Operator's Manual
176 Pages
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HemoSphere
HemoSphere Advanced Monitor Advanced Monitor
Operator’s manual
Edwards Lifesciences
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
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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
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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
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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...
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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
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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
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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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