Ours is named Kalman.
Contents
1. Intended Use Integrity V500 is intended for auditory evoked response testing as an aid in detecting hearing loss amp lesions in the auditory pathway Integrity V500 is a prescription device The labeling instructions amp user operations are designed for trained professionals System Portable PC based consisting of hardware amp computer software Includes carrying case Software Specifications Modules test modalities ABR B Auditory Brainstem Response diagnostic amp threshold ECochG C Electrocochleography DPOAE D Distortion Product Otoacoustic Emissions TEOAE T Transient Evoked Otoacoustic Emissions Software architecture Graphic User Interface GUI Seven tab selectable common for all software modules test modalities user friendly amp 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 SQL based for running tests amp on line viewing results System For system settings amp fully secure data backup restore amp merging from multiple Integrity units Database SQL based secured password protected spreadsheet style data sorting amp query viewing amp off line analysis of test results typing reports printing results amp reports amp exporting data to statistical software About Software identification amp2. ensuring quality hearing healthcare within their communities vivosonic Amplitrode Integrity V500 System and Components VivoLink yiv sonic Vivolink it VivoLink is the world s only wireless combined platform for Auditory Electrophysiological and Otoacoustic Emission assessment as well as hearing screening The included batteries provide clean power for better results a s panaan mina Amplitrode is the world s first patented X e ae A built in microprocessor generates stimuli and analyzes responses in situ bio amplifier Mounted directly on Viste To ensure stimuli precision generation and signal acquisition VivoLink the electrode in situ amplification at the J employs very high A D and D A resolution and sampling rates source reduces electric magnetic and RF It is convenient and comfortable to use and can be secured on an fleld induced noises adult with a lanyard placed next to the baby in a NICU incubator car seat stroller or worn by the baby s caregiver or child as a back pack The result is a clean EEG signal in virtually any environment including NICU ICU OR doctors offices Spring release buttons allow for easy and safe mounting and dismounting of the Amplitrode from the snap electrodes OAE Probe Bone Conductor The OAE packages include a general use probe vented and serviceable that consists of the smallest
3. Customer Support info Output from software Print Customizable PDF or file export Module specific specifications ABR diagnostic amp threshold estimation Stimulation Air AC amp bone conduction BC ipsi amp contralateral Stimuli Click 100 us amp toneburst 0 5 1 2 3 amp 4 kHz Calibration dB pe SPL amp dB nHL for AC dB pe FL amp dB nHL for BC Tone burst windowing Blackman rectangular amp linear Stimulus rate 7 1 to 95 0 per second with 0 1 s step Stimulus polarity Condensation C Rarefaction R Alternating CGR averaged Alternating Split C amp R displayed separately Recording traces Average A B buffers A amp B amp difference A B Recording window From 1 to 30 ms Digital filters Adjustable high pass 30 300 Hz amp low pass 1000 3000 Hz Measured variables Real time Wave Il Ill IV V latencies I III II V l V interpeak intervals Wave amp V amplitudes V I amplitude ratio amp latency specific Correlation Coefficient Latency norms Newborn to adults UCLA Vanderbilt amp Boys Town Masking White noise 0 90 dB HL ECochG Stimuli Click 100 us 65 100 dB nHL 135 dB pe SPL Recording Gold foiled ABR electrode TipTrode Measured variables Baseline SP amp AP latencies amp amplitudes amp SP AP amplitude ratio TEOAE diagnostic amp automated screening Stimuli Click 80 amp 120 us 60 85 dB pe SPL linear amp non linear Measured variables Signa
4. Knowles microphones and powerful mid size receivers speakers a dual microphone design which provides an additional 3 dB of signal to noise ratio SNR and an ultra soft 2m 6 7 ft long cable with clothing clip The probe fits comfortably into the ears of almost any adult or child when fitted with included ear tips and can be used with ear muffs for noise reduction In cases of conductive hearing loss bone conduction ABR tests may be required For this reason a bone conductor is used with minimal artifacts due to Integrity technologies Non Invasive ECochG For those adults requiring additional tests for ailments such as M ni re s Disease Integrity is one of the most patient centric ECochG systems on the market Unlike other systems Integrity is capable of achieving clear ECochG results using gold foiled ear tips allowing for successful test results without touching or perforating the tympanic membrane
5. 14A 13 mm 100 pcs ER3 14B 10 mm PVC Eartips 20 ER3 14E 4 0 mm amp 20 ER3 14D 3 5 mm Starter Single Use Eartip Set 156 pcs in clear box 2 Impedance Tip Adapters 1 Abrasive Skin Prepping Gel Tube 100 pcs PDI Electrode Prep Pads 300 pcs Single use Neuroline Electrodes 12 packs x 25 pack ECochG Starter Gold foiled Eartip Set 20 pcs ER3 26A 13 mm amp 20 pcs ER3 26B 10 mm Spectra 360 Electrode Gel Not included in Pedatric Module Notebook computer 15 screen 1024x768 resolution min 3 USB ports Optional devices Printer Warranty One year warranty on parts amp labor Extended warranty available Regulatory clearances Canada Health Canada Medical Device Licence 67609 Industry Canada IC 6273A V50 United States FDA 510 k KO43396 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 amp Eustachian tube disorders 382 00 382 9 Suppurative amp unspecified otitis media 383 00 383 9 Mastoiditis amp related conditions 384 00 384 9 Othe
