HemoSphere Operator's Manual Ver 2.3 Sept 2018

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, Acumen, Acumen IQ, CCOmbo, CCOmbo V, CO-Set, CO-Set+, FloTrac, FloTrac IQ, HemoSphere, Hypotension Prediction Index, HPI, PediaSat, Swan, Swan-Ganz, Time-InTarget, and TruWave are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. This product is manufactured and distributed under one or more of the following U.S. Patents: 7,220,230; 7,422,562; 7,452,333; 7,785,263; and 7,967,757 and corresponding foreign patents. Additional patents pending.

©2018 Edwards Lifesciences Corporation. All rights reserved. Version 2.3 Manual Release Date: 8/15/2018; Software Version: 1.1

Status = Released

Original Release Date: 9/30/2016

Printed Date: 2018-11-30

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.

Released Date: 2018-08-31

Edwards HemoSphere Advanced Monitor Operator’s Manual

Edwards Lifesciences Services GmbH Edisonstrasse 6 85716 Unterschleissheim, Germany

2

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

CAUTION

Inspect the HemoSphere advanced monitor and all accessories and equipment used with the monitor for damage prior to use. 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.

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

HemoSphere Pressure Cable Monitoring: Describes procedures for setup and operation of vascular pressure monitoring

11

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

3

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Chapter

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WARNING

Released Date: 2018-08-31

Using This Manual

Description

12

Advanced Features: Describes the advanced monitoring features that are currently available for upgrade with the HemoSphere advanced monitoring platform

13

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

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

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Chapter

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Index

4

1 Introduction 1.1 Intended Purpose of this Manual... 17 1.2 Indications For Use... 17 1.2.1 HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module17 1.2.2 HemoSphere Advanced Monitor with HemoSphere Oximetry Cable . . . 18 1.2.3 HemoSphere Advanced Monitor with HemoSphere Pressure Cable... 18 1.3 Contraindications For Use... 18 1.4 Intended Use Statement... 18 1.5 HemoSphere Advanced Monitor Hemodynamic Technology Connections . . 22 1.5.1 HemoSphere Swan-Ganz Module... 22 1.5.2 HemoSphere Pressure Cable... 23 1.5.3 HemoSphere Oximetry Cable... 25 1.5.4 Documentation and Training... 25 1.6 Manual style conventions... 26 1.7 Abbreviations Found in This Manual... 26

Released Date: 2018-08-31

Contents

3 Installation and Setup 3.1 Unpacking... 41 3.1.1 Packaging Contents... 41 3.1.2 Required Accessories for Platform Modules and Cables... 42 3.2 HemoSphere Advanced Monitor Connection Ports... 43 3.2.1 Monitor Front... 43 3.2.2 Monitor Rear... 44 3.2.3 Monitor Right Panel... 45 3.2.4 Monitor Left Panel... 45 3.3 HemoSphere Advanced Monitor Installation... 46 3.3.1 Mounting Options and Recommendations... 46 3.3.2 Battery Installation... 47 3.3.3 Connecting Power Cord... 47

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2.1 Safety Signal Words Definitions... 28 2.1.1 Warning... 28 2.1.2 Caution... 28 2.1.3 Note... 28 2.2 Warnings... 29 2.3 Cautions... 33 2.4 User Interface Symbols... 36 2.5 Symbols on Product Labels... 38 2.6 Applicable Standards... 40 2.7 HemoSphere Advanced Monitor Essential Performance... 40

Printed Date: 2018-11-30

2 Safety and Symbols

4 HemoSphere Advanced Monitor Quick Start 4.1 HemoSphere Swan-Ganz Module Cardiac Output Monitoring... 53 4.1.1 Continuous Cardiac Output Monitoring... 54 4.1.2 Intermittent Cardiac Output Monitoring... 54 4.1.3 Continuous End Diastolic Volume Monitoring... 55 4.2 Monitoring with the HemoSphere Pressure Cable... 56 4.2.1 Pressure Cable Setup... 56 4.2.2 Zero Pressure Cable... 56 4.3 HemoSphere Oximetry Cable Monitoring... 58 4.3.1 In vitro Calibration... 58 4.3.2 In vivo Calibration... 59

