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The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home. The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor.

The Bluebird Single-Use Respiratory Effort Belt (Bluebird) is used to measure chest and abdomen expansion and contraction during respiration. The sensor consists of a sinusoidal wire coil attached along the length of an elastic belt. The inductance of the sensor changes as the belt is stretched. The Bluebird is suitable for connection to the inputs of physiological recording equipment. The Bluebird measures inductance and generates an output signal proportional to the amount of stretch. The elastic belt is held in place by a quick release buckle with a cinch function and the belt is adjusted to fit snugly but comfortably. Electrical connection to the two ends of the embedded coil is through a 1.5mm female touch proof connection jack on each side of belt buckle. The materials are elastics and plastics used in the clothing industry, and fine gauge copper wire for the embedded coil.

The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli. Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis. Guardian can provide remote review outside of the operating room. Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing. The following functions are specifically supported individually or in combination: Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered. Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp. Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes. Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves. Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results. Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results. Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results. Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results. Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system. Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results.

The Cadwell Guardian is a multi-modality intraoperative neurophysiological monitoring system with up to 80 channels of data acquisition. The Guardian system is designed to be flexible and scalable depending on customer and procedural requirements. All systems require a Power Comm and Guardian Base, which contains an electrical Transcranial Stimulator. The user may select up to two Omni Amplifiers, two ES-10 electrical stimulators, one AVX auditory and visual stimulator, and one SMX-32 EEG amplifier that contains a low current electrical stimulator, in order to meet specific requirements. The Guardian requires a (PC) with Windows operating system. The Guardian system uses a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software. Surgical Studio acquires, stores and reviews a wide range of intraoperative neurophysiological data, such as EMG, EEG, SSEP, BAEP, VEP, MEP and TOF, and includes Report Generation.

The Cadwell Apollo System is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.

The Cadwell Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages. The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K180269) with support for Apollo hardware using single or combinations of amplifiers, a photic stimulator, and interfaces with a Cadwell or 3rd party oximeter devices. Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.

The Cadwell ApneaTrak device is intended for home sleep testing, including the acquisition of physiological and environmental data. The recorded signals are then transmitted to a PC so that they can be viewed. ApneaTrak is intended for use on patients older than 2 years of age. ApneaTrak is intended for use in hospitals, sleep centers and other sleep testing environments, including the patient's home. ApneaTrak is intended to be used when prescribed by a qualified healthcare provider for use on patients suspected of sleep disorders, specifically Sleep Disordered Breathing (SDB) and requires review by qualified medical personnel. ApneaTrak is NOT intended to perform automatic diagnosis.

Cadwell's ApneaTrak is a sleep diagnostic system consisting of: (1) acquisition hardware that can acquire, record, store, and transfer up to 3 channels of ExG (including EEG, EMG, ECG, and EOG signals) data, 2 respiratory effort channels, 1 thermistor channel, 1 pressure channel, 1 snore channel, and 1 oximetry channel; (2) a host electronic device (typically a PC) capable of running the software as well as charging and interfacing with the acquisition device; and (3) software that allows for device configuration and data download. ApneaTrak is connected, by a clinical user, to a host device via USB cable for initialization. After initialization and having been given instruction on correct clinical use of the device, ApneaTrak is then used by the patient at home. The device acquires and stores physiological and/or environmental data to onboard memory. After use, the device is returned to the clinical user, who connects the device to the host PC. The software downloads and stores data from the device in European Data Format (EDF).

