HemoSphere Operator's Manual Ver 1.2 April 2018

Edwards Lifesciences HemoSphere Advanced Monitor Operator’s Manual Because of continuing product improvement, prices and specifications are subject to change without notice. Changes to this manual, either in response to user input or to continuing product improvements, are accomplished through reissue. If, in the normal use of this manual, errors, omissions, or incorrect data are noted, please contact Edwards Technical Support or your local Edwards representative. Edwards Technical Support United States and Canada (24 hours)... 800.822.9837 or [email protected] Outside the U.S. and Canada (24 hours)... 949.250.2222 Europe... +8001.8001.801 or [email protected] In the UK... 0870 606 2040 - Option 4 In Ireland... 01 8211012 Option 4 CAUTION

Federal (USA) law restricts this device to sale by or on the order of a physician.

Manufactured by

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 Made in USA

Trademarks

Edwards, Edwards Lifesciences, the stylized E logo, CCOmbo, CCOmbo V, CO-Set, CO-Set+, HemoSphere, PediaSat, Swan and Swan-Ganz are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Copyright ©2017 Edwards Lifesciences LLC. All rights reserved. Version 1.2 Release Date: 4/28/2017 Original Release Date: 9/30/2016

Edwards Lifesciences Services GmbH Edisonstrasse 6 85716 Unterschleissheim, Germany

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Using This Manual The Edwards Lifesciences HemoSphere advanced monitor operator’s manual is comprised of eleven chapters, eight appendices, and an index. Figures in this manual are intended for reference only and may not be an exact replication of the screens as a result of continuous software improvements. WARNING

Read this operator's manual carefully before attempting to use the Edwards Lifesciences HemoSphere advanced monitor. Refer to the instructions for use provided with each compatible accessory before using it with the HemoSphere advanced monitor.

CAUTION

Inspect all accessories and equipment for damage prior to use with the HemoSphere advanced monitor. Damage may include cracks, scratches, dents, exposed electrical contacts, or any signs that the housing may be compromised.

WARNING

To prevent injury to patient or user, damage to platform, or inaccurate measurements, do not use any damaged or non-compatible platform accessories, components or cables.

Chapter

Description

1

Introduction: Provides an overview of the HemoSphere advanced monitor

2

Safety and Symbols: Includes WARNINGS, CAUTIONS, and NOTES that are found in the manual, as well as illustrations of labels found on the HemoSphere advanced monitor and accessories

3

Installation and Setup: Provides information about setting up the HemoSphere advanced monitor and connections for the first time

4

HemoSphere Advanced Monitor Quick Start: Provides experienced clinicians and users of bedside monitors instructions for immediate monitor use

5

Navigating the HemoSphere Advanced Monitor: Provides information on monitoring screen views

6

User Interface Settings: Provides information about the various display settings including patient information, language and international units, alarm volume, system time, and system date. It also provides instructions for selecting the screen appearance

7

Advanced Settings: Provides information on advanced settings including alarm targets, graphical scales, serial port setup, and Demo Mode.

8

Data Export and Connectivity: Provides information on monitor connectivity for transferring patient and clinical data

9

HemoSphere Swan-Ganz Module Monitoring: Describes procedures for setup and operation of continuous cardiac output, intermittent cardiac output, and right ventricular end diastolic volume monitoring using the Swan-Ganz module

10

Oximetry Monitoring: Describes procedures for calibration and operation of oximetry (oxygen saturation) measurement

11

Help and Troubleshooting: Describes the Help menu and provides a list of faults, alerts, and messages, with causes and suggested actions.

