HemoSphere Operators Manual Ver 2.1 March 2021

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, ClearSight, CO-Set, CO-Set+, FloTrac, FORE-SIGHT, FORE-SIGHT ELITE, HemoSphere, Hypotension Prediction Index, HPI, PediaSat, Physiocal, Swan, Swan-Ganz, Time-In-Target, 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.

© 2021 Edwards Lifesciences Corporation. All rights reserved. Version 4.2 Manual Release Date: MARCH 2021; Software Version: 2.1 Original Release Date: 9/30/2016

Edwards Lifesciences Services GmbH Edisonstrasse 6 85716 Unterschleissheim, Germany

2

Using This Manual 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. The Edwards HemoSphere advanced monitor operator’s manual is comprised of fifteen 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 Settings: Provides information on monitor connectivity for transferring patient and clinical data

9

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

11

HemoSphere Noninvasive ClearSight Module Monitoring: Describes the methodology behind ClearSight technology and gives instructions for setup and application of patient monitoring equipment as well as how to measure noninvasive blood pressure, cardiac output, stroke volume, stroke volume variation, and systemic vascular resistance

12

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

13

Tissue Oximetry Monitoring: Describes procedures for setup and operation of FORE-SIGHT ELITE tissue oximetry monitoring

14

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

15

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

4

Contents 1 Introduction 1.1 Intended Purpose of this Manual... 21 1.2 Indications For Use... 21 1.2.1 HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module21 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 and FORE-SIGHT ELITE Oximeter Module... 22 1.2.5 HemoSphere Advanced Monitor with HemoSphere ClearSight Module . 23 1.3 Contraindications For Use... 23 1.3.1 HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Oximeter Module... 23 1.3.2 HemoSphere Advanced Monitor with HemoSphere ClearSight Module . 23 1.4 Intended Use Statement... 23 1.5 Expected Clinical Benefit... 29 1.6 HemoSphere Advanced Monitor Hemodynamic Technology Connections . . 29 1.6.1 HemoSphere Swan-Ganz Module... 30 1.6.2 HemoSphere Pressure Cable... 31 1.6.3 HemoSphere Oximetry Cable... 32 1.6.4 HemoSphere Tissue Oximetry Module... 32 1.6.5 HemoSphere ClearSight Module... 33 1.6.6 Documentation and Training... 34 1.7 Manual Style Conventions... 34 1.8 Abbreviations Found in This Manual... 35

2 Safety and Symbols

2.1 Safety Signal Words Definitions... 37 2.1.1 Warning... 37 2.1.2 Caution... 37 2.1.3 Note... 37 2.2 Warnings... 38 2.3 Cautions... 45 2.4 User Interface Symbols... 51 2.5 Symbols on Product Labels... 54 2.6 Applicable Standards... 55 2.7 HemoSphere Advanced Monitor Essential Performance... 55

3 Installation and Setup

3.1 Unpacking... 56 3.1.1 Packaging Contents... 56 3.1.2 Required Accessories for Platform Modules and Cables... 57

5

3.2 HemoSphere Advanced Monitor Connection Ports... 59 3.2.1 Monitor Front... 59 3.2.2 Monitor Rear... 60 3.2.3 Monitor Right Panel... 61 3.2.4 Monitor Left Panel... 61 3.3 HemoSphere Advanced Monitor Installation... 62 3.3.1 Mounting Options and Recommendations... 62 3.3.2 Battery Installation... 63 3.3.3 Connecting Power Cord... 63 3.3.3.1 Equipotential Connection... 64 3.3.4 Connecting and Disconnecting a Hemodynamic Monitoring Module . . . 64 3.3.5 Connecting and Disconnecting a Hemodynamic Monitoring Cable... 65 3.3.6 Connecting Cables from External Devices... 65 3.4 Initial Start Up... 66 3.4.1 Start Up Procedure... 66 3.4.2 Select Language... 66

4 HemoSphere Advanced Monitor Quick Start

4.1 HemoSphere Swan-Ganz Module Cardiac Output Monitoring... 69 4.1.1 Continuous Cardiac Output Monitoring... 70 4.1.2 Intermittent Cardiac Output Monitoring... 70 4.1.3 Continuous End Diastolic Volume Monitoring... 71 4.2 Monitoring with the HemoSphere Pressure Cable... 72 4.2.1 Pressure Cable Setup... 72 4.2.2 Zero Pressure Cable... 72 4.3 HemoSphere Oximetry Cable Monitoring... 74 4.3.1 In vitro Calibration... 74 4.3.2 In vivo Calibration... 75 4.4 HemoSphere Tissue Oximetry Module Monitoring... 77 4.4.1 Connecting the HemoSphere Tissue Oximetry Module... 77 4.5 HemoSphere ClearSight Module Monitoring... 79 4.5.1 Connecting the HemoSphere Noninvasive System... 79

