HemoSphere Operators Manual Ver 3.5 Jan 2022

Edwards 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, Acumen, Acumen HPI, Acumen IQ, CCOmbo, CCOmbo V, CO-Set, CO-Set+, FloTrac, ForeSight, FORE-SIGHT, ForeSight Elite, FORE-SIGHT ELITE, ForeSight Jr, HemoSphere, HPI, PediaSat, Swan, Swan-Ganz, Time-In-Target, and TruWave are trademarks of Edwards Lifesciences Corporation or its affiliates. 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.

©2022 Edwards Lifesciences Corporation. All rights reserved. Version 3.5 Manual Release Date: JANUARY 2022; Software Version: 02.0 Original Release Date: 9/30/2016

Edwards Lifesciences Services GmbH Edisonstrasse 6 85716 Unterschleissheim, Germany

Edwards Lifesciences B.V. Verlengde Poolseweg 16 4818 CL Breda, Netherlands

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Users and/or patients should report any serious incidents to the manufacturer and the Competent Authority of the Member State in which the user and/or patient is established.

Using This Manual The Edwards HemoSphere advanced monitor operator’s manual is comprised of fourteen 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. Carefully read these instructions for use, which address the warnings, precautions, and residual risks for this medical device. WARNING

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.

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

3

Chapter

Description

10

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

11

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

12

Tissue Oximetry Monitoring: Describes procedures for setup and operation of ForeSight Elite tissue oximetry monitoring

13

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

14

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

Index

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Contents 1 Introduction 1.1 Intended Purpose of this Manual... 21 1.2 Indications For Use... 22 1.2.1 HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module22 1.2.2 HemoSphere Advanced Monitor with HemoSphere Oximetry Cable . . . 22 1.2.3 HemoSphere Advanced Monitor with HemoSphere Pressure Cable... 22 1.2.4 HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module ... 23 1.3 Contraindications For Use... 23 1.4 Intended Use Statement... 23 1.5 Expected Clinical Benefit... 28 1.6 HemoSphere Advanced Monitor Hemodynamic Technology Connections . . 28 1.6.1 HemoSphere Swan-Ganz Module... 29 1.6.2 HemoSphere Pressure Cable... 30 1.6.3 HemoSphere Oximetry Cable... 31 1.6.4 HemoSphere Tissue Oximetry Module... 32 1.6.5 Documentation and Training... 32 1.7 Manual style conventions... 33 1.8 Abbreviations Found in This Manual... 33

2 Safety and Symbols

2.1 Safety Signal Words Definitions... 35 2.1.1 Warning... 35 2.1.2 Caution... 35 2.1.3 Note... 35 2.2 Warnings... 36 2.3 Cautions... 42 2.4 User Interface Symbols... 47 2.5 Symbols on Product Labels... 49 2.6 Applicable Standards... 51 2.7 HemoSphere Advanced Monitor Essential Performance... 51

3 Installation and Setup

3.1 Unpacking... 52 3.1.1 Packaging Contents... 52 3.1.2 Required Accessories for Platform Modules and Cables... 53 3.2 HemoSphere Advanced Monitor Connection Ports... 54 3.2.1 Monitor Front... 55 3.2.2 Monitor Rear... 56 3.2.3 Monitor Right Panel... 57 3.2.4 Monitor Left Panel... 57

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3.3 HemoSphere Advanced Monitor Installation... 58 3.3.1 Mounting Options and Recommendations... 58 3.3.2 Battery Installation... 59 3.3.3 Connecting Power Cord... 59 3.3.3.1 Equipotential Connection... 60 3.3.4 Connecting and Disconnecting a Hemodynamic Monitoring Module . . . 60 3.3.5 Connecting and Disconnecting a Hemodynamic Monitoring Cable... 61 3.3.6 Connecting Cables from External Devices... 61 3.4 Initial Start Up... 62 3.4.1 Start Up Procedure... 62 3.4.2 Select Language... 62

