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The Delphi Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals and to transmit them digitally to a computer. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc.). The device is not intended for use in life support systems.

The Delphi Amplifier has been designed as a mobile recording device for EEG (electroencephalography) signals. It provides access to recorded data over a USB connection to external software over its signal driver interface. The Delphi Amplifier is powered via a USB connection and does not require any additional power source. The Delphi Amplifier supports EEG acquisition and storage by Referential DC input channels, and Parallel trigger input channels. The Delphi Amplifier enables connection of up to 48 referential channels and 8bit trigger input channel. Impedance values can be measured for all referential electrodes as well as the reference. An SDK (Software Development Kit) is available for direct amplifier communication. The device is powered by the USB port connection to a computer. The USB port supports interface to the computer running the SDK.

The NExT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles. The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis.

EMG Family devices (NEXT Station and NEXT Station Advanced) are capable of detecting electrical signals produced by the central and peripheral nervous systems and by striated muscles. In connection with a PC, where the Galileo NT Line software is installed, they allow to perform both spontaneous and evoked electromyographic activity easily and in all their phases. Their fields of application are Electromyography (EMG) and Evoked Potentials (EP). EB Neuro EMG Family devices include all the elements necessary for the acquisition of neurographic signals, for their analog-digital conversion and pre-processing, for audio monitoring, for the delivery of electrical, acoustic and visual stimulation. The functions of user interface, presentation, post-processing, storage, signals archiving and printing and data extracted from them are managed by a PC installed with the Galileo NT Line software. Two versions are available depending on the support where the Medical Device is placed: - “Mobile” is a mobile device placed on a cart, powered at 115V by Isolation Transformer and connected with a PC with Galileo NT Line medical device software running on the PC. - “Portable” is a portable device placed on a desk, powered at 115V by medical power supply and connected with a PC with Galileo NT Line medical device software running on a Laptop PC.

DreamClear is intended for use on both adults and children to collect, amplify, and transmit physiological signals acquired from a patient, including electroencephalogram (EEG), electrooculography (EOG), limb movement, respiration effort, air pressure, and peripheral oxygen saturation (SpO2). DreamClear is intended for use on the order of a physician and is non-sterile. While primarily intended for use with dedicated polysomnography software to aid in the diagnosis of sleep disorders, DreamClear may be used to amplify physiological signals for any medical diagnostic procedure that does not involve: - use alone as an apnea monitor or as a critical component in an apnea monitoring system; or - use alone as a life support device or as a critical component of a life support system.

DreamClear is a physiological signal amplifier and medical device data system that captures and streams various physiological parameters via Bluetooth for remote data analysis and diagnosis of sleep disorders. DreamClear features analog sensor interface circuits for Electroencephalograph (EEG), Electrooculography (EOG) and Electromyography (EMG) signals. Additionally, the device includes digital sensor interface circuits for nasal and oral airflow (breathing pattern), microphone (snoring), heart rate and blood oxygen saturation with pulse oximeter (SpO2). The DreamClear may be used in either a Basic Kit or Extended Kit configuration. The DreamClear device in its Basic Kit configuration includes the chest belt, pulse oximeter, and nasal cannula. The Basic Kit configuration has the following channels: thoracic effort, nasal pressure, pulse rate, SpO2, body position, and snore. The data recorded by the Basic Kit may be exported for optional display and analysis using third-party software products. When the DreamClear device is used in the Extended Kit configuration, the additional channels of EEG and EOG are used, which gives the DreamClear a total of eight (8) channels.

BE Plus PRO and Neurotravel LIGHT are intended to be used for Electroencephalography (EEG) and Polysomnography (PSG) exams, in combination with the Galileo NT Line software, for human beings to assist the user in diagnosis and monitoring of disorders of the central and peripheral nervous system and muscles.

EEG Family devices (BE plus PRO and Neurotravel LIGHT) are active medical devices composed of various parts necessary to allow the achievement of their intended use. All these parts are intended to be interconnected to achieve the specified medical purpose. EEG Family devices can be used in patients, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions. EEG Family devices are capable of acquiring the bioelectric signal generated by the electrical potentials of the neurons of the cerebral cortex, by means of suitable signal, stimulus electrodes. This signal, of the order of a first and then, filtered to claim it of noise and offset. It is then digitized by a high-resolution analog-to-digital converter at a certain sampling rate. The signals acquired and converted into digital format are transferred to a Host PC through a special serial communication with a dedicated protocol and then can be processed by the Galileo NT software to complete the intended use. The software part allows the implementation of many specific functions of visualization, measurement, processing and storage of brain signals, acquired by the acquisition unit, based on the clinical area of interest. EEG Family devices are offered in the following two configurations: - Mobile: All components are mounted on a mobile trolley. - Portable: All components are mounted on a stationary desktop.

