HemoSphere Advanced Patient Monitor Operators Manual Ver 3.3 sw ver 2.0 Nov 2019

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, HemoSphere, HemoSphere Swan-Ganz, Hypotension Prediction Index, 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.

©2019 Edwards Lifesciences Corporation. All rights reserved. Version 3.3 Manual Release Date: NOVEMBER 2019; Software Version: 2.0 Original Release Date: 9/30/2016

Edwards Lifesciences Services GmbH Edisonstrasse 6 85716 Unterschleissheim, Germany

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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

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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... 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 22 1.3 Contraindications For Use... 22 1.4 Intended Use Statement... 23 1.5 Expected Clinical Benefit... 27 1.6 HemoSphere Advanced Monitor Hemodynamic Technology Connections . . 27 1.6.1 HemoSphere Swan-Ganz Module... 27 1.6.2 HemoSphere Pressure Cable... 28 1.6.3 HemoSphere Oximetry Cable... 30 1.6.4 HemoSphere Tissue Oximetry Module... 30 1.6.5 Documentation and Training... 31 1.7 Manual style conventions... 31 1.8 Abbreviations Found in This Manual... 32

2 Safety and Symbols 2.1 Safety Signal Words Definitions... 34 2.1.1 Warning... 34 2.1.2 Caution... 34 2.1.3 Note... 34 2.2 Warnings... 35 2.3 Cautions... 41 2.4 User Interface Symbols... 46 2.5 Symbols on Product Labels... 48 2.6 Applicable Standards... 50 2.7 HemoSphere Advanced Monitor Essential Performance... 50

3 Installation and Setup 3.1 Unpacking... 51 3.1.1 Packaging Contents... 51 3.1.2 Required Accessories for Platform Modules and Cables... 52 3.2 HemoSphere Advanced Monitor Connection Ports... 53 3.2.1 Monitor Front... 54 3.2.2 Monitor Rear... 55 3.2.3 Monitor Right Panel... 56 3.2.4 Monitor Left Panel... 56

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3.3 HemoSphere Advanced Monitor Installation... 57 3.3.1 Mounting Options and Recommendations... 57 3.3.2 Battery Installation... 58 3.3.3 Connecting Power Cord... 58 3.3.3.1 Equipotential Connection... 59 3.3.4 Connecting and Disconnecting a Hemodynamic Monitoring Module . . . 59 3.3.5 Connecting and Disconnecting a Hemodynamic Monitoring Cable... 60 3.3.6 Connecting Cables from External Devices... 60 3.4 Initial Start Up... 61 3.4.1 Start Up Procedure... 61 3.4.2 Select Language... 61

4 HemoSphere Advanced Monitor Quick Start 4.1 HemoSphere Swan-Ganz Module Cardiac Output Monitoring... 64 4.1.1 Continuous Cardiac Output Monitoring... 65 4.1.2 Intermittent Cardiac Output Monitoring... 65 4.1.3 Continuous End Diastolic Volume Monitoring... 66 4.2 Monitoring with the HemoSphere Pressure Cable... 67 4.2.1 Pressure Cable Setup... 67 4.2.2 Zero Pressure Cable... 67 4.3 HemoSphere Oximetry Cable Monitoring... 69 4.3.1 In vitro Calibration... 69 4.3.2 In vivo Calibration... 70 4.4 HemoSphere Tissue Oximetry Module Monitoring... 72 4.4.1 Connecting the HemoSphere Tissue Oximetry Module... 72

5 Navigating the HemoSphere Advanced Monitor 5.1 HemoSphere Advanced Monitor Screen Appearance... 74 5.2 Navigation Bar... 76 5.3 Monitor Views... 79 5.3.1 Parameter Tiles... 79 5.3.1.1 Change Parameters... 79 5.3.1.2 Change Alarm/Target... 81 5.3.1.3 Status Indicators... 81 5.3.2 Main Monitoring View... 82 5.3.3 Graphical Trend Monitoring View... 83 5.3.3.1 Graphical Trend Scroll Mode... 84 5.3.3.2 Intervention Events... 85 5.3.3.3 Live Blood Pressure Waveform Display... 87 5.3.4 Tabular Trends... 88 5.3.4.1 Tabular Trend Scroll Mode... 88 5.3.5 Graphical/Tabular Trends Split... 89 5.3.6 Physiology Screen... 90 5.3.6.1 SVV Slope Indicator... 91 5.3.7 Cockpit Screen... 91 5.3.8 Physio Relationship... 92 5.3.8.1 Continuous and Historical Modes... 92