4 HemoSphere Advanced Monitor Quick Start

4.1 HemoSphere Swan-Ganz Module Cardiac Output Monitoring... 65 4.1.1 Continuous Cardiac Output Monitoring... 66 4.1.2 Intermittent Cardiac Output Monitoring... 66 4.1.3 Continuous End Diastolic Volume Monitoring... 67 4.2 Monitoring with the HemoSphere Pressure Cable... 68 4.2.1 Pressure Cable Setup... 68 4.2.2 Zero Pressure Cable... 68 4.3 HemoSphere Oximetry Cable Monitoring... 70 4.3.1 In vitro Calibration... 70 4.3.2 In vivo Calibration... 71 4.4 HemoSphere Tissue Oximetry Module Monitoring... 73 4.4.1 Connecting the HemoSphere Tissue Oximetry Module... 73

5 Navigating the HemoSphere Advanced Monitor

5.1 HemoSphere Advanced Monitor Screen Appearance... 75 5.2 Navigation Bar... 77 5.3 Monitor Views... 80 5.3.1 Parameter Tiles... 80 5.3.1.1 Change Parameters... 80 5.3.1.2 Change Alarm/Target... 82 5.3.1.3 Status Indicators... 82 5.3.2 Main Monitoring View... 83 5.3.3 Graphical Trend Monitoring View... 84 5.3.3.1 Graphical Trend Scroll Mode... 85 5.3.3.2 Intervention Events... 86 5.3.3.3 Live Blood Pressure Waveform Display... 88 5.3.4 Tabular Trends... 89 5.3.4.1 Tabular Trend Scroll Mode... 89 5.3.5 Graphical/Tabular Trends Split... 90 5.3.6 Physiology Screen... 91 5.3.6.1 SVV Slope Indicator... 92 5.3.7 Cockpit Screen... 92 5.3.8 Physio Relationship... 93 5.3.8.1 Continuous and Historical Modes... 93

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5.3.8.2 Parameter Boxes... 95 5.3.8.3 Setting Targets and Entering Parameter Values... 95 5.3.9 Goal Positioning Screen... 96 5.4 Focused Monitoring Format... 96 5.4.1 Select Monitoring View... 96 5.4.2 Blood Pressure Waveform Tile... 97 5.4.3 Focused Parameter Tile... 97 5.4.4 Change Parameters... 98 5.4.5 Change Alarms /Targets... 98 5.4.6 Focused Main Screen... 98 5.4.7 Focused Graphical Trend Screen... 99 5.4.8 Focused Charting Screen... 99 5.5 Clinical Tools... 100 5.5.1 Select Monitoring Mode... 100 5.5.2 CVP Entry... 101 5.5.3 Derived Value Calculator... 101 5.5.4 Event Review... 102 5.6 Information Bar... 104 5.6.1 Battery... 105 5.6.2 Screen Brightness... 106 5.6.3 Alarm Volume... 106 5.6.4 Screen Capture... 106 5.6.5 Lock Screen... 106 5.7 Status Bar... 107 5.8 Monitor Screen Navigation... 107 5.8.1 Vertical Scrolling... 107 5.8.2 Navigation Icons... 108

6 User Interface Settings

6.1 Password Protection... 110 6.1.1 Changing passwords... 111 6.2 Patient Data... 111 6.2.1 New Patient... 112 6.2.2 Continue Monitoring Patient... 113 6.2.3 View Patient Data... 113 6.3 General Monitor Settings... 114 6.3.1 Change Language... 114 6.3.2 Change Date and Time Display... 115 6.3.2.1 Adjust Date or Time... 115 6.3.3 Monitoring Screens Settings... 115 6.3.4 Time Intervals / Averaging... 116 6.3.4.1 Display Parameter Value Change... 116 6.3.4.2 CO/Pressure Averaging Time... 117 6.3.5 Analog Pressure Signal Input... 117 6.3.5.1 Calibration... 120