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3.3.3.1 Equipotential Connection... 48 3.3.4 Connecting and Disconnecting a Hemodynamic Monitoring Module . . . 48 3.3.5 Connecting and Disconnecting a Hemodynamic Monitoring Cable... 49 3.3.6 Connecting Cables from External Devices... 49 3.4 Initial Start Up... 50 3.4.1 Start Up Procedure... 50 3.4.2 Select Language... 50

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5.1 HemoSphere Advanced Monitor Screen Appearance... 61 5.2 Navigation Bar... 63 5.3 Monitor Views... 65 5.3.1 Parameter Globes... 66 5.3.1.1 Change Parameters... 66 5.3.1.2 Change Alarm/Target... 66 5.3.1.3 Status Indicators... 67 5.3.2 Graphical Trend Monitoring View... 68 5.3.2.1 Graphical Trend Scroll Mode... 69 5.3.2.2 Intervention Events... 69 5.3.2.3 Live Arterial Waveform (ART) Display... 71 5.3.3 Tabular Trends... 71 5.3.3.1 Tabular Trend Scroll Mode... 72 5.3.4 Graphical/Tabular Trends Split... 72 5.3.5 Big Numbers... 73 5.3.6 Physiology Screen... 73 5.3.6.1 SVV Slope Indicator... 74 5.3.6.2 Historic Physiology Screen... 75 5.3.7 Cockpit Screen... 75 5.3.8 Physio Relationship... 75 5.3.8.1 Continuous and Historical Modes... 76 5.3.8.2 Parameter Boxes... 78 5.3.8.3 Setting Targets and Entering Parameter Values... 78 5.3.9 Goal Positioning Screen... 79 5.4 Clinical Actions... 80 5.4.1 Select Monitoring Mode... 80

Printed Date: 2018-11-30

5 Navigating the HemoSphere Advanced Monitor

7 Advanced Settings 7.1 Alarms / Targets... 101 7.1.1 Silence Alarms... 102 7.1.1.1 Physiological Alarms... 102 7.1.1.2 Technical Alarms... 103 7.1.2 Set Alarm Volume... 103 7.1.3 Set Targets... 103 7.1.4 Alarms / Targets Setup Screen... 104 7.1.5 Configure All Targets... 105 7.1.6 Configure Targets and Alarms for One Parameter... 106 7.2 Adjust Scales... 107 7.3 Serial Port Setup... 109 7.4 Demo Mode... 109 7.5 Engineering... 110

8 Data Export and Connectivity Settings 8.1 Export Data... 111 8.1.1 Data Download... 111 8.2 Clear Data and Settings... 112 8.2.1 Restore Factory Defaults... 112

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6.1 Patient Data... 89 6.1.1 New Patient... 89 6.1.2 Continue Monitoring Patient... 91 6.1.3 View Patient Data... 91 6.2 Monitor Settings... 92 6.2.1 General Monitor Settings... 92 6.2.1.1 Change Language... 92 6.2.2 Change Date and Time Display... 93 6.2.2.1 Adjust Date or Time... 94 6.2.3 Monitoring Screens Settings... 94 6.2.4 Time Intervals / Averaging... 95 6.2.5 Analog Pressure Signal Input... 96 6.2.5.1 Calibration... 99

Printed Date: 2018-11-30

6 User Interface Settings

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5.4.2 Historical Graphical Trends... 81 5.4.3 CVP Entry... 81 5.4.4 Derived Value Calculator... 81 5.4.5 Event Review... 82 5.5 Information Bar... 84 5.5.1 Battery... 84 5.5.2 Lock Screen... 85 5.6 Status Bar... 86 5.7 Monitor Screen Navigation... 86 5.7.1 Vertical Scrolling... 86 5.7.2 Navigation Icons... 87