3

Appendix

Description

A

Specifications

B

Accessories

C

Equations for Calculated Patient Parameters

D

Monitor Settings and Defaults

E

Thermodilution Computation Constants

F

Monitor Care, Service and Support

G

Guidance and Manufacturer's Declaration

H

Glossary

Index

4

Contents 1 Introduction 1.1 Intended Purpose of this Manual... 15 1.2 Indications For Use... 15 1.2.1 HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module15 1.2.2 HemoSphere Advanced Monitor with HemoSphere Oximetry Cable . . . 16 1.3 Contraindications For Use... 16 1.4 Intended Use Statement... 16 1.5 HemoSphere Advanced Monitor Hemodynamic Technology Connections . . 18 1.5.1 HemoSphere Swan-Ganz Module... 18 1.5.2 HemoSphere Oximetry Cable... 19 1.5.3 Documentation and Training... 20 1.6 Manual style conventions... 20 1.7 Abbreviations Found in This Manual... 21

2 Safety and Symbols 2.1 Safety Signal Words Definitions... 22 2.1.1 Warning... 22 2.1.2 Caution... 22 2.1.3 Note... 22 2.2 Warnings... 23 2.3 Cautions... 26 2.4 User Interface Symbols... 29 2.5 Symbols on Product Labels... 30 2.6 Applicable Standards... 32 2.7 HemoSphere Advanced Monitor Essential Performance... 32

3 Installation and Setup 3.1 Unpacking... 33 3.1.1 Packaging Contents... 33 3.1.2 Required Accessories for Platform Modules and Cables... 34 3.2 HemoSphere Advanced Monitor Connection Ports... 35 3.2.1 Monitor Front... 35 3.2.2 Monitor Rear... 36 3.2.3 Monitor Right Panel... 37 3.2.4 Monitor Left Panel... 37 3.3 HemoSphere Advanced Monitor Installation... 38 3.3.1 Mounting Options and Recommendations... 38 3.3.2 Battery Installation... 39 3.3.3 Connecting Power Cord... 39 3.3.3.1 Equipotential Connection... 40 3.3.4 Connecting and Disconnecting a Hemodynamic Monitoring Module . . . 40

5

3.3.5 Connecting and Disconnecting a Hemodynamic Monitoring Cable... 41 3.3.6 Connecting Cables from External Devices... 41 3.4 Initial Start Up... 41 3.4.1 Start Up Procedure... 41 3.4.2 Select Language... 42

4 HemoSphere Advanced Monitor Quick Start 4.1 HemoSphere Swan-Ganz Module Cardiac Output Monitoring... 43 4.1.1 Continuous Cardiac Output Monitoring... 44 4.1.2 Intermittent Cardiac Output Monitoring... 44 4.1.3 Continuous End Diastolic Volume Monitoring... 45 4.2 HemoSphere Oximetry Cable Monitoring... 46 4.2.1 In vitro Calibration... 46 4.2.2 In vivo Calibration... 47

5 Navigating the HemoSphere Advanced Monitor 5.1 HemoSphere Advanced Monitor Screen Appearance... 48 5.2 Navigation Bar... 50 5.3 Monitor Views... 51 5.3.1 Parameter Globes... 52 5.3.1.1 Change Parameters... 52 5.3.1.2 Change Alarm/Target... 53 5.3.1.3 Status Indicators... 54 5.3.2 Graphical Trend Monitoring View... 54 5.3.2.1 Graphical Trend Scroll Mode... 55 5.3.2.2 Intervention Events... 56 5.3.3 Tabular Trends... 58 5.3.3.1 Tabular Trend Scroll Mode... 58 5.3.4 Graphical/Tabular Trends Split... 59 5.3.5 Physiology Screen... 60 5.3.5.1 Historic Physiology Screen... 61 5.3.6 Cockpit Screen... 61 5.3.7 Physio Relationship... 61 5.3.7.1 Continuous and Historical Modes... 62 5.3.7.2 Parameter Boxes... 64 5.3.7.3 Setting Targets and Entering Parameter Values... 64 5.4 Clinical Actions... 65 5.4.1 Derived Value Calculator... 65 5.4.2 Event Review... 65 5.5 Information Bar... 66 5.5.1 Battery... 66 5.5.2 Lock Screen... 67 5.6 Status Bar... 68 5.7 Monitor Screen Navigation... 68 5.7.1 Vertical Scrolling... 68 5.7.2 Navigation Icons... 68

