Edwards HemoSphere Operator's Manual

Edwards Lifesciences

HemoSphere Advanced Monitor

Operator’s manual

Edwards Lifesciences HemoSphere Advanced Monitor Operator’s Manual

Because of continuing product improvement, prices and specifications are subject to change without notice. Changes to this manual, either in response to user input or to continuing product improvements, are accomplished through reissue. If, in the normal use of this manual, errors, omissions, or incorrect data are noted, please contact Edwards Technical Support or your local Edwards representative.

Edwards Technical Support

United States and Canada (24 hours) . . . . . . . . 800.822.9837 or tech_support@edwards.com

Outside the U.S. and Canada (24 hours). . . . . . 949.250.2222

Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . +8001.8001.801 or techserv_europe@edwards.com

In the UK. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0870 606 2040 - Option 4

In Ireland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 01 8211012 Option 4

CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician.

Manufactured by Edwards Lifesciences LLC

One Edwards Way Irvine, CA 92614 Made in USA

Trademarks Edwards, Edwards Lifesciences, the stylized E logo, CCOmbo, CCOmbo V,

CO-Set, CO-Set+, HemoSphere, PediaSat, Swan and Swan-Ganz are trademarks of Edwards Lifesciences Corporation.

All other trademarks are the property of their respective owners.

Version 1.2 Release Date: 4/28/2017

Original Release Date: 9/30/2016

Edwards Lifesciences Services GmbH

Edisonstrasse 6 85716 Unterschleissheim, Germany

Using This Manual

The Edwards Lifesciences HemoSphere advanced monitor operator’s manual is comprised of eleven chapters, eight appendices, and an index. Figures in this manual are intended for reference only and may not be an exact replication of the screens as a result of continuous software improvements.

WARNING Read this operator's manual carefully before attempting to use the Edwards

Lifesciences HemoSphere advanced monitor.

Refer to the instructions for use provided with each compatible accessory before using it with the HemoSphere advanced monitor.

CAUTION Inspect all accessories and equipment for damage prior to use with the

HemoSphere advanced monitor. Damage may include cracks, scratches, dents, exposed electrical contacts, or any signs that the housing may be compromised.

WARNING To prevent injury to patient or user, damage to platform, or inaccurate

measurements, do not use any damaged or non-compatible platform accessories, components or cables.

Chapter Description

1 Introduction: Provides an overview of the HemoSphere advanced monitor

2 Safety and Symbols: Includes WARNINGS, CAUTIONS, and NOTES that are

found in the manual, as well as illustrations of labels found on the HemoSphere advanced monitor and accessories

3 Installation and Setup: Provides information about setting up the HemoSphere

advanced monitor and connections for the first time

4 HemoSphere Advanced Monitor Quick Start: Provides experienced clinicians

and users of bedside monitors instructions for immediate monitor use

5 Navigating the HemoSphere Advanced Monitor: Provides information on

monitoring screen views

6 User Interface Settings: Provides information about the various display settings

including patient information, language and international units, alarm volume, system time, and system date. It also provides instructions for selecting the screen appearance

7 Advanced Settings: Provides information on advanced settings including alarm

targets, graphical scales, serial port setup, and Demo Mode.

8 Data Export and Connectivity: Provides information on monitor connectivity for

transferring patient and clinical data

9 HemoSphere Swan-Ganz Module Monitoring: Describes procedures for setup

and operation of continuous cardiac output, intermittent cardiac output, and right ventricular end diastolic volume monitoring using the Swan-Ganz module

10 Oximetry Monitoring: Describes procedures for calibration and operation of

oximetry (oxygen saturation) measurement

11 Help and Troubleshooting: Describes the Help menu and provides a list of

faults, alerts, and messages, with causes and suggested actions.

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

Contents

1 Introduction

1.1 Intended Purpose of this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

1.2 Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

1.2.1 HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module15

1.2.2 HemoSphere Advanced Monitor with HemoSphere Oximetry Cable . . . 16

1.3 Contraindications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1.4 Intended Use Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1.5 HemoSphere Advanced Monitor Hemodynamic Technology Connections . . 18

1.5.1 HemoSphere Swan-Ganz Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

1.5.2 HemoSphere Oximetry Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

1.5.3 Documentation and Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

1.6 Manual style conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

1.7 Abbreviations Found in This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

2 Safety and Symbols

2.1 Safety Signal Words Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

2.1.1 Warning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

2.1.2 Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

2.1.3 Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

2.2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

2.3 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

2.4 User Interface Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

2.5 Symbols on Product Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

2.6 Applicable Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

2.7 HemoSphere Advanced Monitor Essential Performance . . . . . . . . . . . . . . . . . 32

3 Installation and Setup

3.1 Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

3.1.1 Packaging Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

3.1.2 Required Accessories for Platform Modules and Cables . . . . . . . . . . . . . .34

3.2 HemoSphere Advanced Monitor Connection Ports . . . . . . . . . . . . . . . . . . . . . 35

3.2.1 Monitor Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

3.2.2 Monitor Rear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

3.2.3 Monitor Right Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

3.2.4 Monitor Left Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

3.3 HemoSphere Advanced Monitor Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

3.3.1 Mounting Options and Recommendations. . . . . . . . . . . . . . . . . . . . . . . . .38

3.3.2 Battery Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

3.3.3 Connecting Power Cord. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

3.3.3.1 Equipotential Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40

3.3.4 Connecting and Disconnecting a Hemodynamic Monitoring Module . . .40

3.3.5 Connecting and Disconnecting a Hemodynamic Monitoring Cable. . . . . 41

3.3.6 Connecting Cables from External Devices. . . . . . . . . . . . . . . . . . . . . . . . .41

3.4 Initial Start Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

3.4.1 Start Up Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41

3.4.2 Select Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

4 HemoSphere Advanced Monitor Quick Start

4.1 HemoSphere Swan-Ganz Module Cardiac Output Monitoring . . . . . . . . . . . . 43

4.1.1 Continuous Cardiac Output Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . .44

4.1.2 Intermittent Cardiac Output Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . 44

4.1.3 Continuous End Diastolic Volume Monitoring . . . . . . . . . . . . . . . . . . . . .45

4.2 HemoSphere Oximetry Cable Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

4.2.1 In vitro Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46

4.2.2 In vivo Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

5 Navigating the HemoSphere Advanced Monitor

5.1 HemoSphere Advanced Monitor Screen Appearance . . . . . . . . . . . . . . . . . . . . 48

5.2 Navigation Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

5.3 Monitor Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

5.3.1 Parameter Globes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

5.3.1.1 Change Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

5.3.1.2 Change Alarm/Target. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.3.1.3 Status Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54

