VIVO - INTEG D_SHEET APR_17.qxd
Contents
1. 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 f 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 f ratio 1 2 and 1 22 f gt f4 System Noise and System DP lt 10 dB SPL at 75 75 dB SPL stimulus Measured variables Signal noise and SNR at fz frequencies Pass refer criteria Multiple flexible user selectable ASSR late 2007 Stimuli AM FM mixed AM and FM single ear and simultaneous R amp 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 vivosonic Vivosonic Inc 120 5525 Eglinton Ave West Toronto Ontario Canada M9C 5K5 Fax 1 416 231 2289 Toll free 1 877 255 7685 E mail sales vivosonic com Telephone 1 416 231 9997 www vivosonic com Copyright Vivosonic Inc 2007 All rights reserved Document No 11228 Rev 1 09 Apr 2007 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 H2. 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 Summer 2007 ECochG C Electrocochleography DPOAE D Distortion Product Otoacoustic Emission TEOAE T Transient Evoked Otoacoustic Emission ASSR S Auditory Steady State Response late 2007 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 Patients spreadsheet style data entry for patient demographic information Planner spreadsheet style data entry for scheduling appointments Protocol password protected for setting protocol parameters Test SOL 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 SOl 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
3. Integrity V500 Data Sheet Freedom from sedation from interferences of mobility Product Overview Integrity Vivosonic Integrity V500 is the world s only Wireless System for Auditory Electrophysiological Assessment and Hearing screening Constellation of new patented technologies makes clear ABR results attainable in virtually any patient of any age and virtually any environment These award winning technologies include in situ amplification with the patented Amplitrode wireless communication with the VivoLink and digital Kalman weighted filtering Amplitrode Amplitrode is the world s only patented in situ bio amplifier mounted directly on the electrode In situ amplification i e at the source reduces electric magnetic and RF field induced noises The result is a clean EEG signal in virtually any environment including NICU ICU OR doctors offices To provide comfort and safety Amplitrode and its Clips have springs and release buttons for easy mounting and dismounting from the snap electrodes VivoLink VivoLink is the world s only wireless platform for Auditory Electrophysiological Assessment and Screening It is battery powered and controlled from a remote computer via wireless communication Built in microprocessor generates stimuli and analyzes responses To ensure precision of stimuli generation and signal acquisition VivoLink employs very high A D and D A FROS
4. T SULLIVAN North American Technology Innovation Award Award winning technology e in Audiology resolution and sampling rates VivoLink is very convenient and comfortable to use with newborns infants young children and adults It can be secured on the adult s chest with a lanyard placed next to the baby in a crib car seat or stroller worn by the baby s caregiver secured to the bed or incubator in the NICU or conveniently placed in a toddler s toy back pack Mobility makes testing comfortable and easy for both the patient and the clinician Kalman weighted Filtering Vivosonic s patented algorithms Kalman Filtering optimize digital signal processing to dramatically reduce artifacts coming from muscular and ocular electrical activity yielding clear responses in virtually any patient It is ideal for testing non sedated non sleeping non relaxed and even active patients like feeding infants and playing children Clinical benefits Integrity obviates sedation with the associated risks and costs Integrity makes it possible to test patients who are not candidates for sedation and to provide them with the care they need This way Integrity sets a new standard of patient care integrity Freedom in Audiology Integrity V500 Data Sheet Specifications Intended use Integrity V500 is indicated for auditory evoked response testing as an aid in detecting hearing loss and lesions in the
5. ndromes 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 Integrity is designed and produced through a state of the art Quality Management System certified to ISO 13485 2003 R S CERTIFIC aA gt Qs ph 2003 SGS Printed in Canada
6. specific specifications ABR diagnostic and threshold estimation Stimulation Air AC and bone conduction BC ipsi and contralateral Stimuli Click 100 us and tone bursts 0 5 1 2 3 and 4 kHz Calibration dB pe SPL and dB 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 amp R averaged Alternating Split C amp R displayed separately Recording traces Average A B buffers A and B and difference 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 Il Ill IV V latencies I Ill III V l V interpeak intervals Wave 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 Summer 2007 Stimulus Air conducted click 100 us 35 dB nHL rate 37 7 per second Screening criteria Statistic based variance ratio not template based ECochG Stimuli Click 100 us 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 us 60 85 dB pe SPL linear
7. tooth dongle Charger and 8 AA NiMH batteries User s Manual carrying case Notebook computer 15 screen 1024x768 resolution 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 and 6 778 955 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 sy
8. z 60 Hz or switched OFF Patient isolation Radio frequency spread spectrum wireless RF transmission hopping 2 402 to 2 480 MHz emitted power lt 1 02 mW connection range 30 feet 10 meters Connectors ER3 A R amp L insert earphones B 71 bone conductor OAE Probe Amplitrode Physical 0 8 Ib 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 MQ at 60Hz Noise level 8 nV root Hz at 100 Hz Common Mode Rejection Rate 2115 dB at 60 and 50 Hz Electrodes Snap type Neuroline 720 00 S or equivalent OAE Probe Design Common for DPOAE and TEQAE 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 Q 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 Blue
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