5 Navigating the HemoSphere Advanced Monitor

5.1 HemoSphere Advanced Monitor Screen Appearance... 81 5.2 Navigation Bar... 83 5.3 Monitor Views... 86 5.3.1 Parameter Tiles... 87 5.3.1.1 Change Parameters... 87 5.3.1.2 Change Alarm/Target... 88 5.3.1.3 Status Indicators... 89 5.3.2 Main Monitoring View... 90 5.3.3 Graphical Trend Monitoring View... 90 5.3.3.1 Graphical Trend Scroll Mode... 91 5.3.3.2 Intervention Events... 92 5.3.3.3 Live Blood Pressure Waveform Display... 94

6

5.3.4 Tabular Trends... 95 5.3.4.1 Tabular Trend Scroll Mode... 95 5.3.5 Graphical/Tabular Trends Split... 96 5.3.6 Physiology Screen... 97 5.3.6.1 SVV Slope Indicator... 98 5.3.7 Cockpit Screen... 98 5.3.8 Physio Relationship... 99 5.3.8.1 Continuous and Historical Modes... 99 5.3.8.2 Parameter Boxes... 101 5.3.8.3 Setting Targets and Entering Parameter Values... 101 5.3.9 Goal Positioning Screen... 102 5.4 Focused Monitoring Format... 102 5.4.1 Select Monitoring View... 102 5.4.2 Blood Pressure Waveform Tile... 103 5.4.3 Focused Parameter Tile... 103 5.4.4 Change Parameters... 104 5.4.5 Change Alarms /Targets... 104 5.4.6 Focused Main Screen... 104 5.4.7 Focused Graphical Trend Screen... 105 5.4.8 Focused Charting Screen... 105 5.5 Clinical Tools... 106 5.5.1 Select Monitoring Mode... 106 5.5.2 CVP Entry... 107 5.5.3 Derived Value Calculator... 107 5.5.4 Event Review... 108 5.6 Information Bar... 111 5.6.1 Battery... 112 5.6.2 Screen Brightness... 113 5.6.3 Alarm Volume... 113 5.6.4 Screen Capture... 113 5.6.5 Lock Screen... 113 5.7 Status Bar... 114 5.8 Monitor Screen Navigation... 114 5.8.1 Vertical Scrolling... 114 5.8.2 Navigation Icons... 115

6 User Interface Settings

6.1 Password Protection... 117 6.1.1 Changing passwords... 118 6.2 Patient Data... 119 6.2.1 New Patient... 119 6.2.2 Continue Monitoring Patient... 120 6.2.3 View Patient Data... 121 6.3 General Monitor Settings... 121 6.3.1 Change Language... 121 6.3.2 Change Date and Time Display... 122

7

7 Advanced Settings

6.3.2.1 Adjust Date or Time... 122 6.3.3 Monitoring Screens Settings... 123 6.3.4 Time Intervals / Averaging... 123 6.3.4.1 Display Parameter Value Change... 123 6.3.4.2 CO/Pressure Averaging Time... 124 6.3.5 Analog Pressure Signal Input... 125 6.3.5.1 Calibration... 127

7.1 Alarms/Targets... 130 7.1.1 Silence Alarms... 131 7.1.1.1 Physiological Alarms... 131 7.1.1.2 Technical Alarms... 132 7.1.2 Set Alarm Volume... 132 7.1.3 Set Targets... 132 7.1.4 Alarms/Targets Setup Screen... 133 7.1.5 Configure All Targets... 134 7.1.6 Configure Targets and Alarms for One Parameter... 135 7.2 Adjust Scales... 136 7.3 Physiology and Physio Relationship Screen SVV/PPV Parameter Settings . . 138 7.4 20-Second Flow Parameter Settings... 138 7.5 Demo Mode... 139

8 Data Export and Connectivity Settings

8.1 Export Data... 140 8.1.1 Data Download... 140 8.1.2 Diagnostic Export... 142 8.2 Wireless Settings... 142 8.3 HIS Connectivity... 142 8.3.1 Patient Demographic Data... 144 8.3.2 Patient Physiological Data... 144 8.3.3 Physiological Alarms and Device Faults... 144 8.4 Cyber Security... 145 8.4.1 HIPAA... 145