5.3.2 Graphical Trend Monitoring View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

5.3.2.1 Graphical Trend Scroll Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

5.3.2.2 Intervention Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56

5.3.3 Tabular Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58

5.3.3.1 Tabular Trend Scroll Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58

5.3.4 Graphical/Tabular Trends Split. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59

5.3.5 Physiology Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

5.3.5.1 Historic Physiology Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61

5.3.6 Cockpit Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61

5.3.7 Physio Relationship . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

5.3.7.1 Continuous and Historical Modes . . . . . . . . . . . . . . . . . . . . . . . . . 62

5.3.7.2 Parameter Boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64

5.3.7.3 Setting Targets and Entering Parameter Values . . . . . . . . . . . . . .64

5.4 Clinical Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

5.4.1 Derived Value Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

5.4.2 Event Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65

5.5 Information Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

5.5.1 Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

5.5.2 Lock Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67

5.6 Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

5.7 Monitor Screen Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

5.7.1 Vertical Scrolling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68

5.7.2 Navigation Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

6 User Interface Settings

6.1 Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

6.1.1 New Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

6.1.2 Continue Monitoring Patient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72

6.1.3 View Patient Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

6.2 Monitor Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

6.2.1 General Monitor Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

6.2.1.1 Change Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .73

6.2.2 Change Date and Time Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

6.2.2.1 Adjust Date or Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74

6.2.3 Monitoring Screens Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

6.2.4 Time Intervals / Averaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

6.2.5 Analog Pressure Signal Input. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

6.2.5.1 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77

7 Advanced Settings

7.1 Alarms / Targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

7.1.1 Silence Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

7.1.1.1 Physiological Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

7.1.1.2 Technical Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

7.1.2 Set Alarm Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

7.1.3 Set Targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81

7.1.4 Alarms / Targets Setup Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

7.1.5 Configure All Targets. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

7.1.6 Set Custom Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84

7.1.7 Configure Targets and Alarms for One Parameter . . . . . . . . . . . . . . . . . .85

7.2 Adjust Scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

7.3 Serial Port Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

7.4 Demo Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

7.5 Engineering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88

8 Data Export and Connectivity Settings

8.1 Export Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

8.1.1 Data Download . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

8.2 Clear Data and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

8.2.1 Restore Factory Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90

8.3 Wireless Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

8.4 HIS Connectivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

8.4.1 Patient Demographic Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92

8.4.2 Patient Physiological Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93

8.4.3 Physiological Alarms and Device Faults . . . . . . . . . . . . . . . . . . . . . . . . . . .93

8.5 Cyber Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

8.5.1 HIPAA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94

9 HemoSphere Swan-Ganz Module Monitoring

9.1 Connecting the HemoSphere Swan-Ganz Module . . . . . . . . . . . . . . . . . . . . . . 95

9.1.1 Patient CCO Cable Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .97

9.2 Continuous Cardiac Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

9.3 Intermittent Cardiac Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

9.4 EDV/RVEF Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

9.5 SVR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

10 Oximetry Monitoring

10.1 Oximetry Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

10.2 In Vitro Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

10.3 In Vivo Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

10.4 Signal Quality Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

10.5 Recall Oximetry Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

10.6 HGB Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

10.7 HemoSphere Oximetry Cable Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

10.8 New Catheter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

11 Troubleshooting

11.1 On Screen Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

11.2 Monitor Status Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

11.3 HemoSphere Advanced Monitor Error Messages . . . . . . . . . . . . . . . . . . . . . 120

11.4 HemoSphere Swan-Ganz Module Error Messages . . . . . . . . . . . . . . . . . . . . 123

9.2.1 Connecting the Patient Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98

9.2.2 Initiating Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

9.2.3 Thermal Signal Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100

9.2.4 CO Countdown Timer and STAT CO . . . . . . . . . . . . . . . . . . . . . . . . . . .100

9.3.1 Connecting Patient Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .101

9.3.1.1 Probe Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102

9.3.2 Configuration Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102

9.3.2.1 Select Injectate Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103

9.3.2.2 Select Catheter Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103

9.3.2.3 Select Computation Constant. . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

9.3.2.4 Select Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104

9.3.3 Instructions for Bolus Measurement Modes . . . . . . . . . . . . . . . . . . . . . . 104

9.3.4 Thermodilution Summary Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

9.4.1 Connecting Patient Cables. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .107

9.4.2 Connecting the ECG Interface Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . .107

9.4.3 Initiating Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .108

9.4.4 Active EDV Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

9.4.5 STAT EDV and RVEF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110

10.2.1 In Vitro Calibration Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113

11.3.1 System Faults/Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

11.3.2 System Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122

11.3.3 Numeric Keypad Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .122

11.4.1 CO Faults/Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .123

11.4.2 EDV and SV Faults/Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124

11.4.3 iCO Faults/Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

11.4.4 SVR Faults/Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .127

11.4.5 General Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128

11.5 Oximetry Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

11.5.1 Oximetry Faults/Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

11.5.2 Oximetry Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

11.5.3 Oximetry General Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . .131

Appendix A: Specifications

A.1 Essential Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

A.2 HemoSphere Advanced Monitor Specifications . . . . . . . . . . . . . . . . . . . . . 133

A.3 HemoSphere Battery Pack Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

A.4 HemoSphere Swan-Ganz Module Specifications . . . . . . . . . . . . . . . . . . . . . 135

A.5 HemoSphere Oximetry Cable Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 136

Appendix B: Accessories

B.1 Accessories List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

B.2 Additional Accessories Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

B.2.1 Roll Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

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

D.1 Patient Data Input Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

D.2 Trend Scale Default Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

D.3 Parameter Display and Configurable Alarm/Target Ranges . . . . . . . . . . . . . . 145

D.4 Alarm and Target Defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

D.5 Alarm Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

D.6 Language Default Settings* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Appendix E: Computation Constants

E.1 Computation Constant Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Appendix F: System Care, Service and Support

F.1 General Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

F.2 Cleaning the Monitor and Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

F.3 Cleaning the Platform Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

F.3.1 Cleaning the HemoSphere Oximetry Cable . . . . . . . . . . . . . . . . . . . . . . . 152

F.3.2 Cleaning the Patient CCO Cable and Connector . . . . . . . . . . . . . . . . . . .153

F.4 Service and Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

F.5 Edwards Lifesciences Regional Headquarters . . . . . . . . . . . . . . . . . . . . . . . . . 154

F.6 Monitor Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

F.6.1 Battery Recycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .154

F.7 Preventive Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

F.7.1 Battery Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

F.7.1.1 Battery Conditioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .155

F.7.1.2 Battery Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

F.8 Testing of Alarm Signals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

F.9 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

Appendix G: Guidance and Manufacturer’s Declaration

G.1 Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

G.2 Instructions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157

G.3 Wireless Technology Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

Appendix H: Glossary

G.3.1 Quality of Service for Wireless Technology . . . . . . . . . . . . . . . . . . . . . .165

G.3.2 Wireless Security Measures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166

G.3.3 Troubleshooting Wireless Coexistence Issues . . . . . . . . . . . . . . . . . . . . . 166

G.3.4 Federal Communication Commission (FCC) Interference Statements .166

G.3.5 Industry Canada Statements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