6 User Interface Settings

6

6.1 Patient Data... 70 6.1.1 New Patient... 70 6.1.2 Continue Monitoring Patient... 72 6.1.3 View Patient Data... 72 6.2 Monitor Settings... 72 6.2.1 General Monitor Settings... 72 6.2.1.1 Change Language... 73 6.2.2 Change Date and Time Display... 73 6.2.2.1 Adjust Date or Time... 74 6.2.3 Monitoring Screens Settings... 75 6.2.4 Time Intervals / Averaging... 75 6.2.5 Analog Pressure Signal Input... 75 6.2.5.1 Calibration... 77

7 Advanced Settings 7.1 Alarms / Targets... 79 7.1.1 Silence Alarms... 80 7.1.1.1 Physiological Alarms... 80 7.1.1.2 Technical Alarms... 80 7.1.2 Set Alarm Volume... 80 7.1.3 Set Targets... 81 7.1.4 Alarms / Targets Setup Screen... 82 7.1.5 Configure All Targets... 83 7.1.6 Set Custom Defaults... 84 7.1.7 Configure Targets and Alarms for One Parameter... 85 7.2 Adjust Scales... 86 7.3 Serial Port Setup... 87 7.4 Demo Mode... 88 7.5 Engineering... 88

8 Data Export and Connectivity Settings 8.1 Export Data... 89 8.1.1 Data Download... 89 8.2 Clear Data and Settings... 90 8.2.1 Restore Factory Defaults... 90 8.3 Wireless Settings... 90 8.4 HIS Connectivity... 91 8.4.1 Patient Demographic Data... 92 8.4.2 Patient Physiological Data... 93 8.4.3 Physiological Alarms and Device Faults... 93 8.5 Cyber Security... 94 8.5.1 HIPAA... 94

9 HemoSphere Swan-Ganz Module Monitoring 9.1 Connecting the HemoSphere Swan-Ganz Module... 95 9.1.1 Patient CCO Cable Test... 97 9.2 Continuous Cardiac Output... 98

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9.2.1 Connecting the Patient Cables... 98 9.2.2 Initiating Monitoring... 99 9.2.3 Thermal Signal Conditions... 100 9.2.4 CO Countdown Timer and STAT CO... 100 9.3 Intermittent Cardiac Output... 101 9.3.1 Connecting Patient Cables... 101 9.3.1.1 Probe Selection... 102 9.3.2 Configuration Settings... 102 9.3.2.1 Select Injectate Volume... 103 9.3.2.2 Select Catheter Size... 103 9.3.2.3 Select Computation Constant... 104 9.3.2.4 Select Mode... 104 9.3.3 Instructions for Bolus Measurement Modes... 104 9.3.4 Thermodilution Summary Screen... 106 9.4 EDV/RVEF Monitoring... 107 9.4.1 Connecting Patient Cables... 107 9.4.2 Connecting the ECG Interface Cable... 107 9.4.3 Initiating Measurement... 108 9.4.4 Active EDV Monitoring... 109 9.4.5 STAT EDV and RVEF... 110 9.5 SVR... 110

10 Oximetry Monitoring 10.1 Oximetry Setup... 111 10.2 In Vitro Calibration... 112 10.2.1 In Vitro Calibration Error... 113 10.3 In Vivo Calibration... 113 10.4 Signal Quality Indicator... 115 10.5 Recall Oximetry Data... 115 10.6 HGB Update... 116 10.7 HemoSphere Oximetry Cable Reset... 117 10.8 New Catheter... 117

11 Troubleshooting 11.1 On Screen Help... 118 11.2 Monitor Status Lights... 119 11.3 HemoSphere Advanced Monitor Error Messages... 120 11.3.1 System Faults/Alerts... 120 11.3.2 System Warnings... 122 11.3.3 Numeric Keypad Errors... 122 11.4 HemoSphere Swan-Ganz Module Error Messages... 123 11.4.1 CO Faults/Alerts... 123 11.4.2 EDV and SV Faults/Alerts... 124 11.4.3 iCO Faults/Alerts... 126 11.4.4 SVR Faults/Alerts... 127 11.4.5 General Troubleshooting... 128