9 HemoSphere Swan-Ganz Module Monitoring

9.1 Connecting the HemoSphere Swan-Ganz Module... 146 9.1.1 Patient CCO Cable Test... 148 9.1.2 Parameter Selection Menu... 149 9.2 Continuous Cardiac Output... 150 9.2.1 Connecting the Patient Cables... 150 9.2.2 Initiating Monitoring... 151 9.2.3 Thermal Signal Conditions... 152 9.2.4 CO Countdown Timer... 152 9.2.5 STAT CO... 153 9.2.6 20-Second Flow Parameters... 153 9.2.6.1 PAP Waveform Troubleshooting... 153

8

9.3 Intermittent Cardiac Output... 153 9.3.1 Connecting Patient Cables... 154 9.3.1.1 Probe Selection... 154 9.3.2 Configuration Settings... 155 9.3.2.1 Select Injectate Volume... 155 9.3.2.2 Select Catheter Size... 156 9.3.2.3 Select Computation Constant... 156 9.3.2.4 Select Mode... 156 9.3.3 Instructions for Bolus Measurement Modes... 156 9.3.4 Thermodilution Summary Screen... 158 9.4 EDV/RVEF Monitoring... 159 9.4.1 Connecting Patient Cables... 159 9.4.2 Connecting the ECG Interface Cable... 160 9.4.3 Initiating Measurement... 161 9.4.4 Active EDV Monitoring... 162 9.4.5 STAT EDV and RVEF... 163 9.5 SVR... 163

10 Monitoring with the HemoSphere Pressure Cable

10.1 Pressure Cable Overview... 164 10.2 Monitoring Mode Selection... 166 10.3 FloTrac Sensor Monitoring... 167 10.3.1 Connect FloTrac or Acumen IQ Sensor... 168 10.3.2 Set Averaging Time... 168 10.3.3 Zero Arterial Pressure... 169 10.3.4 SVR Monitoring... 170 10.4 Pressure Cable Monitoring with a TruWave DPT... 170 10.4.1 Connect TruWave DPT... 170 10.4.2 Zero Intravascular Pressure... 171 10.5 Pressure Cable Monitoring in Swan-Ganz Module Monitoring Mode... 172 10.6 Zero & Waveform Screen... 173 10.6.1 Select Pressure and Zero Sensor... 174 10.6.2 Pressure-Out... 174 10.6.3 Waveform Confirmation... 174

11 HemoSphere ClearSight Module Noninvasive Monitoring

11.1 HemoSphere Noninvasive System Methodology... 175 11.1.1 Volume Clamp Method... 175 11.1.2 Physiocal Method... 176 11.1.3 Waveform Reconstruction and Hemodynamic Analysis (ClearSight Algorithm)... 176 11.1.4 Heart Reference Sensor... 176 11.1.5 Discoloration, Numbness, or Tingling of the Fingertip... 176 11.1.6 Single Cuff Monitoring... 176 11.1.7 Double Cuff Monitoring... 177 11.1.8 Methodology References... 177

9

11.2 Connecting the HemoSphere Noninvasive System... 177 11.2.1 Apply the Pressure Controller... 180 11.2.2 Select Finger Cuff Size... 181 11.2.3 Apply Finger Cuff(s)... 181 11.2.4 Zero and Apply the Heart Reference Sensor... 182 11.2.5 General Troubleshooting of HemoSphere Noninvasive System Monitoring ... 182 11.3 Optional HRS... 184 11.3.1 Patient Sedated and Stationary... 184 11.3.2 Update Offset Value During Monitoring... 186 11.3.3 Change Patient Positioning Mode... 186 11.4 SQI... 186 11.5 Physiocal Display... 187 11.6 ClearSight Settings and Cuff Options... 187 11.6.1 Cuff Pressure Release Mode... 188 11.7 Blood Pressure Calibration... 189 11.8 Output Signal to Patient Monitor... 190

12 Venous Oximetry Monitoring

12.1 Oximetry Cable Overview... 191 12.2 Venous Oximetry Setup... 191 12.3 In Vitro Calibration... 193 12.3.1 In Vitro Calibration Error... 194 12.4 In Vivo Calibration... 194 12.5 Signal Quality Indicator... 195 12.6 Recall Venous Oximetry Data... 196 12.7 HGB Update... 197 12.8 HemoSphere Oximetry Cable Reset... 198 12.9 New Catheter... 198

