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The neo monitor is an 8-channel electroencephalograph (EEG) acquisition software. The device is intended to record and display EEG and aEEG signals for monitoring the brain status of neonatal patients (defined as from birth to 28 days postdelivery, and corresponding to a postconceptual age of 24 to 46 weeks). The device is to be used in a hospital environment by qualified clinical practitioners. The device does not provide any diagnostic conclusion about the patient's condition to the user.

The nëo™ system is a reduced montage neonatal electroencephalograph device that acquires, displays, stores, and archives electroencephalographic signals from the brain. By application of electrodes at specific location on the cranium,using up to 10 surface electrodes placed at specific locations the system functions to measure and record electrical activity of the brain by acquisition of electroencephalograph data and amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner). The neo System is an electromedical device incorporating software. The device itself has no patient contact, but is intended for use with FDA-cleared ECG electrodes. nëo™ Monitor software, which, when installed into a compatible touchscreen PC and paired with a physiological signal amplifier (eego model EE-411) forms the nëo™ Monitor System. The system is a compact and easy-to-use and can be set on a bedside table, pole-mounted, or on a cart in the neonatal care areas. The system, as-delivered to the customer, is comprised of: - nëo Monitor software (pre-installed) - 15" Panel PC - eego EE-411 model amplifier - Mounting plate - nëo User Manual .

The QP-160AK EEG Trend Program is a software-only device intended to calculate and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in electroencephalography, who will exercise professional judgment when using the information. The intended use is as follows: · The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. · The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform. • The burst suppression parameters of this software (interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG. • The seizure detection component of QP-160AK is intended to mark previously acquired EEG waveforms of adult (greater than or equal to 18 years) that may correspond to electrographic seizures in order to aid in identification of seizure events and help review and annotation of EEG traces by user. EEG should be recorded with full scalp montage at the standard 10/20 system. The notifications for seizure detection are provided. QP-160AK notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert. This device does not provide any diagnostic conclusion about the patient's condition to the user. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.

The QP-160AK EEG Trend Program is a software-only device. When installed in Nihon Kohden neurology products with EEG measurement function, the device calculates and displays EEG data obtained from the neurology product's system. In addition, the QP-160AK EEG Trend Program identifies trends in the EEG data over extended periods of time in order for trained healthcare professionals to observe changes over time. The program's existing main features are listed below: - Calculate and display aEEG, DSA, FFT and burst suppression ratio trend . - Display up to 64 channel EEG ● - . Display SpO2 and ETCO2 trends - Operation by touch panel buttons - . Data management with Neuro Workbench software The modification is to add: - Seizure detection and notification .

1) Cadwell AmpliScan is a software-only device indicated for use with electroencephalographic (EEG) data from Cadwell Arc application software. Cadwell AmpliScan is distributed solely for use with Cadwell Arc software. 2) The Cadwell AmpliScan device is for prescription use only by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgement when using the information. 3) This device does not provide any diagnostic conclusion about the patient's condition to the user. 4) Cadwell AmpliScan uses electroencephalographic (EEG) data to calculate and display a quantitative aEEG measure. This quantitative measure should always be interpreted by the user in conjunction with review of the original EEG waveforms. The aEEG quantitative measure of Cadwell AmpliScan is intended to monitor the state of the brain.

Cadwell AmpliScan is a software-only device distributed solely for use with the application software commonly known and marketed as Cadwell Arc software. Cadwell Ampliscan software is installed with installation of Arc software, and does not require installation or removal separate from the Arc application. The Cadwell AmpliScan software-only device applies the Amplitude-Integrated EEG (aEEG) algorithm referred to as the Cerebral Function Monitor (CFM) to stored data within the Cadwell Arc software, and stores and displays the results.