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11.5 Oximetry Error Messages... 129 11.5.1 Oximetry Faults/Alerts... 129 11.5.2 Oximetry Warnings... 130 11.5.3 Oximetry General Troubleshooting... 131

Appendix A: Specifications A.1 Essential Performance Characteristics... A.2 HemoSphere Advanced Monitor Specifications... A.3 HemoSphere Battery Pack Specifications... A.4 HemoSphere Swan-Ganz Module Specifications... A.5 HemoSphere Oximetry Cable Specifications...

132 133 135 135 136

Appendix B: Accessories B.1 Accessories List... 137 B.2 Additional Accessories Description... 138 B.2.1 Roll Stand... 138

Appendix C: Equations for Calculated Patient Parameters Appendix D: Monitor Settings and Defaults D.1 Patient Data Input Range... D.2 Trend Scale Default Limits... D.3 Parameter Display and Configurable Alarm/Target Ranges... D.4 Alarm and Target Defaults... D.5 Alarm Priorities... D.6 Language Default Settings*...

144 144 145 146 147 148

Appendix E: Computation Constants E.1 Computation Constant Values...

149

Appendix F: System Care, Service and Support F.1 General Maintenance... 151 F.2 Cleaning the Monitor and Modules... 152 F.3 Cleaning the Platform Cables... 152 F.3.1 Cleaning the HemoSphere Oximetry Cable... 152 F.3.2 Cleaning the Patient CCO Cable and Connector... 153 F.4 Service and Support... 153 F.5 Edwards Lifesciences Regional Headquarters... 154 F.6 Monitor Disposal... 154 F.6.1 Battery Recycling... 154 F.7 Preventive Maintenance... 155 F.7.1 Battery Maintenance... 155 F.7.1.1 Battery Conditioning... 155 F.7.1.2 Battery Storage... 155 F.8 Testing of Alarm Signals... 155 F.9 Warranty... 155

Appendix G: Guidance and Manufacturer’s Declaration G.1 Electromagnetic Compatibility...

9

157

G.2 Instructions for Use... 157 G.3 Wireless Technology Information... 163 G.3.1 Quality of Service for Wireless Technology... 165 G.3.2 Wireless Security Measures... 166 G.3.3 Troubleshooting Wireless Coexistence Issues... 166 G.3.4 Federal Communication Commission (FCC) Interference Statements . 166 G.3.5 Industry Canada Statements... 167 G.3.6 European Union R&TTE Statements... 168

Appendix H: Glossary

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List of Figures Figure 1-1 HemoSphere advanced monitor hemodynamic technology connections... 18 Figure 3-1 HemoSphere advanced monitor front view... 35 Figure 3-2 HemoSphere advanced monitor rear view (shown with HemoSphere Swan-Ganz module)... 36 Figure 3-3 HemoSphere advanced monitor right panel... 37 Figure 3-4 HemoSphere advanced monitor left panel (shown with no modules)... 37 Figure 3-5 HemoSphere power entry cover - screw locations... 40 Figure 3-6 Startup screen... 42 Figure 3-7 Language selection screen... 42 Figure 4-1 HemoSphere Swan-Ganz module monitoring connection overview... 43 Figure 4-2 Oximetry connection overview... 46 Figure 5-1 HemoSphere advanced monitor screen features... 49 Figure 5-2 Navigation bar - HemoSphere Swan-Ganz module monitoring... 50 Figure 5-3 Example of monitoring screen selection window... 52 Figure 5-4 Example of key parameter selection popup window... 53 Figure 5-5 Parameter globe... 54 Figure 5-6 Graphical trend screen... 55 Figure 5-7 Graphical trend- intervention window... 56 Figure 5-8 Graphical trend screen - intervention information balloon... 57 Figure 5-9 Tabular trend screen... 58 Figure 5-10 Tabular increment popup... 58 Figure 5-11 Physiology screen... 60 Figure 5-12 Cockpit monitoring screen... 61 Figure 5-13 Physio relationship screen... 62 Figure 5-14 Historic physio relationship data screen... 63 Figure 5-15 Physio relationship parameter boxes... 64 Figure 5-16 Physio relationship target/enter popup... 64 Figure 5-17 Information Bar - HemoSphere Swan-Ganz Module... 66 Figure 5-18 Lock screen... 67 Figure 5-19 Status bar... 68 Figure 6-1 New or continuing patient screen... 70 Figure 6-2 New Patient Data screen... 71 Figure 6-3 Monitor Settings... 72 Figure 6-4 General Monitor Settings... 73 Figure 6-5 Date / Time Settings... 74 Figure 7-1 Alarms / Targets configuration... 83

