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Neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As powered muscle stimulator: - Temporary Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood flow in the treatment area - Muscle re-education - Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles - Maintaining or increasing range of motion As external functional neuromuscular stimulator: - Helps to relearn voluntary motor functions of the extremities The device must be used by trained and qualified personnel.

The g.Estim FES is a constant-current powered muscle stimulator that can deliver rectangular electrical pulses with alternating polarities, lengths and amplitudes, or trains of such pulses. The device is battery supplied and can be connected via USB to a computer. It can be triggered via software or with a hand or foot switch. The programmable parameters of the stimulator are: frequency, current, pulse width, ramp up and down and session length. The phase width and the stimulation current can be changed during stimulation; the other parameters can only be changed when the stimulator is stopped. Stimulation can be started and stopped using a configurable ramp for smooth on- and offsets. A LED shows the stimulus onset. The system consists of the stimulator, a USB connector cable to connect the device to a host computer, patient cables for electrode connection and a software package including the driver and a graphical user interface. Optional trigger out cables and trigger in cables as well as a hand switch and foot switch to trigger the stimulator are available. The device stops stimulation if an over-load is detected or the electrodes are disconnected. A foot switch or hand switch can be used to trigger the stimulator. The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate. g.Estim FES works in the same manner as the approved predicate devices.

The system is intended to statistically evaluate brain activity reflected in a broad band of high-gamma frequencies in the human electroencephalogram (EEG). These measures should always be interpreted in conjunction with review of the original EEG waveform. cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.Hlamp.

cortiQ PRO is a system that uses g.Hlamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the highgamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements. cortiQ PRO reads in the digital data from the g.Hlamp amplification system (1200 Hz sampling frequency, up to 256 channels) via USB into the processing computer. The data is acquired without bandpass and notch filtering and without bipolar derivation. The software allows one to select the channels that should be acquired and stores the raw data together with header information for later off-line analysis. Raw data is visualized on a raw data scope to inspect the data quality. The scope allows scaling of the data in amplitude and time. Furthermore the software allows scaling of all the channels to the same amplitude to make the interpretation easier. In the scope, it is possible to select a new ground and reference channel and to exclude a channel from the processing (if the data quality is bad). The raw data scope filters the data with a high-pass filter to remove DC-offsets for optimal visualization. cortiQ PRO allows the operator to select an experimental paradigm that instructs the patient to perform certain tasks. The instructions are presented on a patient computer screen or are given via a speaker. The user can select, start and terminate the experimental paradigm. Additionally, the number of repetitions can be selected. A dedicated paradigm editor creates new paradigm files or modifies existing paradigms. The rapid cortical mapping functions perform a common average reference (CAR) of all the active channels to remove common mode signals such as power line interference. Then the module calculates the high-gamma activity in certain frequency ranges for the different tasks and compares the high-gamma activity to those of another task according to the selected paradigm. Then a statistical analysis is performed and significant activation is plotted as bubble on the defined electrode position in order to identify important regions. When the mapping has ended, cortiQ PRO automatically generates a mapping report containing the montage definition, the paradigm definition, and the mapping results. This report is stored as pdf and can be printed. The mapping result is also stored for later analysis. cortiQ PRO allows the operator to define montage definition files in the montage creator by loading predefined electrode grids from different manufacturers. Each grid has a certain number of channels. The montage creator allows the operator to assign a patient's name and date of birth, and a montage name to each file. Furthermore, it allows the operator to assign a grid name to each electrode grid. The grids can be placed on different background images to make the location interpretation easier. Electrodes from a grid can be disabled, used as reference or as ground electrodes. The grids can be resized or rotated. The montage creator assigns also the electrode grids automatically to the amplifier inputs channels and creates a report with the channel definition. The results can be stored to be modified later. The report is stored as pdf and can be printed. cortiQ PRO comes with an installs the software under Windows. A hardlock is required to start the mapping software. The mapping system comes with Instructions for use and a training program.

The g.Estim PRO is intended for functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex. The device must be used by trained and qualified personnel within a medical environment.

