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The STM9000 is intended for stimulation of peripheral nerves for diagnostic purposes.

The STM 9000 are magnetic stimulators used for magnetic stimulation. Magnetic stimulation is a noninvasive technique for stimulating neural and cortical tissue. Application areas of magnetic stimulation are a subset of the application areas for current stimulation. The STM 9000 is connected to a magnetic coil which transfers the magnetic stimulation to the tissue. The STM 9000 consists of power electronics to generate the magnetic field in the magnetic coil. The STM 9000 is controlled via a simple user interface, enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is capable of biphasic and monophasic waveforms and the stimulate with a frequency up to 100 pulses per second (pps).

The GALILEO NT Line software is intended to record and display EEG, PSG, EMG and EP data acquired from the patient body through EBNeuro proprietary, FDA cleared, Acquisition Platform.(BE Plus LTM K121986, BE micro K093728, Nemus 2 system K133517.) The device is intended to be used in the clinical and hospital environment (including the hospital room, emergency room, intensive care unit, neuro-intensive care unit) to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles

Galileo NT Line is a software package running on a Personal Computer under Windows Operative System. This package is devoted to the complete management of various exams in the Neurodiagnostic field of application, as electroencephalography, electromyography, Evoked Potentials etc. The product is essentially a suite of applications dedicated to the comprehensive management of neurological diagnostics in a Department of Neurophysiology, etc. ... starting from the patient's acceptance, the execution of specific tests, and finally to the production of the exam reports. The package is substantially made by a common "platform" and by various independent modules, each of which is devoted to a particular application (EEG, Video EEG, EMG, EP, ICU, etc.). All the parts of the package together with the related User Documentation are residing on the same distribution media (a DVD). As illustrated by figure 1 below, GALILEO NT Line (simply Galileo NT in other documents of this submission) is a "software only device" that can control and acquire data from a series of (FDA cleared) Amplifier platforms developed by EBNeuro for the Neurodiagnostic field and specifically : - 1. BE micro (K093728) - 2. BE Plus LTM (K121986) - 3. Nemus 2 (K133517) For each of the above devices, Galileo NT provides the appropriate "software interface" module in order to allow the control of the Amplifier (and of all the accessories eventually provided with it, as, for example, the Evoked Potential stimulators embedded in the Nemus 1 and 2 hardware) and in order to collect the acquired data. The data, once acquired from the amplifier, are "passed" to the specialized module for successive handling as display, measure, printing, trending, archiving and so on.

The Nemus 2 System is intended to acquire the bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The acquired signals are transmitted to a PC during recording of neurophysiology examinations. The Nemus 2 System consists of a physiological signal amplifier, an evoked response auditory stimulator, an evoked response electrical stimulator, and an evoked response photic stimulator. The user needs to assure compatibility of the Nemus 2 System to the other components of the user's own system.

The Nemus 2 System is made up of the Nemus 2 Amplifier/Stimulator, an AC/DC converter to power the amplifier, a "junction box" to connect the system to the Host PC, and (optionally) by a dedicate keyboard and a Flash LED stimulator. The Nemus 2 System is intended to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The acquired signals are transmitted to a PC during recording of neurophysiology examinations. The device may use electrical stimulus, sound stimulus, or visual stimulus for use in evoked response analysis. The Nemus 2 System is an amplifier/stimulator device especially developed to amplify biological signals. The amplifier captures the biological signal from the human body through specialized sensors or electrodes, amplifies the very low electrical signal, and filters it to accomplish an antialiasing in order to make an optimal ANALOG to DIGITAL conversion. The data, once converted in numerical form, are "passed" to a host computer, which at this point is free to elaborate the data following the logic of the application software running on the host. The Nemus 2 System is not involved in the data management performed by the host.

The BE Plus LTM / GWi Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

The BE Plus LTM / GWi amplifiers system, which has 64 channels, is an amplifier system which collects the bioelectric signals from the surface of the human body trough appropriate electrodes or sensors, intensify the very low signal captured (typically the amplitude range is of the order of the uVolts), condition them (filtering), convert them in numeric form and pass these data to the "host" elaboration unit (Personal Computer or equivalent system). For these reason this device is not intended for a "direct" use by the physician but rather by a "manufacturer" or "System Builder" (a company or a researcher) which wants to build a "complete" medical device using the "BE Plus LTM / GWi" amplifier device as the "acquiring part" of the whole system. BE Plus LTM / GWi is therefore intended to be assembled into an electromedical system by a System Builder, who will define the specific intended use of the assembled medical device.