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Figure 7-2 Set custom default Alarms / Targets... 84 Figure 7-3 Set individual parameter alarms and targets... 85 Figure 7-4 Graphical trend screen... 86 Figure 7-5 Adjust scales... 86 Figure 7-6 Tabular increment popup... 87 Figure 8-1 HIS- Patient query screen... 92 Figure 8-2 HIS- New patient data screen... 93 Figure 9-1 HemoSphere Swan-Ganz module connection overview... 96 Figure 9-2 Patient CCO cable test connections... 97 Figure 9-3 CO connection overview... 99 Figure 9-4 iCO connection overview... 102 Figure 9-5 iCO new set configuration screen... 103 Figure 9-6 Thermodilution summary screen... 106 Figure 9-7 EDV/RVEF connection overview... 107 Figure 10-1 Oximetry connection overview... 112 Figure 11-1 HemoSphere advanced monitor LED indicators... 119

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List of Tables Table 1-1 HemoSphere Swan-Ganz module available parameters list... 16 Table 1-2 HemoSphere oximetry cable available parameters list... 17 Table 1-3 HemoSphere Swan-Ganz module with oximetry cable available parameters list... 17 Table 1-4 HemoSphere Swan-Ganz module parameters description... 18 Table 1-5 HemoSphere oximetry cable parameters description... 19 Table 1-6 Operator’s manual style conventions... 20 Table 1-7 Acronyms, Abbreviations... 21 Table 2-1 Monitor display symbols... 29 Table 2-2 Symbols on product labels... 30 Table 2-3 Applicable standards... 32 Table 3-1 HemoSphere advanced monitoring components... 33 Table 3-2 Accessories required for monitoring parameters with HemoSphere Swan-Ganz module ... 34 Table 3-3 Accessories required for monitoring parameters with HemoSphere oximetry cable . 34 Table 5-1 Graphical trend scroll rates... 55 Table 5-2 Intervention events... 57 Table 5-3 Tabular trend scroll rates... 59 Table 5-4 Reviewed events... 65 Table 5-5 Battery status... 66 Table 6-1 Analog input parameter ranges... 77 Table 7-1 Visual alarm indicator colors... 79 Table 7-2 Target status indicator colors... 81 Table 7-3 Target defaults... 82 Table 8-1 Wi-Fi connection status... 91 Table 8-2 HIS connectivity status... 92 Table 9-1 Available HemoSphere Swan-Ganz module parameters and required connections . 97 Table 9-2 Unstable thermal signal time lapse for CO alert and fault messages... 100 Table 10-1 In vitro calibration options... 113 Table 10-2 In vivo calibration options... 114 Table 10-3 Signal quality indicator levels... 115 Table 11-1 HemoSphere advanced monitor visual alarm indicator... 119 Table 11-2 HemoSphere advanced monitor power light... 119 Table 11-3 System faults/alerts... 120 Table 11-4 HemoSphere advanced monitor warnings... 122 Table 11-5 Numeric keypad errors... 122 Table 11-6 HemoSphere Swan-Ganz module CO faults/alerts... 123

