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The MediByte™ is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. The data is downloaded after the recording is completed and the assist software enables the trained human professional typically a Registered Sleep Technologist or Medical Doctor - to verify the results of the study and generate a report. Target Population: Children and adult patients who are screened during sleep disorder studies. Environment of Use: The majority of the screenings occur either in the home at in a clinical setting. The MediByte™ is intended to be used only by or on the order of a physician.

The MediByte™ is a palm-sized recording device capable of acquiring and storing physiological signals from FDAcleared sensors and transmitting the physiological data to a computer through the Universal Serial Bus (USB) port. The MediByte™ records up to 8 channels of physiological signals: either electromyogram (EMG), or electrocardiogram (EKG); as well as chest effort; abdominal effort; airflow pressure; snoring; body position; arterial oxygen saturation (SpO2); and pulse rate. The signals cannot be viewed in real time, but can be downloaded after collection for assisted analysis by a human professional trained in the analysis and reporting of sleep disorders medicine. The MediByte™ is powered by one ½ AA battery and connects to a computer via the MediByte™ USB communication cable. The MediByte™ and sensors are both typically worn by the patient during the recording and all patient contact materials consist of latex-free biocompatible material.

The BRAEBON Medical Corporation MEDIPalm-20™ is intended for use in collecting, recording and disclaying physiological data from FDA-cleared sensors during studies in both a cinical and home environment and for transmitting this data to an electrically isolated FDA-cleared polysomnographic analysis station for analysis. The MEDIPalm-20™ is a portable data recorder used to collect physiological signals for transfer to an FDA-cleared polysomnographic analysis station capable of reading European Data Format (.edf) files.

The MEDIPalm-20™ is a hand-held recording device capable of acquiring and storing physiological signals from FDA-cleared sensors and transmitting the physiological data to a computer through the Universal Serial Bus (USB) port. The MEDIPalm-20™ records up to 16 channels of physiological signals: any combination of eight differential analog channels of electroencephalogram (EEG), electronyogram (EOG), electrocardiogram (EMG), and electrocardiogram (EKG) signals; as well as chest effort; abdominal effort; airflow pressure; snoring; body position; arterial oxygen saturation (SaO2); pulse rate; and SaO2 probe status. The signals can be viewed in real time on a built-in LCD or on a remote computer. The data can be downloaded after collection for analysis on any FDA-deared polysomnographic analysis station capable of reading European Data Formatted files.

The Ultima Snoring Mike provides a qualitative measure of snoring for recording onto an FDA-cleared data acquisition system.

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An indicator of respiratory airflow for recording onto a data acquisition system.

The Ultima Airflow Pressure Sensors, Models #0580L, are small interface devices which convert levels of air pressure to corresponding levels of voltage which can be recorded on any FDA-cleared physiological recorder intended to record low-level electrical signals. The purpose of the device is to detect respiratory airflow. There is one pneumatic input for air pressure, and one set of electrical outputs representing the electrical equivalent of the pressure. The electrical outputs are the active or positive output and the reference or negative output. This device uses a disposable nasal cannula with a disposable 0.2 um hydrophobic filter. The cannula and filter attach to the patient and connect to the pressure input labeled "INPUT" using a standard luer connector. The electrical output connectors are made with 1.5 mm-safety connectors that connect to either an FDA-cleared AC amplifier or an FDA-cleared DC amplifier with a low frequency filter setting of less than 0.05 Hz and a high frequency filter setting of 15 -30 Hz. The Ultima Airflow Pressure Sensor consists of a red ABS plastic enclosure measuring approximately 1.5"(W) x 2.8"(L) x 0.6"(H). The device is battery powered with one 3.6 volt 1/2AA lithium cell. The estimated battery life is 450 hours (50 - eight hour uses), with an On/Off switch provided to conserve battery life when not in use. The device has a 0.14-Hz blinking status LED: green indicates proper operation, red indicates low battery. The battery can be replaced by removing the battery cover, removing the battery and inserting a new one in the orientation shown in the battery compartment of the unit. The pressure sensor is attached either to a bed frame or to a wall with a Velcro strap.

A qualitative measure of respiratory airflow for recording onto a data acquisition system.

Ultima Airflow Sensor, 1051

An indicator of respiratory effort for recording onto a data acquisition system.

Ultima Respiratory Effort Sensor, 0520 and 0522

The BRAEBON MEDICAL CORPORATION Ultima Body Position Sensor™ is intended for use during sleep disorder studies as an indicator of body position. The sensor uses a threevolt lithium battery and plugs directly into either a DC amplifier or multiplexer.

The BRAEBON MEDICAL CORPORATION Ultima Body Position Sensor™ is intended for use during sleep disorder studies as an indicator of body position. The sensor uses a threevolt lithium battery and plugs directly into either a DC amplifier or multiplexer.