Company

Spacelabs Healthcare Receives 510(k) Clearance for Sidestream Capnography Module

Wednesday, August 15, 2012

Issaquah, Wash., Spacelabs Healthcare today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Capnography Pod – a compact, sidestream gas analyzer compatible with the company’s new qube™ patient monitor. The Capnography Pod provides a non-invasive method of measuring the concentration of carbon dioxide in a gas mixture, to aid in determining the patient’s ventilatory, circulatory and metabolic status during conscious sedation or under anesthesia.

Healthcare facilities now embrace the use of capnography beyond the outpatient/day-surgery areas to include the monitoring of patients during procedural sedation for gastrointestinal endoscopy and those who are receiving patient-controlled analgesia.

“Capnography is widely recognized as enhancing patient safety particularly with regard to patients who control their pain medication via pump,” said Nicholas Ong, President of Spacelabs Healthcare. “This is a very valuable tool that allows caregivers to be notified, for example, if a patient’s breathing is becoming compromised as a result of overmedicating.” 

Spacelabs’ capnography module fits seamlessly onto the qube patient monitor. qube offers portability, accessibility and heightened connectivity – from bedside throughout transport – and is a recent addition to Spacelabs’ Art of Monitoring portfolio that also includes the XPREZZON™ patient monitor, AriaTele™ digital transmitters, and ICS XPREZZ™ mobile app for iPad.