13

Table 11-7 HemoSphere Swan-Ganz module EDV and SV faults/alerts... 124 Table 11-8 HemoSphere Swan-Ganz module iCO faults/alerts... 126 Table 11-9 HemoSphere Swan-Ganz module SVR faults/alerts... 127 Table 11-10 HemoSphere Swan-Ganz module general troubleshooting... 128 Table 11-11 Oximetry faults/alerts... 129 Table 11-12 Oximetry warnings... 130 Table 11-13 Oximetry general troubleshooting... 131 Table A-1 HemoSphere advanced monitor essential performance – non-transient electromagnetic phenomena... 132 Table A-2 HemoSphere advanced monitor essential performance – transient electromagnetic phenomena... 133 Table A-3 HemoSphere advanced monitor physical and mechanical specifications... 133 Table A-5 HemoSphere advanced monitor technical specifications... 134 Table A-4 HemoSphere advanced monitor environmental specifications... 134 Table A-6 HemoSphere battery pack physical specifications... 135 Table A-7 HemoSphere battery pack environmental specifications... 135 Table A-8 HemoSphere battery pack technical specifications... 135 Table A-9 HemoSphere Swan-Ganz module physical specifications... 135 Table A-11 HemoSphere oximetry cable specifications... 136 Table A-12 HemoSphere oximetry cable parameter measurement specifications... 136 Table A-10 HemoSphere Swan-Ganz module parameter measurement specifications... 136 Table B-1 HemoSphere advanced monitor components... 137 Table C-1 Cardiac and oxygenation profile equations... 139 Table D-1 Patient information... 144 Table D-2 Graphical trend parameter scale defaults... 144 Table D-3 Configurable parameter alarm and display ranges... 145 Table D-4 Parameter alarm red zone and target defaults... 146 Table D-5 Parameter alarm red zone priorities... 147 Table D-6 Language default settings... 148 Table E-1 Computation constants for bath temperature probe... 149 Table E-2 Computation constants for in-line temperature probe... 150 Table G-1 List of accessories, cables and sensors necessary for compliance... 157 Table G-2 Electromagnetic emissions... 158 Table G-3 Guidance and Manufacturer's Declaration - Immunity to RF wireless communications equipment... 159 Table G-4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the HemoSphere advanced monitor... 160 Table G-5 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)... 161 Table G-6 Electromagnetic Immunity (RF Radiated and Conducted)... 162 Table G-7 HemoSphere advanced monitor wireless information... 163

14

1

Introduction Contents

Intended Purpose of this Manual...15 Indications For Use...15 Contraindications For Use...16 Intended Use Statement...16 HemoSphere Advanced Monitor Hemodynamic Technology Connections...18 Manual style conventions...20 Abbreviations Found in This Manual...21

1.1 Intended Purpose of this Manual This manual describes the features and monitoring options of the Edwards Lifesciences 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 Lifesciences 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.

15

HemoSphere Advanced Monitor

1.2.2

1 Introduction

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 (SvO2 and ScvO2) 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. A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Swan-Ganz module are listed below in table 1-1. Only iCO, iCI, iSVR, and iSVRI are available to the pediatric patient population. Table 1-1 HemoSphere Swan-Ganz module available parameters list Abbreviation

Description

Patient population

CO

continuous cardiac output

sCO

STAT cardiac output

CI

continuous cardiac index

sCI

STAT cardiac index

EDV

right ventricular end diastolic volume

sEDV

STAT right ventricular end diastolic volume

EDVI

right ventricular end diastolic volume index

sEDVI

STAT right ventricular end diastolic volume index

HRavg

averaged heart rate

LVSWI

left ventricular stroke work index

PVR

pulmonary vascular resistance

PVRI

pulmonary vascular resistance index

RVEF

right ventricular ejection fraction

sRVEF

STAT right ventricular ejection fraction

RVSWI

right ventricular stroke work index

SV

stroke volume

SVI

stroke volume index

SVR

systemic vascular resistance

SVRI

systemic vascular resistance index

16

adult only

HemoSphere Advanced Monitor

1 Introduction

Table 1-1 HemoSphere Swan-Ganz module available parameters list (continued) Abbreviation

