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The ACCUSOM device is indicated for use in the diagnostic evaluation of adults with possible sleep apnea. The ACCUSOM can score obstructive apneas, which includes mixed apneas. The ACCUSOM device is intended for use in the home and clinic setting.

The ACCUSOM device is a battery and line powered ventilatory effort recorder. The ACCUSOM device is indicated for use in the diagnostic evaluation of adults with possible sleep apnea. The ACCUSOM can score obstructive apneas, which includes mixed apneas. The ACCUSOM device is intended for use in the home and clinic setting. As with the predicate Silent Night V device, the ACCUSOM is supplied to patients only upon physician order for use in Home Sleep Testing. The ACCUSOM device is positioned on the patient's arm. The sensors are positioned on the patient's body and connect into the ACCUSOM device. The ACCUSOM contains identical functions and the same algorithm as the predicate Silent Night V device (K000253). The indications for use of the ACCUSOM are identical to the Silent Night V (K000253). The ACCUSOM device provides physiological measurements that are identical to the predicate Silent Night V device including: Arterial oxygen saturation level (SpO2)) (Sampled every 5 (+/- 0.2 . seconds)), Pulse Rate (Sampled every 5 (+/- 0.2 seconds)), Respiration effort signal (Sampled every 100 (+/- 0.5 mseconds)), Airflow waveform corrected for ambient room noise (Sampled at 5.2083 kHz, . accurate to 100ppm over the operating temperature range). Throughout a typical sleep study, sleep disordered breathing information and statistics are stored into the ACCUSOM memory. The stored information includes time and duration of apneas and hypopneas, blood oxygen saturation levels, pulse rate, respiratory effort level, sound intensity level, epoch numbers, and paused time intervals. The new ACCUSOM device can retain three 8.5-hour sleep studies. Existing software retrieves, scores, displays and prints the collected data on a personal computer platform. A summary report and event log can be provided to the physician to view the sleep data. The ACCUSOM is a battery-powered device with cables that attach to a nasal sensor, to a respiratory effort sensor, and to a blood oxygen saturation sensor (SpO2). The ACCUSOM contains visual and audible sensor status indicators for the patient's convenience. At the end of each night of testing, the sensors are removed and the ACCUSOM is plugged into a wall outlet to recharge and to upload the previous night's data using the cellular network to NovaSom, Inc. for report preparation. If the cellular network is insufficient in the patient's residence, the ACCUSOM data will be downloaded using the traditional RS232 cable connection upon receipt at NovaSom, Inc.