10 Monitoring with the HemoSphere Pressure Cable 10.1 Pressure Cable Overview... 133 10.2 Monitoring Mode Selection... 135 10.3 FloTrac Sensor Monitoring... 135 10.3.1 Connect FloTrac or FloTrac IQ/Acumen IQ Sensor... 136 10.3.2 Set Averaging Time... 137 10.3.3 Zero Arterial Pressure... 137 10.3.4 SVR monitoring... 138 10.4 Pressure Cable Monitoring with a TruWave DPT... 139 10.4.1 Connect TruWave DPT... 139 10.4.2 Zero Intravascular Pressure... 139 10.5 Pressure Cable Monitoring in Swan-Ganz Module Monitoring Mode... 140

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9.1 Connecting the HemoSphere Swan-Ganz Module... 117 9.1.1 Patient CCO Cable Test... 119 9.2 Continuous Cardiac Output... 120 9.2.1 Connecting the Patient Cables... 120 9.2.2 Initiating Monitoring... 121 9.2.3 Thermal Signal Conditions... 122 9.2.4 CO Countdown Timer and STAT CO... 122 9.3 Intermittent Cardiac Output... 123 9.3.1 Connecting Patient Cables... 123 9.3.1.1 Probe Selection... 124 9.3.2 Configuration Settings... 124 9.3.2.1 Select Injectate Volume... 125 9.3.2.2 Select Catheter Size... 125 9.3.2.3 Select Computation Constant... 126 9.3.2.4 Select Mode... 126 9.3.3 Instructions for Bolus Measurement Modes... 126 9.3.4 Thermodilution Summary Screen... 128 9.4 EDV/RVEF Monitoring... 129 9.4.1 Connecting Patient Cables... 129 9.4.2 Connecting the ECG Interface Cable... 129 9.4.3 Initiating Measurement... 131 9.4.4 Active EDV Monitoring... 131 9.4.5 STAT EDV and RVEF... 132 9.5 SVR... 132

Printed Date: 2018-11-30

9 HemoSphere Swan-Ganz Module Monitoring

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8.3 Wireless Settings... 113 8.4 HIS Connectivity... 114 8.4.1 Patient Demographic Data... 115 8.4.2 Patient Physiological Data... 116 8.4.3 Physiological Alarms and Device Faults... 116 8.5 Cyber Security... 116 8.5.1 HIPAA... 116

11 Oximetry Monitoring 11.1 Oximetry Setup... 143 11.2 In Vitro Calibration... 144 11.2.1 In Vitro Calibration Error... 145 11.3 In Vivo Calibration... 145 11.4 Signal Quality Indicator... 147 11.5 Recall Oximetry Data... 147 11.6 HGB Update... 148 11.7 HemoSphere Oximetry Cable Reset... 149 11.8 New Catheter... 149

Released Date: 2018-08-31

10.6 Zero & Waveform Screen... 141 10.6.1 Select Pressure and Zero Sensor... 142 10.6.2 Pressure-Out... 142 10.6.3 Waveform Confirmation... 142

12.1 Acumen Hypotension Prediction Index (HPI) Software Feature... 150 12.1.1 Acumen Hypotension Prediction Index (HPI)... 152 12.1.2 HPI as a Key Parameter... 153 12.1.3 HPI Alarm... 154 12.1.4 HPI on Information Bar... 155 12.1.5 Disable HPI Information Bar Indicator... 155 12.1.6 HPI High Alert Popup... 156 12.1.7 HPI Secondary Screen... 157 12.1.8 Clinical Application... 158 12.1.9 Additional Parameters... 159 12.1.10 Clinical Validation... 160 12.1.11 References... 163 12.2 Enhanced Parameter Tracking... 164 12.2.1 GDT Tracking... 164 12.2.1.1 Key Parameter and Target Selection... 164 12.2.1.2 Active GDT Tracking... 165 12.2.1.3 Historical GDT... 166 12.2.2 SV Optimization... 166 12.2.3 GDT Report Download... 167

Printed Date: 2018-11-30

12 Advanced Features

13.1 On Screen Help... 168 13.2 Monitor Status Lights... 169 13.3 Pressure Cable Communication... 170 13.4 HemoSphere Advanced Monitor Error Messages... 170 13.4.1 System Faults/Alerts... 170 13.4.2 System Warnings... 173 13.4.3 Numeric Keypad Errors... 173 13.5 HemoSphere Swan-Ganz Module Error Messages... 174