Description

Patient population

iCO

intermittent cardiac output

iCI

intermittent cardiac index

iSVR

intermittent systemic vascular resistance

iSVRI

intermittent systemic vascular resistance index

adult and pediatric

A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere advanced monitor and a connected HemoSphere oximetry cable are listed below in table 1-2. Table 1-2 HemoSphere oximetry cable available parameters list Abbreviation

Description

Patient population

SvO2

mixed venous oxygen saturation

ScvO2

central venous oxygen saturation

adult and pediatric

A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere Swan-Ganz module and oximetry cable are listed below in table 1-3. Table 1-3 HemoSphere Swan-Ganz module with oximetry cable available parameters list Abbreviation

Description

DO2

oxygen delivery

DO2I

oxygen delivery index

VO2

oxygen consumption

VO2e

estimated oxygen consumption when ScvO2 is being monitored

VO2I

oxygen consumption index

VO2Ie

estimated oxygen consumption index when ScvO2 is being monitored

WARNING

Patient population

adult and pediatric

Improper use of the HemoSphere advanced monitor could present a hazard to the patient. Carefully read the “warnings” section of this manual, located in chapter 2, before using the platform. The HemoSphere advanced monitor is intended for use only in patient assessment. This instrument must be used in conjunction with a bedside physiological monitor and/or patient clinical signs and symptoms. If hemodynamic values obtained from the device are not consistent with the clinical presentation of the patient, consider troubleshooting before initiating treatment options. ECG signal input and all parameters derived from heart rate measurements have not been evaluated for pediatric patients and are therefore not available for that patient population.

17

HemoSphere Advanced Monitor

1 Introduction

1.5 HemoSphere Advanced Monitor Hemodynamic Technology Connections The HemoSphere advanced monitor is equipped with three technology expansion module slots (two standard size and one large [L-Tech] size) and two cable ports. Module and cable connection points are located on the left side panel. See figure 1-1.

L-Tech expansion module slot (1)

L-Tech expansion module

expansion module slots (2)

expansion modules (2)

cable ports (2)

Figure 1-1 HemoSphere advanced monitor hemodynamic technology connections Each module/cable is associated with a specific Edwards hemodynamic monitoring technology. Currently available modules include the HemoSphere Swan-Ganz module, introduced below and in detail in chapter 9, HemoSphere Swan-Ganz Module Monitoring. Currently available cables include the HemoSphere oximetry cable, introduced below and described in detail in chapter 10, Oximetry Monitoring.

1.5.1

HemoSphere Swan-Ganz Module

The HemoSphere Swan-Ganz module enables continuous cardiac output (CO) and intermittent cardiac output (iCO) monitoring with an Edwards patient CCO cable and compatible Swan-Ganz catheter. Right ventricular end diastolic volume (EDV) monitoring is available with slaved in heart rate (HRavg) data from a bedside patient monitor. The HemoSphere Swan-Ganz module fits into a standard module slot. For more information, see chapter 9, HemoSphere Swan-Ganz Module Monitoring. Table 1-4 lists the parameters available while using the HemoSphere Swan-Ganz module. Table 1-4 HemoSphere Swan-Ganz module parameters description Parameter

Description

Technology

continuous cardiac output (CO)

continuous assessment through advanced thermodilution technology of the volume of blood pumped by the heart measured in liters per minute

Swan-Ganz CCO and CCOmbo catheters

continuous cardiac index (CI)

continuous cardiac output relative to body surface area (BSA)

Swan-Ganz CCO and CCOmbo catheters

18

HemoSphere Advanced Monitor

1 Introduction

Table 1-4 HemoSphere Swan-Ganz module parameters description (continued) Parameter

Description

Technology

intermittent cardiac output (iCO)

intermittent assessment through the bolus thermodilution method of the volume of blood pumped by the heart measured in liters per minute

Swan-Ganz thermodilution catheters

intermittent cardiac index (iCI)

intermittent cardiac output relative to body surface area (BSA)

