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The Embla BreathSensor provides a qualitative air flow signal by oral and/or nasal temperature sensitive resistive components for recording onto a recording system in support of airflow analysis and sleep studies. The Embla BreathSensor does not provide any diagnostic conclusion about the patient's condition to the user. The Embla BreathSensor user is a qualified medical practitioner in a hospital environment only who will exercise their professional judgment in using this information.

The Embla BreathSensors (Model 970 Series) are airflow thermistors used as an accessory to a polysomnogram (PSG) or sleep study recording system. The BreathSensor family is comprised of two different variations: Models 971 Adult and Model 974 Small Adult/Child. The BreathSensors are for use with any standard PSG amplifier or recorder. An interface cable connects the BreathSensor to the polysomnography equipment. Embla BreathSensors are designed to provide a qualitative measure of respirations (flow) from the mouth and/or nose. The user selects the appropriate size of BreathSensor based on their clinical judgment. The nasal and/or oral temperature sensor elements are carbon ink placed on a substrate. The carbon ink is the temperature sensitive material. Silver ink interfaces with the carbon ink temperature sensing elements to provide a connection to the interface cable. The Embla BreathSensors are non-sterile, single patient use, disposable devices.

The XactTrace® Single Use Respiratory Effort Belt System is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment. The intended environments are hospitals, institutions, sleep centers, sleep clinics. The XactTrace® Single Use Respiratory Effort Belt System is intended for diagnostics purposes only and is not intended to be used as an apnea monitor.

The XactTrace Single Use Respiratory Effort Belt System subject device applies Respiratory Inductive Plethysmography (RIP) Sensor Belts to support respiratory effort signals used in the diagnosis of sleep disorders or sleep related respiratory disorders. The XactTrace Single Use Respiratory Effort Belt System subject device supports a measure of changes in inductance as a result of changes in abdominal, thorax circumference. There are two variations of the XactTrace® Single Use Respiratory Effort Belt System: 1. XactTrace® Single Use Cut-to-Fit Respiratory Effort Belt System, and 2. XactTrace® Single Use Pre-Sized Respiratory Effort Belt System. The XactTrace Single Use Cut-to-Fit Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Locks (belt connectors) with a cable that connects to a recording device. The system supports conversion of changes in inductance to a digital signal that provides both qualitative information of respiratory effort. The Sensor Belt of the XactTrace Single Use Cut-To-Fit Belt variation is cut by the medical professional to appropriate lengths to fit patient abdomen, thorax circumference. The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation consists of a single use disposable Sensor Belt and Snap Sensors (Sensor Belt connectors) with a cable that connects to a recording device. The XactTrace Single Use Pre-Sized Respiratory Effort Belt variation supports conversion of Sensor Belt changes in inductance to a signal that provides both qualitative and quantitative information of respiratory effort. XactTrace Single Use Pre-Sized Respiratory Effort belts are available in four sizes: Pediatric, Small, Medium and Large. An optional Inductive Interface Cable (RIP Processor) is available to interface with PSG systems that accept the 1.5mm female touchproof connectors, and do not have internal RIP Sensor Belt technology. Both variations of XactTrace Respiratory Effort Belts are interfaced with either an optional external Inductive Interface Cable or a RIP technology compatible Embla PSG system amplifier. Compatible Embla amplifiers are identified by keyhole connectors for Sensor Belt input.

The Disposable Snap Electrodes are intended to be used with compatible 1.5mm touchproof button snap cables for transferring surface biopotential signals to use during sleep studies, EEG, EMG, and recording evoked potential signals from a cutaneous location. For use on Adults.

The Disposable Snap Electrode is a cutaneous applied electrode supporting interface of biopotential signals to user equipment. The Snap Electrode has a 4 mm snap contact that can connect with commercially available snap electrode lead wires.