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7 Advanced Settings 7.1 Alarms / Targets... 122 7.1.1 Silence Alarms... 123 7.1.1.1 Physiological Alarms... 123 7.1.1.2 Technical Alarms... 124 7.1.2 Set Alarm Volume... 124 7.1.3 Set Targets... 124 7.1.4 Alarms/Targets Setup Screen... 125 7.1.5 Configure All Targets... 126 7.1.6 Configure Targets and Alarms for One Parameter... 127 7.2 Adjust Scales... 128 7.3 Physiology and Physio Relationship Screen SVV/PPV Parameter Settings . . 130 7.4 Demo Mode... 130

8 Data Export and Connectivity Settings

8.1 Export Data... 132 8.1.1 Data Download... 132 8.1.2 Diagnostic Export... 133 8.2 Wireless Settings... 134 8.3 HIS Connectivity... 134 8.3.1 Patient Demographic Data... 135 8.3.2 Patient Physiological Data... 136 8.3.3 Physiological Alarms and Device Faults... 136 8.4 Cyber Security... 137 8.4.1 HIPAA... 137

9 HemoSphere Swan-Ganz Module Monitoring

9.1 Connecting the HemoSphere Swan-Ganz Module... 138 9.1.1 Patient CCO Cable Test... 140 9.1.2 Parameter Selection Menu... 141 9.2 Continuous Cardiac Output... 142 9.2.1 Connecting the Patient Cables... 142 9.2.2 Initiating Monitoring... 143 9.2.3 Thermal Signal Conditions... 144 9.2.4 CO Countdown Timer... 144 9.2.5 STAT CO... 145 9.3 Intermittent Cardiac Output... 145 9.3.1 Connecting Patient Cables... 145 9.3.1.1 Probe Selection... 146 9.3.2 Configuration Settings... 146 9.3.2.1 Select Injectate Volume... 147 9.3.2.2 Select Catheter Size... 147 9.3.2.3 Select Computation Constant... 148 9.3.2.4 Select Mode... 148 9.3.3 Instructions for Bolus Measurement Modes... 148 9.3.4 Thermodilution Summary Screen... 150

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9.4 EDV/RVEF Monitoring... 151 9.4.1 Connecting Patient Cables... 151 9.4.2 Connecting the ECG Interface Cable... 151 9.4.3 Initiating Measurement... 153 9.4.4 Active EDV Monitoring... 153 9.4.5 STAT EDV and RVEF... 154 9.5 SVR... 154

10 Monitoring with the HemoSphere Pressure Cable

10.1 Pressure Cable Overview... 155 10.2 Monitoring Mode Selection... 157 10.3 FloTrac Sensor Monitoring... 158 10.3.1 Connect FloTrac or Acumen IQ Sensor... 159 10.3.2 Set Averaging Time... 159 10.3.3 Zero Arterial Pressure... 160 10.3.4 SVR monitoring... 161 10.4 Pressure Cable Monitoring with a TruWave DPT... 161 10.4.1 Connect TruWave DPT... 161 10.4.2 Zero Intravascular Pressure... 162 10.5 Zero & Waveform Screen... 163 10.5.1 Select Pressure and Zero Sensor... 163 10.5.2 Pressure-Out... 163 10.5.3 Waveform Confirmation... 164

11 Venous Oximetry Monitoring

11.1 Oximetry Cable Overview... 165 11.2 Venous Oximetry Setup... 165 11.3 In Vitro Calibration... 167 11.3.1 In Vitro Calibration Error... 168 11.4 In Vivo Calibration... 168 11.5 Signal Quality Indicator... 170 11.6 Recall Venous Oximetry Data... 170 11.7 HGB Update... 172 11.8 HemoSphere Oximetry Cable Reset... 172 11.9 New Catheter... 173

12 HemoSphere Tissue Oximetry Module Monitoring

12.1 HemoSphere Tissue Oximetry Module Monitoring... 174 12.2 ForeSight Elite Tissue Oximeter Overview... 175 12.2.1 ForeSight Elite Module Mounting Solutions... 176 12.2.2 Installing the Mounting Clip... 176 12.2.3 Removing the Mounting Clip... 178 12.3 Connecting the HemoSphere Tissue Oximetry Module and ForeSight Elite Module ... 180 12.3.1 Attaching Sensors to the Patient... 183 12.3.1.1 Selecting a Sensor Site... 183