6. ise level 8 nV root Hz at 100 Hz Common Mode Rejection Rate gt 120 dB at 60 amp 50 Hz gt 135 dB typical Electrodes Snap type Neuroline 720 00 S OAE Probe Design Common for DPOAE amp TEOAE 2 microphones 2 receivers Easy cleaning Mini brush disinfecting wipes No detachable parts Configurations All Integrity V500 Systems V51 Vivolink Wireless Interface Module Ver 4 5 with V51 PS amp V51 GS Notebook Computer Carrying Case Peltor ear muffs Battery Charger 8 NIMH AA rechargeable batteries Integrity V500 Software Installation CD ROM Integrity V500 User s Manual Database Software Module Pediatric ABR Modules A51 Amplitrode in situ Pre amplifier 1 Set ER3 A ABR Insert Earphones B 71 Bone Conductor Calibration CD ROM Includes Disposables Starter Set for 100 Patients General Practice Modules A51 Amplitrode in situ Pre amplifier 1 Set ER3 A ABR Insert Ear phones B 71 Bone Conductor Calibration CD ROM ECochG ER3 28V Electrode Eartip Cable with Clip Snap and Starter Gold foiled Eartip Set 20 pcs ER3 26A 13 mm and 20 pcs ER3 26B 10 mm Spectra 360 Electrode Gel Includes Disposables Starter Set for 100 Patients TEOAE amp DPOAE Modules P40 General Use OAE Probe Probe Cleaning Tool Set Starter Single Use Eartip Set 156 pcs in clear box DPOAE Software License and or TEOAE Software License Disposables Starter Set for 100 Patients Foam Eartip Set for ER3 A ABR Insert Earphone 100 pcs ER3
7. l noise amp SNR in 1 KHz 1 1 2 1 4 1 6 oct bands Pass refer criteria Multiple flexible user selectable DPOAE diagnostic amp automated screening Sumi 12 Trequencies 0 5 0 75 4 152 2 5 5 5 2 5 5 4 45 5 5 5 0 7 2 8 kHz levels 40 75 dB SPL f2 f1 ratio 1 2 amp 1 22 f2 gt f1 System Noise amp System DP lt 10 dB SPL at 75 75 dB SPL stimulus Measured variables Signal noise amp SNR at f2 frequencies Pass refer criteria Multiple flexible user selectable Hardware specifications VivoLink wireless interface module Gain User selectable 0 10 20 amp 40 dB post Amplitrode Sampling rate 38 400 samples per second sps A D amp 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 amp 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 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 lb 350g weight 7 2 18cm Lx 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 MOQ at 60Hz No
8. o an invaluable tool for hard to test patients from the general population Flexible Options to Suit Your Situational Needs With variable options that can include Non Sedated ABR OAE and Non Invasive ECochG Vivosonic s innovative Integrity enables clinicians to perform Auditory Electrophysiological or Otoacoustic Emission assessment on almost any patient from newborns to seniors Test Wirelessly In Virtually Any Situation The first system to possess wireless capabilities Integrity is a revolution in portable diagnostics fitting unobtrusively on an alert child s back who is playing quietly during testing or into the OR In addition the Amplitrode a miniature electrode mounted bio amplifier protects against electromagnetic noise delivering clear results in places with electric and magnetic interferences such as Neonatal Intensive Care Units NICU hospitals military medical centers Operating Rooms OR and other clinical settings Integrity is also valuable in the rare instances where anesthesia is necessary and can be used for intra operative monitoring Improved Patient Care and Economics Hospitals will eliminate patient risk associated with anesthesia and shorten the test to service timeliness In addition they will also be helping to reduce the burden of anesthesia costs on the national healthcare system Integrity will enable private clinics to lessen patient referrals out and increase their patient population
9. r disorders of tympanic membrane 385 00 385 9 Other disorders of middle ear amp mastoid 386 00 386 9 Vertiginous syndromes amp 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 amp giddiness 5 5 son l C Toll Free 1 877 255 7685 Fax 416 231 2289 E mail sales vivosonic com Online www vivosonic com Integrity Vivolink and Amplitrode are all registered trademarks of Vivosonic Inc U S Patent Nos 6 463 411 6 778 955 7 206 625 120 5525 Eglinton Ave W and 7 286 983 Other patents pending in the US and other countries FDA FCC Cleared Health Canada Licensed CE Marked Toronto ON M9C 5K5 Document No 11230 r 2 30 Mar 09 integrity Non Sedated ABR OAEs Non Invasive ECochG Diagnostic System a SONIC SIT T eles sales vivosonic com WWW vivosonic com integrity Integrity s patented and award winning technologies reduce or eliminate many of the frustrations hampering today s Audiologists performing ABR tests by allowing for superior overall performance in clinical results patient care and economic efficiency High Definition ABR Without Sedation Using Kalman Weighted Filtering the Integrity is able to generate superior diagnostic results without sedation This is particularly suitable to pediatric patients who can now feed speak play or wake up while being tested It is als
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