cutting edge technology in a compact, portable device with extremely low operating costs
EvokeDx is the next generation icVEP + VEP + ERG device developed by Konan Medical and leading scientists in visual electrophysiology. It’s compact, all-in-one form factor features numerous market-leading technologies including: intuitive touch-screen user interface Organic LED stimulus display, infrared gaze and attention monitoring dual-channel amplifier, and powerful Fourier (Frequency domain) analytics with intuitive reporting. EvokeDx is a fresh approach to visual electrophysiology.
Visual Evoked Potentials (VEP) provide objective, quantitative information about the functional integrity of discrete visual pathways in a non-invasive manner. This is new information that is complementary to the structural analysis obtained from technologies such as OCT and Fundus photography, and augments subjective information from standard visual acuity and perimetry. Electroretinograms (ERG) reflect the integrity of the optics, photoreceptors, bipolar cells and retinal ganglion cells. Clinically, ERGs may be useful when patients have abnormal VEPs to differentiate between retinal dysfunction occurring in the optic nerve, optic radiations and occipital cortex.
The Operator side of EvokeDx features an intuitive, touch-screen enabled user experience graphically guiding the operator easily through the test sequence:
Analytics instantly displays test results and Fourier analytics. One-touch help screens provide context-sensitive explanations of all analytic components for all tests. A robust comparison feature allows instant comparisons. For example:
The patient side of EvokeDx features a high specification OLED stimulus display, patient gaze / attention tracking, and easy plug-in for electrodes to internal dual-channel amplifier. Say goodbye to asking the patient to hold a single-channel amplifier!
The optional Viewer application allows physicians to (via 256 bit encryption) securely access the EvokeDx database across the network to review and manipulate the Fourier analytics. Dig deep into the patient results, which can also be printed or saved as PDF documents.
| FEATURE | BENEFIT | FEATURE | BENEFIT | |
|---|---|---|---|---|
| OLED stimulus display | Premium specification, with linearization and microsecond timing, successfully addresses luminance artifact contamination known to affect LCD displays | NIH clinical data | Multi-center clinical study: differentiation of glaucoma and normals with icVEP-LC1 | |
| All-in-one design | Beautiful, compact, delivered in one box, and can be mobilized with optional case | Patented icVEP test strategies | Low Contrast Bright (single step), Bright Sweep, Dark Sweep | |
| Gaze monitor | On-screen gaze monitoring allows operator to easily monitor both test recording and patient attention | Test library | 16 different icVEP, VEP, ERG | |
| EvokeDx Viewer | Viewer application allows secure remote access by physician to test results on device | Touch-screen UI | User interface is beautiful, intuitive, logical, easy to use | |
| Integrated amplifier | Double-shielded, internal amplifier ... no need for the patient to hold parts of the test equipment | Fourier transform analytics | T2circ, Sine : Cosine, Amp-Phase, and MSC | |
| Single or dual channel recording | Record single channel (3 lead) or bilateral ERG or simultaneous VEP & ERG (5 lead) ... in one go! | Very short interval testing | Test is divided into multiple short sequences typically 2 to 6 seconds each | |
| Luminance calibration | Simple (auto and semi-auto) calibration, linearization, and calibration history | Child-attention animations | Selectable high-quality videos to capture and hold attention | |
| Synchronous data collection | Data collection is synchronized using low-latency Polling technique (non-IRQ) with the stimulus frame rate to eliminate time gap shifting and enhance Fourier transformed calculations | Auditory cues for patient | No sound (or associated data contamination) from intra-test sound files | |
| Low-cost, disposable electrodes | Other 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 & keepers | Simplified, secure, comfortable setup, placement of VEP electrodes in scalp plus great apposition during testing. Not required, an optional convenience. | EMR | EHR | Local or network reports configuration | |
| Simple software upgrades | Software is easily kept current with either on-request or on-screen notice of a new version | Integrated data backup | Local or network locations |
| EVOKEDX STIMULUS | ||||
| Resolution | 1920 x 1080 | Patterns | Patented isolated-check, checkerboard, gratings, windmill-dartboard, uniform field | |
| Frame rate | 60 Hz | Temporal functions | Sine wave, square wave, superimposed two sinusoid | |
| Grey level | 8 bit resolution | Sweep display | Up to 10 steps with variable contrast, spatial frequency, and temporal frequency |