G.3.6 European Union R&TTE Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

List of Figures

Figure 1-1 HemoSphere advanced monitor hemodynamic technology connections . . . . . . . . . 18

Figure 3-1 HemoSphere advanced monitor front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Figure 3-2 HemoSphere advanced monitor rear view (shown with HemoSphere Swan-Ganz

module) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Figure 3-3 HemoSphere advanced monitor right panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

Figure 3-4 HemoSphere advanced monitor left panel (shown with no modules) . . . . . . . . . . . 37

Figure 3-5 HemoSphere power entry cover - screw locations . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Figure 3-6 Startup screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Figure 3-7 Language selection screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Figure 4-1 HemoSpher

Figure 4-2 Oximetry connection overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Figure 5-1 HemoSphere advanced monitor screen features . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Figure 5-2 Navigation bar - HemoSphere Swan-Ganz module monitoring . . . . . . . . . . . . . . . . 50

Figure 5-3 Example of monitoring screen selection window . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Figure 5-4 Example of key parameter selection popup window . . . . . . . . . . . . . . . . . . . . . . . . . 53

Figure 5-5 Parameter globe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Figure 5-6 Graphical trend screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Figure 5-7 Graphical trend- intervention window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Figure 5-8 Graphical trend screen - intervention information balloon . . . . . . . . . . . . . . . . . . . . 57

Figure 5-9 Tabular trend screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 5-10 Tabular increment popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

Figure 5-11 Physiology screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Figure 5-12 Cockpit monitoring screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Figure 5-13 Physio relationship screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Figure 5-14 Historic physio relationship data screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Figure 5-15 Physio relationship parameter boxes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Figure 5-16 Physio relationship target/enter popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Figure 5-17 Information Bar - HemoSphere Swan-Ganz Module . . . . . . . . . . . . . . . . . . . . . . . 66

Figure 5-18 Lock screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Figure 5-19 Status bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Figure 6-1 New or continuing patient screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Figure 6-2 New Patient Data screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71

Figure 6-3 Monitor Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Figure 6-4 General Monitor Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Figure 6-5 Date / Time Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

Figure 7-1 Alarms / Targets configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83

e Swan-Ganz module monitoring connection overview . . . . . . . . . . . . 43

Figure 7-2 Set custom default Alarms / Targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

Figure 7-3 Set individual parameter alarms and targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Figure 7-4 Graphical trend screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Figure 7-5 Adjust scales . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Figure 7-6 Tabular increment popup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Figure 8-1 HIS- Patient query screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Figure 8-2 HIS- New patient data screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Figure 9-1 HemoSphere Swan-Ganz module connection overview . . . . . . . . . . . . . . . . . . . . . . 96

Figure 9-2 Patient CCO cable test connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Figure 9-3 CO connection overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Figure 9-4 iCO connection overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102

Figure 9-5 iCO new set configuration screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Figure 9-6 Thermodilution summary screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Figure 9-7 EDV/RVEF connection overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

Figure 10-1 Oximetry connection overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Figure 11-1 HemoSphere advanced monitor LED indicators . . . . . . . . . . . . . . . . . . . . . . . . . . 119

List of Tables

Table 1-1 HemoSphere Swan-Ganz module available parameters list . . . . . . . . . . . . . . . . . . . . 16

Table 1-2 HemoSphere oximetry cable available parameters list . . . . . . . . . . . . . . . . . . . . . . . . . 17

Table 1-3 HemoSphere Swan-Ganz module with oximetry cable available parameters list . . . . 17

Table 1-4 HemoSphere Swan-Ganz module parameters description . . . . . . . . . . . . . . . . . . . . . 18

Table 1-5 HemoSphere oximetry cable parameters description . . . . . . . . . . . . . . . . . . . . . . . . . 19

Table 1-6 Operator’s manual style conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Table 1-7 Acronyms, Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Table 2-1 Monitor display symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Table 2-2 Symbols on product labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Table 2-3 Applicable standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Table 3-1 HemoSphere advanced monitoring components . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Table 3-2 Accessories required for monitoring parameters with HemoSphere Swan-Ganz module

. . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Table 3-3 Accessories required for monitoring parameters with HemoSphere oximetry cable . 34

Table 5-1 Graphical trend scroll rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

Table 5-2 Intervention events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Table 5-3 Tabular trend scroll rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

Table 5-4 Reviewed events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Table 5-5 Battery status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Table 6-1 Analog input parameter ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

Table 7-1 Visual alarm indicator colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Table 7-2 Target status indicator colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Table 7-3 Target defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Table 8-1 Wi-Fi connection status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

Table 8-2 HIS connectivity status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92

Table 9-1 Available HemoSphere Swan-Ganz module parameters and required connections . 97

Table 9-2 Unstable thermal signal time lapse for CO alert and fault messages . . . . . . . . . . . . 100

Table 10-1 In vitro calibration options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

Table 10-2 In vivo calibration options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

Table 10-3 Signal quality indicator levels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

Table 11-1 HemoSphere advanced monitor visual alarm indicator . . . . . . . . . . . . . . . . . . . . . . 119

Table 11-2 HemoSphere advanced monitor power light . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Table 11-3 System faults/alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

Table 11-4 HemoSphere advanced monitor warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Table 11-5 Numeric keypad errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Table 11-6 HemoSphere Swan-Ganz module CO faults/alerts . . . . . . . . . . . . . . . . . . . . . . . . 123

Table 11-7 HemoSphere Swan-Ganz module EDV and SV faults/alerts . . . . . . . . . . . . . . . . 124

Table 11-8 HemoSphere Swan-Ganz module iCO faults/alerts . . . . . . . . . . . . . . . . . . . . . . . . 126

Table 11-9 HemoSphere Swan-Ganz module SVR faults/alerts . . . . . . . . . . . . . . . . . . . . . . . . 127

Table 11-10 HemoSphere Swan-Ganz module general troubleshooting . . . . . . . . . . . . . . . . . 128

Table 11-11 Oximetry faults/alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

Table 11-12 Oximetry warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

Table 11-13 Oximetry general troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Table A-1 HemoSphere advanced monitor essential performance – non-transient electromagnetic

phenomena . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

Table A-2 HemoSphere advanced monitor essential performance – transient electromagnetic

phenomena . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Table A-3 HemoSphere advanced monitor physical and mechanical specifications . . . . . . . . 133

Table A-5 HemoSphere advanced monitor technical specifications . . . . . . . . . . . . . . . . . . . . 134

Table A-4 HemoSphere advanced monitor environmental specifications . . . . . . . . . . . . . . . . 134

Table A-6 HemoSphere battery pack physical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Table A-7 HemoSphere battery pack environmental specifications . . . . . . . . . . . . . . . . . . . . . 135

