Edwards HemoSphere Operator's Manual

Download

Page 1

Edwards Lifesciences

HemoSphere Advanced Monitor

Operator’s manual

Page 2

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

Page 3

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.

Page 4

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

Page 5

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

Page 6

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

Page 7

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

Page 8

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

Page 9

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

Page 10

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

Page 11

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

Page 12

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

Page 13

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

Page 14

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

Page 15

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.

Page 16

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

Page 17

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.

Page 18

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

Page 19

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

Page 20

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.

Page 21

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

Page 22

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.

Page 23

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)

Page 24

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)

Page 25

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)

Page 26

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)

Page 27

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)

Page 28

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)

Page 29

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

Page 30

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.

Page 31

HemoSphere Advanced Monitor 2 Safety and Symbols

Table 2-2 Symbols on product labels (continued)

Symbol Description

Consult instructions for use on eifu.edwards.com

Instructions for use in electronic form is available by phone or website address.

Intertek ETL

Catalogue number

Serial number

Authorized representative in the European Community

Magnetic resonance unsafe

CE conformity marking per European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

Lot number

Table 2-2 Symbols on product labels (continued)

Symbol Description

USB 3.0

Ethernet connection

Analog input 1

Analog input 2

DPT pressure output

Defibrillation proof type CF applied part or connection

ECG

ECG input from external monitor

High-Definition Multimedia Interface output

Connector: serial COM output (RS232)

Additional Packaging Labels

Keep contents dry

Part number

Lead-free

Underwriters Laboratories product certification mark

Recyclable Lithium-Ion

Do not disassemble

Do not incinerate

Connector Identification Labels

Equipotential terminal stud

USB 2.0

Fragile. Handle with care

This end up

Do not use if package is damaged

Box made from recyclable cardboard

Keep away from direct sunlight.

Page 32

HemoSphere Advanced Monitor 2 Safety and Symbols

Table 2-2 Symbols on product labels (continued)

Symbol Description

Temperature limitations (X = lower limit, Y = upper limit)

Humidity limitations (X = lower limit, Y = upper limit)

NOTE For all accessory product labels, refer to symbol table contained in accessory

instructions for use.

2.6 Applicable Standards

Table 2-3 Applicable standards

Standard Title

IEC 60601-1:2005 / A1:2012 Medical electrical equipment — Part 1: General requirements for basic

safety and essential performance + amendment 1 (2012)

IEC 60601-1-2: 2014 Medical electrical equipment — Part 1-2: General requirements for basic

safety and essential performance — Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC 60601-2-49:2011 Particular requirements for the basic safety and essential performance of

multifunction patient monitoring equipment

IEEE 802.11 b/g/n Telecommunications and information exchange between systems Local

and metropolitan area networks — Specific requirements Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications

2.7 HemoSphere Advanced Monitor Essential Performance

The platform shall provide display of continuous CO and intermittent CO with a compatible Swan-Ganz catheter according to the specifications provided in appendix A. The platform shall provide display of SvO ScvO

with a compatible oximetry catheter according to the specifications provided in appendix A. The

platform shall provide alarm, alert, indicator, and/or system status when unable to provide accurate measurement of the applicable hemodynamic parameter. For more information, see Essential Performance Characteristics on page 132.

Page 33

Installation and Setup

Contents

Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

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

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

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

3.1 Unpacking

Examine the shipping container for any signs of damage that may have occurred during transit. If any damage is detected, photograph the package and contact Edwards technical support for assistance. Perform a visual inspection of the packaging contents for damage. Damage may include cracks, scratches, dents or any signs that the monitor, modules or cable housing may be compromised. Report any evidence of external damage.

3.1.1 Packaging Contents

The HemoSphere advanced monitoring platform is modular and therefore packaging configurations will vary depending upon the kit ordered. The HemoSphere advanced monitoring system, which is the base kit configuration, contains the HemoSphere advanced monitor, mains power cord, power entry cover, HemoSphere battery pack, two expansion modules, one L-Tech expansion module, a quick start guide and a USB stick containing this operator’s manual. See table 3-1. Additional items that may be included and shipped with other kit configurations include the HemoSphere Swan-Ganz module, patient CCO cable, and HemoSphere oximetry cable. Disposable and accessory items may be delivered separately. It is recommended that the user confirm the receipt of all ordered equipment. Refer to appendix B: Accessories, for a full list of available accessories.

