The Mays and Associates (MAI) Polysomnogram (PSG) System is a full featured sleep lab recording system. It is comprised of OmniAmp amplifier module in the patient’s room that is connected to a PC with the OmniPro recording and display software. The OmniAmp provides a multichannel isolated interface for (5) EEG, (2) EOG, (3) chin EMG, airflow, (2) respiration effort belts, ECG, (2) leg EMG and SPO2. The OmniAmp provides electrode impedance testing during set-up and is powered through the interface cable which can be up to 50′ long. The OmniPro software displays and records the measured signals during overnight sessions. It sends the patient data files to a analysis center where the files are scored then sent to the patient’s physician. The MAI PSG System was deployed in 2005 and has been an integral part of a successful sleep study service.
Cooper Consulting Service was the project leader in the development of the MAI system and provided the documentation system for FDA design control requirements and for the 510(k) submission. CCS designed and developed the OmniAmp amplifier module and interface cable. CCS guided the system through safety, EMC and software V&V testing. CCS designed the test fixtures and developed the test procedures for production and maintenance of the system. CCS has maintained the DMR, DHF and SOPs and has supported MAI during FDA inspections. CCS has provided post market support for MAI by performing complaint investigations and product design improvements.