Neuron-Spectrum-3

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  • Features
  • Specifications
  • Standard Set
  • Warranty
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19-channel Neurophysiological System for EEG and EP

 

IMPORTANT NOTE! 

 

Neuron- Spectrum-3 is a Class II medical device, subject to regulatory requirements in Canada and the USA.

 

Neuron-Spectrum-3 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.

 

Clinical EEG analysis provides diagnostic information regarding 3 main issues: evidence for brain damage, disease prognosis, brain damage localization.

 

Neuron-Spectrum-3 is a portable device that can be simply connected to the computer via USB interface, ideal for the inpatient and outpatient settings.

 

Neuron-Spectrum-3 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-3 key features:

 

· High sampling rate and low noise level.

 

· Impedance indication on the front panel.

 

· Standard electrode cap connector.

 

· Operation in electromagnetically unshielded environments – no shielding required.

 

· Convenient and high-quality EEG acquisition.

 

· 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.

 

· EEG analysis during acquisition.

 

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

 

· Extensive database, HL7 compatibility.

19-channel Clinical Diagnostic EEG System

 

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.

 

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

 

EEG/VEEG can be recorded over prolonged periods of time – half-day, full day, and longer.

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.

 

High sampling rate and low noise level

 

The high sampling rate (up to 5000 Hz) allows recording high-frequency signal components without “smoothing-out” EEG sharp wave events or drops in EEG amplitude.

 

The low noise level allows applying the most careful EEG filtration, thus, avoid filtering-out useful information contained in the native signal.

 

Impedance indication on the front panel

 

Digital EEG and EP systems and computers are often placed in different rooms or even at a distance from each other. Neuron-Spectrum-3 has LED indicators that allow observing the signal quality during the electrode placement on the spot.

 

Standard electrode cap connector

 

Neuron-Spectrum-3 is equipped with the standard electrode cap connector. Thus, the use of adapters or other accessories to attach the cap is not required.

 

Operates in unshielded rooms

 

Neuron-Spectrum-3 can be used in any unshielded room. This increases the personnel convenience and patient’s comfort while decreasing the expenses for system installation and use – capital and operating costs.

 

Portable Digital EEG and EP System

 

Neuron-Spectrum-3 can be easily used on-location. The device is powered via USB cable, and this cable is also used to transfer data to computer. Hence, it can be powered by the notebook battery, and perform an EEG study at any location.

 

EEG Analysis during Acquisition

 

Neuron-Spectrum-3 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-3 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 SoftwareNeurosoft 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.

EEG Channels

Number of channels

19

Sampling rate

100, 200, 500, 1000, 5000 Hz

Input Voltage range

1 – 12,000 µV (0.002-12 mV)

Ratio error of voltage measurement in the amplitude range:

· from 10 to 50 µV

· from 51 µV to 450 mV

 

within ± 15 %

within ± 5%

Relative error of time interval measurement in the range from 10 µs to 10 s

within ± 2%

Sensitivity

1–1000 μV/mm, with 1 μV/mm step

Relative error of sensitivity

within ± 5%

Sweep speed at EEG recording

3–960 mm/s, with 1 mm/s step

Sweep speed at EP recording

5, 10, 20, 50, 100, 200, 500 ms/div

Ratio error of sweep speed

within ±2%

High pass filter

0.05 – 10 Hz, with step 0.01 Hz

Low pass filter

5–200 Hz, with 0.1 Hz step

Common-mode rejection

110 dB

Input noise level within 0.5-200 Hz (rms value)

≤ 2 μV (≤ 0.3 μV)

Input impedance

400 MΩ

Patient leakage current

≤ 50 nA

Polygraphic channels

Number of channels

1

Ratio error of voltage measurement in the range:

· from 200 up to 500 μV

· from 0.5 up to 100 mV

 

within ± 15%

within ± 7%

Sensitivity

0.001, 0.002, 0.005, 0.007, 0.01, 0.02, 0.05, 0.07, 0.1, 0.2, 0.5 mV/mm

High pass filter

0.05, 0.1, 0.2, 0.5, 0.7, 1.5, 2, 5, 10 Hz

Low pass filter

5, 10, 15, 35, 75, 100, 150, 200 Hz

Bandpass flatness in the range:

· from 0.5 to 200 Hz

· from 0.05 to 0.5 Hz and from 200 to 250 Hz

 

from –10 to +5 %

from –30 to +5 %

Suppression ratio of power frequency by notch filter

≥ 40 dB

Input noise level within 0.05-200 Hz

≤ 3 μV

Input impedance

400 MΩ

Patient leakage current

50 nA

Common-mode rejection

100 dB

Photic stimulator

Number of channels

1

Stimulus duration

0.1–3000 ms

Relative deviation of stimulus duration

within ±10%

Maximum brightness of LED stimulator (FS-1)

16000 ± 1600 cd/m2

Stimulation rate

0.1–100 Hz

Relative deviation of stimulation rate

within ±1 %

Left / Right / Bi-lateral stimulation

yes

Pattern stimulator

Stimulation rate

0.1–10 Hz

Relative deviation of stimulation frequency

within ±10 %

Pattern size

4 x 3, 8 x 6, 16 x 12, 32 x 24, 64 x 48 sqr.