13 HemoSphere Tissue Oximetry Module Monitoring

13.1 HemoSphere Tissue Oximetry Module Monitoring... 199 13.2 FORE-SIGHT ELITE Oximeter Module Overview... 200 13.2.1 FORE-SIGHT ELITE Oximeter Module Mounting Solutions... 201 13.2.2 Installing the Mounting Clip... 201 13.2.2.1 Attaching the Mounting Clip Vertically... 201 13.2.2.2 Attaching the Mounting Clip Horizontally... 202 13.2.3 Removing the Mounting Clip... 203 13.3 Connecting the HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Oximeter Module... 205 13.3.1 Attaching Sensors to the Patient... 208 13.3.1.1 Selecting a Sensor Site... 208 13.3.1.2 Preparing the Sensor Site... 210 13.3.1.3 Applying Sensors... 210 13.3.1.4 Connecting Sensors to Cables... 213

10

14 Advanced Features

13.3.2 Disconnecting Sensors After Monitoring... 214 13.3.3 Monitoring Considerations... 214 13.3.3.1 FORE-SIGHT ELITE Oximeter Module Use During Defibrillation ... 214 13.3.3.2 Interference... 215 13.3.3.3 Interpreting StO2 Values... 215 13.3.4 Skin Check Timer... 217 13.3.5 Set Averaging Time... 217 13.3.6 Signal Quality Indicator... 217 13.3.7 Tissue Oximetry Physiology Screen... 217

14.1 Acumen™ Hypotension Prediction Index (HPI) Software Feature... 219 14.1.1 Acumen Hypotension Prediction Index (HPI)... 221 14.1.2 HPI as a Key Parameter... 222 14.1.3 HPI Alarm... 224 14.1.4 HPI on Information Bar... 225 14.1.5 Disable HPI Information Bar Indicator... 225 14.1.6 HPI High Alert Popup... 226 14.1.7 HPI Secondary Screen... 226 14.1.8 Clinical Application... 228 14.1.9 Additional Parameters... 229 14.1.10 Clinical Validation... 231 14.1.10.1 Surgical Patients... 231 14.1.10.2 Non-Surgical Patients... 231 14.1.11 References... 236 14.2 Enhanced Parameter Tracking... 237 14.2.1 GDT Tracking... 237 14.2.1.1 Key Parameter and Target Selection... 237 14.2.1.2 Active GDT Tracking... 238 14.2.1.3 Historical GDT... 239 14.2.2 SV Optimization... 239 14.2.3 GDT Report Download... 239 14.3 Fluid Responsiveness Test... 240 14.3.1 Passive Leg Raise Test... 240 14.3.2 Fluid Bolus Test... 242 14.3.3 Historical Test Results... 243

15 Troubleshooting

15.1 On Screen Help... 244 15.2 Monitor Status Lights... 245 15.3 Pressure Cable Communication... 246 15.4 FORE-SIGHT ELITE Oximeter Module Sensor Communication... 247 15.5 Pressure Controller Communication... 248 15.6 HemoSphere Advanced Monitor Error Messages... 249 15.6.1 System/Monitoring Faults/Alerts... 249 15.6.2 System/Monitoring Warnings... 252

11

15.6.3 Numeric Keypad Errors... 252 15.7 HemoSphere Swan-Ganz Module Error Messages... 253 15.7.1 CO Faults/Alerts... 253 15.7.2 EDV and SV Faults/Alerts... 254 15.7.3 iCO Faults/Alerts... 255 15.7.4 SVR Faults/Alerts... 256 15.7.5 20-Second Parameters Faults/Alerts... 257 15.7.6 General Troubleshooting... 257 15.8 Pressure Cable Error Messages... 259 15.8.1 General Pressure Cable Faults/Alerts... 259 15.8.2 CO Faults/Alerts... 260 15.8.3 SVR Faults/Alert... 262 15.8.4 MAP Faults/Alert... 262 15.8.5 General Troubleshooting... 263 15.9 HemoSphere ClearSight Module Error Messages... 264 15.9.1 Faults/Alerts... 264 15.10 Venous Oximetry Error Messages... 270 15.10.1 Venous Oximetry Faults/Alerts... 270 15.10.2 Venous Oximetry Warnings... 271 15.10.3 Venous Oximetry General Troubleshooting... 272 15.11 Tissue Oximetry Error Messages... 272 15.11.1 Tissue Oximetry Faults/Alerts... 272 15.11.2 Tissue Oximetry General Troubleshooting... 274

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... A.8 HemoSphere ClearSight Module Specifications...