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13 Advanced Features

12.3.1.2 Preparing the Sensor Site... 185 12.3.1.3 Applying Sensors... 185 12.3.1.4 Connecting Sensors to Cables... 188 12.3.2 Disconnecting Sensors After Monitoring... 189 12.3.3 Monitoring Considerations... 189 12.3.3.1 Module Use During Defibrillation... 189 12.3.3.2 Interference... 190 12.3.3.3 Interpreting StO2 Values... 190 12.3.4 Skin Check Timer... 191 12.3.5 Set Averaging Time... 192 12.3.6 Signal Quality Indicator... 192 12.3.7 Tissue Oximetry Physiology Screen... 192

13.1 Acumen Hypotension Prediction Index (HPI) Software Feature... 193 13.1.1 Acumen Hypotension Prediction Index (HPI)... 195 13.1.2 HPI as a Key Parameter... 196 13.1.3 HPI Alarm... 198 13.1.4 HPI on Information Bar... 199 13.1.5 Disable HPI Information Bar Indicator... 199 13.1.6 HPI High Alert Popup... 200 13.1.7 HPI Secondary Screen... 200 13.1.8 Clinical Application... 202 13.1.9 Additional Parameters... 203 13.1.10 Clinical Validation... 205 13.1.10.1 Surgical Patients... 205 13.1.10.2 Non-Surgical Patients... 205 13.1.10.3 Clinical Validation Study Results... 207 13.1.11 Additional Clinical Data... 210 13.1.11.1 Study Design... 210 13.1.11.2 Patient Demographics... 212 13.1.11.3 Study Results... 214 13.1.11.4 Study Summary... 218 13.1.11.5 Conclusion... 219 13.1.12 References... 219 13.2 Enhanced Parameter Tracking... 220 13.2.1 GDT Tracking... 220 13.2.1.1 Key Parameter and Target Selection... 220 13.2.1.2 Active GDT Tracking... 221 13.2.1.3 Historical GDT... 222 13.2.2 SV Optimization... 222 13.2.3 GDT Report Download... 222 13.3 Fluid Responsiveness Test... 223 13.3.1 Passive Leg Raise Test... 223 13.3.2 Fluid Bolus Test... 225 13.3.3 Historical Test Results... 226

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14 Troubleshooting 14.1 On Screen Help... 227 14.2 Monitor Status Lights... 228 14.3 Pressure Cable Communication... 229 14.4 ForeSight Elite Module Sensor Communication... 230 14.5 HemoSphere Advanced Monitor Error Messages... 230 14.5.1 System Faults/Alerts... 230 14.5.2 System Warnings... 233 14.5.3 Numeric Keypad Errors... 234 14.6 HemoSphere Swan-Ganz Module Error Messages... 234 14.6.1 CO Faults/Alerts... 234 14.6.2 EDV and SV Faults/Alerts... 236 14.6.3 iCO Faults/Alerts... 236 14.6.4 SVR Faults/Alerts... 238 14.6.5 General Troubleshooting... 238 14.7 Pressure Cable Error Messages... 239 14.7.1 General Pressure Cable Faults/Alerts... 239 14.7.2 CO Faults/Alerts... 240 14.7.3 SVR Faults/Alert... 242 14.7.4 MAP Faults/Alert... 243 14.7.5 General Troubleshooting... 243 14.8 Venous Oximetry Error Messages... 245 14.8.1 Venous Oximetry Faults/Alerts... 245 14.8.2 Venous Oximetry Warnings... 246 14.8.3 Venous Oximetry General Troubleshooting... 247 14.9 Tissue Oximetry Error Messages... 247 14.9.1 Tissue Oximetry Faults/Alerts... 247 14.9.2 Tissue Oximetry General Troubleshooting... 249

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... A.7 HemoSphere Tissue Oximetry Specifications...