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13 Troubleshooting

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13.5.1 CO Faults/Alerts... 174 13.5.2 EDV and SV Faults/Alerts... 175 13.5.3 iCO Faults/Alerts... 176 13.5.4 SVR Faults/Alerts... 177 13.5.5 General Troubleshooting... 178 13.6 Pressure Cable Error Messages... 180 13.6.1 General Pressure Cable Faults/Alerts... 180 13.6.2 CO Faults/Alerts... 181 13.6.3 SVR Faults/Alert... 183 13.6.4 MAP Faults/Alert... 183 13.6.5 General Troubleshooting... 184 13.7 Oximetry Error Messages... 185 13.7.1 Oximetry Faults/Alerts... 185 13.7.2 Oximetry Warnings... 186 13.7.3 Oximetry General Troubleshooting... 187

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 Pressure Cable Specifications... A.6 HemoSphere Oximetry Cable Specifications...

188 189 191 192 193 193

B.1 Accessories List... 194 B.2 Additional Accessories Description... 195 B.2.1 Roll Stand... 195

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*...

202 202 203 205 206 207

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Appendix B: Accessories

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

208

F.1 General Maintenance... 210 F.2 Cleaning the Monitor and Modules... 211 F.3 Cleaning the Platform Cables... 211 F.3.1 Cleaning the HemoSphere Oximetry Cable... 212 F.3.2 Cleaning the Patient CCO Cable and Connector... 212 F.3.3 Cleaning the Pressure Cable... 213

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Appendix F: System Care, Service and Support

Appendix G: Guidance and Manufacturer’s Declaration G.1 Electromagnetic Compatibility... 217 G.2 Instructions for Use... 218 G.3 Wireless Technology Information... 223 G.3.1 Quality of Service for Wireless Technology... 225 G.3.2 Wireless Security Measures... 226 G.3.3 Troubleshooting Wireless Coexistence Issues... 226 G.3.4 Federal Communication Commission (FCC) Interference Statements . 226 G.3.5 Industry Canada Statements... 227 G.3.6 European Union R&TTE Statements... 227

Released Date: 2018-08-31

F.4 Service and Support... 213 F.5 Edwards Lifesciences Regional Headquarters... 214 F.6 Monitor Disposal... 215 F.6.1 Battery Recycling... 215 F.7 Preventive Maintenance... 215 F.7.1 Battery Maintenance... 215 F.7.1.1 Battery Conditioning... 215 F.7.1.2 Battery Storage... 215 F.8 Testing of Alarm Signals... 216 F.9 Warranty... 216

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Appendix H: Glossary

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12

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Figure 1-1 HemoSphere advanced monitor hemodynamic technology connections... 22 Figure 3-1 HemoSphere advanced monitor front view... 43 Figure 3-2 HemoSphere advanced monitor rear view (shown with HemoSphere Swan-Ganz module)... 44 Figure 3-3 HemoSphere advanced monitor right panel... 45 Figure 3-4 HemoSphere advanced monitor left panel (shown with no modules)... 45 Figure 3-5 HemoSphere advanced monitor power entry cover - screw locations... 48 Figure 3-6 Startup screen... 50 Figure 3-7 Language selection screen... 51 Figure 4-1 HemoSphere Swan-Ganz module monitoring connection overview... 53 Figure 4-2 Pressure cable connection overview... 56 Figure 4-3 Oximetry connection overview... 58 Figure 5-1 HemoSphere advanced monitor screen features... 62 Figure 5-2 Navigation bar... 63 Figure 5-3 Example of monitoring screen selection window... 65 Figure 5-4 Example of key parameter selection popup window... 66 Figure 5-5 Parameter globe... 67 Figure 5-6 Graphical trend screen... 68 Figure 5-7 Graphical trend- intervention window... 69 Figure 5-8 Graphical trend screen - intervention information balloon... 71 Figure 5-9 Tabular trend screen... 71 Figure 5-10 Tabular increment popup... 72 Figure 5-11 Big numbers screen... 73 Figure 5-12 Physiology screen while monitoring with HemoSphere Swan-Ganz module... 73 Figure 5-13 Cockpit monitoring screen... 75 Figure 5-14 Physio relationship screen while monitoring with HemoSphere Swan-Ganz module 76 Figure 5-15 Historic physio relationship data screen... 77 Figure 5-16 Physio relationship parameter boxes... 78 Figure 5-17 Physio relationship target/enter popup... 78 Figure 5-18 Goal positioning screen... 79 Figure 5-19 Information Bar - HemoSphere Swan-Ganz Module... 84 Figure 5-20 Information Bar - HemoSphere Pressure Cable... 84 Figure 5-21 Lock screen... 86 Figure 5-22 Status bar... 86 Figure 6-1 New or continuing patient screen... 89