Appendix B: Accessories

275 278 280 280 282 282 283 285

B.1 Accessories List... 287 B.2 Additional Accessories Description... 288 B.2.1 Roll Stand... 288 B.2.2 Oximetry Cradle... 288

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...

12

295 295 296 298

D.5 Alarm Priorities... D.6 Language Default Settings*...

299 300

E.1 Computation Constant Values...

301

Appendix E: Computation Constants

Appendix F: System Care, Service and Support

F.1 General Maintenance... 303 F.2 Cleaning the Monitor and Modules... 304 F.3 Cleaning the Platform Cables... 304 F.3.1 Cleaning the HemoSphere Oximetry Cable... 305 F.3.2 Cleaning the Patient CCO Cable and Connector... 305 F.3.3 Cleaning the HemoSphere Pressure Cable... 306 F.3.4 Cleaning the FORE-SIGHT ELITE Oximeter Module... 306 F.3.5 Cleaning the Heart Reference Sensor and Pressure Controller... 307 F.4 Service and Support... 307 F.5 Edwards Lifesciences Regional Headquarters... 308 F.6 Monitor Disposal... 309 F.6.1 Battery Recycling... 309 F.7 Preventive Maintenance... 309 F.7.1 Battery Maintenance... 309 F.7.1.1 Battery Conditioning... 309 F.7.1.2 Battery Storage... 309 F.7.2 HemoSphere ClearSight Module Maintenance... 310 F.8 Testing of Alarm Signals... 310 F.9 Warranty... 310

Appendix G: Guidance and Manufacturer’s Declaration

G.1 Electromagnetic Compatibility... 311 G.2 Instructions for Use... 311 G.3 Wireless Technology Information... 318 G.3.1 Quality of Service for Wireless Technology... 320 G.3.2 Wireless Security Measures... 321 G.3.3 Troubleshooting Wireless Coexistence Issues... 321 G.3.4 Federal Communication Commission (FCC) Interference Statements . 321 G.3.5 Industry Canada Statements... 322 G.3.6 European Union R&TTE Statements... 322

Appendix H: Glossary

13

List of Figures Figure 1-1 HemoSphere advanced monitor hemodynamic technology connections... 29 Figure 3-1 HemoSphere advanced monitor front view... 59 Figure 3-2 HemoSphere advanced monitor rear view (shown with HemoSphere Swan-Ganz module)... 60 Figure 3-3 HemoSphere advanced monitor right panel... 61 Figure 3-4 HemoSphere advanced monitor left panel (shown with no modules)... 61 Figure 3-5 HemoSphere advanced monitor power entry cover - screw locations... 64 Figure 3-6 Startup screen... 66 Figure 3-7 Language selection screen... 67 Figure 4-1 HemoSphere Swan-Ganz module monitoring connection overview... 69 Figure 4-2 Pressure cable connection overview... 72 Figure 4-3 Oximetry connection overview... 74 Figure 4-4 HemoSphere tissue oximetry module connection overview... 77 Figure 4-5 HemoSphere noninvasive system connection overview... 79 Figure 5-1 HemoSphere advanced monitor screen features... 82 Figure 5-2 Navigation bar and icons 1invasive monitoring, 2noninvasive monitoring, 3graphical trend screens... 83 Figure 5-3 Example of monitoring screen selection window... 86 Figure 5-4 Example of key parameter selection tile configuration menu... 88 Figure 5-5 Parameter tile... 89 Figure 5-6 Main monitoring view... 90 Figure 5-7 Graphical trend screen... 91 Figure 5-8 Graphical trend- intervention window... 92 Figure 5-9 Graphical trend screen - intervention information balloon... 94 Figure 5-10 Tabular trend screen... 95 Figure 5-11 Tabular increment popup... 95 Figure 5-12 Physiology screen while monitoring with HemoSphere Swan-Ganz module... 97 Figure 5-13 Cockpit monitoring screen... 98 Figure 5-14 Physio relationship screen while monitoring with HemoSphere Swan-Ganz module ... 99 Figure 5-15 Historic physio relationship data screen... 100 Figure 5-16 Physio relationship parameter boxes... 101 Figure 5-17 Physio relationship target/enter popup... 101 Figure 5-18 Goal positioning screen... 102 Figure 5-19 Focused parameter tile... 103 Figure 5-20 Focused parameter tile – parameter and alarm/target selection... 104

