Portable Respiratory Monitor - India CDSCO Medical Device Registration

Product Information

The Capnostream™35 is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (Capnostream 35 Portable Respiratory Monitor) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion and motion conditions and for patients who are well or poorly perfused. The Capnostream™35 also provides the clinician with integrated pulmonary index (Capnostream 35 Portable Respiratory Monitor), apnea per hour (Capnostream 35 Portable Respiratory Monitor) and oxygen desaturation index (Capnostream 35 Portable Respiratory Monitor) values. IPI is intended for pediatric and adult patients only. A/hr ODI is intended for age 22 and up. The OxiMax SPD™ alert (Capnostream 35 Portable Respiratory Monitor) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs. The Nellcor™ respiration rate parameter is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities. Other than the OxiMax SPD™ alert and Nellcor™ respiration rate features, the device is intended for use in hospitals, hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.