1. Cadwell Bolt is a software-only device intended for post-hoc analysis of EEG data. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information. This device is intended to be used with EEG data from patients of all ages. 2. Cadwell Bolt includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG data. These include the following 10 analyzers: - -Amplitude Integrated EEG (aEEG), - -Peak Envelope, - -Envelope Asymmetry, - -Spectrogram, - -Band Power. - -Power Ratio, - -Spectral Entropy, - -Burst Suppression Ratio, - -Inter-burst Interval, and - -Bursts-per-Minute. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG data. A minimum of one epoch of data is required to perform Bolt analysis. 3. The aEEG functionality included in Cadwell Bolt is intended to monitor the state of the brain. 4. Cadwell Bolt can provide notifications, based on user-defined thresholds, for quantitative EEG measures such as a notification within the application software that can be used when processing a record during acquisition. Delays can occur between the beginning of an event and when the Bolt notification will be shown to a user. Cadwell Bolt notifications cannot be used as a substitute for real-time monitoring of the underlying EEG data by a trained expert. This device does not provide any diagnostic conclusion about the patient's condition to the user as part of its output. The software does not contain automated detection algorithms.

Cadwell Bolt is a software-only device for use with EEG data. The Cadwell Bolt receives EEG data as an input and uses this input to calculate and display the following quantitative measures of electroencephalographic data: (1) amplitude integrated EEG (aEEG), (2) peak envelope, (3) envelope asymmetry, (4) spectrogram, (5) band power, (6) power ratio. (7) spectral entropy, (8) burst suppression ratio. (9) inter-burst interval, and (10) bursts-per-minute. In addition to the 10 analyzers mentioned above, Cadwell Bolt calculates if a value is greater than a user-defined threshold. A horizontal black bar is displayed in the trend window and signifies the current threshold setting. The user may move the bar up/down to adjust the threshold. Thresholding is available for the following trends: . peak envelope, . envelope asymmetry, spectrogram, . band power, and ● power ratio. . The Cadwell Bolt device performs analysis on a userdefined set of EEG channels within the EEG data and displays graphical results to be interpreted by qualified medical practitioners. Additional user-selectable parameters are available depending on the analyzer selected for display. These parameters include frequency ranges or bands for analysis, number of epochs to average, and minimum burst suppression durations. Using the userdefined thresholds, Cadwell Bolt can provide notifications to the user and can optionally highlight the associated EEG data. Notifications and/ or highlights can be accepted or rejected by a qualified medical practitioner. Additional features and user-selectable parameters include: Output display color Output display size ● Output display name Epoch length ● Notch filter ● Selected inputs (bipolar or referential) . Output display time scale (y-axis)

Zenith is an electroneurodiagnostic device that accepts, measures, and stores electrical activity of the brain via scalp and intracranial electroencephalography (EEG) signals, and, utilizing an integrated switch matrix, relays stimulation signals to the patient. It can obtain, display and store electrophysiological data from the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The data is used to perform neurodiagnostic evaluations, including EEG and direct cortical stimulation. Zenith Cadwell acquisition software. Zenith is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative testing on patients of all ages.

The Cadwell Zenith System is a high channel-count Electroencephalogram (EEG) system capable of cortical stimulation via the optional stimulator and built in switch matrix. The system is capable of acquiring, storing, and reviewing neurophysiological data and report generation. The Cadwell Zenith System can be configured in a portable or fixed room configuration. Carts are available for purchase with the system. The Cadwell Zenith System consists of one (1) or more Zenith amplifiers, an IOMAX Base Module, and an optional IOMAX Cortical Module. Additionally, a Patient Event Button, USB Photic Stimulator, and USB Footswitch can be purchased separately

The Cadwell Apollo System is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages.

The Cadwell Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for ambulatory electroencephalograph (EEG) and polysomnography (PSG) and/or clinical studies of patients of all ages. The Apollo system consists of a Recorder, a 64-channel and/or 32-channel Amplifier, a patient event button, a microphone, and various connecting cables. Optional accessories include the Arc photic stimulator, a video recording camera, and a cart for the equipment. Previously FDA cleared accessories used with the Apollo system consist of various electrodes, leads, and cables. The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K133355) with support for Apollo hardware using single or combinations of amplifiers, and a photic stimulator. Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.

