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The Silent Night V is indicated for use in the diagnostic evaluation of adults with possible sleep disorders. The Silent Night V can score obstructive apneas, which includes mixed apneas.

The Silent Night V is a portable, line-powered ventilatory effort recorder for use in the home for the diagnostic evaluation of the patient. The device consists of a bedside unit which is positioned on the patient and the sensors are placed on the patient's body and connect into the patient module. The Silent Night V contains the same functions as its predecessor, Silent Night II, with the addition of two other functions. The functionality of Silent Night V has been expanded from the previous estimation device, (Silent Night II K973902) to include ventilatory effort monitoring. The Silent Night V provides the following data: - Arterial oxygen saturation level (SP02) - Pulse rate - Respiration effort signal - Respiration sound corrected for ambient room noise. Throughout a typical sleep study, sleep-disordered breathing information and statistics are stored into the memory. The stored information includes time and duration of apneas and hypopneas, block apneas, number of apneas and hypopneas, number of central apneas, number of mixed apneas, number of obstructive apneas, number of desaturation events, number of pulse events, number of respiratory effort events, number of sound events, minimum saturation levels, pulse rate, respiratory effort level, sound measurement level, open in intervals, pulse rate, respiratory effort level, sound measurement level, open in intervals. Current storage capacity is 512 Kbytes, which is sufficient to retain three 8-hour studies. Software has been developed to retrieve, score, display and print the collected data on a personal computer. The collected data is provided to the physician to view the sleep data.

The Silent Night II is indicated for use in the diagnostic evaluation of adults with possible Obstructive Sleep Apnea. It is intended to record a patient's respiratory pattern during sleep. The device is designed for prescription use in home screening of adults with possible sleep disorders. Information provided by the device includes the numbers of apneic and hypopneic events and the proportion of these events to the total sleep duration; and snoring levels (in decibels). The device is capable of recording four nights or up to 40 hours for an individual patient, after which time the sleep data are downloaded for provision to the prescribing physician.

The Silent Night™ II is a modified version of the legally marketed Silent Night I. The device is a portable, line-powered ventilatory effort recorder intended for use in the home screening of possible sleep disorders. The metal box has two receptacle connectors: one for input power and another for the microphone cable. The sensing microphone and the ambient noise microphone are located at the distal end of the cable, and are attached to the user by means of a modified conventional plastic oxygen cannula. The sensing microphone, located directly beneath the patient's nose, senses respiratory sounds during sleep. The ambient microphone, angled to the side of the patient's nose, senses room ambient noise and measures snoring levels. The Silent Night II is capable of recording up to four nights of sleep study data. The beginning and end of the sleep study are controlled by the use of the START and STOP buttons, located on the front of the unit. An LCD indicates operational status and has a sound level bar, used by the patient at the beginning of the study to verify adequate sensing of breathing sounds by the device. The device operates by sensing the sound field (breathing sounds + room ambient noise) via the two microphones. Breathing sounds are extracted from all sounds received. The signals are filtered, analyzed, and processed to differentiate between types of sounds and to classify sounds as regular snoring or breathing, hypopnea, or annes. When beep study is completed, the cumulatively logged data are downloaded by Local Site a personal computer. Specialized software and provides, for each night of the sleep study, information about apneas, hypopneas, and snoring levels.