The g.Estim PRO is a neural, constant current, monophasic stimulator for electrical stimulation of the brain (cortical stimulator). The device is battery supplied and can be controlled via USB from a computer. It can be trigged via software or with external devices and can provide beside the stimulation pulse also trigger signals for other devices. The system consists of the stimulator, a USB connector cable to connect the device to a host computer, trigger out cables and trigger in cables, the driver and software package (including a graphical user interface and communication interface). Additionally the device can be triggered with a hand switch and/or foot switch. The stimulator can be programmed and is a constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes or trains of such pulses. The device is connected via USB to a computer and on the computer stimulator settings can be performed. On the computer a graphical user interface allows to perform all settings required for the stimulator. The stimulator is battery powered and has an optical isolation from the computer for safety reasons. A LED shows the stimulus time point. The stimulator allows to send trigger pulses to external devices to synchronize the stimulus e.g. with EEG data acquisition devices. Such a trigger pulse can be programmed to occur prior to the stimulus so that e.g. a switching unit can switch before the stimulus occurs and can last longer than the electrical pulse to switch back after the pulse. Furthermore the triggers can be perfectly aligned with the stimulus so that an accurate trigger signal can be sent to the external device. The trigger lines are TTL compatible. Two trigger lines are supported. The stimulus can be triggered via the software running on the computer or via external inputs to the stimulator. Important is that the stimulus is triggered very accurately for perfect synchronization. A foot switch or hand switch can be used to trigger the stimulator. The trigger input is TTL compatible. One trigger line is supported. The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The results are shown in the graphical user interface and can be passed also to other applications via an interface. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate. g. Estim PRO works in the same manner as the approved and predicate device.

The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.

g.Nautilus PRO is g.tec's bio-potential amplifier with wireless data transmission technology. The device allows the acquisition of up to 32 EEG (Electroencephalogram) channels with 24 bit resolution. The sampling frequency can be set up to 250 or 500 Hz. g.Nautilus PRO is available with 8-32 channels. The wireless amplifier is transmitting data to a PC or notebook with 2.4 GHz technology. On the computer a receiver unit is connected with USB. Up to 32 analog to digital converters perform the simultaneous sampling. The sampling frequency can be set to 250 Hz or 500 Hz. Each analog to digital converter is operating with 1.024 MHz and performs a 2048 times oversampling for 500 Hz. A sampling frequency of 250 Hz vields to an over-sampling rate of 4096 with a very high signal to noise ratio. Furthermore, the device has an internal impedance check unit. g.Nautilus PRO works with either active gel or active dry electrodes and comes with an EEG cap with chinstrap. The device is controlled via its driver and application programming interface (API), which is part of the g.tec device service g.NEEDaccess. The device is battery supplied. The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children and infants. The host computer must use Microsoft Windows. g.Nautilus PRO comes with a C Application Programming Interface (C API) which allows to control the device. The system consists of the charging device, the g.Nautilus PRO Headset (the amplification and digitization unit with EEG electrodes, cap and chin-strap), the receiver unit (with USB connector cable to connect the device to a host computer), the driver and the C API software. g.Nautilus PRO works in the same manner as the approved and predicate device.

The g.Hlamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer via the USB port connection. These biopotentials include for example electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), and electrocardiogram (ECG).

The g.Hlamp is a fully programmable system which provides a total of 256 analog input channels each of which can be configured, amplified and converted to digital form (analog to digital conversion). The applied part is digitally isolated. The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 601-1 requirements, which feeds in +5V DC. Internally, the +5V DC is further isolated by a dedicated DC/DC type converter. The g.Hlamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer via the USB port connection. These biopotentials include for example electroencephalogram (EEG), electromyogram (EMG), electrooculogram (EOG), and electrocardiogram (ECG). It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals. The host computer must use Microsoft Windows 7. g.Hlamp comes a driver and with a C Application Programming Interface (C API) which allows to control the device. The system consists of the AC/DC adapter (power supply unit), g.HIamp (the amplification and digitization unit), electrode connector boxes with cables to the g.HIamp (to connect EEG electrodes), a USB connector cable to connect the device to a host computer and the driver and C API software.

Measuring, recording and analysis of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG.

The g.USBamp is a fully programmable system which provides a total of 16 analog input channels each of which can be configured, amplified and converted to digital form (analog to digital conversion). The applied part is optically isolated. The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 601-1 requirements, which feeds in +5V DC. Internally, the +5V DC is further isolated by a dedicated DC/DC type converter. The g.USBamp is intended to be used for measuring, recording and analysing of electrical activity of the brain and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data, converts it into digital form and passes it on to a host computer running appropriate software. The device can be used for adults, children, infants and animals. The host computer must use Microsoft XP. g.USBamp comes with a C Application Programming Interface (C API) which allows to control the device. The system consists of the AC/DC adapter (power supply unit), g.USBamp (the amplification and digitization unit), a USB connector cable to connect the device to a host computer and the C API. g.USBamp works in the same manner as the approved and predicate device.