The REMbrandt software is intended for Polysomnography studies and allows recording, displaying, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The REMbrandt software allows: Automated analysis of physiological signals that is intended for use only in adults; An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values; The REMbrandt software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

The REMbrandt software consists of three applications, DataLab, Analysis Manager and REMbrandt Manager, which run on a desktop or laptop computer and require no specialized hardware. They are Windows based applications used by trained medical professionals to investigate sleep disorders. The REMbrandt software collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and detectors to analyze the signals, which aid in the interpretation of a sleep study. The software consists of four main functional areas: A. Data Acquisition & Display (REMbrandt DataLab), B. Scoring/Review & Analysis (REMbrandt Analysis Manager), C. Report Generation (REMbrandt Analysis Manager), D. Archiving & Data Management (REMbrandt Manager). The REMbrandt software contains eight (8) computer-assisted scoring analyzers. All automatic detection tools are provided as time saving aids to assist trained medical practitioners in the review and analysis of vast amounts of data. Each computer-assisted scoring analyzer runs a specific type of event marking or numeric value processing in the study and each can be enabled individually as needed at the discretion of the user. The scoring rule parameters used in the computer-assisted scoring analyzers depend on available input signals in the study as well as user defined settings. All output from computer assisted scoring analyzers require medical professional review and acceptance.

The RemLogic software is intended for Polysomnography studies and allows recording, displaying, and storage of physiological signals to assist in the diagnosis of various sleep related respiratory disorders. The RemLogic software allows: Automated analysis of physiological signals that is intended for use only in adults; An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values; The RemLogic software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

The RemLogic Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used by trained medical professionals to investigate sleep disorders. The RemLogic application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and analyzers to analyze the signals, which aid in the interpretation of a sleep study. The software consists of three main functional areas: Acquisition, Scoring & Review, and Reports. It also contains a number of computer-assisted scoring analyzers for various sleep events.

The Sandman Elite software is intended for Polysomnography studies on pediatric and adult patients, and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows: - Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values; - An optional automated analysis of physiological signals that is intended for use only in adults; - An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. The Sandman software is intended for use only by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.

The Sandman Elite Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used at sleep labs by trained clinicians to investigate sleep disorders. The Sandman Elite application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and modules to analyze the signals, which aid in the interpretation of a sleep study. The software consists of four main applications: Collection, Analysis, Data Management, and Configuration. The Sandman Elite application also includes a separate independent Report Builder module. All data are stored either locally or on a remote hard disk (network server). Provisions exist for archiving to several appropriate types of digital media, most frequently CD ROM. The Sandman Elite application software contains a number of computer-assisted scoring modules for analysis of adult patient data only.

The Embletta MPR (Multiple Parameter Recorder) Sleep Data Recording System is a digital recording system designed to be used under the direction of a physician or trained technician or applied by a layperson under the direction of a physician or trained technician. The system records multiple physiological parameters for the purpose of simultaneous (on-line recording) or subsequent (ambulatory recording) uploading to a separate PC based data presentation software for graphical and numerical representation to allow trained personnel to identify sleep disorders. The data collected by this recording system will provide physicians with information to make a diagnosis of sleep disorders such as: • Obstructive Sleep Apnea Syndrome • Central Alveolar Hypoventilation Syndrome • Central Sleep Apnea Syndrome • Restless Legs Syndrome • Periodic Limb Movement Disorder • Primary Snoring • Sleep-Related Neurogenic Tachypnea • Cheyne-Stokes-Breathing The Embletta MPR is a digital recording device designed to be used under the direction of a physician or trained technician but may be applied by a layperson. The Embletta MPR records multiple physiological parameters from a sleeping patient for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep-related medical disorders by trained personnel. The Embletta MPR is intended to be used for adult and pediatric (excluding neonatal and infant) studies. The device is not equipped with alarms and is not intended to be used as a monitor. The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort. The device does not monitor or diagnose the patient and does not issue any alarms.

