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EvokeDx - Next Generation visual electrophysiology

EvokeDx Features

FEATUREBENEFIT FEATUREBENEFIT
OLED stimulus displayPremium specification, with linearization and microsecond timing, successfully addresses luminance artifact contamination known to affect LCD displaysNIH clinical dataMulti-center clinical study: differentiation of glaucoma and normals with icVEP-LC1
All-in-one designBeautiful, compact, delivered in one box, and can be mobilized with optional casePatented icVEP test strategiesLow Contrast Bright (single step), Bright Sweep, Dark Sweep
Gaze monitorOn-screen gaze monitoring allows operator to easily monitor both test recording and patient attentionTest library16 different icVEP, VEP, ERG
EvokeDx ViewerViewer application allows secure remote access by physician to test results on deviceTouch-screen UIUser interface is beautiful, intuitive, logical, easy to use
Integrated amplifierDouble-shielded, internal amplifier ... no need for the patient to hold parts of the test equipmentFourier transform analyticsT2circ, Sine : Cosine, Amp-Phase, and MSC
Single or dual channel recordingRecord single channel (3 lead) or bilateral ERG or simultaneous VEP & ERG (5 lead) ... in one go!Very short interval testingTest is divided into multiple short sequences typically 2 to 6 seconds each
Luminance calibrationSimple (auto and semi-auto) calibration, linearization, and calibration historyChild-attention animationsSelectable high-quality videos to capture and hold attention
Synchronous data collectionData collection is synchronized using low-latency Polling technique (non-IRQ) with the stimulus frame rate to eliminate time gap shifting and enhance Fourier transformed calculationsAuditory cues for patientNo sound (or associated data contamination) from intra-test sound files
Low-cost, disposable electrodesOther systems may require costly, proprietary electrodes ... EvokeDx uses low cost solutions for patient disposables.Precision visual acuity ETDRS & pediatric optotypes calibrated to test distance
Electrode T-band & keepersSimplified, secure, comfortable setup, placement of VEP electrodes in scalp plus great apposition during testing. Not required, an optional convenience.EMR | EHRLocal or network reports configuration
Simple software upgradesSoftware is easily kept current with either on-request or on-screen notice of a new versionIntegrated data backupLocal or network locations

EvokeDx Specifications

EVOKEDX STIMULUS
Resolution1920 x 1080PatternsPatented isolated-check, checkerboard, gratings, windmill-dartboard, uniform field
Frame rate60 HzTemporal functionsSine wave, square wave, superimposed two sinusoid
Grey level8 bit resolutionSweep displayUp to 10 steps with variable contrast, spatial frequency, and
temporal frequency
Gamma correctionSoftware
DATA ACQUISITION
Analog - digital
conversion
16 bit resolutionData-timing controlLow-latency Polling method (non-IRQ) to synchronize data collection to stimulus frame rate to decrease variability in response measures
Sampling rate480 S/sElectrodes3 and 5 with disposable AgCl
SIGNAL AMPLIFICATION - meets or exceeds ISCEV - International Society for Clinical Electrophysiology of Vision and FDA regulatory requirements
ChannelsDifferential, One or TwoFiltersFourier bandwidth 0.5 to 100 Hz, Fourier notch filter
Gain20,000Input range+/- 6 mV ??
CMRRCommon Mode Rejection
Ratio > 120 dB
Input impedance2 X 1012 ??
Ohm isolation voltage1.5 kVPower supply+8 to +15 VDC
DATA PROCESSINGDATA ANALYSIS
Steady-state responseSpectrum analysisT2CIRCDigital Fourier Transform driven statistical analysis reducing complex waveform to amplitude and phase angle
Transient responseArtifact removalMSCCoherence (Magnitude Squared Coherence) of recorded response
compared to frequency response noise
Digital filtersLow, high, even/odd, notchFSTATStatistical definition of difference between two samples and confidence interval
SYSTEM HARDWARE
Integrated computerOperator: 22" touchscreenPower100-240 VAC; 50/60 Hz; 5.5 A; isolation transformer included
Gaze / eye monitoringInfrared 770-950 nm camera (ISO grp)WiFi / bluetoothPrinting, EMR network communications, secure support
Dimensions20.7 x 9.5 x 16.4 inches W x D x H (52.6 x 41.6 x 16.2 cm)Weight50 lbs (22.7 kgs)
REGULATORY
USAFDA 510(k) K081591 5

EvokeDx FAQ

Why Fourier analytics?

Fourier TransformTraditionally, visual electrophysiology data has been analyzed in the time domain, typically with a transient response, looking at one or two peaks to try to draw conclusions as to whether or not the response is affected. EvokeDx features a discrete Fourier transform from the time domain to the frequency domain, allowing data from the entire response to be included in the analysis.

Much as when OCT leaped from the time domain to the spectral domain, an entirely new set of statistical tools are available in the frequency domain to simplify the clinician’s assessment of VEP and ERG responses.

What makes icVEP (isolated-check) so special?
patented icVEP (isolated-check VEP) are low-contrast, high temporal frequency tests thought to target the magnocellular pathway

patented icVEP (isolated-check VEP) are low-contrast, high temporal frequency tests thought to target the magnocellular pathway

EvokeDx is designed for visual electrophysiology measurement.  This includes VEP, ERG, and our proprietary icVEP test strategy that was the subject of an NIH funded, multi-center clinical trial.  icVEP is a low-contrast, high temporal frequency pattern that sinusoidally varies in contrast at 10 Hz.  With a well functioning pathway, and the Fourier Transform, we expect to measure a sinusoidal variance in signal at exactly 10 Hz at the visual cortex.