Table A-8 HemoSphere battery pack technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Table A-9 HemoSphere Swan-Ganz module physical specifications . . . . . . . . . . . . . . . . . . . . 135

Table A-11 HemoSphere oximetry cable specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Table A-12 HemoSphere oximetry cable parameter measurement specifications . . . . . . . . . . 136

Table A-10 HemoSphere Swan-Ganz module parameter measurement specifications . . . . . . 136

Table B-1 HemoSphere advanced monitor components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Table C-1 Cardiac and oxygenation profile equations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Table D-1 Patient information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Table D-2 Graphical trend parameter scale defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Table D-3 Configurable parameter alarm and display ranges . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Table D-4 Parameter alarm red zone and target defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

Table D-5 Parameter alarm red zone priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Table D-6 Language default settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Table E-1 Computation constants for bath temperature probe . . . . . . . . . . . . . . . . . . . . . . . . 149

Table E-2 Computation constants for in-line temperature probe . . . . . . . . . . . . . . . . . . . . . . . 150

Table G-1 List of accessories, cables and sensors necessary for compliance . . . . . . . . . . . . . . 157

Table G-2 Electromagnetic emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Table G-3 Guidance and Manufacturer's Declaration - Immunity to RF wireless communications

equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

Table G-4 Recommended Separation Distances between Portable and Mobile RF Communications

Equipment and the HemoSphere advanced monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

Table G-5 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field) . . . . . . . 161

Table G-6 Electromagnetic Immunity (RF Radiated and Conducted) . . . . . . . . . . . . . . . . . . . 162

Table G-7 HemoSphere advanced monitor wireless information . . . . . . . . . . . . . . . . . . . . . . . 163

Introduction

Contents

Intended Purpose of this Manual. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

Contraindications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

Intended Use Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16

HemoSphere Advanced Monitor Hemodynamic Technology Connections. . . . . . . . . . . . . . . . . . . . . . . .18

Manual style conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Abbreviations Found in This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

1.1 Intended Purpose of this Manual

This manual describes the features and monitoring options of the Edwards Lifesciences HemoSphere advanced monitor. The HemoSphere advanced monitor is a modular device that displays monitored data obtained through Edwards hemodynamic technologies.

This manual has been prepared for use with the Edwards Lifesciences HemoSphere advanced monitor by trained critical care clinicians, nurses, and physicians in any hospital environment where critical care is administered.

This manual provides the operator of the HemoSphere advanced monitor with setup and operating instructions, device interfacing procedures, and limitations.

1.2 Indications For Use

1.2.1 HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module

The HemoSphere advanced monitor when used with the HemoSphere Swan-Ganz module and Edwards Swan-Ganz catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.

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

HemoSphere Advanced Monitor 1 Introduction

1.2.2 HemoSphere Advanced Monitor with HemoSphere Oximetry Cable

The HemoSphere advanced monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO

and ScvO2) and derived hemodynamic parameters in a hospital

environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.

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

1.3 Contraindications For Use

The HemoSphere advanced monitor has no contraindications for use.

1.4 Intended Use Statement

The HemoSphere advanced monitoring platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting.

The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters.

A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Swan-Ganz module are listed below in table 1-1. Only iCO, iCI, iSVR, and iSVRI are available to the pediatric patient population.

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

Abbreviation Description Patient population

CO continuous cardiac output

sCO STAT cardiac output

CI continuous cardiac index

sCI STAT cardiac index

EDV right ventricular end diastolic volume

sEDV STAT right ventricular end diastolic volume

EDVI right ventricular end diastolic volume index

sEDVI STAT right ventricular end diastolic volume index

avg

LVSWI left ventricular stroke work index

PVR pulmonary vascular resistance

PVRI pulmonary vascular resistance index

RVEF right ventricular ejection fraction

sRVEF STAT right ventricular ejection fraction

RVSWI right ventricular stroke work index

SV stroke volume

SVI stroke volume index

SVR systemic vascular resistance

SVRI systemic vascular resistance index

averaged heart rate

adult only

HemoSphere Advanced Monitor 1 Introduction

Table 1-1 HemoSphere Swan-Ganz module available parameters list (continued)

Abbreviation Description Patient population

iCO intermittent cardiac output

iCI intermittent cardiac index

iSVR intermittent systemic vascular resistance

iSVRI intermittent systemic vascular resistance index

adult and pediatric

A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere advanced monitor and a connected HemoSphere oximetry cable are listed below in table 1-2.

Table 1-2 HemoSphere oximetry cable available parameters list

Abbreviation Description Patient population

SvO

ScvO

mixed venous oxygen saturation

central venous oxygen saturation

adult and pediatric

A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere Swan-Ganz module and oximetry cable are listed below in table 1-3.

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

list

Abbreviation Description Patient population

I oxygen delivery index

e estimated oxygen consumption when ScvO2 is

I oxygen consumption index

Ie estimated oxygen consumption index when

oxygen delivery

oxygen consumption

being monitored

is being monitored

ScvO

adult and pediatric

WARNING Improper use of the HemoSphere advanced monitor could present a hazard to the patient.

Carefully read the “warnings” section of this manual, located in chapter 2, before using the platform.

The HemoSphere advanced monitor is intended for use only in patient assessment. This instrument must be used in conjunction with a bedside physiological monitor and/or patient clinical signs and symptoms. If hemodynamic values obtained from the device are not consistent with the clinical presentation of the patient, consider troubleshooting before initiating treatment options.

ECG signal input and all parameters derived from heart rate measurements have not been evaluated for pediatric patients and are therefore not available for that patient population.

HemoSphere Advanced Monitor 1 Introduction

L-Tech expansion module

expansion modules (2)

cable ports (2)

L-Tech expansion module slot (1)

expansion module slots (2)

1.5 HemoSphere Advanced Monitor Hemodynamic Technology Connections

The HemoSphere advanced monitor is equipped with three technology expansion module slots (two standard size and one large [L-Tech] size) and two cable ports. Module and cable connection points are located on the left side panel. See figure 1-1.

Figure 1-1 HemoSphere advanced monitor hemodynamic technology connections

Each module/cable is associated with a specific Edwards hemodynamic monitoring technology. Currently available modules include the HemoSphere Swan-Ganz module, introduced below and in detail in chapter 9, HemoSphere Swan-Ganz Module Monitoring. Currently available cables include the HemoSphere oximetry cable, introduced below and described in detail in chapter 10, Oximetry Monitoring.

1.5.1 HemoSphere Swan-Ganz Module

The HemoSphere Swan-Ganz module enables continuous cardiac output (CO) and intermittent cardiac output (iCO) monitoring with an Edwards patient CCO cable and compatible Swan-Ganz catheter. Right ventricular end diastolic volume (EDV) monitoring is available with slaved in heart rate (HR data from a bedside patient monitor. The HemoSphere Swan-Ganz module fits into a standard module slot. For more information, see chapter 9, HemoSphere Swan-Ganz Module Monitoring. Table 1-4 lists the parameters available while using the HemoSphere Swan-Ganz module.

