Neuron-Spectrum-4

21-channel Digital Clinical Diagnostic EEG and EP System

Neuron- Spectrum-4 is a Class II medical device, subject to regulatory requirements in Canada and the USA.

Neuron-Spectrum-4 is the US FDA 510(k)-cleared (see K133995 in the Downloads Section), and is available in the USA for specified intended use.

It is not Health Canada-licensed and is available in Canada for investigational testing only – under PART 3 Medical Devices for Investigational Testing Involving Human Subjects of the Medical Devices Regulations (SOR/98-282).

Electroencephalography (EEG) is a method of studying the brain by means of recording its bioelectrical activity. Therefore, if there is any pathological process causing brain dysfunction, it will be reflected in different EEG abnormalities.

Neuron-Spectrum-4 is a portable device that can be simply connected to the computer via USB interface, ideal for clinical inpatient, including bedside, and outpatient settings.

Neuron-Spectrum-4 is highly efficient – clinically and economically.

The recorded EEG data is displayed on the computer screen and can be printed out on any printer.

The included software performs brain mapping as well as spectral, periodometric and coherent analyses of EEG.

Neuron-Spectrum-4 key features:

· High-quality EEG acquisition and analysis.

· Any electrode can be used as reference.

· Impedance indication on the front panel.

· Standard electrode cap connector.

· Automatic detection of spikes and sharp waves.

· Event markers.

· Wave measurement, trace magnifier, spectral analyses, trends.

· Video-EEG (VEEG) with up to 3 video cameras, including IP cameras and audio-recording with up to 2 microphones, synchronized with EEG recording, and simultaneous EEG-traces and video-audio-record review capabilities.

· Long-term (Long-duration) EEG/VEEG monitoring – over 84 hours.

· Quantitative electroencephalography (qEEG).

· Comprehensive exam reports, including templates.

· Brain mapping and bar charts.

· Operation in electromagnetically unshielded environments – no shielding required.

· Touch-proof connectors and alligator clips with leads.

· EEG analysis during acquisition.

· Data export to Excel, MATLAB, and other statistical software for further statistical analysis.

· Extensive database, HL7 compatibility.

21-channel Digital Clinical Diagnostic EEG and EP System

The Neuron-Spectrum product line consists of the modern high-tech electronic medical devices of premium quality satisfying the most stringent requirements of demanding customers – from private clinics to advanced Neurophysiologist.

Digital data-processing includes brain mapping, spectral, coherent, and periodometric analysis, and automatic report generation.  EEG signal is displayed on the computer monitor with up to 2560×1600-pixel resolution, and is printed-out on common printer paper.

Electrode impedance is indicated on the front panel.

Neuron-Spectrum instruments can be used for polysomnography, video monitoring and long-term EEG monitoring, 3-D dipole localization of pathological activity sources, evoked potential testing, heart-rate variability study, and biofeedback training.

High-quality EEG acquisition

High sampling rate allows recording high-frequency signal components without smoothing-out sharp EEG components and EEG amplitude drops.

Low noise level makes it possible to use moderate EEG filtering or using raw EEG. It allows preserving useful EEG information for analysis.

Video-EEG (VEEG)

Video-EEG can be recorded with up to 3 video cameras, including IP cameras (with optional Neuron-Spectrum-Video software).  As well, audio-recording can be performed with up to 2 microphones.

IP cameras can be used, with LAN or Wi-Fi interfaces.

Video-recording is synchronized with EEG recording, with simultaneous EEG-traces and video-record review capabilities, including transparent video overlay over EEG traces.

Electrocardiogram (ECG, EKG) recording

ECG can be recorded simultaneously with EEG – through Polygraphic Channel 1, with ECG accessories included in the Delivery Set.

Long-term (long-duration) EEG/VEEG monitoring

EEG/VEEG can be recorded over prolonged periods of time – 2-12 hours (half-day), 12-36 hours (full day), 36-60 hours (two days), 60-84 hours (three days), and longer than 84 hours.