The Background Pattern Classification algorithm is intended for: · Neonatal patients, defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 37 to 46 weeks, in clinical environments such as the intensive care unit, operating room, and for clinical research. • To analyze and identify background patterns in aEG, including continuous and discontinuous activity, burst suppression, low voltage, and inactive patterns. The aEEG must be obtained from a pair of parietal electrodes located at positions corresponding with P3 and P4 of the International 10/20 System. The background pattern classification algorithm must be reviewed and interpreted by qualified clinical practitioners. The device does not provide any diagnostic conclusion about the patient's condition.

BPc™ is a software only product that identifies background patterns seen on aEEG signal recorded from a pair of parietal electrodes (P3-P4) in neonates, defined as from birth to 28 days post-delivery, and corresponding to a post-conceptual age of 37 to 46 weeks. The classification of aEEG background pattern into one of five different classes is done in accordance with the scoring scheme described in the following table: 1. Continuous (C): Continuous activity with lower (minimum) amplitude around (5 to) 7 to 10 µV and maximum amplitude of 10 to 25 (to 50) µV. 2. Discontinuous (DC): Discontinuous background with minimum amplitude variable, but below 5 µV, and maximum amplitude above 10 µV. 3. Burst-suppression (BSA): Discontinuous background with minimum amplitude without variability at 0 to 1 (2) µV and bursts with amplitude >25 µV. BS+ denotes burst density >100 bursts/h, and BS- means burst density <100 bursts/h. 4. Low v oltage (LV): Continuous background pattern of very low voltage (around or below 5 µV). 5. Inactive, flat (FT): Primarily inactive (isoelectric tracing) background below 5 uV. Similar to basic EEG interpretation, pattern recognition forms the basis of aEEG interpretation. The classification scheme takes in consideration variations in the amplitude for the lower and upper margin of the aEEG signal. The BPc™ algorithm applies a set of rules to estimate the background pattern based on upper and lower margins of the aEEG signal. The output of the device consists in marked regions with the corresponding background pattern name and a list of detected patterns in the signal. These detections (marked regions) are then reviewed. accepted or discarded by the qualified medical practitioner. The software does not make any final decisions that result in any automatic diagnosis or treatment. None of the components of the device is responsible for data acquisition, review or any other function different from analysis.

The AE-918P EEG Neuro Unit is an 8 channel EEG measuring unit that connects to a Nihon Kohden patient monitor and is intended to monitor brain function. The unit amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor. The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as SEF, MDF, PPF, TP, CSA, DSA, %Theta, %Alpha, %Beta, %Gamma, Abs Delta, Abs Alpha, Abs Beta, and Abs Gamma. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveform. The aEEG functionality included in the AE-918P EEG Neuro Unit is intended to monitor the state of the brain. The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home under direct supervision of a medical professional.

The AE-918P is an 8 channel digital Electroencephalography (EEG) that connects to a Nihon Kohden patient monitor. It receives EEG data from patients and digitizes the signals, the waveforms and analysis are displayed on a Nihon Kohden Patient Monitor. The AE-918P is contained in a small enclosure that contains the EEG amplifier and digital circuitry. This enclosure is mounted to the bottom of the patient monitor and connects to the patient monitor through the multilink cable.

The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.

The CerebraLogik consists of a dual channel EEG amplifier that is put near the monitored patient. The amplifier is connected, using an interface cable, to a Mennen Medical patient monitor via the UIM input of the monitor. The monitor has display options for both real time EEG and history of Amplitude Integrated EEG - aEEG. The monitor stores both EEG and aEEG signals for the duration of the EEG monitoring.

The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings. - The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain. - The signals acquired from P3-P4 channel is intended to assist in the assessment of Hypoxic-Ischemic Encephalopathy severity and long-term outcome, in full term neonates (postconceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event. - The RecogniZe seizure detection algorithm is intended to mark sections of EEG/aEEG that may correspond to electrographic seizures in only the centro-parietal regions of full term neonates (defined as from birth to 28 days post-delivery, and corresponding to a postconceptual age of 37 to 46 weeks). EEG recordings should be obtained from centro-parietal electrodes (located at P3, P4, C3 and C4 according to 10/20 system). The output of the Recognize algorithm is intended to assist in post hoc assessment of EEG/aEEG traces by qualified clinical practitioners, who will exercise professional judgment in using the information. The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.

