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The Galaxy System (which includes the Jupiter amplifier and Galaxy software) is intended for use as a polysomnographic system to acquire record, display, print and store physiological parameters to assist clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers, clinics or other test environments where adults or infants require the documentation of sleep or other physiological disorders. The Galaxy system does not provide alarms and is not intended for use as an automated apnea monitor.

The Galaxy system (which includes the Jupiter and Galaxy software) is a Polysomnography System that is intended to acquire, record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders. The system can record, monitor, store and transfer of up to 42 channels of biophysical parameters. Generally the device is capable of acquiring and displaying the following parameters: - EEG . - EOG (eye movement) ● - Chin EMG . - . Leg EMG (leg movement) - ECG (single channel) ● - . Chest respiratory effort - . Abdomen respiratory effort - . Nasal Flow Thermistor - . Nasal Flow Pressure - . Body position - . Snoring - Oximeter . - . Patient "Event" button The components of the Galaxy system include: - Headbox/Amplifiers (i.e., "BrainBox EEG amplifier, "Touchproof connector box", "Jupiter 1. amplifier") – Galaxy can support two amplifier/headbox models, 1166 and 1142. Both models are electrically exactly the same, except for the differences between the number of channels. - Ethernet Interface - Isolator (ISO101) - Connecting Wires - Desktop Computer - Electrodes Third party electrodes and sensors such as surface electrodes compatible with 32 AC inputs by means of touch-proof connectors, "Nonin oximeter (XPOD3012)," and "respiratory effort sensors" can be used with the system, but these sensors are not provided with the device. Only sensors specifically tested and verified for use with the device should be used and are listed in the user's manual. - Galaxy Software The Galaxy software's main functionalities include the following: - a. Record and display signals Collect and display PSG parameters. Plot acquired data on screen (within a time window of 30 seconds) and store on hard-disk of computer. - b. Provide tools for Manual Review of Data Allow the user to review and manually analyze data, edit this analysis and delete the entered events if needed. Software also displays the user annotations along with the signal traces, as trend overview over the night and as a list, and allows the user to review the acquired data after the completion of the recording to examine and annotate afterwards (offline). - c. Generate Patient Reports The software calculates summaries of the manually scored data and print them as tabulated reports and shows simple computer calculations like average value, rates etc ... Galaxy also has the following additional functions: - changing the mode of the amplifier for calibration, impedance check or data acquisition . - sending commands to set sample rate of the digitization, to specify the recording montage . and to receive data from the Jupiter amplifier via Ethernet interface. The device does not provide any automatic scoring algorithms.