Appendix B: Accessories

250 252 254 255 256 257 257

B.1 Accessories List... 259 B.2 Additional Accessories Description... 260 B.2.1 Roll Stand... 260 B.2.2 Oximetry Cradle... 260

Appendix C: Equations for Calculated Patient Parameters Appendix D: Monitor Settings and Defaults

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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*...

267 267 268 270 271 272

E.1 Computation Constant Values...

273

Appendix E: Computation Constants

Appendix F: System Care, Service and Support

F.1 General Maintenance... 275 F.2 Cleaning the Monitor and Modules... 276 F.3 Cleaning the Platform Cables... 276 F.3.1 Cleaning the HemoSphere Oximetry Cable... 277 F.3.2 Cleaning the Patient CCO Cable and Connector... 277 F.3.3 Cleaning the HemoSphere Pressure Cable... 278 F.3.4 Cleaning the ForeSight Elite Tissue Oximeter Module... 278 F.4 Service and Support... 279 F.5 Edwards Lifesciences Regional Headquarters... 280 F.6 Monitor Disposal... 281 F.6.1 Battery Recycling... 281 F.7 Preventive Maintenance... 281 F.7.1 Battery Maintenance... 281 F.7.1.1 Battery Conditioning... 281 F.7.1.2 Battery Storage... 281 F.8 Testing of Alarm Signals... 282 F.9 Warranty... 282

Appendix G: Guidance and Manufacturer’s Declaration

G.1 Electromagnetic Compatibility... 283 G.2 Instructions for Use... 284 G.3 Wireless Technology Information... 291 G.3.1 Quality of Service for Wireless Technology... 293 G.3.2 Wireless Security Measures... 294 G.3.3 Troubleshooting Wireless Coexistence Issues... 294 G.3.4 Federal Communication Commission (FCC) Interference Statements . 294 G.3.5 Industry Canada Statements... 295 G.3.6 European Union R&TTE Statements... 295

Appendix H: Glossary

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List of Figures Figure 1-1 HemoSphere advanced monitor hemodynamic technology connections... 27 Figure 3-1 HemoSphere advanced monitor front view... 54 Figure 3-2 HemoSphere advanced monitor rear view (shown with HemoSphere Swan-Ganz module)... 55 Figure 3-3 HemoSphere advanced monitor right panel... 56 Figure 3-4 HemoSphere advanced monitor left panel (shown with no modules)... 56 Figure 3-5 HemoSphere advanced monitor power entry cover - screw locations... 59 Figure 3-6 Startup screen... 61 Figure 3-7 Language selection screen... 62 Figure 4-1 HemoSphere Swan-Ganz module monitoring connection overview... 64 Figure 4-2 Pressure cable connection overview... 67 Figure 4-3 Oximetry connection overview... 69 Figure 4-4 HemoSphere tissue oximetry module connection overview... 72 Figure 5-1 HemoSphere advanced monitor screen features... 75 Figure 5-2 Navigation bar... 76 Figure 5-3 Example of monitoring screen selection window... 79 Figure 5-4 Example of key parameter selection tile configuration menu... 80 Figure 5-5 Parameter tile... 81 Figure 5-6 Main monitoring view... 83 Figure 5-7 Graphical trend screen... 84 Figure 5-8 Graphical trend- intervention window... 85 Figure 5-9 Graphical trend screen - intervention information balloon... 87 Figure 5-10 Tabular trend screen... 88 Figure 5-11 Tabular increment popup... 88 Figure 5-12 Physiology screen while monitoring with HemoSphere Swan-Ganz module... 90 Figure 5-13 Cockpit monitoring screen... 91 Figure 5-14 Physio relationship screen while monitoring with HemoSphere Swan-Ganz module 92 Figure 5-15 Historic physio relationship data screen... 93 Figure 5-16 Physio relationship parameter boxes... 94 Figure 5-17 Physio relationship target/enter popup... 94 Figure 5-18 Goal positioning screen... 95 Figure 5-19 Focused parameter tile... 96 Figure 5-20 Focused parameter tile – parameter and alarm/target selection... 97 Figure 5-21 Focused main screen... 97 Figure 5-22 Focused Graphical Trend Screen... 98