Table 3-1 HemoSphere advanced monitoring components

HemoSphere advanced monitoring system (base kit)

• HemoSphere advanced monitor

• HemoSphere battery pack

• mains power cord

• power entry cover

• L-Tech expansion module

• expansion module (2)

• quick start guide

• operator’s manual (on USB stick)

Page 34

HemoSphere Advanced Monitor 3 Installation and Setup

3.1.2 Required Accessories for Platform Modules and Cables

The following tables identify accessories required to display specific monitored and calculated parameters for the specified hemodynamic technology module or cable:

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

Ganz module

Monitored and calculated parameters

Required Accessory CO EDV RVEF SVR iCO SV

patient CCO cable

ECG cable

analog pressure input cable(s)

injectate temperature probe

Swan-Ganz thermodilution catheter

Swan-Ganz CCO catheter or SwanGanz CCOmbo catheter

Swan-Ganz CCOmbo V catheter

••••••

•• •

•

• •••

••••••

NOTE Not all parameters can be monitored or calculated in pediatric patients. See table 1-1 on

page 16 for available parameters.

Table 3-3 Accessories required for monitoring parameters with HemoSphere oximetry

cable

Monitored and

calculated

parameters

Required Accessory ScvO

PediaSat oximetry catheter or compatible central venous oximetry catheter

Swan-Ganz oximetry catheter

•

SvO

•

WARNING Shock hazard: Do not attempt to connect/disconnect system cables while hands are

wet. Ensure that hands are dry prior to disconnecting system cables.

CAUTION 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.

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.

Page 35

HemoSphere Advanced Monitor 3 Installation and Setup





 visual alarm indicator  power button

3.2 HemoSphere Advanced Monitor Connection Ports

The following monitor views illustrate the connection ports and other key features of the front, rear, and side panels of the HemoSphere advanced monitor.

3.2.1 Monitor Front

Figure 3-1 HemoSphere advanced monitor front view

Page 36

HemoSphere Advanced Monitor 3 Installation and Setup





















 mains power cord

connection (power entry cover removed)

 HDMI port

 Ethernet port

 USB port

 COM1 serial port

connector (RS-232)

 Analog input 1

 Analog input 2

 ECG input

 pressure output

 equipotential

terminal stud

3.2.2 Monitor Rear

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

module)

Page 37

HemoSphere Advanced Monitor 3 Installation and Setup





 USB port  battery door







 L-Tech expansion module slot  expansion module slots (2)  cable ports (2)

3.2.3 Monitor Right Panel

Figure 3-3 HemoSphere advanced monitor right panel

3.2.4 Monitor Left Panel

Figure 3-4 HemoSphere advanced monitor left panel (shown with no

modules)

Page 38

HemoSphere Advanced Monitor 3 Installation and Setup

3.3 HemoSphere Advanced Monitor Installation

3.3.1 Mounting Options and Recommendations

The HemoSphere advanced monitor should be placed on a stable flat surface or securely mounted on a compatible stand, according to your institution’s practices. A roll stand for the HemoSphere advanced monitor is available as an optional accessory. See Additional Accessories Description on page 138 more information. Contact your local Edwards representative for recommendations on additional mounting options.

WARNING Explosion Hazard! Do not use the HemoSphere advanced monitor in the presence

of flammable anesthetic mixture with air or with oxygen or nitrous oxide.

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.

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

The HemoSphere advanced monitor must be positioned in an upright position to ensure IPX1 ingress protection.

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

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

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.

All IEC/EN 60950 equipment, including printers, to be positioned no closer than 1.5 meters to the patient’s bed.

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

environmental specifications in appendix A.

Do not expose the HemoSphere advanced monitor to dirty or dusty environments.

Do not obstruct the HemoSphere advanced monitor ventilation openings.

Do not use the HemoSphere advanced monitor in environments where strong lighting makes the LCD screen difficult to view.

Do not use the monitor as a handheld device.

Page 39

HemoSphere Advanced Monitor 3 Installation and Setup

3.3.2 Battery Installation

Open the battery door (figure 3-3) and insert the battery into the battery bay, ensuring pack is fully inserted and seated. Close the battery door and ensure that the latch is securely fastened. Follow instructions below to connect the power cord and then fully charge the battery. Do not use a new battery pack as a power source until it has been fully charged.