This novel test strategy is available in three variants: single contrast bright check, sweep of contrasting, bright checks, and sweep of contrasting dark checks.

What is a Library of tests?

EvokeDx libraryEvokeDx features multiple visual electrophysiology test configurations with commonly used parameters for icVEP, VEP, and ERG.

Why are you not using proprietary electrodes?

Visual electrophysiology has been performed for decades using a large assortment of EEG sensors, both generic and speciality, built to gather as large as possible amplitudes in the least invasive manner (something that is generally mutually exclusive).  Konan strategically utilizes standard snap connectors to give our customers a choice, both now and in the future, of the types of electrodes selected.  Use of a proprietary connector would have locked you into purchasing single-supplier, high-cost products.

Our low cost scalp electrodes for VEP are standard EEG electrodes that provide good signal amplitudes.  They are easy to apply with minimal preparation.   The optional T-Band further simplifies application and enhances consistent apposition with the scalp. The standard EEG skin electrodes used for ERG testing are easy to prep for, apply, and also provide good signal amplitudes. We expect that additional options will be available in the future, allowing you to be able to continue to decide on the best balance of cost, convenience and performance.

Why is patient attention / gaze monitoring important?
EvokeDx integrated infrared gaze monitoring and tracking

EvokeDx integrated infrared gaze monitoring and tracking

Our gaze monitoring system provides an on-screen video feed of the patient for the technician to easily monitor test progress and patient attention.  Inattention, excessive blinking, and closed eyes will distort the collected data.  Prompt attention to attentiveness will mean fewer test repeats, happier patients and better office efficiency.

What is the advantage of a two channel amplifier?

1 Channel2 ChannelEvokeDx will record one or two channels of data.  With a 5-wire lead cable, a patient can be easily prepped to do bilateral ERG recordings in a single go.

What does EvokeDx Viewer do?

EvokeDx ViewerViewer is a new application designed to work with EvokeDx.  Viewer allows the physician to view and dive deeper into a patient’s results from a remote location, securely (256 bit encryption), over the local area network. Viewer is NOT a simple utility to see a report; it is has the same robust Fourier analytic tools, filtering, and comparison features built in, exactly as if one is working on an EvokeDx system.

What are KonanCare's secure remote access and diagnostics?

KonanCare customer support

Most Konan Medical products come standard with a permission-based, encrypted, remote access tool for on-request customer support. This feature of KonanCare provides our customers with expert technical and clinical assistance without the need for an on-site visit.  KonanCare remote access is invaluable for staff training, hardware and software troubleshooting, and assistance with clinical interpretation.

How do I monitor changes over time?

EvokeDx compare functionEvokeDx’s “Compare” tool allows you to overlay two different exams to simply visually assess a change or difference. The Compare tool is useful to assess right versus left eyes at the same visit, or same eye over time.

Note that EvokeDx data is protected by 256 bit encryption and is HIPPA compliant.

I use another VEP / ERG system, why should I change?

The Next Generation icVEPMany early-adopter practices purchased (and often fully paid for) first generation clinical electrophysiology devices. Just as purchasers of time-domain OCT devices found the expanded applications and robust assessment features clinically important enough to justify moving to a spectral domain system, our customers are echoing this with EvokeDx.

Another important consideration may be ongoing costs of disposable products. If you have a first generation device and find your self annoyed with high monthly electrode and cable replacement costs, and really wish that there were better analytic tools for clinical assesment available, contact sales@KonanMedical to get a tailored estimate of the real costs of ownership.

Why does Konan use low cost, non-proprietary electrodes?

Visual electrophysiology has been performed for decades using generic and specialty electrodes. We elected to utilize industry standard snap connectors so that customers are not obligated to use the electrodes recommended and sold by Konan Medical.

Our inexpensive VEP (EEG) electrodes are designed for use on the scalp.   They are easy to apply, require minimal preparation, and produce good signal amplitudes. The optional T-Band further simplifies application and enhances consistent apposition with the scalp. The standard EEG skin electrodes used for ERG testing are easy to prep for and apply, providing good signal amplitudes.

Does EvokeDx work with EMR / EHR systems?

EvokeDx uses the same network-based file naming and location convention successfully used with our CellChek systems in thousands of clinical settings. DICOM compliance is expected in 2016.

Is EvokeDx HIPAA Compliant?

256 bit encryptionAbsolutely.  Some first generation systems may not have adequate safeguards for data protection to HIPAA requirements, and the doctor may have unintended liability for this non-compliance.

1. US Patent 06966650: Method and Apparatus for and Automated Procedure to Detect and Monitor Early-stage Glaucoma. 2. Victor JD, Mask J. A new statistic for steady-state evoked potentials, Electroencephalogy Clin Neurophysiol, 1991, 78:378-388. 3. Zemon V, Tsai JC, et al. Novel electrophysiological instrument for rapid and objective assessment of magnocellular deficits associated with glaucoma, Doc. Ophthalmol, 2008, 17:233-243. 4. Kim D, Zemon V, Saperstein A, Butler B, Javitt D. Dysfunction of early-stage processing in schizophrenia: harmonic analysis, Schizophr. Res, 2005, 76:55-65. 5. FDA 510(k) K081591. This device is used as a tool for assessment of visual function. It cannot be used as a definitive diagnostic indicator. The configuration and interpretation of the test shall be made by users based upon their knowledge and understanding of VEPs in response to stimuli. Diagnosis of a patient is the responsibility of a licensed physician.