|
| Gamma correction | Software | |||
| DATA ACQUISITION | ||||
| Analog - digital conversion |
16 bit resolution | Data-timing control | Low-latency Polling method (non-IRQ) to synchronize data collection to stimulus frame rate to decrease variability in response measures | |
| Sampling rate | 480 S/s | Electrodes | 3 and 5 with disposable AgCl | |
| SIGNAL AMPLIFICATION - meets or exceeds ISCEV - International Society for Clinical Electrophysiology of Vision and FDA regulatory requirements | ||||
| Channels | Differential, One or Two | Filters | Fourier bandwidth 0.5 to 100 Hz, Fourier notch filter | |
| Gain | 20,000 | Input range | +/- 6 mV ?? | |
| CMRR | Common Mode Rejection Ratio > 120 dB |
Input impedance | 2 X 1012 ?? | |
| Ohm isolation voltage | 1.5 kV | Power supply | +8 to +15 VDC | |
| DATA PROCESSING | DATA ANALYSIS | |||
| Steady-state response | Spectrum analysis | T2CIRC | Digital Fourier Transform driven statistical analysis reducing complex waveform to amplitude and phase angle | |
| Transient response | Artifact removal | MSC | Coherence (Magnitude Squared Coherence) of recorded response compared to frequency response noise |
|
| Digital filters | Low, high, even/odd, notch | FSTAT | Statistical definition of difference between two samples and confidence interval | |
| SYSTEM HARDWARE | ||||
| Integrated computer | Operator: 22" touchscreen | Power | 100-240 VAC; 50/60 Hz; 5.5 A; isolation transformer included | |
| Gaze / eye monitoring | Infrared 770-950 nm camera (ISO grp) | WiFi / bluetooth | Printing, EMR network communications, secure support | |
| Dimensions | 20.7 x 9.5 x 16.4 inches W x D x H (52.6 x 41.6 x 16.2 cm) | Weight | 50 lbs (22.7 kgs) | |
| REGULATORY | ||||
| USA | FDA 510(k) K081591 5 | |||
Discrete Fourier analysis is used to decompose the complex and repetitive time-based waveform into a spectrum of sinusoidal functions, “frequency components”, each quantified by an amplitude and phase value to be used with a series of Fourier statistical tools.
Konan’s patented Isolated Check VEP (icVEP™) is a low-contrast, high temporal frequency, sinusoidally modulated stimulus thought to target the magnocellular pathway.
EvokeDx features a novel test administration method, “Very Short Runs”, typically 2 to 6 seconds each, enabling easier patient compliance, better staff satisfaction, and ultimately mathematically advantaged in the signal averaging process.
The EvokeDx test library includes both novel and ISCEV standard visual electrophysiology systems. Grouped by icVEP, VEP, and ERG strategies, simply select the test, the eye(s) being tested, and whether recorded with one or two channels.
EvokeDx electrode leads feature standard snap connectors to allow the utilization of high quality, non-proprietary EEG electrodes that cost significantly less than the proprietary electrodes offered by other vendors.
Contact Konan Medical for a review of how substantial this cost savings really is in your practice.
SBIR Glaucoma investigation, reported 94% and 92% accuracy respectively in separating glaucomatous from non-glaucoma patients using the patented icVEP protocol. Independent assessments in June 2013 at two sites in Beijing (TongRen and YouYi) report equivalent findings using icVEP.
Off-the-shelf LCD monitors used by some other companies introduce an undesirable luminance artifact that may contaminate a transient response. Our linearized Organic Light Emitting Diode (OLED) monitor eliminates luminance artifact while adding microsecond timing.
EvokeDx utilizes an IR gaze-monitor to assist in patient positioning, and attention / fixation during the test. A graphical heat map provides the operator with real-time feedback on the monitor while the test is being conducted.
Kid-friendly, video animations are one-touch available to capture the child’s attention and test immediately with our novel “Very Short Run” strategy. This simplifies lack of attention problems encountered with extended test sequences and re-tests from attention lapses.
Konan products feature “KonanCare”, an integrated remote support tool, to enable secure, permission-based, real-time, onboard training and technical support. Yet another cutting-edge feature designed to enhance support and training while reducing costs and downtime.
A fast and simple luminance calibration feature is included to periodically verify monitor luminance output critical for precision testing. Systems are individually calibrated at manufacture, but all monitors change luminance characteristics over time. We make it easy to maintain optimum performance.
Our scientists have incorporated a low-latency technique to synchronize data collection as opposed to video-card based “IRQ” methods. Synchronous data is designed to avoid errors from side-lobe leakage. Automated artifact rejection also simplifies high-quality data collection.
Reunión virtual con el Dr. Julian Triviño (Colombia)