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Figure 5-23 Focused Charting Screen... 99 Figure 5-24 Focused Charting View – Configure Columns... 99 Figure 5-25 Information Bar - HemoSphere Swan-Ganz Module... 104 Figure 5-26 Information Bar - HemoSphere Pressure Cable... 104 Figure 5-27 Lock screen popup... 106 Figure 5-28 Status bar... 106 Figure 6-1 New or continuing patient screen... 111 Figure 6-2 New Patient Data screen... 112 Figure 6-3 General Monitor Settings... 113 Figure 7-1 Alarms / Targets configuration... 126 Figure 7-2 Set individual parameter alarms and targets... 127 Figure 7-3 Graphical trend screen... 128 Figure 7-4 Adjust scales... 129 Figure 7-5 Tabular increment popup... 130 Figure 8-1 HIS- Patient query screen... 135 Figure 8-2 HIS- New patient data screen... 136 Figure 9-1 HemoSphere Swan-Ganz module connection overview... 139 Figure 9-2 Patient CCO cable test connections... 141 Figure 9-3 HemoSphere Swan-Ganz module key parameter selection window... 142 Figure 9-4 CO connection overview... 143 Figure 9-5 iCO connection overview... 146 Figure 9-6 iCO new set configuration screen... 147 Figure 9-7 Thermodilution summary screen... 150 Figure 9-8 EDV/RVEF connection overview... 151 Figure 10-1 HemoSphere pressure cable... 156 Figure 10-2 Zero & Waveform screen... 164 Figure 11-1 Venous oximetry connection overview... 167 Figure 12-1 ForeSight Elite tissue oximeter front view... 176 Figure 12-2 ForeSight Elite tissue oximeter rear view... 176 Figure 12-3 Mounting clip – module slide attachment points... 177 Figure 12-4 Module case – mounting clip attachment points... 177 Figure 12-5 Attaching the mounting clip vertically (figure in process)... 178 Figure 12-6 Attaching the mounting clip horizontally... 179 Figure 12-7 Removing the mounting clip... 180 Figure 12-8 HemoSphere tissue oximetry module connection overview... 181 Figure 12-9 ForeSight Elite module status LED... 183 Figure 12-10 Removing protective liner from sensor... 186 Figure 12-11 Sensor placement (cerebral)... 187 Figure 12-12 Sensor placement (non-cerebral)... 188 Figure 12-13 Connecting a sensor to the preamp cable... 189

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Figure 12-14 Connecting a sensor to the preamp cable... 190 Figure 12-15 Tissue Oximetry Physiology Screens... 193 Figure 13-1 HPI key parameter tile... 198 Figure 13-2 HPI key parameter on cockpit screen... 199 Figure 13-3 Information bar with HPI... 200 Figure 13-4 Parameter settings - Hypotension Prediction Index... 200 Figure 13-5 HPI high alert popup... 201 Figure 13-6 HPI secondary screen... 202 Figure 13-7 HPI secondary screen – graphical trend value display... 203 Figure 13-8 GDT Menu Screen - Key Parameter Selection... 212 Figure 13-9 GDT Menu Screen - Target Selection... 212 Figure 13-10 GDT Active Tracking... 213 Figure 13-11 Fluid Responsiveness Test – New Test Screen... 215 Figure 13-12 Fluid Responsiveness Test – Results Screen... 217 Figure 14-1 HemoSphere advanced monitor LED indicators... 220 Figure 14-2 Pressure cable LED indicator... 221 Figure 14-3 ForeSight Elite tissue oximeter module LED indicators... 222