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List of Figures

Released Date: 2018-08-31 Printed Date: 2018-11-30 Status = Released

Figure 6-2 New Patient Data screen... 90 Figure 6-3 Monitor Settings... 92 Figure 6-4 General Monitor Settings... 93 Figure 6-5 Date / Time Settings... 94 Figure 7-1 Alarms / Targets configuration... 105 Figure 7-2 Set individual parameter alarms and targets... 106 Figure 7-3 Graphical trend screen... 107 Figure 7-4 Adjust scales... 107 Figure 7-5 Tabular increment popup... 108 Figure 8-1 HIS- Patient query screen... 114 Figure 8-2 HIS- New patient data screen... 115 Figure 9-1 HemoSphere Swan-Ganz module connection overview... 118 Figure 9-2 Patient CCO cable test connections... 120 Figure 9-3 CO connection overview... 121 Figure 9-4 iCO connection overview... 124 Figure 9-5 iCO new set configuration screen... 125 Figure 9-6 Thermodilution summary screen... 128 Figure 9-7 EDV/RVEF connection overview... 129 Figure 10-1 HemoSphere pressure cable... 134 Figure 10-2 Zero & Waveform screen with zeroed FloTrac sensor... 141 Figure 11-1 Oximetry connection overview... 144 Figure 12-1 HPI key parameter globe... 154 Figure 12-2 HPI key parameter on cockpit screen... 155 Figure 12-3 Information bar with HPI... 156 Figure 12-4 Parameter settings - HPI information bar toggle button... 156 Figure 12-5 HPI high alert popup... 157 Figure 12-6 HPI secondary screen... 158 Figure 12-7 GDT Menu Screen - Key Parameter Selection... 165 Figure 12-8 GDT Menu Screen - Target Selection... 165 Figure 12-9 GDT Active Tracking... 166 Figure 13-1 HemoSphere advanced monitor LED indicators... 170 Figure 13-2 Pressure cable LED indicator... 171

13

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Printed Date: 2018-11-30 Status = Released

Table 1-1 HemoSphere Swan-Ganz module available parameters list... 19 Table 1-2 HemoSphere oximetry cable available parameters list... 19 Table 1-3 HemoSphere Swan-Ganz module with oximetry cable available parameters list... 20 Table 1-4 HemoSphere pressure cable available parameters list... 20 Table 1-5 HemoSphere pressure cable with oximetry cable available parameters list... 21 Table 1-6 HemoSphere Swan-Ganz module parameters description... 23 Table 1-7 HemoSphere pressure cable key parameters description... 24 Table 1-8 HemoSphere oximetry cable parameters description... 25 Table 1-9 Operator’s manual style conventions... 26 Table 1-10 Acronyms, Abbreviations... 26 Table 2-1 Monitor display symbols... 36 Table 2-2 Symbols on product labels... 38 Table 2-3 Applicable standards... 40 Table 3-1 HemoSphere advanced monitoring components... 41 Table 3-2 Cables and catheters required for monitoring parameters with HemoSphere Swan-Ganz module... 42 Table 3-3 Sensor options for monitoring parameters with HemoSphere pressure cable... 42 Table 3-4 Catheters required for monitoring parameters with HemoSphere oximetry cable . . 42 Table 5-1 Graphical trend scroll rates... 69 Table 5-2 Intervention events... 70 Table 5-3 Tabular trend scroll rates... 72 Table 5-4 Reviewed events... 82 Table 5-5 Battery status... 85 Table 6-1 CO/pressure averaging time and display update rates... 96 Table 6-2 Analog input parameter ranges... 98 Table 7-1 Visual alarm indicator colors... 101 Table 7-2 Target status indicator colors... 104 Table 8-1 Wi-Fi connection status... 113 Table 8-2 HIS connectivity status... 114 Table 9-1 Available HemoSphere Swan-Ganz module parameters and required connections 119 Table 9-2 Unstable thermal signal time lapse for CO alert and fault messages... 122 Table 10-1 HemoSphere pressure cable configurations and available key parameters... 134 Table 11-1 In vitro calibration options... 145 Table 11-2 In vivo calibration options... 146 Table 11-3 Signal quality indicator levels... 147