Table 1-4 HemoSphere Swan-Ganz module parameters description

Parameter Description Technology

continuous cardiac output (CO)

continuous cardiac index (CI)

continuous assessment through advanced thermodilution technology of the volume of blood pumped by the heart measured in liters per minute

continuous cardiac output relative to body surface area (BSA)

)

avg

Swan-Ganz CCO and CCOmbo catheters

HemoSphere Advanced Monitor 1 Introduction

Table 1-4 HemoSphere Swan-Ganz module parameters description (continued)

Parameter Description Technology

intermittent cardiac output (iCO)

intermittent cardiac index (iCI)

right ventricular ejection fraction (RVEF)

right ventricular end diastolic volume (EDV)

stroke volume (SV) amount of blood ejected from the ventricles

stroke volume index (SVI) stroke volume relative to body surface area

systemic vascular resistance (SVR)

systemic vascular resistance index (SVRI)

intermittent assessment through the bolus thermodilution method of the volume of blood pumped by the heart measured in liters per minute

intermittent cardiac output relative to body surface area (BSA)

continuous assessment through advanced thermodilution technology and algorithm analysis of the percentage of blood volume ejected from the right ventricle during systole

continuous assessment of the volume of blood in the right ventricle at the end of diastole calculated by dividing stroke volume (mL/beat) by RVEF(%)

with each contraction derived from CO assessment and heart rate (SV = CO/HR x

1000)

(BSA)

a derived measure of impedance to blood flow from left ventricle (afterload)

systemic vascular resistance relative to body surface area (BSA)

Swan-Ganz thermodilution catheters

Swan-Ganz CCOmbo V catheters with ECG signal input

Swan-Ganz CCO,CCOmbo, and CCOmbo V catheters with ECG signal input

Swan-Ganz CCO and CCOmbo catheters with MAP and CVP analog pressure signal input

1.5.2 HemoSphere Oximetry Cable

The HemoSphere oximetry cable enables mixed venous oxygen saturation (SvO (ScvO

) monitoring with a compatible Edwards oximetry

catheter. The HemoSphere oximetry cable plugs into a monitoring cable receptacle and can be used in combination with other hemodynamic monitoring technologies. For more information on oximetry monitoring, see chapter 10, Oximetry Monitoring. Table 1-5 lists the parameters available while using the HemoSphere oximetry cable.

Table 1-5 HemoSphere oximetry cable parameters description

Parameter Description

central venous oximetry (ScvO

mixed venous oximetry

)

(SvO

oxygen consumption (VO

) or central venous oxygen saturation

venous oxygen saturation as measured in the superior

)

vena cava

venous oxygen saturation as measured in the pulmonary artery

) the amount of oxygen used by the body per minute

HemoSphere Advanced Monitor 1 Introduction

Table 1-5 HemoSphere oximetry cable parameters description (continued)

Parameter Description

estimated oxygen consumption (VO2e)

oxygen consumption index

(VO

estimated oxygen consumption index (VO

Ie)

an estimate of the amount of oxygen used by the body per minute (ScvO2 monitoring only)

the amount of oxygen used by the body per minute indexed against body surface area (BSA)

an estimate of the amount of oxygen used by the body per minute indexed against body surface area (BSA)

1.5.3 Documentation and Training

Available documentation and training for the HemoSphere advanced monitor includes:

• HemoSphere Advanced Monitor Operator’s Manual

• HemoSphere Advanced Monitor Quick Start Guide

• HemoSphere Swan-Ganz Module Instructions for Use

• HemoSphere Oximetry Cable Instructions for Use

Instructions for Use are included with HemoSphere Advanced Monitor components. See table B-1, “HemoSphere advanced monitor components,” on page 137. For more information on how you can receive training or available documentation for the HemoSphere advanced monitor, contact your local Edwards representative or Edwards Technical Support. See appendix F, System Care, Service and Support..

1.6 Manual style conventions

Table 1-6 lists the style conventions used in this manual.

Table 1-6 Operator’s manual style conventions

Convention Description

Bold Bold text indicates a software term. This word or phrase will appear on the

screen as shown.

Bold button A button is a touch screen access point for the option appearing in bold.

For example, the Review button appears on screen as:



Oximetry Calibration icon

An arrow is shown between two on screen menu options that are selected consecutively by the operator.

An icon is a touch screen access point for the menu or navigation graphic shown. See table 2-1 on page 29 for full list of menu icons shown on the HemoSphere advanced monitor.

Bold text with a menu icon indicates an icon that is paired with a software term appearing on the screen as shown.

HemoSphere Advanced Monitor 1 Introduction

1.7 Abbreviations Found in This Manual

Table 1-7 Acronyms, Abbreviations

Abbreviation Definition

A/D analog/digital

BSA body surface area

BT blood temperature

arterial oxygen content

CaO

CI cardiac index

CO cardiac output

CCO continuous cardiac output

CVP central venous pressure

I oxygen delivery index

DPT disposable pressure transducer

EDV end diastolic volume

EDVI end diastolic volume index

efu ejection fraction unit

Hct hematocrit

HIS hospital information systems

HGB hemoglobin

HR heart rate

avg

iCO intermittent cardiac output

IEC International Electrotechnical

IT injectate temperature

LED light emitting diode

LVSWI left ventricular stroke work index

MAP mean arterial pressure

MPAP mean pulmonary artery pressure

PA pulmonary artery

PaO

PAWP pulmonary artery wedge pressure

POST power-on self test

PvO

RVEF right ventricular ejection fraction

RVSWI right ventricular stroke work index

sCI STAT cardiac index

sCO STAT cardiac output

ScvO

sEDV STAT end diastolic volume

sEDVI STAT end diastolic volume index

SpO

SQI signal quality indicator

(used when describing certain SwanGanz catheters and patient CCO cable)

oxygen delivery

average heart rate

Commission

partial pressure of arterial oxygen

partial pressure of venous oxygen

central venous oximetry

pulse oximetry saturation

Table 1-7 Acronyms, Abbreviations (continued)

Abbreviation Definition

sRVEF STAT right ventricular ejection fraction

ST surface temperature

STAT fast estimate of parameter value

SV stroke volume

SVI stroke volume index

SvO

SVR systemic vascular resistance

SVRI systemic vascular resistance index

Touch Interact with the HemoSphere advanced

TD thermodilution

USB Universal Serial Bus

I oxygen consumption index

e estimation of oxygen consumption

Ie estimated oxygen consumption index

mixed venous oxygen saturation

monitor by touching the screen.

oxygen consumption

Safety and Symbols

Contents

Safety Signal Words Definitions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

User Interface Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

Symbols on Product Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30

Applicable Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32

HemoSphere Advanced Monitor Essential Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32

2.1 Safety Signal Words Definitions

2.1.1 Warning

A warning advises against certain actions or situations that could result in personal injury or death.