BE micro/Trea intended use is collecting and recording physiological data to be used in neurology (EEG), polysomnography (PSG) and sleep disorder studies. The BE micro is intended for pediatric to adult population, and can be used either home or hospital environments. The BE micro/Trea is only to be used under the direction or supervision of a physician, or other trained health care professional.

The BE micro is manufactured by EBNeuro and intended for use in collecting and recording physiological data to be used in diagnosis in EEG (electroencephalography) and PSG (sleep disorder studies) clinical investigation. The BE micro is a portable multi-channel recording system that capture and digitally amplifies neurological (EEG) and/or Polysomnography (PSG) physiological activity and records the acquired data onto an internal NAND flash memory chip and/or sends those data directly to a PC via the USB port. The BE micro system is a small, lightweight recording system that is comfortable for the patient and simple for the clinician to set up. The Amplifier can be worn by the patient allowing in such way the patient to freely move or sleep while recordings are being made, allowing a more comfortable and efficient test.

NEMUS systems are diagnostic medical systems able to detect the electric signals produced by the peripheral nerve system and by skeletal muscles. The NEMUS system is intended to monitor, record and display the bioelectric signal produced by the muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular diseases (EMG). The device may use electrical stimulus or sound stimulus for use in evoked response measurements (EP).

There are two configurations of NeMus: NeMus System and NeMus PC Peripheral. The "Nemus system" is a complete system provided with a cart (expressly designed for this device and equipped with isolation transformer, the base unit support mobile arm, places for computer, keyboard, footswitch, printer, and dedicated keyboard and so on. The complete system provided of all the part ordered by the customer is completely wired, assembled and tested in factory before to ship to the final user. Like the hardware parts, all the needed software is installed and configured in factory. The "Nemus PC Peripheral" is a base kit (constituted by the NeMus 1 Amplifier the AC/DC adapter, cables and GALILEO NT management software) which, by adding a Personal Computer, becomes a digital electromiograph system. This configuration is developed and verified in order to allow a Distributor or the User to "build" an acquisition/processing EMG signal system by using the NeMus 1 acquisition module, the GALILEO NT/MYTOWIN management software and their own Personal Computer (and peripherals). However the PC must be compliant with EBNeuro specified minimum requirements. Of course the "system builder" must follow all the indications detailed in the related User Manual provided with the system. In this kind of system configuration, the "base kit" provided by EBNeuro is a sort of "peripheral" of a PC system. This configuration allows the Distributor or the User to use its own PC, cart or other "system" arrangement of its choice. NeMus systems are diagnostic medical systems able to detect the electric signals produced by the peripheral nerve system and by skeletal muscles. The Nemus system is intended to monitor, record and display the bioelectric signal produced by the muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis of neuromuscular diseases (EMG). The device may use electrical stimulus or sound stimulus for use in evoked response measurements (EP).

Intended for use in collecting and recording physiological data to be used in polysomnography and sleep disorder studies. The Sandman Pocket is intended for pediatric through adult patient populations, and can be used in either home or hospital environments. The Sandman Pocket is not intended for use as life supporting equipment such, as a vital sign monitoring in an intensive care unit. The device does not produce alarms and is not intended as an automated apnea monitor. The Sandman Pocket is only to be used under the direction or supervision of a physician, technologist or clinician.

