CDSCO UID IMP/MD/2021/000135_162e8bca984f1a185bbe400302552cf2_d8c52cab66e0a8d235f041deaf3bc346

Hemodynamic Monitoring System

Edwards Lifesciences (India) Private Limited,·Device Class Class C·India CDSCO·Brand: FORE-SIGHT ELITE™ Tissue Oximeter Module

Registration details

UID: IMP/MD/2021/000135_162e8bca984f1a185bbe400302552cf2_d8c52cab66e0a8d235f041deaf3bc346
Device class: Class C
Brand name: FORE-SIGHT ELITE™ Tissue Oximeter Module
License holder: Edwards Lifesciences (India) Private Limited,
Approving authority: CDSCO
Product information: The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, FloTrac, Acumen IQ, and TruWave DPT sensors, and Edwards’s finger cuff(FORE-SIGHT ELITE™ Tissue Oximeter Module). A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere ClearSight module. The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and an Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. 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 HemoSphere advanced monitor and compatible Edwards finger cuff(FORE-SIGHT ELITE™ Tissue Oximeter Module) noninvasively measures blood pressure and associated hemodynamic parameters. Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used. The Edwards Lifesciences Acumen Hypotension Prediction Index (FORE-SIGHT ELITE™ Tissue Oximeter Module) feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (FORE-SIGHT ELITE™ Tissue Oximeter Module) and the associated hemodynamics. The Acumen HPI feature is intended for use in operating room (FORE-SIGHT ELITE™ Tissue Oximeter Module) patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (FORE-SIGHT ELITE™ Tissue Oximeter Module) parameter