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The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.

The BraiNet is used by licensed medical professionals to support placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of stimulation and recording. The BraiNet is provided to the user non-sterile. The BraiNet is a single patient use, disposable devices. The BraiNet is made from elastic and Velcro commercial garment grade materials.

The Nicolet Subdural Strip Electrodes can be temporarily placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.

Subdural Strip Electrodes are used by licensed medical professionals to support stimulation and recording of biopotentials from the surface of the brain or the subdural space above the surface of the brain. The electrodes connect to medical equipment in support of stimulation and recording. The electrodes are provided to the user sterile. The electrodes are single patient use, disposable devices. The electrodes are made from the same materials as the predicate devices. The electrode lead wires terminate in a safety connector, complying with the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898. These electrodes do not contain active electronics or software. The electrodes connect to the user's medical equipment.

The SNAP device is intended to monitor a patient's EEG. A derived EEG measure, the SNAP Index, indicates the patient's brain activity level. The SNAP device is used under the guidance and interpretation of a licensed medical professional.

The SNAP device records and displays a processed EEG parameter called the SNAP Index, records and displays a time based trend of the SNAP Index and displays a real time EEG signal. The SNAP system has four significant components: 1. A Visor SNAP module, which is inserted into the springboard slot of a Handspring Visor handheld computer. 2. A disposable, single patient use SNAP Electrode for acquiring the EEG signal. 3. A patient cable which connects the Visor SNAP module to the patient electrode. 4. SNAP personal computer application software, which is provided for use on personal computers operating with Microsoft Windows® operating systems.

The Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.

The Nicolet Electrocautery Detector interfaces between the auditory signal output from a nerve monitor and the nerve monitor's external speaker. The Electrocautery Detector automatically mutes the nerve monitor speaker when electrocautery interference is detected.

Concentric, Monopolar, Hook Wire and Hypodermic EMG Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.

EMG electrodes are applied in the study of biopotentials such as electromyograph (EMG), nerve conduction and stimulation/response. Electrodes are invasive as they are placed in contact with nerve or muscle tissue. The electrodes consist of a needle with a connector/lead wire attached. The connector/lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician. The EMG electrodes consist of a needle with a connector or lead wire attached. The connector or lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The EMG Electrodes are provided sterile and for single patient use.

The BioRehab System is used for electromyography (EMG) biofeedback support of relaxation and muscle reeducation. The BioRehab System may be used by licensed medical practitioners to support their methods of muscle relaxation and reeducation/rehabilitation. The BioRehab System can be used in hospital, physician office, clinics, long-term patient care facilities, home and other therapy locations.

The BioRehab System consists of an EMG amplifier, computer and software. Under the care and guidance of a physician or therapist, the BioRehab System supports relaxation and muscle reeducation by the application of electromyography (EMG) biofeedback. The BioRehab System supports patient game playing under EMG control. The patient consciously controls the EMG signal level from the therapist's selected muscle groups.

The Bravo Multi-Modality System is intended to record and display EEG, EP, EMG and TCD data in the clinic and hospital (including the hospital room, operating room, emergency room, intensive care unit, neuro intensive care unit, critical care unit, etc.), and to import and display data from third-party monitoring devices such as vital signs monitors. It is intended to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.

The Bravo Multi-Modality System is a personal computer-based digital data recorder for continuously monitoring various types of neurological information, including: (i) neuroelectric and neuromuscular data pertaining to the patient's central and peripheral nervous system and muscles, and (ii) neurovascular data pertaining to blood flow in the patient's brain and related blood vessels. The intended use of this device is to record and display EEG, EMG, EP and TCD signals; and to import and display data from third-party monitoring devices, such as vital signs monitors. EEG signals are passively recorded using electrically-conductive electrodes that are placed in electrical contact with the patient's skin or nervous system. EMG and EP signals are recorded using electrically-conductive electrodes that are placed in electrical contact with the patient's skin, nervous system or muscles. EMG signals are passively recorded, while EP signals are evoked using a light source, a sound source, or an electrical stimulator. TCD signals are actively recorded using a non-invasive ultrasound transducer that emits and records ultrasound energy. The ultrasound energy is applied externally to the skin, passes through the skin and body tissues, reflects off blood molecules moving in the blood stream, passes back through the body tissues and skin, and returns to the transducer. Movement of the blood molecules causes a frequency or "Doppler" shift in the returned ultrasound energy, which is detected and converted into a signal representing the velocity of the blood from which the ultrasound energy was reflected. Third-party monitoring devices, such as vital signs monitors, acquire and display a variety of physiological data from the patient. Importing and displaying such data is done by taking an output signal directly from such monitoring devices without any additional connections to the patient. Data obtained from the monitoring device is then displayed, analyzed or stored by the Bravo Multi-Modality System independently of how the third-party device handles the data.

The Satellite is intended to acquire EEG data from patients that are stationary or ambulatory, regardless of whether they are inside or outside a medical-care facility.

The Satellite is a portable, battery-powered, digital electroencephalographic (EEG) data recorder that is designed to be carried in a hip belt worn by the patient. The intended use of this device is to record the patient's EBG while the patient is ambulatory or at home. Recorded EEG data is stored in a removable hard disk drive, which the medical practitioner can then remove from the data recorder and connect to a standard personal computer. The personal computer is then used to review and analyze the EEG data, generate reports, and provide longer-term storage for the EEG data. The personal computer also performs various system utility functions on the data recorder, such as programming the user-selectable parameters, and measuring the electrical impedance of the EEG electrode connections. A battery pack and charger also accompany the data recorder. These items are designed so the battery pack cannot be recharged while it is powering the data recorder, so the data recorder (which may be attached to the patient) cannot be connected to the AC-powered charger. The device is intended to complement Nicolet's existing line of EEG systems, including the Voyageur digital EEG system (K921927B) and BMSI long-term EEG monitoring system (K891405A). Neither of these devices currently provides the capability for ambulatory or athome EEG data recording, however, both will record and playback EEG data that is similar to the data recorded by the Satellite.