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Glide is to be used exclusively for exoprosthetic fittings of the upper limb.

Glide is a surface electromyography (EMG) electrode and control system intended to be used with an upper limb prosthesis. Glide detects surface EMG signals using IBT Electrodes V2 placed on the user's skin. These signals are processed by Glide and are used to drive the upper limb prosthesis. Glide is compatible with industry standard domes. Glide does not have any direct skin contacting parts. Glide is compatible with most hands, wrists, and elbows that accept industry standard inputs. Glide accepts power from the prosthesis batteries and outputs control signals to hands, wrists, and other prosthetic components. The components of Glide are assembled into the prosthesis by a certified prosthetist or trained technician according to the individual needs of the amputee. Glide is a reusable single patient use device. Glide does not replace or modify any functionality of connected prosthetic components. Adjustments to the Glide components can be performed through Bluetooth data transfer using the IBT Control Application. The IBT Control Application runs on the iPad OS platform and allows the prosthetist to adjust the settings of the system, such as assignment of input filtered signal to prosthesis movements, adjustment of gains, etc. Glide components: - Core2 Controller (90010) - Output Cable (90020-XX) - IBT Remote Dome Electrodes (upto 8) - Electrode Cables - IBT Control Application - Core2 Fabrication Kit (94001) - Documentation - Dome Fabrication Kit (optional)

Sense System with IBT Electrodes is to be used exclusively for external prosthetic fittings of upper limbs.

The Sense System is a surface electromyography (EMG) electrode system designed to enhance control of upper limb prosthetic devices. The Sense System detects EMG signals using the IBT Electrodes (previously approved by the FDA under 510k, K173571). The electrode signals are then processed using a pattern recognition algorithm and translated to output signals that are standardized to be compatible with an array of connected prosthetic devices, such as hands, wrists or elbows. The Sense System does not replace or modify any functionality of connected prosthetic components. The Sense System is compatible with most hands, wrists, and elbows that accept industry standard signals. It is typically sold with three-port kidney-style output connectors; however, alternative connectors may be used to ensure compatibility with other components. The Sense System accepts power from IBT's FlexCell Battery system and outputs control signals to hands, wrists, and other prosthetic components. The Sense System is installed in the prosthesis by a trained prosthetist and connected to prosthetic components selected to meet the needs of the individual user. Sense System components: - IBT Electrodes (up to 8) - Signal Processing Box - User Interface Software - Fabrication dummies for electrodes and processing box

The Element system is intended to be used exclusively for myoelectric exoprosthetic fittings of the upper limb.

The Element system is a surface electromyography (EMG) electrode system that is to be used with upper limb prosthetic devices. Element outputs standard envelop EMG signals detected from EMG electrodes (IBT Electrodes) placed on the user's skin. These signals are used as inputs by connected prosthetic devices, such as hands, wrists or elbows. The Element system is an alternative to standard suction socket myoelectrodes, with the advantages of a lower profile, digital signal processing, and wireless gain adjustment. Element does not replace or modify any functionality of connected prosthetic components. Element is compatible with most hands, wrists, and elbows that accept standard analog EMG electrode inputs. The Element system is typically sold with three-port kidney-style output connectors, however alternative connectors may be used to ensure compatibility with other terminal devices. The Element system accepts power from IBT's FlexCell Battery system and outputs control EMG signals to hands, wrists, or other prosthetic components. The Element system is installed in the prosthesis by a trained prosthetist and connected to prosthetic components selected to meet the needs of the individual user. System components: - IBT Electrodes (up to 2) - Signal Processing Box - Element Desktop Software

The Vigilant EEG Monitor (Vigilant 2.0) is an electroencephalograph that works in conjunction with Vigilant bedside monitoring and remote review software. It is intended for measuring and recording the electrical activity of a patient's brain by applying 8 electrodes on the head. The Vigilant EEG Monitor (Vigilant 2.0) requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

The Vigilant EEG Monitor (Model Vigilant 2.0) is a multi-channel EEG monitor. It is intended for monitoring the state of the brain by applying electrodes to a patient's head. It also includes software to enable remote monitoring by a neurologist or other trained personnel. Both acquisition and review of patient data can be performed at the bedside. The Vigilant EEG Monitor does not include a computer monitor or video camera, but these are required for system use. The Vigilant EEG Monitor consists of an EEG acquisition console with junction box and a software CD (bedside EEG monitoring software, server software for remote telecommunications and software for remote monitoring of EEG data). The principal component of the Vigilant EEG monitor is a Porti amplifier and power supply provided by TMS International (Oldenzaal, The Netherlands). The software is designed to be loaded onto an off the shelf computer monitor that may be supplied by the user. It is also designed to interface with a video camera for real-time video monitoring concurrently with EEG monitoring. Neither the computer nor the camera is considered part of the medical device. The EEG signal display can be configured in a reduced mode (up to 4 EEG channels plus quantitative EEG metrics for each channel) or a full mode (up to 8 EEG channels). The display modes and channel display are configurable by the user. In the reduced mode display, the user may select to display either the spectral edge frequency (SEF 95) as a line graph, or the power spectrum (POWER) displayed as four colored line graphs, each representing the standard EEG frequency bands (delta: 0-4Hz, RED: theta: 4-8Hz, YELLOW; alpha: 8-13Hz, GREEN; beta: 13-30Hz, BLUE). Real-time video of the patient from the system camera is displayed in a separate window from the EEG signals. This window may be hidden or resized by the user. The video is recorded in synchronization with the EEG even when it is not displayed and may be replayed during review mode.

The I-2000 Monitor is intended to be used for measuring and recording the electrical activity of a patient's brain, obtained by placing electrodes on the head. The I-2000 Monitor is indicated for use in monitoring the state of the brain by acquisition of electroencephalogram (EEG) signals, in research and clinical environments.

The I-2000 Monitor is a two-channel EEG monitor and consists of a tablet PC, battery powered wireless headbox, headbox charger, and power conditioner integrated into a mobile console. The tablet PC provides processing, display, and storage of EEG signals. User operation of the Monitor is accomplished using the graphical user interface and touch screen tablet PC. The signal display formats are EEG waveforms, EEG power spectrum, and 95% Spectral Edge Frequency. Various amplitude display scales are available and event marking capability is provided. The screen is adjustable for user comfort. The power spectrum will be displayed as a line graph for each of the four frequency bands traditionally used to quantify EEG signals [Delta (0-4 Hz), Theta (4-8Hz), Alpha (8-13Hz) and Beta (13-30 Hz)] over time. The 95% spectral edge frequency is the frequency below which 95% of the total EEG power is concentrated. This is also displayed as a line graph over time. The headbox provides amplification, digitization, and transmission of EEG signals. Wireless Bluetooth communication provides complete electrical isolation of the patient from the monitor. The headbox is recharged in a custom charger within the console when not being used for monitoring. EEG signal processing includes data checking for artifact and electrode contact impedance. Stored EEG signals may be exported to removable storage. The integrated console features a stable base with 6 casters and a power conditioner to provide an additional protection barrier for both users and patients.