Edwards HemoSphere

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Introduction
Contents
Intended Purpose of this Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Contraindications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Intended Use Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
HemoSphere Advanced Monitor Hemodynamic Technology Connections. . . . . . . . . . . . . . . . . . . . . . . .22
Manual style conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Abbreviations Found in This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
1.1 Intended Purpose of this Manual
This manual describes the features and monitoring options of the Edwards HemoSphere advanced monitor.
The HemoSphere advanced monitor is a modular device that displays monitored data obtained through
Edwards hemodynamic technologies.
This manual has been prepared for use with the Edwards HemoSphere advanced monitor by trained critical
care clinicians, nurses, and physicians in any hospital environment where critical care is administered.
This manual provides the operator of the HemoSphere advanced monitor with setup and operating
instructions, device interfacing procedures, and limitations.
1.2 Indications For Use
1.2.1 HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module
The HemoSphere advanced monitor when used with the HemoSphere Swan-Ganz module and Edwards
Swan-Ganz catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of
cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital
environment. Refer to the Edwards Swan-Ganz 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.
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14