Swan-Ganz thermodilution catheters

right ventricular ejection fraction (RVEF)

continuous assessment through advanced thermodilution technology and algorithm analysis of the percentage of blood volume ejected from the right ventricle during systole

Swan-Ganz CCOmbo V catheters with ECG signal input

right ventricular end diastolic volume (EDV)

continuous assessment of the volume of blood in the right ventricle at the end of diastole calculated by dividing stroke volume (mL/beat) by RVEF(%)

Swan-Ganz CCOmbo V catheters with ECG signal input

stroke volume (SV)

amount of blood ejected from the ventricles with each contraction derived from CO assessment and heart rate (SV = CO/HR x 1000)

Swan-Ganz CCO,CCOmbo, and CCOmbo V catheters with ECG signal input

stroke volume index (SVI)

stroke volume relative to body surface area (BSA)

Swan-Ganz CCO,CCOmbo, and CCOmbo V catheters with ECG signal input

systemic vascular resistance (SVR)

a derived measure of impedance to blood flow from left ventricle (afterload)

Swan-Ganz CCO and CCOmbo catheters with MAP and CVP analog pressure signal input

systemic vascular resistance index (SVRI)

systemic vascular resistance relative to body surface area (BSA)

Swan-Ganz CCO and CCOmbo catheters with MAP and CVP analog pressure signal input

1.5.2

HemoSphere Oximetry Cable

The HemoSphere oximetry cable enables mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2) monitoring with a compatible Edwards oximetry catheter. The HemoSphere oximetry cable plugs into a monitoring cable receptacle and can be used in combination with other hemodynamic monitoring technologies. For more information on oximetry monitoring, see chapter 10, Oximetry Monitoring. Table 1-5 lists the parameters available while using the HemoSphere oximetry cable. Table 1-5 HemoSphere oximetry cable parameters description Parameter

Description

central venous oximetry (ScvO2)

venous oxygen saturation as measured in the superior vena cava

mixed venous oximetry (SvO2)

venous oxygen saturation as measured in the pulmonary artery

oxygen consumption (VO2)

the amount of oxygen used by the body per minute

19

HemoSphere Advanced Monitor

1 Introduction

Table 1-5 HemoSphere oximetry cable parameters description (continued)

1.5.3

Parameter

Description

estimated oxygen consumption (VO2e)

an estimate of the amount of oxygen used by the body per minute (ScvO2 monitoring only)

oxygen consumption index (VO2I)

the amount of oxygen used by the body per minute indexed against body surface area (BSA)

estimated oxygen consumption index (VO2Ie)

an estimate of the amount of oxygen used by the body per minute indexed against body surface area (BSA)

Documentation and Training

Available documentation and training for the HemoSphere advanced monitor includes: •

HemoSphere Advanced Monitor Operator’s Manual

•

HemoSphere Advanced Monitor Quick Start Guide

•

HemoSphere Swan-Ganz Module Instructions for Use

•

HemoSphere Oximetry Cable Instructions for Use

Instructions for Use are included with HemoSphere Advanced Monitor components. See table B-1, “HemoSphere advanced monitor components,” on page 137. For more information on how you can receive training or available documentation for the HemoSphere advanced monitor, contact your local Edwards representative or Edwards Technical Support. See appendix F, System Care, Service and Support..

1.6 Manual style conventions Table 1-6 lists the style conventions used in this manual. Table 1-6 Operator’s manual style conventions Convention

Description

Bold

Bold text indicates a software term. This word or phrase will appear on the screen as shown.

Bold button

A button is a touch screen access point for the option appearing in bold. For example, the Review button appears on screen as:



An arrow is shown between two on screen menu options that are selected consecutively by the operator. An icon is a touch screen access point for the menu or navigation graphic shown. See table 2-1 on page 29 for full list of menu icons shown on the HemoSphere advanced monitor.

Oximetry Calibration icon

Bold text with a menu icon indicates an icon that is paired with a software term appearing on the screen as shown.

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