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List of Tables Table 1-1 HemoSphere Swan-Ganz module available parameters list... 24 Table 1-2 HemoSphere oximetry cable available parameters list... 24 Table 1-3 HemoSphere Swan-Ganz module with oximetry cable available parameters list... 25 Table 1-4 HemoSphere pressure cable available parameters list... 26 Table 1-5 HemoSphere pressure cable with oximetry cable available parameters list... 27 Table 1-6 HemoSphere tissue oximetry module available parameters list... 27 Table 1-7 HemoSphere Swan-Ganz module parameters description... 29 Table 1-8 HemoSphere pressure cable key parameters description... 30 Table 1-9 HemoSphere oximetry cable parameters description... 31 Table 1-10 HemoSphere tissue oximetry module parameters description... 32 Table 1-11 Operator’s manual style conventions... 33 Table 1-12 Acronyms, Abbreviations... 33 Table 2-1 Monitor display symbols... 47 Table 2-2 Symbols on product labels... 49 Table 2-3 Applicable standards... 51 Table 3-1 HemoSphere advanced monitoring components... 52 Table 3-2 Cables and catheters required for monitoring parameters with HemoSphere Swan-Ganz module... 53 Table 3-3 Sensor options for monitoring parameters with HemoSphere pressure cable... 53 Table 3-4 Catheters required for monitoring parameters with HemoSphere oximetry cable . . 54 Table 3-5 Accessories required for monitoring parameters with HemoSphere tissue oximetry module... 54 Table 5-1 Graphical trend scroll rates... 85 Table 5-2 Intervention events... 87 Table 5-3 Tabular trend scroll rates... 90 Table 5-4 Reviewed events... 102 Table 5-5 Battery status... 106 Table 6-1 HemoSphere advanced monitor password levels... 110 Table 6-2 Advanced setup menu navigation and password protection... 110 Table 6-3 Export data menu navigation and password protection... 111 Table 6-4 CO/pressure averaging time and display update rates – minimally-invasive monitoring mode... 117 Table 6-5 Analog input parameter ranges... 119 Table 7-1 Visual alarm indicator colors... 122 Table 7-2 Target status indicator colors... 124 Table 7-3 Target defaults... 125

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Table 8-1 Wi-Fi connection status... 134 Table 8-2 HIS connectivity status... 135 Table 9-1 Available HemoSphere Swan-Ganz module parameters and required connections 140 Table 9-2 Unstable thermal signal time lapse for CO alert and fault messages... 144 Table 10-1 HemoSphere pressure cable configurations and available key parameters... 156 Table 11-1 In vitro calibration options... 168 Table 11-2 In vivo calibration options... 169 Table 11-3 Signal quality indicator levels... 170 Table 12-1 Tissue oximetry sensor locations... 182 Table 12-2 Sensor selection matrix... 184 Table 12-3 StO2 validation methodology... 191 Table 13-1 HPI display configurations... 194 Table 13-2 HPI value graphical and audible display elements... 195 Table 13-3 HPI versus other key parameters: similarities and differences... 197 Table 13-4 Parameter status colors for HPI... 198 Table 13-5 Patient demographics (surgical patients)... 205 Table 13-6 Patient demographics (non-surgical patients)... 206 Table 13-7 Non-surgical patient characteristics (N=298)... 206 Table 13-8 Non-surgical patient characteristics (N=228)... 206 Table 13-9 Clinical validation studies* (surgical patients)... 207 Table 13-10 Clinical validation studies* (non-surgical patients)... 207 Table 13-11 Clinical validation (surgical patients [N=52])... 208 Table 13-12 Clinical validation (non-surgical patients [N=298])... 209 Table 13-13 HPI prospective subject selection criteria... 211 Table 13-14 MPOG historical control patient selection criteria... 211 Table 13-15 Patient demographics (MPOG study)... 212 Table 13-16 Procedure type (HPI)... 212 Table 13-17 Surgery type by CPT grouping... 214 Table 13-18 Receiver operating characteristics (ROC) for HPI subjects (N=482)*... 214 Table 13-19 Mean IOH duration – Primary effectiveness endpoint... 215 Table 13-20 Intraoperative hypotension AUC - ITT, pivotal subjects... 215 Table 13-21 Effectiveness stratified by MAP level, HPI study versus MPOG historical control 216 Table 13-22 Frequency pattern of subjects and intervention instances by HPI threshold... 217 Table 13-23 HPI study - 30 days postoperative composite endpoint components - CC analysis population (pivotal subjects, n=400)... 218 Table 13-24 Length of stay... 218 Table 13-25 GDT Target Status Indicator Colors... 221 Table 14-1 HemoSphere advanced monitor visual alarm indicator... 228 Table 14-2 HemoSphere advanced monitor power light... 229 Table 14-3 Pressure cable communication light... 229