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5.3.8.2 Parameter Boxes... 94 5.3.8.3 Setting Targets and Entering Parameter Values... 94 5.3.9 Goal Positioning Screen... 95 5.4 Focused Monitoring Format... 95 5.4.1 Select Monitoring View... 95 5.4.2 Blood Pressure Waveform Tile... 96 5.4.3 Focused Parameter Tile... 96 5.4.4 Change Parameters... 97 5.4.5 Change Alarms /Targets... 97 5.4.6 Focused Main Screen... 97 5.4.7 Focused Graphical Trend Screen... 98 5.4.8 Focused Charting Screen... 98 5.5 Clinical Tools... 99 5.5.1 Select Monitoring Mode... 99 5.5.2 CVP Entry... 100 5.5.3 Derived Value Calculator... 100 5.5.4 Event Review... 101 5.6 Information Bar... 103 5.6.1 Battery... 104 5.6.2 Screen Brightness... 105 5.6.3 Alarm Volume... 105 5.6.4 Screen Capture... 105 5.6.5 Lock Screen... 105 5.7 Status Bar... 106 5.8 Monitor Screen Navigation... 106 5.8.1 Vertical Scrolling... 106 5.8.2 Navigation Icons... 107

6 User Interface Settings 6.1 Password Protection... 109 6.1.1 Changing passwords... 110 6.2 Patient Data... 110 6.2.1 New Patient... 111 6.2.2 Continue Monitoring Patient... 112 6.2.3 View Patient Data... 112 6.3 General Monitor Settings... 113 6.3.1 Change Language... 113 6.3.2 Change Date and Time Display... 114 6.3.2.1 Adjust Date or Time... 114 6.3.3 Monitoring Screens Settings... 114 6.3.4 Time Intervals / Averaging... 115 6.3.4.1 Display Parameter Value Change... 115 6.3.4.2 CO/Pressure Averaging Time... 116 6.3.5 Analog Pressure Signal Input... 117 6.3.5.1 Calibration... 119

7 Advanced Settings

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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 9.4 EDV/RVEF Monitoring... 151

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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... 157 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 Pressure Cable Monitoring in Swan-Ganz Module Monitoring Mode... 163 10.6 Zero & Waveform Screen... 164 10.6.1 Select Pressure and Zero Sensor... 164 10.6.2 Pressure-Out... 164 10.6.3 Waveform Confirmation... 165

11 Venous Oximetry Monitoring 11.1 Oximetry Cable Overview... 166 11.2 Venous Oximetry Setup... 166 11.3 In Vitro Calibration... 168 11.3.1 In Vitro Calibration Error... 169 11.4 In Vivo Calibration... 169 11.5 Signal Quality Indicator... 170 11.6 Recall Oximetry Data... 171 11.7 HGB Update... 172 11.8 HemoSphere Oximetry Cable Reset... 173 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... 175 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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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 Advanced Features 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 13.1.11 References... 210 13.2 Enhanced Parameter Tracking... 211 13.2.1 GDT Tracking... 211 13.2.1.1 Key Parameter and Target Selection... 211 13.2.1.2 Active GDT Tracking... 212 13.2.1.3 Historical GDT... 213 13.2.2 SV Optimization... 213 13.2.3 GDT Report Download... 213 13.3 Fluid Responsiveness Test... 214 13.3.1 Passive Leg Raise Test... 214 13.3.2 Fluid Bolus Test... 216 13.3.3 Historical Test Results... 217

14 Troubleshooting 14.1 On Screen Help... 218 14.2 Monitor Status Lights... 219 14.3 Pressure Cable Communication... 220 14.4 ForeSight Elite Module Sensor Communication... 221 14.5 HemoSphere Advanced Monitor Error Messages... 221 14.5.1 System Faults/Alerts... 221

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14.5.2 System Warnings... 224 14.5.3 Numeric Keypad Errors... 224 14.6 HemoSphere Swan-Ganz Module Error Messages... 226 14.6.1 CO Faults/Alerts... 226 14.6.2 EDV and SV Faults/Alerts... 227 14.6.3 iCO Faults/Alerts... 228 14.6.4 SVR Faults/Alerts... 229 14.6.5 General Troubleshooting... 230 14.7 Pressure Cable Error Messages... 231 14.7.1 General Pressure Cable Faults/Alerts... 231 14.7.2 CO Faults/Alerts... 232 14.7.3 SVR Faults/Alert... 234 14.7.4 MAP Faults/Alert... 235 14.7.5 General Troubleshooting... 235 14.8 Venous Oximetry Error Messages... 237 14.8.1 Venous Oximetry Faults/Alerts... 237 14.8.2 Venous Oximetry Warnings... 238 14.8.3 Venous Oximetry General Troubleshooting... 239 14.9 Tissue Oximetry Error Messages... 239 14.9.1 Tissue Oximetry Faults/Alerts... 239 14.9.2 Tissue Oximetry General Troubleshooting... 241

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...

