Edwards HemoSphere

HemoSphere Advanced Monitor 1 Introduction
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1.2.2 HemoSphere Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere advanced monitor when used with the HemoSphere pressure cable and an Edwards
arterial pressure-based cardiac output (CO) sensor is indicated for use in critical care patients in which the
balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may
be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed
therapy protocol in a hospital environment. Refer to the Edwards arterial pressure-based CO sensor
indications for use statement for information on target patient populations specific to the sensor being used.
The HemoSphere advanced monitor when used with the HemoSphere pressure cable and an Edwards
disposable pressure transducer (DPT) sensor is indicated for use in critical care patients requiring
intravascular pressure monitoring. Refer to the Edwards DPT or Swan-Ganz catheter indications for use
statements for information on target patient population specific to the sensor being used.
The Acumen™ Hypotension Probability Indicator (HPI) feature provides the clinician with physiological
insight into a patient's probability of trending toward a hypotensive event (defined as mean arterial pressure
< 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature
is intended for use in 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
Probability Indicator parameter. Refer to the Edwards FloTrac IQ sensor indications for use statement for
information on target patient populations.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for
each patient population.
1.2.3 HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere advanced monitor when used with the HemoSphere oximetry cable and Edwards
oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of
venous oxygen saturation (SvO
2
and ScvO
2
) and derived hemodynamic parameters in a hospital
environment. Refer to the Edwards oximetry catheter indications for use statement for information on target
patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for
each patient population.
1.3 Contraindications For Use
The HemoSphere advanced monitor has no contraindications for use.
1.4 Intended Use Statement
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, and pressure monitoring sensors and catheters.
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14