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Table 14-4 ForeSight Elite module LED communication light... 230 Table 14-5 System faults/alerts... 230 Table 14-6 HemoSphere advanced monitor warnings... 233 Table 14-7 Numeric keypad errors... 234 Table 14-8 HemoSphere Swan-Ganz module CO faults/alerts... 234 Table 14-9 HemoSphere Swan-Ganz module EDV and SV faults/alerts... 236 Table 14-10 HemoSphere Swan-Ganz module iCO faults/alerts... 236 Table 14-11 HemoSphere Swan-Ganz module SVR faults/alerts... 238 Table 14-12 HemoSphere Swan-Ganz module general troubleshooting... 238 Table 14-13 HemoSphere pressure cable general faults/alerts... 239 Table 14-14 HemoSphere pressure cable CO faults/alerts... 240 Table 14-15 HemoSphere pressure cable SVR faults/alerts... 242 Table 14-16 HemoSphere pressure cable MAP faults/alerts... 243 Table 14-17 HemoSphere pressure cable general troubleshooting... 243 Table 14-18 Venous oximetry faults/alerts... 245 Table 14-19 Venous oximetry warnings... 246 Table 14-20 Venous oximetry general troubleshooting... 247 Table 14-21 Tissue oximetry faults/alerts... 247 Table 14-22 Tissue oximetry general troubleshooting... 249 Table A-1 HemoSphere advanced monitor essential performance – transient and non-transient electromagnetic phenomena... 251 Table A-2 HemoSphere advanced monitor physical and mechanical specifications... 252 Table A-3 HemoSphere advanced monitor environmental specifications... 252 Table A-4 HemoSphere advanced monitor transportation environmental specifications... 253 Table A-5 HemoSphere advanced monitor technical specifications... 253 Table A-6 HemoSphere battery pack physical specifications... 254 Table A-7 HemoSphere battery pack environmental specifications... 254 Table A-8 HemoSphere battery pack technical specifications... 254 Table A-9 HemoSphere Swan-Ganz module physical specifications... 255 Table A-10 HemoSphere Swan-Ganz module parameter measurement specifications... 255 Table A-11 HemoSphere pressure cable physical specifications... 256 Table A-12 HemoSphere pressure cable parameter measurement specifications... 256 Table A-13 HemoSphere oximetry cable physical specifications... 257 Table A-14 HemoSphere oximetry cable parameter measurement specifications... 257 Table A-15 HemoSphere tissue oximetry module physical specifications... 257 Table A-16 ForeSight Elite tissue oximeter module physical specifications... 258 Table A-17 HemoSphere tissue oximetry module with ForeSight Elite oximeter module parameter measurement specifications... 258 Table B-1 HemoSphere advanced monitor components... 259 Table C-1 Cardiac and oxygenation profile equations... 261

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Table D-1 Patient information... 267 Table D-2 Graphical trend parameter scale defaults... 267 Table D-3 Configurable parameter alarm and display ranges... 268 Table D-4 Parameter alarm red zone and target defaults... 270 Table D-5 Parameter alarms, faults, and alerts priorities... 271 Table D-6 Language default settings... 272 Table E-1 Computation constants for bath temperature probe... 273 Table E-2 Computation constants for in-line temperature probe... 274 Table G-1 Electromagnetic emissions... 285 Table G-2 Guidance and Manufacturer's Declaration - Immunity to RF wireless communications equipment... 285 Table G-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the HemoSphere advanced monitor... 287 Table G-4 In band wireless coexistence – Threshold of Interference (Tol) and Threshold of Communication (ToC) between HemoSphere advanced monitor (EUT) and external devices 288 Table G-5 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)... 289 Table G-6 Electromagnetic Immunity (RF Radiated and Conducted)... 290 Table G-7 HemoSphere advanced monitor wireless information... 291

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