The Sandman Pocket is a physiological data recorder that is part of a polysomnography system. It consists of two units: the Recorder Unit, which stores the data and sends it to a USB port, and Headbox Unit, which is the connection point for all patient sensors with the exception of the Nellcor Puritan Bennett oximetry probe. The role of the Sandman Pocket is only to capture the data and pass it to the host with the necessary accuracy and reliability according to the product and communication control specifications. A fundamental characteristic of the Sandman Pocket is the ability to be an ambulatory/portable physiological data recorder. Because of its small size and light weight (about 210 grams including the battery), the system is compact and durable. The Headbox Unit is used for connecting patient electrodes and sensors. It includes Bipolar channels, pressure sensors, power supply for a dedicated body position sensor, an abdomen sensor, a chest sensor, a snore sensor and a thermistor. The patient inputs are isolated with a CF type isolation level. The Sandman Pocket device is provided without standard sensors. The system builder should integrate the device with FDA cleared Nellcor Puritan Bennett sensors only and specified for the usage with NELL-1 module. The Headbox Unit captures the biological signals from the human body surface through specialized sensors and electrodes, while the Recorder Unit amplifies the very low electrical signal and filters the signals to make an optimal ANALOG to DIGITAL conversion. The data, once converted in numerical form, are sent to a host computer for review and analysis. The host can "program" the amplifier behavior by setting the sampling frequency and the dynamic range allowed and so on. The host computer reads the acquired data through a dedicated interchange protocol, and allows a clinician to analyze the data using sleep review analysis software, provided by the end user or system builder. The clinician must use an electrically isolated computer (with a medical grade isolation transformer or medical grade power supply) or batterysupplied laptop when the Sandman Pocket device is connected to the host PC and the patient is connected to the Sandman Pocket Headbox. The Sandman Pocket system is not in any way involved in the data management performed by the host. The host computer must operate using one of the following Operating System: Microsoft Windows 98 / ME / NT / 2K / XP. The device has a built-in impedance meter. This function allows the clinician to check the electrode contact impedance and display the results of the check on the display. The display is located in the Recorder Unit, while the circuitry controlling the impedance meter is located in the Headbox Unit. The Sandman Pocket can be powered through 3 Alkaline 1.5V standard non rechargeable batteries or via the USB cable. The user is recommended to use a medical grade type PC. The Sandman Pocket system consists of two interconnected units: the Headbox Unit and the Recorder Unit.

The BE Plus / AURA-LTM64 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

The BE Plus / AURA-LTM64 Amplifier is a fully programmable system which provides a total of 64 analog input channels each of which can be configured, amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 60601-1 requirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter. The BE Plus / AURA-LTM64 Amplifier is intended to be used to amplify and filter bioelectric signals captured via a lead or transducer on the surface of the human body. It captures the data, converts it into a digital form and passes it on to a host computer running appropriate amplification software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Polysomnography (Sleep Analysis) and General Polygraphy. The BE Plus / AURA-LTM64 Amplifier does not contains a Pulse Oximeter module. The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP. The BE Plus / AURA-LTM64 Amplifier system consists of three interconnected units: the amplifier box, the PC interface (PCMCIA interface or BE Net) and the AC/DC adapter; optionally the system may be completed by a led visual stimulator.

The Nic36 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

The Nic36 Amplifer is a fully programmable system which provides a total of 36 analog input channels each of which can be configured as monopolar or bipolar. The bioelectric signals are amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter. The Nic36 Amplifier is intended to be used to amplify and filter bioelectric signals captured via a lead or transdaor on the surface of the human body. It captures the data, converts it into a digital format and transmits it on to a host computer running appropriate software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy. The Nic36 Amplifier does not contain a Pulse Oximeter module. The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP. The Nic36 Amplifier system consists of three interconnected units: the amplifier box, the PCMCIA or BE Net interface and the AC/DC adapter; optionally the system may be completed by a led visual stimulator.

The SD20 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

The Sandman SD20 Amplifer is a fully programmable system which provides a total of 22 analog input channels cach of which can be configured, amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 601-1 requirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter. The Sandman SD20 Amplifier is intended to be used to amplify and filter bioelectric signals captured via a lead or transducer on the surface of the human body. It captures the data, converts it into a digital form and passes it on to a host computer running appropriate amplification software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy. The Sandman SD20 Amplifier contains a Pulse Oximeter module. The data measured from this module is passed to the host computer together with the other channels' data. The MP100 Pulse Oximeter module, developed by Nellcor Puritan Bennett, is substantially equivalent to Nellcor Puritan Bennett's MP400 Pulse Oximeter module cleared with EB Neuro's Mizar Amplifier via K003154. The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP. The Sandman SD20 Amplifier system consists of four interconnected units: the headbox, the amplifier box, the PC interface (BE Net/Sandman eLink) and the AC/DC adapter.