NOTE To ensure that the battery charge level displayed on the monitor is accurate, please

condition the battery before first use. For information on battery maintenance and conditioning, see Battery Maintenance on page 155.

The HemoSphere battery pack is intended as a backup power source during power-loss and can only support monitoring for a limited time period.

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

batteries could seriously injure patients or clinicians.

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.

To prevent any interruptions to monitoring during power loss, it is recommended to use the HemoSphere advanced monitor with the battery inserted.

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

3.3.3 Connecting Power Cord

Before connecting the power cord to the rear panel of the monitor, ensure that the power entry cover is installed:

1 If the power entry cover is already installed, remove the two screws (figure 3-5) that attach the

power entry cover to the rear panel of the monitor.

2 Connect the detachable power supply cord. Ensure that the plug is seated securely.

3 Attach the power cord entry cover over the plug by routing the power cord through the cover

opening and then pressing the cover and gasket up against the rear panel of the monitor, aligning the two screw holes.

4 Reinsert the screws to fasten the cover onto the monitor.

5 Plug power cord into a hospital grade outlet.

WARNING Do not use the HemoSphere advanced monitoring platform without an installed power

cord entry cover. Failure to do so may result in fluid ingress.

Page 40

HemoSphere Advanced Monitor 3 Installation and Setup

Figure 3-5 HemoSphere power entry cover - screw locations

3.3.3.1 Equipotential Connection

This monitor MUST be grounded during operation (Class I equipment according to IEC 60601-1). If a hospital grade or three-prong receptacle is not available, a hospital electrician must be consulted to ensure proper grounding. An equipotential terminal is provided on the rear panel of the monitor (figure 3-2) to be connected to an equipotential grounding system (equipotential cable).

WARNING 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.

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.

Grounding reliability can only be achieved when the instrument is connected to a receptacle marked “hospital only”, “hospital grade”, or its equivalent.

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.

CAUTION When moving the instrument, be sure to turn off the power and remove the connected

power cord.

3.3.4 Connecting and Disconnecting a Hemodynamic Monitoring Module

The HemoSphere advanced monitor is shipped with two standard expansion modules and one L-Tech expansion module. Before inserting a new monitoring technology module, remove the expansion module by pressing the release button to unlatch and slide the blank module out.

Inspect the new module for external damage before installation. Insert the desired monitoring module into the open slot by applying even pressure to slide and click the module into place.

3.3.5 Connecting and Disconnecting a Hemodynamic Monitoring Cable

Both monitoring cable ports are equipped with a magnetic latch mechanism. Inspect the cable for damage before connecting. A monitoring cable will snap into place when it is properly seated in the port. To disconnect a cable, hold at the plug to pull it away from the monitor.

Page 41

HemoSphere Advanced Monitor 3 Installation and Setup

3.3.6 Connecting Cables from External Devices

The HemoSphere advanced monitor utilizes slaved-in monitored data to calculate certain hemodynamic parameters. This includes data from the pressure input data ports and ECG monitor input port. All slavedin cable connections are located on the rear panel of the monitor (figure 3-2). See Required Accessories for Platform Modules and Cables on page 34 for a list of calculated parameters available with certain cable connections. For more information on configuring the analog pressure ports, see Analog Pressure Signal Input on page 75.

IMPORTANT NOTE The HemoSphere advanced monitor is compatible with pressure

and ECG analog slave inputs from any external patient monitor that has analog slave output ports which meet the signal input specifications identified in appendix A, table A-5 of this operator’s manual. These provide a convenient means to utilize information from a patient monitor to calculate additional hemodynamic parameters for display. This is an optional feature that does not impact the HemoSphere advanced monitor’s primary function of monitoring cardiac output (with the HemoSphere Swan-Ganz module) and venous oxygen saturation (with the HemoSphere oximetry cable).

WARNING 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.

3.4 Initial Start Up

3.4.1 Start Up Procedure

To turn on and off the monitor, press the power button located on the front panel. After turning on the monitor, the Edwards screen is displayed followed by the Power-On Self Test (POST) screen. The POST verifies the monitor meets basic operating requirements by exercising critical hardware components and is performed each time the system is turned on. POST status message is displayed on the startup screen along with system information such as serial numbers and software version numbers.