14

Figure 5-21 Focused main screen... 104 Figure 5-22 Focused Graphical Trend Screen... 105 Figure 5-23 Focused Charting Screen... 106 Figure 5-24 Focused Charting View – Configure Columns... 106 Figure 5-25 Information bar... 112 Figure 5-26 Lock screen popup... 114 Figure 5-27 Status bar... 114 Figure 6-1 New or continuing patient screen... 119 Figure 6-2 New Patient Data screen... 120 Figure 6-3 General Monitor Settings... 122 Figure 7-1 Alarms/Targets configuration... 134 Figure 7-2 Set individual parameter alarms and targets... 135 Figure 7-3 Graphical trend screen... 136 Figure 7-4 Adjust scales... 137 Figure 7-5 Tabular increment popup... 138 Figure 8-1 HIS- Patient query screen... 143 Figure 8-2 HIS- New patient data screen... 144 Figure 9-1 HemoSphere Swan-Ganz module connection overview... 147 Figure 9-2 Patient CCO cable test connections... 149 Figure 9-3 HemoSphere Swan-Ganz module key parameter selection window... 150 Figure 9-4 CO connection overview... 151 Figure 9-5 iCO connection overview... 154 Figure 9-6 iCO new set configuration screen... 155 Figure 9-7 Thermodilution summary screen... 158 Figure 9-8 EDV/RVEF connection overview... 160 Figure 10-1 HemoSphere pressure cable... 165 Figure 10-2 Zero & Waveform screens – Zero sensor and Pressure-Out... 173 Figure 11-1 HemoSphere noninvasive system connection overview... 178 Figure 11-2 Pressure controller application... 180 Figure 11-3 Cuff size selection... 181 Figure 11-4 Heart reference sensor application... 182 Figure 11-5 Patient Positioning Mode Selection – Optional HRS... 184 Figure 11-6 Zero & Waveform screen – Vertical Offset Entry... 185 Figure 11-7 BP Calibration Screen... 189 Figure 11-8 Transmit arterial pressure waveform to patient monitor... 190 Figure 12-1 Venous oximetry connection overview... 192 Figure 13-1 FORE-SIGHT ELITE oximeter front view... 200 Figure 13-2 FORE-SIGHT ELITE oximeter module rear view... 200 Figure 13-3 Mounting clip – module slide attachment points... 201 Figure 13-4 Module housing – mounting clip attachment points... 201

15

Figure 13-5 Attaching the mounting clip vertically... 202 Figure 13-6 Attaching the mounting clip horizontally... 203 Figure 13-7 Removing the mounting clip... 204 Figure 13-8 HemoSphere tissue oximetry module connection overview... 205 Figure 13-9 FORE-SIGHT ELITE oximeter module status LED... 207 Figure 13-10 Removing protective liner from sensor... 210 Figure 13-11 Sensor placement (cerebral)... 211 Figure 13-12 Sensor placement (non-cerebral)... 212 Figure 13-13 Connecting a sensor to the sensor cable connector... 213 Figure 13-14 Connecting a sensor to the FORE-SIGHT ELITE oximeter module – channel status LED... 214 Figure 13-15 Tissue Oximetry Physiology Screens... 217 Figure 14-1 HPI key parameter tile... 223 Figure 14-2 HPI key parameter on cockpit screen... 224 Figure 14-3 Information bar with HPI... 225 Figure 14-4 Parameter settings - Hypotension Prediction Index... 225 Figure 14-5 HPI high alert popup... 226 Figure 14-6 HPI secondary screen... 227 Figure 14-7 HPI secondary screen – graphical trend value display... 228 Figure 14-8 GDT Menu Screen - Key Parameter Selection... 237 Figure 14-9 GDT Menu Screen - Target Selection... 237 Figure 14-10 GDT Active Tracking... 238 Figure 14-11 Fluid Responsiveness Test – New Test Screen... 240 Figure 14-12 Fluid Responsiveness Test – Results Screen... 242 Figure 15-1 HemoSphere advanced monitor LED indicators... 245 Figure 15-2 Pressure cable LED indicator... 246 Figure 15-3 FORE-SIGHT ELITE oximeter module LED indicators... 247 Figure 15-4 Pressure Controller LED Indicators... 248 Figure A-1 Spectral Irradiance and location of light emission aperture... 286

