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The NomadAir PMU810 is intended to record physiological signals acquired from a patient for archival in a sleep study. Data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep-disordered breathing (SDB). The NomadAir PMU810 is intended for use within a hospital, laboratory, clinic, nursing home, or patient's home. The NomadAir PMU810 is intended for use on adults only under the direction of a physician or qualified sleep technician. The NomadAir PMU810, or any accessory, does not include or trigger alarms, and is not intended to be used alone as, or a critical component of, * an alarm or alarm system: * an apnea monitor or apnea monitoring system; or * a life monitor or life monitoring system.

The NomadAir PMU810 is a portable device that records physiological signals used for sleep studies. The device can be worn on the chest or the wrist and is attached to the patient using a RIP belt or a disposable strap comected directly to the patient also wears a pulse oximeter probe, a nasal cannula, and an optional sensor, such as a RIP belt, thermocouple, EMG electrode, or ECG electrode. During the typical workflow of using the clinical user configures the device for a patient. The clinician will give the patient instructions on how to attach the device and send the unit and accessories home with the patient. Before going to bed, the patient will connect everything, then go to sleep. The Nomad Air records the signals from the sensors and saves the data to internal memory. The patient may perform up to 3 sleep studies before returning the device. Once the device, they can connect it to a PC using a USB cable and download the study for analysis.

The Serenity Piezo and Serenity Thermocouple Sensors are intended to measure and limb movement and thermal respiratory flow signals, respectively, from a patient for archival in a polysomnography study. The sensors are accessories to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders. The Serenity Piezo and Serenity Thermocouple Sensors are intended for use on both adults and children by healtheare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional. The Serenity Piezo and Serenity Thermocouple Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and are not intended to be used as a critical component of: - an alarm or alarm system; - · an apnea monitor or apnea monitoring system; or - · life monitor or life monitoring system.

Serenity sleep sensors are intended to measure and output physiologic signals used for Polysomnography (PSG) or Sleep Studies. These devices are to be used as an accessory to compatible amplifiers. Typical sleep amplifiers use sensors and electrodes to collect physiological signals to further digitize, and the amplifiers send these signals to a host PC. Serenity sleep sensors are worn by the patient and connected directly to compatible inputs of an amplifier. The amplifier and related software then processes the signal for review by qualified practitioners to score polysomnograms and diagnose Sleep Disorders. The Serenity Piezo Sensor uses an embedded piezo sensing element to detect the vibrations of snoring or to sense a patient's limb movement. The sensor outputs a signal which corresponds to movements of the limbs or snore vibrations. The Piezo sensor can be placed on the skin or worn in a heel strap. The Serenity Thermocouple Sensor uses thermocouple wire that is ioined together to form sensing elements. Thermocouple junctions under each nostril and in front of the mouth output a signal which corresponds to the patient's thermal airflow. The Serenity Thermocouple sensor is available with an optional cannula hanger to aid in patient usability when worn with an airflow pressure cannula.

The Serenity RIP and Serenity Body Position Sensors are intended to measure and output respiratory effort signals and body position, respectively, from a patient for archival in a polysomnography study. The sensors are accessories to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders. The Serenity RIP and Serenity Body Position Sensors are intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional. The Serenity RIP and Serenity Body Position Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and are not intended to be used as a critical component of: - an alarm or alarm system; - · an apnea monitor or apnea monitoring system; or - · life monitor or life monitoring system.

Serenity sleep sensors are intended to measure and output physiologic signals used for Polysomnography (PSG) or Sleep Studies. These devices are to be used as an accessory to compatible amplifiers. Typical sleep studies use sensors and electrodes to collect, digitize, and send physiological signals to a host PC. Serenity sleep sensors are worn by the patient and connected directly to compatible inputs of an amplifier. The amplifier and related software then processes the signal for review by qualified practitioners to score polysomnograms and diagnose Sleep Disorders The Serenity Body Position uses a 3-axis accelerometer to track the patient's body orientation; outputting a voltage which corresponds to one of 5 positions (sitting/upright, supine, prone, left-side, and rightside). The Serenity RIP Sensor uses respiratory inductance plethysmography to output a waveform which corresponds to patient's respiratory effort. The patient wears an adjustable elastic belt which connects to the RIP driver, the RIP driver then connects to the host device. The Serenity RIP sensor is available for both thorax and abdomen. Thorax and abdomen versions are identical, except that they operate at different frequencies to avoid interference.

The Polysmith Sleep System, Model NT17593 is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders. The Polysmith Sleep System, Model NT17593 is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional. The Polysmith Sleep System, Model NTT7593 is intended for use on both adults and children only under the direction of a physician or qualified sleep technician. The Polysmith Sleep System, Model NTT7593 includes automatic detection of some arrhythmias (including some potentially life threatening arrhythmias), however detection of an arrhythmia may be performed with 30 seconds or more delay, and is based on a single ECG lead only. The Polysmith Sleep System, Model NTI7593, or any accessory, is not intended for the life monitoring of high risk patients, does not include or trigger alarms, and is not intended to be used alone as, or a critical component of, - an alarm or alarm system: - · an apnea monitor or apnea monitoring system; or - · a life monitor or life monitoring system.