The X-trodes System M is intended for prescription use only in the home or healthcare facility to acquire, record, transmit and display physiological signals from adult patients. The X-trodes System M acquires, records, transmits, and displays electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer and gyroscope signals. The X-trodes System M only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision, and reliability.

The X-trodes System M combines hardware, firmware, and software to acquire the following physiological signals: physiologic signal amplifier (EEG), electrooculography (EOG), surface electromyography (sEMG), electrocardiography (ECG), and accelerometer and gyroscope signals. It acquires physiological data through a data acquisition unit connected to electrode arrays patches, applied by a technician or patient to the patient. The data is recorded and transmitted to a cloud where it is converted to an EDF (European Data Format) format, suitable for analysis by third party software.

The DormoTech Vlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.

The DormoTech Vlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It consists of: The Head Unit, The Body Unit, and The Central Unit.

SomniCheck is a prescription-use physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems. The device measures the following signals: - · EEG (4-channel), - · PPG (by Maxim), - · Temperature, - · 3-axis accelerometer, - · Gyroscope (position), and - · Audio/ sound for snoring. It is intended for use on adult patients (18 and older) and can be used in a hospital, clinic, or home.

SomniCheck is an integrated single-use disposable physiological data recorder intended to amplify, digitize, and record data from multiple physiological channels for subsequent transfer to polysomnography systems for neurophysiology or sleep disorder studies. It is intended for adult use and can be used in a hospital, clinic, or patient home. The associated software There is proprietary software that is currently under development, but the subject device's signal recording capabilities have been validated using the Natus Sleepworks K090277 via bench testing. The proprietary sleep software will be submitted in a future 510(k) Submission. The device is affixed to the forehead of the patient and designed for continuous wear (e.g. during sleep) for up to approximately 10 hours. Once activated, the device records data for the duration of the wear period. After the wear period, the device is removed and may be thrown away. The device measures the following signals: - · EEG (4-channel), - PPG (by Maxim®), - · Temperature, - · 3-axis accelerometer, - · Gyroscope (position), and - Audio/ sound for snoring.

The NomadAir PMU810 is intended to record physiological signals acquired from a patient for archival in a sleep study. Data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB). The NomadAir PMU810 is intended for use within a hospital, laboratory, clinic, nursing home, or patient's home. The NomadAir PMU810 is intended for use on adults only under the direction of a physician or qualified sleep technician. The NomadAir PMU810, or any accessory, does not include or trigger alarms, and is not intended to be used alone as, or a critical component of, * an alarm or alarm system: * an apnea monitor or apnea monitoring system; or * a life monitor or life monitoring system.

The NomadAir PMU810 is a portable device that records physiological signals used for sleep studies. The device can be worn on the chest or the wrist and is attached to the patient using a RIP belt or a disposable strap comected directly to the patient also wears a pulse oximeter probe, a nasal cannula, and an optional sensor, such as a RIP belt, thermocouple, EMG electrode, or ECG electrode. During the typical workflow of using the clinical user configures the device for a patient. The clinician will give the patient instructions on how to attach the device and send the unit and accessories home with the patient. Before going to bed, the patient will connect everything, then go to sleep. The Nomad Air records the signals from the sensors and saves the data to internal memory. The patient may perform up to 3 sleep studies before returning the device. Once the device, they can connect it to a PC using a USB cable and download the study for analysis.

The Quick-20m is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

The Quick-20m is a wireless, battery-operated 10-20 montage EEG headset utilizing dry sensor technology. The headset provides an integrated approach to the wireless acquisition of EEG signals. A seated patient is free to exhibit natural movements while real-time data is collected. The Quick-20m includes advanced amplification and shielding to reject ambient electrical noise. The headset obtains high-quality EEG with minimal scalp preparation. Patented mechanisms and a range of replaceable dry sensors align to various head shapes and sizes, maintaining sensor positions in a standard 10-20 layout. EEG channels are digitized with 24 bits of resolution at 500 Hz. The Quick-20m is suitable for general-purpose EEG.

The Digital NeuroPort Biopotential Signal Processing System supports recording, processing, and display of biopotential signals from user-supplied electrodes. Biopotential signals include: Electrocorticography (ECoG), electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG), electroculography (EOG), and Evoked Potential (EP).

The Digital NeuroPort Biopotential Signal Processing System is used to acquire, process, visualize, archive/record signals as acquired from user-supplied electrodes for biopotential monitoring. Signals are acquired using a headstage relay that attaches to the pedestal interface and digitizes the signal through the hub. The Digital NeuroPort System uses preamplifiers, analog to digital converters, a signal processing unit, and software running on a personal computer to visualize and record biopotentials from electrodes in contact with the body.