WARNING This is how warnings appear throughout the text of this manual.

2.1.2 Caution

A caution advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.

CAUTION This is how cautions appear throughout the text of this manual.

2.1.3 Note

A note draws attention to useful information regarding a function or procedure.

NOTE This is how notes appear throughout the text of this manual.

HemoSphere Advanced Monitor 2 Safety and Symbols

2.2 Warnings

The following are warnings that are used in the HemoSphere advanced monitor operator’s manual. They are introduced in the manual where relevant to the function or procedure being described.

• Read this operator's manual carefully before attempting to use the Edwards Lifesciences

HemoSphere advanced monitor.

• Refer to the instructions for use provided with each compatible accessory before using it with the

HemoSphere advanced monitor.

• 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.

• Improper use of the HemoSphere advanced monitor could present a hazard to the patient.

Carefully read the “warnings” section of this manual, located in chapter 2, before using the platform. (chapter 1)

• The HemoSphere advanced monitor is intended for use only in patient assessment. This instrument

must be used in conjunction with a bedside physiological monitor and/or patient clinical signs and symptoms. If hemodynamic values obtained from the device are not consistent with the clinical presentation of the patient, consider troubleshooting before initiating treatment options. (chapter 1)

• ECG signal input and all parameters derived from heart rate measurements have not been evaluated

for pediatric patients and are therefore not available for that patient population. (chapter 1)

• Shock hazard: Do not attempt to connect/disconnect system cables while hands are wet. Ensure

that hands are dry prior to disconnecting system cables. (chapter 3)

• Explosion Hazard! Do not use the HemoSphere advanced monitor in the presence of flammable

anesthetic mixture with air or with oxygen or nitrous oxide. (chapter 3)

• Make sure the HemoSphere advanced monitor is securely positioned or mounted and that all cords

and accessory cables are appropriately arranged to minimize the risk of injury to patients, users or the equipment. (chapter 3)

• Do not stack additional equipment or items on top of the HemoSphere advanced monitor. (chapter

• The HemoSphere advanced monitor must be positioned in an upright position to ensure IPX1

ingress protection. (chapter 3)

• Do not allow any liquids to splash onto the monitoring screen. Liquid buildup may disable the

touchscreen functionality. (chapter 3)

• Do not position the monitor so that it is difficult to access rear panel ports or power cord. (chapter

• Equipment may be used in the presence of electrosurgery and defibrillators. Inaccurate parameter

measurements can be caused by factors such as electrocautery or electrosurgery unit interference. (chapter 3)

• All IEC/EN 60950 equipment, including printers, to be positioned no closer than 1.5 meters to the

patient’s bed. (chapter 3)

HemoSphere Advanced Monitor 2 Safety and Symbols

• Make sure the battery is fully inserted and the battery door is properly latched. Falling batteries

could seriously injure patients or clinicians. (chapter 3)

• Only use Edwards approved batteries with the HemoSphere advanced monitor. Do not charge the

battery pack outside of the monitor. Doing so can damage the battery or injure the user. (chapter 3)

• To prevent any interruptions to monitoring during power loss, it is recommended to use the

HemoSphere advanced monitor with the battery inserted. (chapter 3)

• In cases of power failure and battery depletion, the monitor will go through a controlled shut off

procedure. (chapter 3)

• Do not use the HemoSphere advanced monitoring platform without an installed power cord entry

cover. Failure to do so may result in fluid ingress. (chapter 3)

• Do not use extension cords or multiple socket devices to connect the power cord. Do not use

detachable power cords other than the power cord provided. (chapter 3)

• To avoid the risk of electric shock, the HemoSphere advanced monitor can only be connected to a

supply mains with grounding (protective earth). Do not use three prong to two prong power adaptors. (chapter 3)

• Grounding reliability can only be achieved when the instrument is connected to a receptacle marked

“hospital only”, “hospital grade”, or its equivalent. (chapter 3)

• Disconnect the monitor from the AC source by unplugging mains power cable from the AC Mains.

The On/Off button on the monitor does not disconnect the system from the AC mains supply. (chapter 3)

• Only use HemoSphere advanced monitor accessories, cables and or components that have been

supplied and labeled by Edwards. Using other unlabeled accessories, cables and or components may affect patient safety and measurement accuracy. (chapter 3)

• Upon initiation of a new patient session, the default high/low physiological alarm ranges should be

checked to ensure that they are appropriate for the given patient. (chapter 6)

• Perform New Patient or clear the patient data profile whenever a new patient is connected to the

HemoSphere advanced monitor. Failure to do so may result in previous patient data in the historical displays. (chapter 6)

• The analog communication ports of the HemoSphere advanced monitor share a common ground

that is isolated from the catheter interface electronics. When connecting multiple devices to the HemoSphere advanced monitor, all devices should be provided with isolated power to avoid compromising the electrical isolation of any of the connected devices. (chapter 6)

• Risk and Leakage current of the final system configuration must comply with IEC 60601-1:2005/

A1:2012. It is the responsibility of the user to ensure compliance. (chapter 6)

• Accessory equipment connected to the monitor must be certified according to IEC/EN 60950 for

data-processing equipment or IEC 60601-1:2005/A1:2012 for electromedical equipment. All combinations of equipment must be in compliance with IEC 60601-1:2005/A1:2012 systems requirements. (chapter 6)

• When switching to a different bedside monitor, always check that the default values listed are still

valid. If necessary, reconfigure the voltage range and corresponding parameter range or calibrate. (chapter 6)

HemoSphere Advanced Monitor 2 Safety and Symbols

• Do not turn off the audible alarms in situations in which patient safety could be compromised.

(chapter 7)

• Do not lower the alarm volume to a level that prohibits alarms from being adequately monitored.

Failure to do so could result in a situation where patient safety is compromised. (chapter 7)

• Visual and audible physiological alarms are activated only if the parameter is configured on the

screens as a key parameter (1-4 parameters displayed in parameter globes). If a parameter is not selected and displayed as a key parameter, the audible and visual physiological alarms are not triggered for that parameter. (chapter 7)

• Make sure that Demo Mode is not activated in a clinical setting to ensure that simulated data is not

mistaken for clinical data. (chapter 7)

• Do not use the HemoSphere advanced monitor as part of a Distributed Alarm System. The

HemoSphere advanced monitor does not support remote alarm monitoring/management systems. Data is logged and transmitted for charting purposes only. (chapter 8)

• CO monitoring should always be discontinued when blood flow around the thermal filament is

stopped. Clinical situations where CO monitoring should be discontinued include, but are not limited to: • Time periods when a patient is on cardiopulmonary bypass • Partial withdrawal of the catheter so that the thermistor is not in the pulmonary artery • Removal of the catheter from the patient (chapter 9)

• PACEMAKER PATIENTS – Rate meters may continue to count the pacemaker rate during

occurrences of cardiac arrest or some arrhythmias. Do not rely entirely upon displayed heart rate. Keep pacemaker patients under close surveillance. See table A-5 on page 134 for disclosure of the pacemaker pulse rejection capability of this instrument. (chapter 9)

•

For patients requiring internal or external pacing support, the

HemoSphere advanced monitoring platform should not be used to obtain heart rate and heart rate derived parameters under the following conditions:

• pacer pulse synch output from bedside monitor includes the pacer pulse, however, the characteristics are outside of the pacemaker pulse rejection capabilities specifications as listed in table A-5.