SpO2 monitoring

SpO2 can be monitored during EEG recording with optional monitors.

Quantitative electroencephalography (qEEG)

Quantitative Electroencephalography (qEEG) includes specific parameters such as Rhythmicity, FFT power ratio, and amplitude metrics.

Impedance Indication on the front panel

Neuron-Spectrum-4 LED indicators allow observing the signal quality during the electrode placement, streamlining the workflow, and focusing on the patient and the test.

Standard electrode cap connector

Neuron-Spectrum-4 is equipped with the standard electrode cap connector. Thus, the use of adapters or other accessories to attach the cap are not required.

Touch-proof connectors and alligator clips with leads

Touch-proof connectors and alligator clips are compatible with most of EEG cables and electrodes used to attach the electrodes.

Operation in unshielded rooms

Neuron-Spectrum-4 can be used in any unshielded room. This increases the personnel convenience and patient’s comfort while decreasing the expenses for system installation – capital and operating costs.

EEG analysis during acquisition

Neuron-Spectrum-4 allows starting the analysis of obtained EEG signals during acquisition.

In the Split-Screen mode, you can review the obtained traces in one part of the screen and observe the acquisition of new EEG signals in the other part.

The spikes and sharp waves are marked on the traces automatically. It speeds up the operation, increases patient throughput, and helps seeing more patients during work hours.

Trigger IN/OUT

The Trigger IN/OUT, a double-pin 2.5 mm diameter plug, is used to connect and synchronize with external devices:

· As a trigger-IN – to synchronize the Neuron-Spectrum.NET software with an external stimulus.

· As a trigger-OUT, it is used to deliver the pulse synchronously with the internal stimulators.

Reports

Reports – with recorded traces, numeric data, and comments – are generated on-screen, can be saved, printed out, and shared.

Data storage, retention, and export

EEG measurement data and interpretation, as well as exam reports, are saved in a well-organized software database.  The data and reports can be printed out either at the time of the assessment, or at a later time, and shared with a referring doctor or researcher.

EEG data can be retained as per the institutional and/or state guidelines:  for example, for 7 years or until the patient reaches 18 years of age, whichever is longer.

EEG can be saved as a video clip (*.avi), text file (*.txt or *.rtf), XML file (*.xml),

set of graphical files (*.bmp or *.emf) or in EDF+ format (*.edf), PDF format (Adobe

Portable Document *.pdf), or EDF+ (*.edf).  As well, EEG exams can be save on a removable disk such as CD, DVD, and flash card.

ECG parameters can be exported to Excel spreadsheets, MATLAB, and other statistical software for further data analysis making it an ideal tool for research projects.

Portability

Neuron-Spectrum-4 is portable.  It can be configured as an EEG Workstation on a hospital cart for inpatient use, including bedside, and as a portable set for outpatient use. It can be placed in a Carrying Case – along with a notebook computer – and can be powered from the computer. 

Hence, it can be used both in the clinic and on an outpatient visit.

Software compatibility

Neurosoft Software enables highly efficient operation – saving both capital and operating costs – through a number of compatibility features:

Multiple Neurosoft Software:  Neurosoft Software for various Neurosoft instruments can be installed on the same computer – with no conflict between them.  Moreover, all software can share a single database – for greater convenience and work-flow efficiency.

Multiple computers:  Although only one computer can be used for diagnostic test data recording, each Neurosoft Software License allows using software on an unlimited number of computers.  Thus, the data can be recorded on one computer, and then, the data can be shared, analyzed, reviewed on other computers – with no additional Software Licenses.

Other applications:  Neurosoft Software can operate on a computer with Microsoft Office applications – Word, Excel, Outlook, PowerPoint, Access, Project, as well as Adobe and accounting software.  This is particularly efficient in smaller clinics.