16

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 Swan-Ganz module with pressure cable available parameters list* . . . 25 Table 1-5 HemoSphere pressure cable available parameters list... 26 Table 1-6 HemoSphere pressure cable with oximetry cable available parameters list... 27 Table 1-7 HemoSphere tissue oximetry module with FORE-SIGHT ELITE oximeter module available parameters list... 27 Table 1-8 HemoSphere ClearSight module available parameters list... 28 Table 1-9 HemoSphere ClearSight module with oximetry cable available parameters list... 28 Table 1-10 HemoSphere Swan-Ganz module parameters description... 30 Table 1-11 HemoSphere pressure cable key parameters description... 31 Table 1-12 HemoSphere oximetry cable parameters description... 32 Table 1-13 HemoSphere tissue oximetry module with FORE-SIGHT ELITE oximeter module parameters description... 33 Table 1-14 HemoSphere ClearSight module key parameters description... 33 Table 1-15 Operator’s manual style conventions... 34 Table 1-16 Acronyms, Abbreviations... 35 Table 2-1 Monitor display symbols... 51 Table 2-2 Symbols on product labels... 54 Table 2-3 Applicable standards... 55 Table 3-1 HemoSphere advanced monitoring components... 56 Table 3-2 Cables and catheters required for monitoring parameters with HemoSphere Swan-Ganz module... 57 Table 3-3 Sensor options for monitoring parameters with HemoSphere pressure cable... 57 Table 3-5 Catheters required for monitoring parameters with HemoSphere oximetry cable . . 58 Table 3-6 Accessories required for monitoring parameters with HemoSphere tissue oximetry module... 58 Table 3-4 Finger cuff options for monitoring parameters with HemoSphere ClearSight module ... 58 Table 5-1 Graphical trend scroll rates... 91 Table 5-2 Intervention events... 93 Table 5-3 Tabular trend scroll rates... 96 Table 5-4 Reviewed events... 108 Table 5-5 Battery status... 112 Table 6-1 HemoSphere advanced monitor password levels... 117

17

Table 6-2 Advanced setup menu navigation and password protection... 117 Table 6-3 Export data menu navigation and password protection... 118 Table 6-4 CO/pressure averaging time and display update rates –minimally-invasive monitoring mode... 125 Table 6-5 Analog input parameter ranges... 127 Table 7-1 Visual alarm indicator colors... 130 Table 7-2 Target status indicator colors... 133 Table 7-3 Target defaults... 133 Table 8-1 Wi-Fi connection status... 142 Table 8-2 HIS connectivity status... 143 Table 9-1 Available HemoSphere Swan-Ganz module parameters and required connections 148 Table 9-2 Unstable thermal signal time lapse for CO alert and fault messages... 152 Table 10-1 HemoSphere pressure cable configurations and available key parameters... 165 Table 11-1 Arterial waveform SQI levels... 187 Table 11-2 Physiocal Interval Status... 187 Table 12-1 In vitro calibration options... 194 Table 12-2 In vivo calibration options... 195 Table 12-3 Signal quality indicator levels... 195 Table 13-1 Tissue oximetry sensor locations... 207 Table 13-2 Sensor selection matrix... 209 Table 13-3 StO2 validation methodology... 216 Table 14-1 HPI display configurations... 221 Table 14-2 HPI value graphical and audible display elements... 222 Table 14-3 HPI versus other key parameters: similarities and differences... 223 Table 14-4 Parameter status colors for HPI... 224 Table 14-5 Patient Demographics (surgical patients)... 231 Table 14-6 Patient Demographics (Non-Surgical Patients)... 232 Table 14-7 Non-Surgical Patient Characteristics (N=298)... 232 Table 14-8 Non-Surgical Patient Characteristics (N=228)... 232 Table 14-9 Clinical Validation Studies* (surgical patients)... 233 Table 14-10 Clinical Validation Studies* (non-surgical patients)... 233 Table 14-11 Clinical validation (surgical patients [N=52])... 234 Table 14-12 Clinical Validation (non-surgical patients [N=298])... 235 Table 14-13 GDT Target Status Indicator Colors... 238 Table 15-1 HemoSphere advanced monitor visual alarm indicator... 245 Table 15-3 Pressure cable communication light... 246 Table 15-2 HemoSphere advanced monitor power light... 246 Table 15-4 FORE-SIGHT ELITE oximeter module LED communication light... 247 Table 15-5 Pressure controller communication lights*... 248 Table 15-6 System faults/alerts... 249