• pacer pulse synch output characteristics from bedside monitor cannot be determined (chapter 9)

Note any discrepancies in heart rate (HRavg) with the patient monitor HR and ECG waveform

•

display when interpreting derived parameters such as SV, EDV, RVEF, and associated index parameters. (chapter 9)

• Do not wrap the main body of the oximetry cable in fabric or place directly on the patient's skin

for long periods of time (>10 min). The surface does get warm (up to 45 °C) and needs to dissipate heat to maintain its internal temperature level. A software fault will trigger if the internal temperature exceeds its limits. (chapter 10)

• Before touching Yes to recall oximetry data, confirm that the displayed data matches the current

patient. Recalling incorrect oximetry calibration data and patient demographics will result in inaccurate measurements. (chapter 10)

• Only use approved HemoSphere advanced monitor accessories, cables and or components that

have been supplied and labeled by Edwards. Using unapproved accessories, cables and or components may affect patient safety and measurement accuracy. (appendix B)

HemoSphere Advanced Monitor 2 Safety and Symbols

• The HemoSphere advanced monitor contains no user-serviceable parts. Removing the cover or any

other disassembly will expose you to hazardous voltages. (appendix F)

• Shock or fire hazard! Do not immerse the HemoSphere advanced monitor, modules, or platform

cables in any liquid solution. Do not allow any fluids to enter the instrument. (appendix F)

• Explosion Hazard! Do not open battery, dispose of in fire, store at high temperature or short

circuit. It may ignite, explode, leak or get hot, causing serious personal injury or death. (appendix F)

• Use of accessories, sensors, and cables other than those specified may result in increased

electromagnetic emissions or decreased electromagnetic immunity. (appendix G)

• No modification of the HemoSphere advanced monitor is allowed. (appendix G)

• Portable and mobile RF communication equipment can potentially affect all electronic medical

equipment, including the HemoSphere advanced monitor. Guidance on maintaining appropriate separation between communications equipment and the HemoSphere advanced monitor is provided in table G-4. (appendix G)

2.3 Cautions

The following are cautions that are used in the HemoSphere advanced monitor operator’s manual. They are introduced in the manual where relevant to the function or procedure being described.

• Federal (USA) law restricts this device to sale by or on the order of a physician.

• Inspect all accessories and equipment for damage prior to use with the HemoSphere advanced

monitor. Damage may include cracks, scratches, dents, exposed electrical contacts, or any signs that the housing may be compromised.

• Always grasp the connector, not the cable, when connecting or disconnecting cables. Do not twist

or bend the connectors. Confirm that all sensors and cables are connected correctly and completely before use. (chapter 3)

• To avoid corruption of data on the HemoSphere advanced monitor, always disconnect the patient

CCO cable and oximetry cable from the monitor before using a defibrillator. (chapter 3)

• Do not expose the HemoSphere advanced monitor to extreme temperatures. Refer to

environmental specifications in appendix A. (chapter 3)

• Do not expose the HemoSphere advanced monitor to dirty or dusty environments. (chapter 3)

• Do not obstruct the HemoSphere advanced monitor ventilation openings. (chapter 3)

• Do not use the HemoSphere advanced monitor in environments where strong lighting makes the

LCD screen difficult to view. (chapter 3)

• Do not use the monitor as a handheld device. (chapter 3)

• When moving the instrument, be sure to turn off the power and remove the connected power cord.

(chapter 3)

• When connecting the HemoSphere advanced monitor to external devices, refer to the external

device’s instruction manual for complete instructions. Verify proper operation of the system before clinical use. (chapter 6)

HemoSphere Advanced Monitor 2 Safety and Symbols

• Only properly trained personnel should calibrate the HemoSphere advanced monitor analog ports.

(chapter 6)

• The accuracy of continuous SVR depends upon the quality and accuracy of the MAP and CVP data

transmitted from the external monitors. Since MAP and CVP analog signal quality from the external monitor cannot be validated by the HemoSphere advanced monitor, actual values and the values (including all derived parameters) displayed by the HemoSphere advanced monitor may not be consistent. The accuracy of continuous SVR measurement, therefore, cannot be guaranteed. To aid in determining the quality of the analog signals, regularly compare the MAP and CVP values displayed on the external monitor to the values displayed on the physio relationship screen of the HemoSphere advanced monitor. Refer to the external input device operator’s manual for detailed information regarding accuracy, calibration, and other variables which may impact the analog output signal from the external monitor. (chapter 6)

• Use a virus scan on any USB stick before inserting to prevent a virus or malware infection. (chapter

• Restore Defaults replaces all settings with factory defaults. Any settings changes or customizations

will be permanently lost. Do not restore defaults while monitoring a patient. (chapter 8)

• Do not force the module into the slot. Apply even pressure to slide and click the module into place.

(chapter 9)

• Inaccurate cardiac output measurements may be caused by: • Incorrect placement or position of

the catheter • Excessive variations in pulmonary artery blood temperature. Some examples that cause BT variations include, but are not limited to: * status post cardiopulmonary bypass surgery * centrally administered cooled or warmed solutions of blood products * use of sequential compression devices • Clot formation on the thermistor • Anatomical abnormalities (for example, cardiac shunts) • Excessive patient movement • Electrocautery or electrosurgical unit interference

• Rapid changes in cardiac output (chapter 9)

• Refer to Appendix E to ensure computation constant is the same as specified in the catheter

package insert. If the computation constant differs, enter the desired computation constant manually. (chapter 9)

• Sudden changes in PA blood temperature, such as those caused by patient movement or bolus drug

administration, may cause an iCO or iCI value to be computed. To avoid falsely triggered curves, inject as soon as possible after the Inject message appears. (chapter 9)

• Make sure that the oximetry cable is securely stabilized to prevent unnecessary movement of the

attached catheter. (chapter 10)

• The catheter and the calibration cup must be dry for an accurate oximetry in vitro calibration. Flush

the catheter lumen only after the in vitro calibration has been completed. (chapter 10)