Auditory stimulator

Number of channels

2 (right and left)

Stimulation level (TDH-39 headphones)

0 – 126 dB SPL

Stimulation rate

0.1–100 Hz

Relative deviation of stimulation rate

within ±1 %

Stimulus duration

100–5000 μs

Relative deviation of stimulus duration

within ±15 %

Left / Right / Bi-lateral stimulation

yes

Condensation / rarefaction

yes

Respiratory (breath) channel

Number of channels

1

Breath frequency range

6–30 inhalations per minute

Respiratory channel bandpass

0.05 – 7.5 Hz

Video and audio recording

Maximum number of video cameras

3

IP cameras

Yes, with LAN or Wi-Fi interface

Synchronous with EEG recording, playback, editing

Yes

Long-term (long-duration) recording

Yes

Maximum EEG-Video lag

±1 s (may vary for IP cameras)

Video transparency control

Yes

Maximum number of microphones

2

Trigger IN/OUT to synchronize with external devices

Trigger IN/OUT type

negative polarity TTL pulse

Trigger-IN required pulse duration

≥ 5 μs

Trigger-OUT pulse duration

100 μs

General Parameters and Characteristics

Electronic Unit Interface with computer

USB

Supply voltage:

· Electronic Unit

· Desktop PC-based system

· Notebook PC-based system

 

5 V DC (from USB)

 

110 V AC (60 Hz) / internal battery

Electronic unit power consumption

≤ 2.8 VA

Dimensions of Electronic Unit

140 x 200 x 45 mm

Weight of electronic unit

≤ 0.9 kg

Weight in package (without PC and printer)

≤ 12.5 kg

Applied parts

BF type

Transportation Conditions

Temperature

from -25 to +60°C

Humidity

20 – 95% (non-condensing)

Atmospheric pressure

from 70 kPa

Storage Conditions

Temperature

from +5 to +40°C

Humidity

30-85% (non-condensing)

Atmospheric pressure

70-106 kPa

Operation Conditions

Temperature

from +10 to +35°C

Humidity

30-85% (non-condensing)

Atmospheric pressure

70-106 kPa

 

Electrical Safety and Electromagnetic Compatibility

 

Electromagnetic compatibility (EMC) is provided by IEC 60601-1-2:2007 requirements

fulfillment.

 

The devices are intended for operation in electromagnetic environment, which special

features are specified in Appendix 1 of Technical Manual.

 

Portable and mobile RF communication equipment can affect the system operation.

The use of the equipment not listed in tables 2 - 6 of the present technical manual

may result in increased emission and system decreased immunity.

 

As for safety, each digital EEG system satisfies IEC 60601-1:1988+A1:1991+A2:1995, IEC 60601-1-1:2000 and IEC 60601-2-26:2002. The electronic units of digital EEG systems are supplied by regulated power supply through USB interface, it has double isolation and BF type work parts according to IEC 60601-1.

Neuron-Spectrum-3 electronic unit

1 pc.

Stand for electronic unit SU-3

1 pc.

Stand mount

1 pc.

LED photic stimulator PhS-1

1 pc.

Stand for LED Photic stimulator

1 pc.

Set of EEG electrodes, 23 bridge electrodes NS015106.007, 3 ear electrodes NS015106.015

1 pc.

EEG helmet, yellow: 42-48

1 pc.

EEG helmet, green: 48-54

1 pc.

EEG helmet, blue: 54-62

1 pc.

Cable for bridge or ear EEG electrode, white, 1m

20 pcs.

Cable for bridge or ear EEG electrode, red, 1 m

2 pcs.

Cable for bridge or ear EEG electrode, black, 1 m

1 pc.

Reusable limb clamp ECG electrode F9024SSC, adult

4 pcs.

3-lead ECG cable, 3 m

1 pc.

Technical Manual "Neuron-Spectrum-1, 2, 3, 4, 4/Р"

1 pc.

User manual "Neuron-Spectrum.NET"

1 pc.

Annex to User Manual "Exams Manager"

1 pc.

Carrying Computer Case

1 pc.

License for Neuron-Spectrum.NET software with additional Neuron-Spectrum.NET/EEG software module.

1 pc.

 

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.

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)

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