Internet:  Computers with Neurosoft Software installed can be connected to the Internet.  In an unlikely and rare event that a Microsoft Operating System update affects a Neurosoft software component, it can be restored by Neurosoft software re-installation, with no loss of data. 

Information system integration

Most clinics, networks and research institutions are equipped with information systems to store and process their data.  HL7 (Health Level 7) is the most commonly used interface engine for exchange, integration, sharing and retrieval of electronic data.

HL7-compatibility allows integrating Neuro-IOM-16-V into the information system of a veterinary clinic, clinical network, or research institution.

Disinfection

Electronic Unit – soft cloth gently wrung in phenols (Bacillotex^® etc.), or 70% alcohol, or 0.5% chlorohexidine.

If dangerous virus contamination is suspected – aldehydes (Cidex^® etc.), or chlorinates (Diversol BX^® etc.).

Interface cables and power cords – soft cloth moistened with disinfectant, for example, 1% chloramine solution or 3% hydrogen peroxide solution.

NOTE:  Computer (PC) is not included in Standard Set, but can be supplied as per Customer requirements.

Minimum requirements to PC:

· For the software based on Microsoft .NET platform dual core processor with ≥ 2.6 GHz clock rate and random-access memory (RAM) of ≥ 2 GB is required (4 GB is recommended).  For other software, the clock rate is desired to be ≥ 1200 MHz and RAM ≥ 512 MB.

· Either Windows 8 or Windows 10 operating system is required.  Both 32-bit and 64-bit editions are supported.

· A ground wire must be available as the third wire of the power outlet.  It is not allowed to connect the computers using adaptors that insulate the third wire.

Customized accessory sets

Accessory set, such as electrodes types and quantities, can be customized to specific needs of a clinic or research lab.

Contact us to discuss your accessory needs.

Electronic Unit limited warranty term – 2 years.

During the warranty term, repair is free, and if repair is impossible, Electronic Unit is replaced.  Warranty does not cover mechanical damage and unauthorized opening of Electronic Unit, and defects caused by misuse, and any product that has been altered or modified in any way.

Warranty repair is professionally performed at the Neurosoft Service Center in Ivanovo, RF.  Transportation costs to the Service Center are covered by the Customer, return transportation is covered by Neurosoft.

Customer pays return shipping charges.  We are responsible for the return shipping charges of replaced / repaired products.  Products found to be non-defective will be returned at customer's expense.

Extended warranty is available. Contact us for details.

Accessories (cables, bands, etc.) – 30 days.

Single-use items (electrodes, gels, pastes, etc.) are not covered.

Software updates are free of charge.  Please fill out the online Form to receive a download link to the version you are requesting.

K133995

Neuron-Spectrum.NET – User Manual (version 3) – UM-002-001

Neuron-Spectrum – Brochure-USA

Neuron-Spectrum – Technical Manual – TM002

Current Procedural Terminology (CPT) codes

Summary of CY 2020 Medicare Rules – Long Term EEG Code Provisions

The New CPT Codes for Video-EEG

Summary of Long-term EEG Code Provisions for 2020

New 2020 Long-term EEG Monitoring CPT® Coding Structure

2020 Coding Changes for Long Term EEG/VEEG Services

New 2020 Long-term EEG Monitoring CPT Coding Structure and Relative Value Units

2020 Long-Term EEG Monitoring CPT Codes – Technical Components

Major CPT Code Changes for Long-term Electroencephalography (EEG) in 2020

EEG Guidelines

Guidelines and Consensus Statements – American Clinical Neurophysiology Society

Current practices in long-term video-EEG monitoring services: A survey among partners of the E-PILEPSY pilot network of reference for refractory epilepsy and epilepsy surgery (2016)

The standardized EEG electrode array of the IFCN (2017)

Ambulatory Electroencephalographic (EEG) and Video EEG Monitoring in

the Out-Patient Setting for Adults and Children (2018)

EEG Video Monitoring (2018)