• Performing an in vitro calibration after the oximetry catheter has been inserted into the patient will

yield an inaccurate calibration. (chapter 10)

• The SQI signal is sometimes affected by the use of electrosurgical units. Attempt to distance

electrocautery equipment and cables from the HemoSphere advanced monitor and plug the power cords into separate AC circuits if possible. If signal quality problems persist, call your local Edwards representative for assistance. (chapter 10)

• Do not disconnect the oximetry cable while calibration or data recall are in process. (chapter 10)

HemoSphere Advanced Monitor 2 Safety and Symbols

• If the oximetry cable is being transferred from a HemoSphere advanced monitor to another

HemoSphere advanced monitor, check that the patient height, weight, and BSA are correct prior to beginning monitoring. Re-enter patient data, if necessary. (chapter 10)

• Clean and store the instrument and accessories after each use. (appendix F)

• Do not pour or spray liquid on any portion of the HemoSphere advanced monitor, accessories,

modules, or cables. (appendix F)

• Do not use any disinfecting solution other than the types specified. (appendix F)

• DO NOT: Allow any liquid to come in contact with the power connector Allow any liquid to

penetrate connectors or openings in the monitor case or modules If any liquid does come in contact with any of the above mentioned items, DO NOT attempt to operate the monitor. Disconnect power immediately and call your Biomedical Department or local Edwards representative. (appendix F)

• Conduct periodic inspections of all cables for defects. Do not coil cables tightly when storing.

(appendix F)

• Do not steam, radiate, or EO sterilize the HemoSphere oximetry cable. Do not immerse the

HemoSphere oximetry cable. (appendix F)

• If any electrolytic solution, for example Ringer’s lactate solution, is introduced into the cable

connectors while they are connected to the monitor, and the monitor is turned on, the excitation voltage can cause electrolytic corrosion and rapid degradation of the electrical contacts. (appendix F)

• Do not immerse any cable connectors in detergent, isopropyl alcohol or glutaraldehyde. (appendix

• Do not use a hot air gun to dry cable connectors. (appendix F)

• Recycle or dispose of the lithium-ion battery in accordance to all federal, state, and local laws.

(appendix F)

• The instrument has been tested and complies with the limits of IEC 60601-1-2. These limits are

designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: · Reorient or relocate the receiving device.

· Increase the separation between the equipment. · Consult the manufacturer for help. (appendix G)

HemoSphere Advanced Monitor 2 Safety and Symbols

2.4 User Interface Symbols

The following are icons that appear on the HemoSphere advanced monitor screen. For more information about screen appearance and navigation, see chapter 5, Navigating the HemoSphere Advanced Monitor. Certain icons will only appear while monitoring with a specific hemodynamic technology module or cable, as specified.

Table 2-1 Monitor display symbols

Symbol Description

Navigation Bar Icons

begin CO monitoring (HemoSphere Swan-Ganz module)

stop CO monitoring with CO countdown timer (see CO Countdown Timer and STAT CO on page 100) (HemoSphere Swan-Ganz module)

monitor screen selection

clinical actions menu

settings menu

snapshot (screen capture)

silence audible alarms

Table 2-1 Monitor display symbols (continued)

Symbol Description

event review

patient CCO cable test (HemoSphere Swan-Ganz module)

Menu Navigation Icons

return to main monitoring screen

return to previous menu

cancel

scroll to select item on vertical list

vertical page scroll

horizontal scroll

alarms paused (silenced) with countdown timer (See Silence Audible Alarms on page

51)

monitoring pause exit

Clinical Action Menu Icons

iCO (intermittent cardiac output) (HemoSphere Swan-Ganz module)

oximetry calibration (HemoSphere oximetry cable)

derived value calculator

enter

keypad enter key

keypad backspace key

move cursor left by 1 character

move cursor right by 1 character

keypad cancel key

item enabled

HemoSphere Advanced Monitor 2 Safety and Symbols

Table 2-1 Monitor display symbols (continued)

Symbol Description

item not enabled

clock/waveform - allows user to view historical data or intermittent data

Parameter Globe Icons

clinical/alarm indicators: green: in target range

yellow: out of target range red: red alarm and/or target zone gray: no target set

Alarms / Targets popup: parameter audible alarm indicator enabled

Alarms / Targets popup: parameter audible alarm indicator disabled

signal quality indicator bar See Signal Quality Indicator on page 114 (HemoSphere oximetry cable)

Information Bar Icons

HIS enabled icon on information bar See table 8-2 on page 92

battery life indicator icons on information bar See table 5-5 on page 66

Table 2-1 Monitor display symbols (continued)

Symbol Description

CO countdown (HemoSphere Swan-Ganz module)

averaged heart rate (HemoSphere Swan-Ganz module with ECG input)

Wi-Fi signal See table 8-1 on page 91

Intervention Analysis Icons

intervention analysis button

intervention analysis type indicator for custom event (gray)

intervention analysis type indicator for positional challenge (purple)

intervention analysis type indicator for a fluid challenge (blue)

intervention analysis type indicator for intervention (green)

edit icon on intervention information balloon

keyboard icon for entering notes on intervention edit screen

2.5 Symbols on Product Labels

This section provides the symbols that are on the HemoSphere advanced monitor and other available HemoSphere advanced monitoring platform accessories.

Table 2-2 Symbols on product labels

Symbol Description

Manufacturer

Date of manufacture

Caution: Federal (USA) law restricts this device to sale by, or on the order of a physician.

IPX1

IPX4

Provides protection against vertically falling water to IPX1 standard

Provides protection against water splashing in any direction to IPX4 standard

Table 2-2 Symbols on product labels (continued)

Symbol Description

Separate collection for electrical and electronic equipment in accordance with EC directive 2002/96/EC.

Restriction of Hazardous Substances (RoHS) compliance - China only

Federal Communications Commission (FCC) compliance - USA only

This device contains a non-ionizing radiation transmitter, which can cause RF interference with other devices near this device.

+ 146 hidden pages

Edwards HemoSphere Operator's Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

List of Figures

List of Tables

Introduction

1.1 Intended Purpose of this Manual

1.2 Indications For Use

1.2.1 HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module

1.2.2 HemoSphere Advanced Monitor with HemoSphere Oximetry Cable

1.3 Contraindications For Use

1.4 Intended Use Statement

1.5 HemoSphere Advanced Monitor Hemodynamic Technology Connections

1.5.1 HemoSphere Swan-Ganz Module

1.5.2 HemoSphere Oximetry Cable

1.5.3 Documentation and Training

1.6 Manual style conventions

1.7 Abbreviations Found in This Manual

Safety and Symbols

2.1 Safety Signal Words Definitions

2.1.1 Warning

2.1.2 Caution

2.1.3 Note

2.2 Warnings

2.3 Cautions

2.4 User Interface Symbols

2.5 Symbols on Product Labels