242 244 246 247 248 249 249

Appendix B: Accessories B.1 Accessories List... 251 B.2 Additional Accessories Description... 252 B.2.1 Roll Stand... 252 B.2.2 Oximetry Cradle... 252

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*...

Appendix E: Computation Constants

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259 259 260 262 263 264

E.1 Computation Constant Values...

265

Appendix F: System Care, Service and Support F.1 General Maintenance... 267 F.2 Cleaning the Monitor and Modules... 268 F.3 Cleaning the Platform Cables... 268 F.3.1 Cleaning the HemoSphere Oximetry Cable... 269 F.3.2 Cleaning the Patient CCO Cable and Connector... 269 F.3.3 Cleaning the Pressure Cable... 270 F.3.4 Cleaning the ForeSight Elite Tissue Oximeter Module... 270 F.4 Service and Support... 271 F.5 Edwards Lifesciences Regional Headquarters... 272 F.6 Monitor Disposal... 273 F.6.1 Battery Recycling... 273 F.7 Preventive Maintenance... 273 F.7.1 Battery Maintenance... 273 F.7.1.1 Battery Conditioning... 273 F.7.1.2 Battery Storage... 273 F.8 Testing of Alarm Signals... 274 F.9 Warranty... 274

Appendix G: Guidance and Manufacturer’s Declaration G.1 Electromagnetic Compatibility... 275 G.2 Instructions for Use... 276 G.3 Wireless Technology Information... 282 G.3.1 Quality of Service for Wireless Technology... 284 G.3.2 Wireless Security Measures... 285 G.3.3 Troubleshooting Wireless Coexistence Issues... 285 G.3.4 Federal Communication Commission (FCC) Interference Statements . 285 G.3.5 Industry Canada Statements... 286 G.3.6 European Union R&TTE Statements... 286

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... 175 Figure 12-2 ForeSight Elite tissue oximeter rear view... 175 Figure 12-3 Mounting clip – module slide attachment points... 176 Figure 12-4 Module case – mounting clip attachment points... 176 Figure 12-5 Attaching the mounting clip vertically (figure in process)... 177 Figure 12-6 Attaching the mounting clip horizontally... 178 Figure 12-7 Removing the mounting clip... 179 Figure 12-8 HemoSphere tissue oximetry module connection overview... 180 Figure 12-9 ForeSight Elite module status LED... 182 Figure 12-10 Removing protective liner from sensor... 185 Figure 12-11 Sensor placement (cerebral)... 186 Figure 12-12 Sensor placement (non-cerebral)... 187 Figure 12-13 Connecting a sensor to the preamp cable... 188

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Figure 12-14 Connecting a sensor to the preamp cable... 189 Figure 12-15 Tissue Oximetry Physiology Screens... 192 Figure 13-1 HPI key parameter tile... 197 Figure 13-2 HPI key parameter on cockpit screen... 198 Figure 13-3 Information bar with HPI... 199 Figure 13-4 Parameter settings - Hypotension Prediction Index... 199 Figure 13-5 HPI high alert popup... 200 Figure 13-6 HPI secondary screen... 201 Figure 13-7 HPI secondary screen – graphical trend value display... 202 Figure 13-8 GDT Menu Screen - Key Parameter Selection... 211 Figure 13-9 GDT Menu Screen - Target Selection... 211 Figure 13-10 GDT Active Tracking... 212 Figure 13-11 Fluid Responsiveness Test – New Test Screen... 214 Figure 13-12 Fluid Responsiveness Test – Results Screen... 216 Figure 14-1 HemoSphere advanced monitor LED indicators... 219 Figure 14-2 Pressure cable LED indicator... 220 Figure 14-3 ForeSight Elite tissue oximeter module LED indicators... 221

