Cadwell Laboratories Inc, Kennewick, Wash, has been granted FDA 510(k) clearance for the EasyNet Oximeter and Nasal Pressure Airflow devices to be used with the Cadwell Easy® Ambulatory 2 and Easy III sleep diagnostic systems. The modules use Cadwell’s EasyNet® communications protocol to share data with Cadwell diagnostic products. EasyNet communications protocols manage the transfer of information between multiple networked modules worn by the patient.
“These plug and play modules offer high value to our customers and increase patient comfort and mobility with their small size,” says Bill Antilla, RPSGT, senior product manager for Cadwell. “The addition of these two new modules completes our diagnostics product line and allows Cadwell to offer a full featured ambulatory PSG recorder that can collect 35 channels of sleep related data.” Other EasyNet modules already used by Cadwell systems include the EasyNet Limb Movement accelerometer and the EasyNet Body Position module.
The Cadwell Easy Ambulatory 2 system can collect EEG and PSG data for up to 160 hours, allowing physicians to capture important events that normally occur in the home and work environment. The system can be configured to collect a full 10-20 lead EEG montage or a full PSG montage. The Ambulatory 2 system can create a 3D patient animation by collecting information from EasyNet limb movement and body position modules. Physicians can review a time synchronized virtual patient animation with polysomnographic data to determine body position and limb movements.
The Cadwell Easy III system is a new full featured diagnostic system that can be configured with 32 – 150 channels for EEG, PSG, and epilepsy monitoring studies. The system is capable of using Cadwell EasyNet modules and additional third party sensors offered by other sleep sensor manufacturers.