The Embletta MPR Sleep Data Recording System is the third in the Embla series of small ambulatory sleep recorders. The first was the Embla Compass (also called the Embletta, K041904, Product Code MNR) and the second is the Embletta Gold (K073682, Product Code MNR). The Embletta MPR Sleep Data Recording System records multiple physiological parameters for the purpose of simultaneous or subsequent uploading to a separate PC based data presentation software. The data collected by this recording system will provide physicians with information to make a sleep disorder diagnosis. The Embletta MPR Sleep Data Recording System consists of three small devices that can be used in two separate configurations. The simplest configuration is the battery operated Embletta MPR recorder which is worn by the patient and used alone for small scale sleep studies (2 input + 3 derived channels). The other configuration is the battery operated Embletta MPR *PG' unit (similar to the Embletta MPR but with 6 input + 3 derived channels) which is worn by the patient and used with wireless communication to a separate mains powered Embletta 'TX' unit located remotely from the patient. The Embletta 'TX' unit can also record inputs from separate patient devices (such as CPAP devices). Each of these two configurations basically consists of a simple signal recording unit that can be connected with several electrodes and sensors non-invasively attached to a patient during sleep. The Embletta MPR and the Embletta MPR 'PG' are secured to the patient with a belt and holder.

The N7000 system (with MDrive) is intended for clinical sleep applications, with recording and/or amplification capability of numerous types of physiological signals used by a physician or trained technician for the acquisition of respiratory, electroencephalogram (EEG), electrocardiogram (ECG, EKG), positional, user triggered event and Oximetry parameters from a patient connected Headbox and/or Patient Unit during sleep related studies. The general intended environments are hospitals, institutions, sleep centers, and sleep clinics, but the device should be capable of functioning in any environment where patients can sleep reasonably comfortably. The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria. The N7000 system does not provide any alarms and is not intended to be a monitor. A trained sleep technologist (polysomnographer) and a physician would typically review and analyze the N7000 data when it is communicated and presented on a PC using a separate application software program. The Embla N7000 is intended for use by a physician or trained technician for the acquisition of EEG and polysomnography (PSG) signals and transmission of these signals to a PC during neurophysiologic or sleep examinations. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments. The use of the Embla N7000 system does not involve any patient monitoring or diagnosis.

The original cleared N7000 system consists of 3 separate components; a mains connected Communication Unit (CU) for signal amplification and transmission to a host PC, a Headbox that is cable connected to the CU, and a Patient unit that is cable connected to the Headbox. Patient electrodes are connected to the Headbox and the Patient Unit with several electrodes and sensors non-invasively attached to a patient during sleep. The MDrive device is intended as an alternate upgrade for the current CU component and provides all original functionality and system connectivity that exists with the CU. The major additions that the MDrive provides over the existing CU component in the N7000 svstem are: - A wireless connection option to the host PC, in addition to a wired connection, . 1. - a local keypad and display for the user to perform electrode impedance checking 2. and biocalibration locally rather that from a remote PC, and - study recording capability using an SD card in the event of PC host 3. communication interruption. The SD card study can then be uploaded to the host PC.

The Embletta Gold is a digital recording device designed to be used under the direction of a physician or trained technician but applied by a layperson. The Embletta Gold records multiple physiological parameters for the purpose of simultaneous or subsequent display of the parameters. The displayed data assists in the identification of sleep-related medical disorders by trained personnel. The Embletta Gold is intended to be used for adult and pediatric (excluding neonatal and infant) studies. Note the recorder is not equipped with an alarm device and is not intended to be used as a life monitor. The intended environments include any clean, dry, dust free environment suitable for a patient's relative comfort.

The Embletta GOLD polysomnographic recorder is intended for both clinical and research sleep applications, with 9 input channel capability of several types of physiological signals used by a physician or trained technician for the simultaneous acquisition of respiratory, electroencephalogram (EEG), electrocardiogram (ECG, EKG), positional, user triggered event and Oximetry parameters from a patient during sleep related studies. The device will be capable of a minimum of 24 hours of recording and saving all 9 input channels either to an internal memory or to a connected computer. The general intended environments are hospitals, institutions, sleep centers, sleep clinics, patient homes but the device should be capable of functioning in any environment where patients can sleep reasonably comfortably. The users are the general public, trained physicians, trained sleep technicians (RPGST) or people working under the supervision of one of these professionals. The user may or may not possess knowledge of the physiological signals or test criteria. The recorder does not provide any alarms and is not intended to be a monitor. A trained sleep technologist (polysomnographer) and a physician would typically review and analyze the recorded signals when downloaded and presented on a PC using a separate application software program.