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List of Tables Table 1-1 HemoSphere Swan-Ganz module available parameters list... 23 Table 1-2 HemoSphere oximetry cable available parameters list... 24 Table 1-3 HemoSphere Swan-Ganz module with oximetry cable available parameters list... 24 Table 1-4 HemoSphere pressure cable available parameters list... 25 Table 1-5 HemoSphere pressure cable with oximetry cable available parameters list... 26 Table 1-6 HemoSphere tissue oximetry module available parameters list... 26 Table 1-7 HemoSphere Swan-Ganz module parameters description... 28 Table 1-8 HemoSphere pressure cable key parameters description... 29 Table 1-9 HemoSphere oximetry cable parameters description... 30 Table 1-10 HemoSphere tissue oximetry module parameters description... 30 Table 1-11 Operator’s manual style conventions... 31 Table 1-12 Acronyms, Abbreviations... 32 Table 2-1 Monitor display symbols... 46 Table 2-2 Symbols on product labels... 48 Table 2-3 Applicable standards... 50 Table 3-1 HemoSphere advanced monitoring components... 51 Table 3-2 Cables and catheters required for monitoring parameters with HemoSphere Swan-Ganz module... 52 Table 3-3 Sensor options for monitoring parameters with HemoSphere pressure cable... 52 Table 3-4 Catheters required for monitoring parameters with HemoSphere oximetry cable . . 53 Table 3-5 Accessories required for monitoring parameters with HemoSphere tissue oximetry module... 53 Table 5-1 Graphical trend scroll rates... 84 Table 5-2 Intervention events... 86 Table 5-3 Tabular trend scroll rates... 89 Table 5-4 Reviewed events... 101 Table 5-5 Battery status... 105 Table 6-1 HemoSphere advanced monitor password levels... 109 Table 6-2 Advanced setup menu navigation and password protection... 109 Table 6-3 Export data menu navigation and password protection... 110 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... 169 Table 11-2 In vivo calibration options... 170 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 GDT Target Status Indicator Colors... 212 Table 14-1 HemoSphere advanced monitor visual alarm indicator... 219 Table 14-2 HemoSphere advanced monitor power light... 219 Table 14-3 Pressure cable communication light... 220 Table 14-4 ForeSight Elite module LED communication light... 221 Table 14-5 System faults/alerts... 221 Table 14-6 HemoSphere advanced monitor warnings... 224 Table 14-7 Numeric keypad errors... 224 Table 14-8 HemoSphere Swan-Ganz module CO faults/alerts... 226 Table 14-9 HemoSphere Swan-Ganz module EDV and SV faults/alerts... 227 Table 14-10 HemoSphere Swan-Ganz module iCO faults/alerts... 228 Table 14-11 HemoSphere Swan-Ganz module SVR faults/alerts... 229 Table 14-12 HemoSphere Swan-Ganz module general troubleshooting... 230 Table 14-13 HemoSphere pressure cable general faults/alerts... 231 Table 14-14 HemoSphere pressure cable CO faults/alerts... 232 Table 14-15 HemoSphere pressure cable SVR faults/alerts... 234 Table 14-16 HemoSphere pressure cable MAP faults/alerts... 235

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Table 14-17 HemoSphere pressure cable general troubleshooting... 235 Table 14-18 Venous oximetry faults/alerts... 237 Table 14-19 Venous oximetry warnings... 238 Table 14-20 Venous oximetry general troubleshooting... 239 Table 14-21 Tissue oximetry faults/alerts... 239 Table 14-22 Tissue oximetry general troubleshooting... 241 Table A-1 HemoSphere advanced monitor essential performance – transient and non-transient electromagnetic phenomena... 243 Table A-2 HemoSphere advanced monitor physical and mechanical specifications... 244 Table A-3 HemoSphere advanced monitor environmental specifications... 244 Table A-5 HemoSphere advanced monitor technical specifications... 245 Table A-4 HemoSphere advanced monitor transportation environmental specifications... 245 Table A-6 HemoSphere battery pack physical specifications... 246 Table A-7 HemoSphere battery pack environmental specifications... 246 Table A-8 HemoSphere battery pack technical specifications... 246 Table A-9 HemoSphere Swan-Ganz module physical specifications... 247 Table A-10 HemoSphere Swan-Ganz module parameter measurement specifications... 247 Table A-11 HemoSphere pressure cable physical specifications... 248 Table A-12 HemoSphere pressure cable parameter measurement specifications... 248 Table A-13 HemoSphere oximetry cable physical specifications... 249 Table A-14 HemoSphere oximetry cable parameter measurement specifications... 249 Table A-15 HemoSphere tissue oximetry module physical specifications... 249 Table A-17 HemoSphere tissue oximetry module parameter measurement specifications . . . 250 Table A-16 ForeSight Elite tissue oximeter module physical specifications... 250 Table B-1 HemoSphere advanced monitor components... 251 Table C-1 Cardiac and oxygenation profile equations... 253 Table D-1 Patient information... 259 Table D-2 Graphical trend parameter scale defaults... 259 Table D-3 Configurable parameter alarm and display ranges... 260 Table D-4 Parameter alarm red zone and target defaults... 262 Table D-5 Parameter alarms, faults, and alerts priorities... 263 Table D-6 Language default settings... 264 Table E-1 Computation constants for bath temperature probe... 265 Table E-2 Computation constants for in-line temperature probe... 266 Table G-1 Electromagnetic emissions... 276 Table G-2 Guidance and Manufacturer's Declaration - Immunity to RF wireless communications equipment... 277 Table G-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the HemoSphere advanced monitor... 279 Table G-4 In band wireless coexistence – Threshold of Interference (Tol) and Threshold of Communication (ToC) between HemoSphere advanced monitor (EUT) and external devices 279

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Table G-5 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)... 280 Table G-6 Electromagnetic Immunity (RF Radiated and Conducted)... 281 Table G-7 HemoSphere advanced monitor wireless information... 282

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