18

Table 15-7 HemoSphere advanced monitor warnings... 252 Table 15-8 Numeric keypad errors... 252 Table 15-9 HemoSphere Swan-Ganz module CO faults/alerts... 253 Table 15-10 HemoSphere Swan-Ganz module EDV and SV faults/alerts... 254 Table 15-11 HemoSphere Swan-Ganz module iCO faults/alerts... 255 Table 15-12 HemoSphere Swan-Ganz module SVR faults/alerts... 256 Table 15-13 HemoSphere Swan-Ganz module 20s parameters faults/alerts... 257 Table 15-14 HemoSphere Swan-Ganz module general troubleshooting... 257 Table 15-15 HemoSphere pressure cable general faults/alerts... 259 Table 15-16 HemoSphere pressure cable CO faults/alerts... 260 Table 15-17 HemoSphere pressure cable SVR faults/alerts... 262 Table 15-18 HemoSphere pressure cable MAP faults/alerts... 262 Table 15-19 HemoSphere pressure cable general troubleshooting... 263 Table 15-20 HemoSphere ClearSight module faults/alerts... 264 Table 15-21 HemoSphere ClearSight warnings... 268 Table 15-23 Venous oximetry faults/alerts... 270 Table 15-22 HemoSphere ClearSight general troubleshooting... 270 Table 15-24 Venous oximetry warnings... 271 Table 15-25 Venous oximetry general troubleshooting... 272 Table 15-26 Tissue oximetry faults/alerts... 272 Table 15-27 Tissue oximetry general troubleshooting... 274 Table A-1 HemoSphere advanced monitor essential performance – transient and non-transient electromagnetic phenomena... 276 Table A-2 HemoSphere advanced monitor physical and mechanical specifications... 278 Table A-3 HemoSphere advanced monitor environmental specifications... 278 Table A-4 HemoSphere advanced monitor transportation environmental specifications... 278 Table A-5 HemoSphere advanced monitor technical specifications... 279 Table A-6 HemoSphere battery pack physical specifications... 280 Table A-7 HemoSphere battery pack environmental specifications... 280 Table A-8 HemoSphere battery pack technical specifications... 280 Table A-9 HemoSphere Swan-Ganz module physical specifications... 280 Table A-10 HemoSphere Swan-Ganz module parameter measurement specifications... 281 Table A-11 HemoSphere Swan-Ganz module 20-second flow parameter measurement specifications*... 281 Table A-12 HemoSphere pressure cable physical specifications... 282 Table A-13 HemoSphere pressure cable parameter measurement specifications... 282 Table A-14 HemoSphere oximetry cable physical specifications... 282 Table A-15 HemoSphere oximetry cable parameter measurement specifications... 283 Table A-16 HemoSphere tissue oximetry module physical specifications... 283 Table A-17 FORE-SIGHT ELITE oximeter module physical specifications... 284

19

Table A-18 HemoSphere tissue oximetry module with FORE-SIGHT ELITE oximeter module parameter measurement specifications... 284 Table A-19 HemoSphere ClearSight module physical specifications... 285 Table A-20 HemoSphere ClearSight module environmental specifications... 285 Table A-21 HemoSphere ClearSight module parameter measurement specifications... 285 Table A-22 Edwards finger cuff specifications... 285 Table B-1 HemoSphere advanced monitor components... 287 Table C-1 Cardiac and oxygenation profile equations... 289 Table D-1 Patient information... 295 Table D-2 Graphical trend parameter scale defaults... 295 Table D-3 Configurable parameter alarm and display ranges... 296 Table D-4 Parameter alarm red zone and target defaults... 298 Table D-5 Parameter alarms, faults, and alerts priorities... 299 Table D-6 Language default settings... 300 Table E-1 Computation constants for bath temperature probe... 301 Table E-2 Computation constants for in-line temperature probe... 302 Table G-1 Electromagnetic emissions... 312 Table G-2 Guidance and Manufacturer's Declaration - Immunity to RF wireless communications equipment... 313 Table G-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the HemoSphere advanced monitor... 314 Table G-4 In band wireless coexistence – Threshold of Interference (Tol) and Threshold of Communication (ToC) between HemoSphere advanced monitor (EUT) in Invasive mode and external devices... 314 Table G-5 In band wireless coexistence – Threshold of Interference (Tol) and Threshold of Communication (ToC) between HemoSphere advanced monitor (EUT) in Noni-Invasive mode and external devices... 315 Table G-6 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)... 316 Table G-7 Electromagnetic Immunity (RF Radiated and Conducted)... 317 Table G-8 HemoSphere advanced monitor wireless information... 318

20