I-III, III-V, I-V Amplitudes: Wave I & V, V/I amplitude ratio Latency-specific Correlation Coefficient Latency norms: Newborn to adults Masking: White noise, 0-90 dB HL ASSR – threshold estimation Stimulation: Air-conduction (AC) and Supra-aural headphones Stimulus 0.5, 1, 2, 4 kHz frequencies: Set up to 4 simultaneous frequencies per ear. Stimulus intensity: 0 to 95 dB nHL Set maximum, minimum and initial levels. Modulation 40 Hz and 80 Hz families frequency rates: Modulation type: Modified chirp Threshold search Automated method using two user-definable search method: resolution steps. Users can monitor and adjust settings. Maximum search time: User-definable ASSR detection: Automated Conversion factors: User-definable conversion from ASSR to behavioral Report: Estimated audiogram, ASSR gram DPOAE – diagnostic & 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, 8 kHz levels: 40-75 dB SPL f2/f1 ratio: 1.2 & 1.22 (f2> f1) 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 ECochG – diagnostic Stimulation: Stimuli: Recording: Measured variables: Air-conduction (AC) Click 100 μs, 0-99 dB nHL Gold-foiled ABR electrode (TipTrode™) Baseline, SP & AP latencies & amplitudes, SP/AP amplitude ratio TEOAE – diagnostic & automated screening Stimuli: Click 80, 120 μs, 60-85 dB pe SPL, linear, non-linear Measured variables: Signal, noise, SNR in 1-kHz, 1, 1/2, 1/4, 1/6-oct bands Pass-refer criteria: Multiple, flexible, user-selectable 40 Hz ERP – threshold estimation Stimulation: Air-conduction (AC) and Supra-aural headphones Stimuli: 0-105 dB nHL, Chirp stimuli with center frequency 0.5, 1, 2, 4 kHz Recording traces: Average (A+B), buffers A & B & difference (A-B) Recording window: 125 ms Measured variable: interpeak latency (ms) Hardware Specifications Computer Dual-core laptop with built-in Bluetooth adapter, minimum 3 USB ports, 15” color, 1366x768 resolution; or equivalent. TM VivoLink Sampling rate: 38,400 samples per second (sps) for windows <30ms A/D & D/A resolution: 24 bit Built-in: 4 snaps for parking Amplitrode, power switch, 3 LED indicators for power level, impedance match and wireless ON Software notch filters: 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 < 3 dBm, connection range 30 feet (10 meters) Dimensions: L 7.1” (18cm) x W 3.6” (9.1cm) x H 1.2” (3.2cm) Weight: 0.8 lb (363g) with battery pack Batteries: Vivosonic rechargeable battery pack Amplitrode Nominal gain: 7,600 Frequency band: 30-3000 Hz Input impedance: 1.5 MΩ at 60Hz Noise level: 15 nV/root (Hz) at 100 Hz Common mode >120 dB at 60 & 50 Hz (>130 dB typical) rejection ratio: Electrodes: Snap type, Neuroline 72000-S, NeuroPlus Electrode A10040, NeuroPlus Electrode A10041 OAE Probe Options P81-GP probe: General use. 2 microphones, 2 receivers. No detachable parts. Easy to clean with mini-brush and disinfecting wipes. P81-UG probe: General use and suitable for newborns and infants. 1 microphone, 2 receivers, test cavity. Warranty One year warranty on most new parts and labor (excluding mishandling or misuse). Amplitrode - 180 days. Battery packs – 120 days. Quality System Meets the requirements of ISO 13485, FDA 21 CFR Part 820, Medical Devices Directive 93/42/EEC (CE marking approval). Regulatory Compliance Canada: Health Canada Medical Device Licence 67609. TÜV SÜD 81763. Industry Canada ID 1520A-LMX9838. European Union: CE Registration DE/CA09/0170/1207Ä1 to 1212Ä1, 3157 ETSI EN 300 328 V1.8.1. United States: FDA 510(k) K043396. TÜV SÜD 81763. FCC Part 15, FCC ID ED9LMX9838. Other countries: Please enquire. Configurations Full-featured Laptop computer, VivoLink, A81, A82, ER-3A-800, B71W, Integrity ER3-60 electrode eartip cable with connector, tip adapters, ABR/ECochG: battery pack charging kit, carrying case, shoulder straps, starter kit of disposables and consumables, Integrity V500 ABR/ECochG software, Integrity V500 User’s Manual (PDF), Integrity V500 Quick Reference. Optional: printer Optional: ASSR module, DPOAE/TEOAE module with OAE Probe and test cavity, 40 Hz ERP, supra-aural headphones. North America: 1.877.255.7685 Intl: 1.416.231.9997 Fax: 416.231.2289 E-mail: [email protected] 120-5525 Eglinton Ave. W. Toronto, ON M9C 5K5 Integrity, VivoLink and Aurix are trademarks of Vivosonic Inc. Amplitrode is a registered trademark of Vivosonic Inc. U.S. Patent Nos. 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 Cleared, Health Canada Licensed, CE Marked. Document No. D-11419 Version 2, 05-Mar-2015.