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The Natus BrainWatch System including the Natus BrainWatch Headband, is intended to record and store EEG signals and present these signals visually to assist trained medical staff in making neurological diagnoses in patients aged 2 years and older. The device does not provide any diagnostic conclusions about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Natus BrainWatch System is intended for use within a professional healthcare facility or clinical research environment. The Natus BrainWatch Headband is intended for single-patient use.

The Natus BrainWatch system is a reliable, mobile, and easy-to-use EEG device intended to record, store, and visually present EEG signals to assist trained medical staff in making neurological diagnoses in patients. The system includes a touchscreen tablet as its primary interface. The Natus BrainWatch Headband is a single-use disposable headpiece with an integrated array of 10 passive electrodes that are applied to the patient's head to record EEG signals when connected to an amplifier. The Natus BrainWatch System consists of the following components: Tablet, IV Pole Handle, Amplifier, Headband(s), Gel Pods and a Mobile Application: - Touchscreen Tablet with charger - Single-Use disposable elastic fabric headband with 10 electrodes (available in sizes Small, Medium, and Large) containing: - Hydroflex patch with 2 built-in electrodes - 8 electrodes attached to gel pods used to improve impedance levels labeled L1-L4, R1-R4 - Wireless amplifier that attaches to the headband and connects to the tablet via Bluetooth - IV pole handle that holds the tablet for a hands-free experience - Gels pods attach to the electrodes to improve impedance levels The Natus BrainWatch System is a portable 10-channel EEG monitoring system. 10 patient electrodes are used to record the 10 channels. Channels 1-5 should be used for the patient's left hemisphere, with channel 1 at the front of the patient's head and channel 5 at the back. Channels 6-10 should be used for the patient's right hemisphere, with channel 6 at the front of the patient's head and channel 10 at the back. EEG recording files are transferred wirelessly to a computer from the Natus BrainWatch Tablet using a Wi-Fi connection. The EEG sessions from Natus BrainWatch are stored using a cloudbased solution which allows the end user to view studies at a later date. Recorded sessions can be reviewed remotely on a computer using the Neuroworks EEG software. The device is a portable, 10-channel EEG monitoring system. The device connects to a headband consisting of 10 patient electrodes which are used to form the 10 channels and may be used with any scalp EEG electrodes. The system acquires the EEG signals of a patient and presents the EEG signals in visual formats in real time. The EEG recordings are displayed on a computer or tablet using an EEG viewer software. The visual signals assist trained medical staff to make neurological diagnoses. It does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. Micro-USB cable is used to connect the Natus BrainWatch System to power adapter for charging. Bluetooth is used to connect amplifier with tablet to transfer EEG recording files. When the Natus BrainWatch System is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.

The ALGO Pro Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses Automated Auditory Brainstem Response (AABR®) for automated analysis of Auditory Brainstem Response (ABR) signals recorded from the patient. The screener is intended for babies between the ages of 34 weeks (gestation age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screener is simple to operate. It does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants who are in good health and about to be discharged from the hospital. A typical screening process can be completed in 15 minutes or less. Sites appropriate for screening include the well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

The ALGO® Pro is a fully automated hearing screening device used to screen infants for hearing loss. It provides consistent, objective pass/refer results. The ALGO Pro device utilizes Auditory Brainstem Response (ABR) as the hearing screening technology, which allows the screening of the entire hearing pathway from outer ear to the brainstem. The ABR signal is evoked by a series of acoustic broadband transient stimulus (clicks) presented to a subject's ears using acoustic transducers and recorded by sensors placed on the skin of the patient. The ALGO Pro generates each click stimulus and presents to the patient's ear using acoustic transducers attached to disposable acoustic earphones. The click stimulus elicits a sequence of distinguishable electrophysiological signals produced as a result of signal transmission and neural responses within the auditory nerve and brainstem of the infant. Disposable sensors applied to the infant's skin pick up this evoked response, and the signal is transmitted to the screener via the patient electrode leads. The device employs advanced signal processing technology such as amplification, digital filtering, artifact rejection, noise monitoring and noise-weighted averaging, to separate the ABR from background noise and from other brain activity. The ALGO Pro uses a statistical algorithm based on binomial statistics to determine if there is a response to the stimulus that matches to the ABR template of a normal hearing newborn. If a response is detected that is consistent with the ABR template derived from normal hearing infants (automated auditory brainstem response technology, AABR), the device provides an automated 'Pass' result. A 'Refer' result is automatically generated if the device cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template.

General ophthalmic imaging including retinal, corneal, and external imaging. Photodocumentation of pediatric ocular diseases, including retinopathy of prematurity (ROP). Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease), or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease), or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease) * in 35-37 week postmenstrual infants.

The RetCam Envision system is a contact type wide-field fundus ophthalmic imaging system used for general ophthalmic imaging including retinal, corneal, and external imaging. Photodocumentation of pediatric ocular diseases, including retinopathy of prematurity (ROP). Screening for Type 2 pre-threshold retinopathy of prematurity (ROP) (zone 1, stage 1 or 2, without plus disease, or zone 2, stage 3, without plus disease), or treatment-requiring ROP, defined as Type 1 ROP (zone 1, any stage, with plus disease; zone 1, stage 3 without plus disease; or zone 2, stage 2 or 3, with plus disease), or threshold ROP (at least 5 contiguous or 8 non-contiguous clock hours of stage 3 in zone 1 or 2, with plus disease) * in 35-37 week postmenstrual infants. A fundus camera comprised of handpiece, detachable lens piece, LED light sources, control panel, footswitch and application software running on a PC are used to acquire still images and video of the eye. The LED light is used to illuminate the retina uniformly and the image is transferred from the handpiece to the PC for display storage, review & transfer. The camera focus and image light intensity as well as the image capture is controlled by the user via a button panel on the cart or a footswitch. Controls are also available via the keyboard mouse and touchscreen.

Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information. The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. · The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. · The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. · aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Entropy trending functionalities included in NeuroWorks are intended to assist the user while monitoring the state of the brain. The automated event marking function of Neuroworks is not applicable to these analysis features. · Neuro Works also includes the display of a quantitative EEG plot, Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to DSA. · This device does not provide any diagnostic conclusion about the patient's condition to the user.

Natus NeuroWorks is electroencephalography (EEG) software that displays physiological signals. The software platform is designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessories let you customize your system to meet your specific clinical EEG monitoring needs.

The Natus Photic Stimulator is indicated for photic activation of the EEG study and in the generation of visual evoked potentials.

The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Photic Stimulator is used by trained medical staff in a medical environment to apply photic flashes to the patient during neurophysiology studies such as electroencephalographic (EEG) studies, where it is used as an activation to test photo-sensibility related to epilepsy. The Natus Photic Stimulator is typically used by EEG technicians in the hospital environment in fixed, mobile or portable systems, and with patients of all ages. The lamp head assembly is mounted on an arm allowing easy placement at 30 cm away from the patient's face. The arm is ergonomically designed so that the lamp can be move and rotated in the direction of the patient using a handgrip on the lamp. Trigger pulses applied to the trigger input of the Natus Photic Stimulator generate 1 millisecond photic flashes at specific frequencies, typically in the range of 0.5 Hz to 60 Hz by a white light emitting diode (LED) lamp. The basic operating mode consists of generating a single flash per trigger pulse applied. Flash intensity has a maximum range from 22,000 lux up to 75,000 lux measured at 30 cm from the LED lamp at the position of highest intensity and 3,520 lux to 12,000 lux calculated at 75cm. The frequency and intensity of the flash is controlled by the acquisition software. It can also be used along with evoked potential devices for stimulating visual evoked potentials.

The Natus Brain Monitor Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/ SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.

The Natus Brain Monitor family of amplifiers are intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor family of amplifiers are intended to be used by trained medical professionals, and are designed for use in clinical environments such as hospital rooms, clinics, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use. The Natus Brain Monitor (Natus Embla NDx, Natus Embla SDx) are comprised of a base unit and a breakout box. It is part of a system that is made up of a personal computer, software, a photic stimulator, an isolation transformer, video and audio equipment, networking equipment, and mechanical supports. EEG and other physiological signals from electrodes placed on the head and body as well as other accessories such as pulse oximeters, respiratory effort and airflow sensors can be acquired by the amplifiers. The amplifiers include sensor inputs for respiratory effort and airflow as well as snoring. The amplifiers include an integrated pressure sensor and pulse oximeter module. These signals are digitized and transmitted to the personal computer running the Natus NeuroWorks/SleepWorks software. The signals are displayed on the personal computer and can be recorded to the computer's local storage or to remote networked storage for later review.

The NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. -The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. -The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. -The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. -The aEEG functionality included in NeuroWorks is intended to monitor the state of the brain. The automated event marking function of NeuroWorks is not applicable to aEEG. -NeuroWorks also includes the display of a quantitative EEG plot, Compressed Spectrum Array (CSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to CSA. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Natus NeuroWorks is electroencephalography (EEG) software that displays physiological signals. The software platform is designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessories let you customize your system to meet your specific clinical EEG monitoring needs.

This software is intended for use by qualified research and clinical professionals with specialized training in the use of EEG and PSG recording instrumentation for the digital recording, playback, and analysis of physiological signals. It is suitable for digital acquisition, display, comparison, and archiving of EEG potentials and other rapidly changing physiological parameters.

The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Grass® TWin ® (Grass TWin) is a comprehensive software program intended for Electroencephalography (EEG), Polysomnography (PSG), and Long-term Epilepsy Monitoring (LTM). TWin is incredibly powerful and flexible, but also designed for easy and efficient day-to-day use. Grass TWin is a software product only, and does not include any hardware.

The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus New Yorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery. The Natus Quantum Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monits, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.

The Natus Quantum Amplifier is the front end hardware of an electroencephalograph, and consists of amplifier circuitry, A/D Converters, Digital Signal Processing, digital switch matrix, LCD touch screen interface as well as TCP/IP & USB connection options of PC communication. The Natus Quantum Amplifier can record either in Tethered mode or in Ambulatory Mode. In Ambulatory Mode, data is stored in the Quantum Breakout's internal memory and automatically uploaded to the main study folder when the Quantum Breakout is reconnected to the Natus Base unit. The amplifier is designed to facilitate functional mapping using a Digital Switch Matrix. The Digital Switch Matrix portion of the headbox is a combination of hardware relays and software controls allowing the user (physician or technologist) to switch electrode pairs between the EEG recording amplifier and the external cortical stimulator for stimulus delivery by an external cortical stimulator.

The Comet-PLUS® is designed for use in the recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.

The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Comet-PLUS® (also known as the AS40-PLUS Amplifier System) is designed specifically for the EEG and PSG monitoring lab. The different configurations of the Comet-PLUS feature the AS40-PLUS Amplifier with electroencephalograph (EEG) or polysomnograph (PSG) Comet-PLUS Personality Modules (headboxes) and Natus software. The Comet-PLUS Amplifier is a compact AC Amplifier with up to 57 channels for EEG and PSG recording applications.