Edwards Lifesciences HemoSphere Advanced Monitor

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

EDWARDS LIFESCIENCES (ASIA) PTE. LTD.

Class:

Class C medical device

Manufactured by:

Edwards Lifesciences LLC

Therapeutic area:

Cardiovascular

Therapeutic indications:

The HemoSphere advanced monitoring platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, FloTrac, Acumen IQ, TruWave DPT, ForeSight Elite sensors, ClearSight finger cuffs and Acumen IQ finger cuffs.

Product summary:

Device System Info:[Device with measuring function], [System or Procedure Pack]; Models: HemoSphere advanced monitor - HEM1, HemoSphere battery pack - HEMBAT10, HemoSphere expansion module - HEMEXPM10, HemoSphere oximetry cable - HEMOXSC100, HemoSphere advanced monitor roll stand - HEMRLSTD1000, HemoSphere Swan-Ganz module - HEMSGM10, Patient CCO cable - 70CC2, HemoSphere Pressure Cable - HEMPSC100, HemoSphere Pressure-Out Cable - HEMDPT1000, Acumen IQ Sensor - AIQS6, Acumen IQ Sensor - AIQS6R, Acumen IQ Sensor - AIQS6S, Acumen IQ Sensor - AIQS8, Acumen IQ Sensor - AIQS8C503, Acumen IQ Sensor - AIQS8R, Acumen IQ Sensor - AIQS8S, ForeSight Oximeter Cable - HEMFSM10, HemoSphere Technology Module - HEMTOM10, ForeSight Jr Non-Adhesive Small Sensor - FSESNS, ForeSight Jr Small Sensor - FSESS, ForeSight Jr Medium Sensor - FSESM, ForeSight Large Sensor - FSESL, HemoSphere ClearSight Module - HEMCSM10, Pressure Controller Kit - PC2K, Heart Reference Sensor - EVHRS, Acumen IQ Finger Cuff Small - AIQCS, Acumen IQ Finger Cuff Medium - AIQCM, Acumen IQ Finger Cuff Large - AIQCL, Clearsight Finger Cuff Small Multi Pack - CSCS, Clearsight Finger Cuff Medium Multi Pack - CSCM, Clearsight Finger Cuff Large Multi Pack - CSCL, Acumen IQ Sensor - AIQS65, Acumen IQ Sensor - AIQS85, Pressure Controller Kit - HEMPC2K

Authorization date:

2017-12-11