The Cascade IOMAX™ Intraoperative Monitor with Surgical Studio software (IOMAX) is an electroneurodiagnostic device that acquires, displays and stores physiologic data from peripheral sensory and motor nerves, muscles and the central nervous system, generated either spontaneously or elicited stimuli. The acquired data are necessary to perform somatosensory. auditory and visual evoked potentials (EPs), electroencephalography (EEG), electromyography (EMG), transcranial motor evoked potentials (TcMEPs), direct cortical stimulation, nerve conduction studies and Train of Four (TOF) analysis. SpO2 measures and displays oxygen saturation and heart rate information. The system also delivers direct nerve stimulation required for specific surgical procedures. Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, and stores the electrical activity of the nervous system in response to the stimulation. EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head. Free Run EMG: IOMAX acquires, displays, records, and stores spontaneous EMG activity of motor nerves by continually displaying a live stream of mechanically induced myotome contractions. TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment. Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex. Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle. Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system. Train of Four (TOF) or Twitch Test: IOMAX delivers a train of four pulses and measures, and stores the compound muscle action potential amplitude fade for analysis. SpO2: IOMAX measures and displays oxygen saturation and heart rate information. Remote Reader: IOMAX provides passive, real time remote review of intraoperative monitoring for a physician outside of the operating room. IOMAX is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.

The IOMAX is a multimodality intraoperative neuromonitoring (IONM) system. It consists of Cadwell custom hardware, a standard laptop or desktop personal computer (PC) running a standard off-the-shelf (OTS) operating system (OS), and Cadwell custom software. The modalities recorded, measured and displayed by the IOMAX are: - . Evoked potential (EP) in the form of: - Brainstem auditory (BAEP): O - Visual (VEP); and O - Somatosensory (SSEP). O - Transcranial electrical motor evoked potential (TcMEP). - Electromyography (EMG). ● - Triggered EMG. - Electroencephalogram (EEG). ● - Nerve conduction studies. - Train of four (TOF). ● - SpO2 and heart rate values. ● - Threshold mode. ● - Cortical stimulation.

Cadwell Sierra Summit: Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities. Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user. Cadwell Sierra Ascent: Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems. The Sierra Summit provides a variety of test protocols spanning the various test modalities above. The Cadwell Sierra Summit consists of the following major components: - Sierra Summit console base unit with integrated control panel ● - Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license) - Laptop or Desktop computer (Windows OS) with keyboard and mouse ● - Display monitor ● - Summit software The Sierra Summit has the following optional accessories/components: - Remote Head Box (for 3-12 channel amplifier) ● - StimTroller (Hand Held Electrical Stimulator) - Electrical Stimulator Switch Box ● - Footswitch (single) ● - Visual Stimulators (LED Goggles, LCD Checks) - VEP Calibration Sensor - Headphones or other auditory transducers - Reflex Hammer - Temperature Probe ● - Cart - Isolation Transformer or Medical Grade Power Strip - Printer

1) Cadwell AmpliScan is a software-only device indicated for use with electroencephalographic (EEG) data from Cadwell Arc application software. Cadwell AmpliScan is distributed solely for use with Cadwell Arc software. 2) The Cadwell AmpliScan device is for prescription use only by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgement when using the information. 3) This device does not provide any diagnostic conclusion about the patient's condition to the user. 4) Cadwell AmpliScan uses electroencephalographic (EEG) data to calculate and display a quantitative aEEG measure. This quantitative measure should always be interpreted by the user in conjunction with review of the original EEG waveforms. The aEEG quantitative measure of Cadwell AmpliScan is intended to monitor the state of the brain.

Cadwell AmpliScan is a software-only device distributed solely for use with the application software commonly known and marketed as Cadwell Arc software. Cadwell Ampliscan software is installed with installation of Arc software, and does not require installation or removal separate from the Arc application. The Cadwell AmpliScan software-only device applies the Amplitude-Integrated EEG (aEEG) algorithm referred to as the Cerebral Function Monitor (CFM) to stored data within the Cadwell Arc software, and stores and displays the results.