Blood Pressure Monitoring Device(EV1000 Clinical Platform ) - India CDSCO Medical Device Registration

Product Information

Intended Use – The intended use of the EV1000 Clinical Platform (EV1000A and EV1000NI) is to calculate and display continuous and intermittent Cardiac Output, oximetry (EV1000A and EV1000NI), and compute derived hemodynamic and oxygenation parameters. Indication - The EV1000 Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Platform may be used in all settings in which critical care is provided. Intended Use – The intended use of the EV1000 Noninvasive system is to continuously and noninvasively measure blood pressure and associated hemodynamic parameters. Indication - The EV1000 Clinical Platform NI or Noninvasive system and ClearSight™ Finger Cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform NI and ClearSight™ finger cuffs noninvasively measure blood pressure and associated hemodynamic parameters