The Olympic Brainz Monitor is a three-channel electroencephalograph (EEG) system, as per 21 CFR §882.1400: a device used to measure and record the electrical activity of the patient's brain by placing two or more electrodes on the head. The device does not introduce, transfer or deliver any type of energy to the patient. As any other electroencephalograph the device passively record the electroencephalographic activity from the patient trough the hydrogel electrodes and then process the signal for display, analysis and archiving. The Olympic Brainz Monitor system consists of the following: - Data Acquisition Box (DAB) - Touchscreen Monitor - Roll Stand or optional Desktop Stand - 9 Neonatal Sensor set (K033010) - Software These components have equivalent configuration and functions to those described in K093949 for the OBM Monitor. The Neonatal Sensor set (cleared on K033010) is an accessory to the device that is the only part that enters into contact with the patient. The sensor guarantees acquisition of the electroencephalographic signal and passively transfers it to the main unit. This is a set of five hydrogel skin electrodes that are attached to the patient's head at one extreme and to the Data Acquisition Box at the other extreme using standard touch-proof connectors. The device allows practitioners to acquired, store, review and archive EEG activity from 4 centroparietal locations corresponding to C3, C4. P3 and P4 of the international 10-20 System. The device displays the recorded activity in form of the raw EEG and as amplitude integrated EEG (aEEG). In addition the device now includes a seizure detection algorithm (i.e RecogniZe) to allow automated analysis of the recorded EEG. The RecogniZe Seizure Detection Algorithm identifies sections of the EEG trace where seizure activity is detected. The algorithm comprises filtering of the EEG signal, fragmentation of EEG signal into waves, wave-feature extraction, and elementary, preliminary and final detection. The main idea behind the algorithm is to detect heightened regularity in EEG wave sequences using wave intervals, amplitudes and shapes, as increased regularity is the major distinguishing feature of seizure discharges.

The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information. The intended use for each of the software's outputs is as follows: - The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. - The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform. - The burst suppression parameters of this software (interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.

The OP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. The QP-160AK EEG Trend program is the same as the previous version of QP-160AK cleared under 510k but has two new trends available (DSA Asymmetry trend and FFT Power Asymmetry trend).

The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information. The intended use for each of the software's outputs is as follows: - . The EEG and aEEG waveforms are intended to help the user monitor the state of the brain. - . The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform. - The burst suppression parameters of this software (interval and bursts per . minute) are intended to aid in the identification and characterization of areas of burstsuppression pattern in the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user.

The QP-160AK EEG Trend program is a software program stored on electronic media such as CD Rom. The EEG-1200A OP-160AK Trend program is a device which is installed on the electroencephalograph EEG-1200A Series and records the EEG waveforms and identifies trends in the EEG data over extended periods of time in order for trained health care professionals to observe changes over time. The QP-160AK design features are as follows: - Trend display of aEEG and Burst suppression ratio . - Display of EEG waveform maximum of 64 channels - DC Trend display including analog inputs . - Operations of functions by control buttons adapted to touch panels . - Data management by NeuroWorkbench .

The Olympic Brainz Monitor (OBM) is a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings. - . The signals acquired from P3-P4, C3-P3 and C4-P4 channels are intended for use only with neonatal patients (defined as from birth to 28 days post delivery, and corresponding to a postconceptual age of 24 to 46 weeks) to display aEEG for monitoring the state of the brain. - The signals acquired from P3-P4 channel is intended to assist in the prediction of and severity . of Hypoxic-Ischemic Encephalopathy and long-term outcome in full term neonates (postconceptual age of 37-46 weeks) who have suffered a hypoxic-ischemic event. The Olympic Brainz Monitor does not provide any diagnostic conclusion about the patient's condition.

a three channel electroencephalograph (EEG) acquisition system intended to be used in a hospital environment to record, collect, display and facilitate manual marking of aEEG recordings.