Released Date: 2018-08-31

List of Tables

15

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Table 12-1 HPI display configurations... 151 Table 12-2 HPI value graphical and audible display elements... 152 Table 12-3 HPI versus other key parameters: similarities and differences... 154 Table 12-4 Parameter status colors for HPI... 155 Table 12-6 Clinical Validation Studies*... 162 Table 12-5 Patient Demographics... 162 Table 12-7 Clinical Validation (N=52)... 163 Table 12-8 GDT Target Status Indicator Colors... 166 Table 13-1 HemoSphere advanced monitor visual alarm indicator... 170 Table 13-2 HemoSphere advanced monitor power light... 170 Table 13-3 Pressure cable communication light... 171 Table 13-4 System faults/alerts... 171 Table 13-5 HemoSphere advanced monitor warnings... 174 Table 13-6 Numeric keypad errors... 174 Table 13-7 HemoSphere Swan-Ganz module CO faults/alerts... 175 Table 13-8 HemoSphere Swan-Ganz module EDV and SV faults/alerts... 176 Table 13-9 HemoSphere Swan-Ganz module iCO faults/alerts... 177 Table 13-10 HemoSphere Swan-Ganz module SVR faults/alerts... 178 Table 13-11 HemoSphere Swan-Ganz module general troubleshooting... 179 Table 13-12 HemoSphere pressure cable general faults/alerts... 181 Table 13-13 HemoSphere pressure cable CO faults/alerts... 182 Table 13-14 HemoSphere pressure cable SVR faults/alerts... 184 Table 13-15 HemoSphere pressure cable MAP faults/alerts... 184 Table 13-16 HemoSphere pressure cable general troubleshooting... 185 Table 13-17 Oximetry faults/alerts... 186 Table 13-18 Oximetry warnings... 187 Table 13-19 Oximetry general troubleshooting... 188 Table A-1 HemoSphere advanced monitor essential performance – transient and non-transient electromagnetic phenomena... 189 Table A-2 HemoSphere advanced monitor physical and mechanical specifications... 190 Table A-5 HemoSphere advanced monitor technical specifications... 191 Table A-3 HemoSphere advanced monitor environmental specifications... 191 Table A-4 HemoSphere advanced monitor transportation environmental specifications... 191 Table A-6 HemoSphere battery pack physical specifications... 192 Table A-9 HemoSphere Swan-Ganz module physical specifications... 193 Table A-10 HemoSphere Swan-Ganz module parameter measurement specifications... 193 Table A-7 HemoSphere battery pack environmental specifications... 193 Table A-8 HemoSphere battery pack technical specifications... 193 Table A-11 HemoSphere pressure cable specifications... 194 Table A-12 HemoSphere pressure cable parameter measurement specifications... 194