The Polysmith Sleep System, Model NT17593 is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The device consists of a compatible amplifier, head box, PC, patient sensors, and may include optional external devices, USB DC Box, and audio/video input devices. Compatible amplifiers may use commercially available sensors and electrodes, an internal SpO2 module, and internal pressure transducers to collect, digitize, and send physiological signals to the host PC. The Polysmith software may record from video, speaker and microphone equipment. The Polysmith software may also record auxiliary signals from compatible amplifiers or USB DC Box which allow for data inputs from compatible sources. Polysmith records and displays the data for online or offline review. Qualified practitioners use the information to score polysomnograms and diagnose Sleep Disorders.

The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders. The device is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional. The device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician. The device or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system. The device or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system. The device or any accessory, is not to be used alone as a life support device or as a critical component of a life support system.

The Polysmith Sleep System, Model NTI6600 is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The device consists of a compatible amplifier, head box, PC, patient sensors, and may include optional external devices, USB DC Box, and audio/video input devices. Compatible amplifiers may use commercially available sensors and electrodes, an internal SpO2 module, and internal pressure transducers to collect, digitize, and send physiological signals to the host PC. The Polysmith software may record from video, speaker and microphone equipment. The Polysmith software may also record auxiliary signals from compatible amplifiers or USB DC Box which allow for data inputs from compatible sources. Polysmith records and displays the data for online or offline review. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders.

The Live View Panel is an accessory to EEG and PSG systems, intended to transmit EEG or PSG data to a remote location where the data can be viewed by a clinician to aid in diagnosis of epilepsies, sleep disorders, and other related disorders. The Live View Panel is intended for use by medical personnel within a medical facility, clinic or nursing home, or outside a medical facility under the supervision of a medical professional. The Live View Panel is available for use on all patient populations, including adults and children as determined by the medical professional. This device is not to be used to monitor life threatening situations. This device is not to be used to control life supporting or life sustaining devices.

The Live View Panel (LVP) consists of several software components that allow remote viewing of digitized physiological waveforms and general patient information for the purpose of viewing EEG (electroencephalography) or PSG (polysomnography) patients in real time or in review. The software uses off-the-shelf and custom software components to manage multiple computer displays to facilitate the viewing of several patients simultaneously. The Live View Panel consists of three software components. The Live View Panel Acquisition Interface Server (AIS) located on the acquisition system collects patient data from a recording machine and transmits this information over a network to a client machine. The Live View Panel client program receives this information and displays basic information in grid pattern along with other patients. The Live View Panel Monitor Controller program manages a bank of displays, each displaying a single patient. The Live View Panel grid mimics the physical locations of the monitors to allow the clinician manage and keep track of multiple patients displayed on the bank of displays. The Live View Panel is software only and does not connect to the patient except through a cleared and currently marketed EEG or PSG device. A software module resides on the EEG or PSG device and sends patient data to a remote computer where another software module displays the data on an array of monitors. The software runs on off-the-shelf computers.

The Nomad device is a digital amplifier capable of measuring bio-potential signals that may be incorporated into a Polysomnogram. The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study, such as Limb Movement, Respiration Effort, and SpO2. The data may be analyzed on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders. This device is not to be used alone as an apnea monitor or as a critical component in an apnea monitoring system. This device is intended for use on both adults and children on the order of physician. This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system. The device is not sterile. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

The device is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The bio-potentials are transferred to Polysmith polysomnography software running on a personal computer. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders. The device is intended for use on both adults and children under the direction of a physician or qualified sleep technician.

The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders. This device, or any accessory, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system. This device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system. This device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.

The device is intended to amplify and record physiologic potentials used for Polysomnography (PSG) or Sleep Studies. The bio-potentials are transferred to Polysmith polysomnography software running on a personal computer. Qualified practitioners use the information to score Polysomnograms and diagnose Sleep Disorders. The device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.

This device is intended for use in a sleep laboratory for the acqusition, display, storage, and analysis of polysomnography data obtained from a polygraph with IRIG compatible outputs. It's purpose is to assist a qualified sleep practitioner in the diagnosis of sleep disorders in patients 13 years of age and older. To use the analysis capabilities, there must be at least two EEG channels, two rapid eye movement channels (electroocculograms), a chin EMG (electromyogram) channel, a leg EMG channel, an airflow channel, two respiratory effort channels, and an oxygen desaturation channel. This device is to be used only under the direction of a physician or qualified sleep technician.

POLYSMITH is a polysomnography data acquisition, analysis, display, and storage system, which accepts polysomnography data and allows the operator to view the data on the computer monitor. The device also automatically analyzes the data to determine the sleep stage for each thirty-second epoch and to detect apneas and hypopneas. The hardware consists of a personal computer with an enclosed analog-todigital converter and a connector block for conveniently connecting the input data leads. The device is designed to input data from a polygraph that has IRIG-compatible outputs. To use all analysis capabilities, there should be at least two EEG channels, two rapid eye movement channels (electro-occulograms), a chin EMG (electromyogram), a leg EMG, an ECG, airflow, two respiratory effort channels and an oxygen saturation channel. The software, which is running under the NT operating system, will display all of the acquired data on the computer screen for reviewing and operator editing. The automated analysis feature, designed tor subjects 13 years of age and older, generates multiple reports, including a sleep stage summary, describing the sleep data.