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The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Nicolet EDX with Synergy Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Nicolet EDX with Synergy Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. The Nicolet EDX with Synergy Software is intended to be used by a qualified healthcare provider.

The CareFusion Nicolet EDX system with Synergy Software (Synergy EDX) is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). Synergy EDX provides a variety of tests spanning the various modalities. The Synergy EDX consists of the following major components: - Nicolet EDX console base unit; - Synergy control panel: - Nicolet amplifier (there are two types available: 2 channel (AT2) with two non-switched amplifier channels and an 8 channel (AT2 + 6) amplifier with two non-switched and six switched amplifier channels; - Desktop or laptop computer with a keyboard and mouse; - Display monitor; and - Synergy Software The Synergy EDX optional accessories/components consists of the following: - Nicolet HB6 or HB7 Head Box - Stimulator probes (RS 10 probe, WR 50 Probe, S403 probe) - SP1/SP2 electrical stimulator switching units - Footswitches (single and triple) - LED goggles - Patient response button - Photic strobe - Headphones or other auditory transducers - Cart - Isolation transformer - Printer

The CareFusion Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP). The Nicolet EDX with Viking Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Nicolet EDX with Viking Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. The Nicolet EDX with Viking Software is intended to be used by a qualified healthcare provider.

The CareFusion Nicolet EDX system with Viking Software (Viking EDX) is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform nerve conduction studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). The system can also perform multi-modality recording through Multi-mode programs (MMP). Viking EDX provides a variety of tests spanning the various modalities. The Viking EDX consists of the following major components: - Nicolet EDX console base unit; - Viking control panel; - Nicolet amplifier (there are two types available: 2 channel (AT2) with two non-switched amplifier channels and an 8 channel (AT2 + 6) amplifier with two non-switched and six switched amplifier channels; - Desktop or laptop computer with a keyboard and mouse; - Display monitor; and - Viking Software. The Viking EDX optional accessories/components consists of the following: - Nicolet HB6 or HB7 Head Box - Stimulator probes (RS 10 probe, WR 50 Probe, S403 probe) - SP1/SP2 electrical stimulator switching units - Footswitches (single and triple) - LED goggles - Patient response button - Photic strobe - Headphones or other auditory transducers - Cart - Isolation transformer - Printer

TECA™ ELITE Disposable Concentric Needles 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.

CareFusion 209, Inc. TECATM ELITE Disposable Concentric Needles (TECATM ELITE Needles) are disposable, single use, sterile products intended to sense subcutaneous bioelectrical activity, or to stimulate nerve or muscular response by insertion into the patients muscle(s) through the skin where the recording area can differentiate between individual motor units. TECATM ELITE Needles are connected to an electromyographic (EMG) device through a cable. The EMG device detects and displays the biopotential information to the user. TECATM ELITE Needles consist of a stainless steel tube with a conductive core. A polyesterimide isolative coating resides between the core and the stainless steel tube. The exterior surface of the needle is dipped in a low-friction lubricant. TECATM ELITE Needles are passive devices, and do not contain electrical hardware components or software. The following device modifications were made to the TECATM ELITE Needles: Modification of the core material; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the packaging materials.

TECA™ elite Disposable Monopolar Needles 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.

CareFusion TECAT™ elite Disposable Monopolar Needles (TECATM elite Needles) are disposable, single use, sterile products intended to sense subcutaneous bioelectrical activity, or to stimulate nerve or muscular response by insertion into the patients muscle(s) through the skin where the recording area can differentiate between individual motor units. TECATM elite Needles are connected to an electromyographic (EMG) device through a cable. The EMG device detects and displays the biopotential information to the user. TECAT™ elite Needles are stainless steel, platinum alloy, and/or gold plated stainless steel, and coated with a polytetrafluoroethylene (PTFE) insulator. A low-friction lubricant is applied to the exterior surface of the needle. TECAT™ elite Needles are passive devices, and do not contain electrical hardware components or software. The following device modifications were made to the TECAT™ elite Needles: Reformulation of the PTFE exterior needle coating; Addition of a low friction lubricant to the exterior surface of the needle; and Modification of the needle tip geometry.

The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.

The Nicolet Wireless Amplifiers are used in a wide variety of EEG applications including: Ambulatory (at home or in transit to home), OR, LTM, EEG, Sleep and ICU. The proposed amplifiers are small portable devices that can run on main electrical A/C power or use a portable battery pack. The proposed device consists of two models designated as the 32 channel and the 64 channel amplifier. These units can acquire from up to 32 or 64 channels, they can be grouped or "cascaded" together for more channels. The amplifiers are capable of acquiring a variety of electrophysiological signals at variable sampling frequencies. These signals include EEG, EKG, EMG, EP, temperature, blood pressure, pulse, and other signals standard to neurological and sleep testing. The amplifiers have wireless capability and a battery pack for mobile data acquisition. Wireless access points collect the wireless data transmissions. The amplifiers can be connected to the Ethernet by a cable and also to AC power. The amplifiers are IP addressable and can be connected directly to a network device. In all situations the amplifiers store a copy of the data locally to allow for data back-up. This amplifier provides storage and subsequent transmission of data that is not transferred live when the amplifier is in out of range situations.