Released Date: 2018-08-31 Status = Released

Printed Date: 2018-11-30

Table A-13 HemoSphere oximetry cable specifications... 194 Table A-14 HemoSphere oximetry cable parameter measurement specifications... 194 Table B-1 HemoSphere advanced monitor components... 195 Table C-1 Cardiac and oxygenation profile equations... 197 Table D-1 Patient information... 203 Table D-2 Graphical trend parameter scale defaults... 203 Table D-3 Configurable parameter alarm and display ranges... 204 Table D-4 Parameter alarm red zone and target defaults... 206 Table D-5 Parameter alarm red zone priorities... 207 Table D-6 Language default settings... 208 Table E-1 Computation constants for bath temperature probe... 209 Table E-2 Computation constants for in-line temperature probe... 210 Table G-2 Guidance and Manufacturer's Declaration - Immunity to RF wireless communications equipment... 220 Table G-1 Electromagnetic emissions... 220 Table G-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the HemoSphere advanced monitor... 221 Table G-4 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)... 222 Table G-5 Electromagnetic Immunity (RF Radiated and Conducted)... 223 Table G-6 HemoSphere advanced monitor wireless information... 224

16

Introduction Contents

Intended Purpose of this Manual...17 Indications For Use...17 Contraindications For Use...18

Released Date: 2018-08-31

1

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 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

Printed Date: 2018-11-30

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.

Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

17

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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.

HemoSphere Advanced Monitor

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.

1.2.3

HemoSphere Advanced Monitor with HemoSphere Pressure Cable

The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure 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 FloTrac sensor, FloTrac IQ/Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used.

Released Date: 2018-08-31

1.2.2

1 Introduction

The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient’s likelihood of future hypotensive events (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 operating room (OR) 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 Prediction Index (HPI) parameter.

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.

Status = Released

The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, and FloTrac, FloTrac IQ/Acumen IQ, and TruWave DPT sensors.

Printed Date: 2018-11-30

Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

18

HemoSphere Advanced Monitor

1 Introduction

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.

Sub-system technology used

Abbreviation

Definition

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

Patient population

Hospital environment

adult only

operating room, intensive care unit, emergency room

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

iCO

intermittent cardiac output

iCI

intermittent cardiac index

iSVR

intermittent systemic vascular resistance

iSVRI

intermittent systemic vascular resistance index

Printed Date: 2018-11-30

HemoSphere Swan-Ganz module

RVEF

Released Date: 2018-08-31

Table 1-1 HemoSphere Swan-Ganz module available parameters list

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.

Abbreviation

Definition

SvO2

mixed venous oxygen saturation

ScvO2

central venous oxygen saturation

19

Sub-system technology used

Patient population

HemoSphere oximetry cable

adult and pediatric

Hospital environment operating room, intensive care unit, emergency room

Status = Released

Table 1-2 HemoSphere oximetry cable available parameters list

HemoSphere Advanced Monitor

1 Introduction

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.

Sub-system technology used

Abbreviation

Definition

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

HemoSphere Swan-Ganz module and HemoSphere oximetry cable

Patient population

Hospital environment

adult and pediatric

operating room, intensive care unit, emergency room

Released Date: 2018-08-31

Table 1-3 HemoSphere Swan-Ganz module with oximetry cable available parameters list

A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere pressure cable are listed below in table 1-4. Table 1-4 HemoSphere pressure cable available parameters list

CO

continuous cardiac output

CI

continuous cardiac index

CVP

central venous pressure

DIA

diastolic blood pressure

dP/dt*

maximal slope of the arterial pressure upstroke

Eadyn*

dynamic arterial elastance

MAP

mean arterial blood pressure

MPAP

mean pulmonary artery blood pressure

PR

pulse rate

SV

stroke volume

SVI

stroke volume index

SVR

systemic vascular resistance

SVRI

systemic vascular resistance index

SVV

stroke volume variation

SYS

systolic blood pressure

HPI*

Acumen hypotension prediction index

HemoSphere pressure cable

Patient population

adult only

Hospital environment

operating room, intensive care unit, emergency room

operating room only

*HPI parameters are available when using a FloTrac IQ/Acumen IQ sensor and if the HPI feature is activated. Activation is only available in certain areas. Please contact your local Edwards representative for more information on enabling this advanced feature.

20

Printed Date: 2018-11-30

Definition

Status = Released

Abbreviation

Sub-system technology used