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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transcranial (Adult Cephalic) and Peripheral Vascular Diagnostic Device

The Pioneer TC8080 applies ultrasound probes of 1.6 MHz Pulsed Wave (PW), 2 MHz PW, 4 MHz PW and Continuous Wave (CW), 8 MHz, PW/CW, 16 MHz PW and 20 MHz PW to support Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation.

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 VersaLab APM, antepartum monitor is a Perinatal Monitoring system for non-invasively measuring and graphically showing both maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display as well as a permanent record on a thermal strip chart printer. This data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy [Non-Stress Test].

Perinatal Monitoring system for non-invasively measuring and graphically showing both maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display as well as a permanent record on a thermal strip chart printer.

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.

The NEN provides intra-operative image guidance during neurosurgical operations. The NEN provides and operation and provides feedback and provides feedback concerning actions performed and parameters set.

Nicolet Biomedical Electromagnetic Navigation System

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.