Page 42

HemoSphere Advanced Monitor 3 Installation and Setup

Figure 3-6 Startup screen

NOTE If the diagnostic tests detect an error condition, a system error screen will replace the

startup screen. See chapter 11: Troubleshooting or appendix F: System Care, Service and Support. Otherwise, call your Edwards Lifesciences representative for assistance.

3.4.2 Select Language

Upon initial HemoSphere advanced monitor startup, language options are offered which affect the displayed language, time and date formats, and units of measurement. The language selection screen appears after the software has initialized and POST is complete. Selecting the language also sets the display units and the time and date format to the default settings for that language (see appendix D: Monitor Settings and Defaults).

Each of the language-related settings can be changed later in the Date/Time screen of the Monitor Settings screen and in the language option through Monitor Settings

When the language selection screen appears, touch the desired language for use.

 General.

Figure 3-7 Language selection screen

NOTE Figure 3-6 and figure 3-7 are examples of startup and language selection screens.

Page 43

 thermistor connection

 thermal filament

connection

 injectate temperature

probe connection

 patient CCO cable

 HemoSphere Swan-

Ganz module

 HemoSphere advanced

monitor

HemoSphere Advanced Monitor Quick Start

Contents

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

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

NOTE This chapter is intended for experienced clinicians. It provides brief instructions for

using the HemoSphere advanced monitor. Refer to the manual chapters for more detailed information, warnings, and cautions.

4.1 HemoSphere Swan-Ganz Module Cardiac Output Monitoring

Refer to figure 4-1 for HemoSphere Swan-Ganz module monitoring connections.

Figure 4-1 HemoSphere Swan-Ganz module monitoring connection overview

Page 44

HemoSphere Advanced Monitor 4 HemoSphere Advanced Monitor Quick Start

1 Ensure that the HemoSphere advanced monitor is off and then insert the HemoSphere Swan-

Ganz module into the monitor. The module will click when properly engaged.

2 Press the power button to turn on the HemoSphere advanced monitor. All functions are accessed

through the touch screen.

3 Select Continue Same Patient button or New Patient button and enter new patient data.

4 Connect the patient CCO cable to the HemoSphere Swan-Ganz module.

5 Touch the monitor screen selection icon to select the desired monitoring screen view.

6 Touch outside of a parameter globe to select the desired key parameter from the parameter popup.

7 Touch wit hin a parameter globe to adjust Alarms/Targets.

8 Depending on catheter type, continue to step 9 in one of the following sections:

• section 4.1.1 for CO monitoring

• section 4.1.2 for iCO monitoring

• section 4.1.3 for EDV monitoring

4.1.1 Continuous Cardiac Output Monitoring

9 Attach the thermistor  and thermal filament  Swan-Ganz CCO catheter connections

(figure 4-1) to the patient CCO cable.

10 Verify that the catheter is properly inserted into the patient.

11 Touch the start monitoring icon . A countdown clock will appear on the stop monitoring

icon to indicate the time until the first CO value. After approximately 3 to 6 minutes, when

sufficient data has been obtained, a CO value will appear in the parameter globe.

12 The time until the next CO measurement is displayed on the information bar. For longer time

spans between calculations, select STAT CO (sCO) as a key parameter. sCO is a fast estimate of the CO value.

13 Touch the stop monitoring icon to stop CO monitoring.

4.1.2 Intermittent Cardiac Output Monitoring

Follow steps 1-8 at the start of section 4.1 before proceeding.

9 Attach the Swan-Ganz catheter thermistor connection (, figure 4-1) to the patient CCO cable.

10 Connect the injectate temperature probe to the injectate temperature probe connector  on the

patient CCO cable. The injectate system type (in-line or bath) is automatically detected.

11 Touch clinical actions icon  iCO icon .

12 Select the following settings on the new set configuration screen:

• Injectate Volume: 10 mL, 5 mL, or 3 mL (bath type probe only)

• Catheter Size: 5.5F, 6F, 7F, 7.5F, or 8F

• Comp Constant: Auto, or keypad appears for manual entry when selected

Page 45

HemoSphere Advanced Monitor 4 HemoSphere Advanced Monitor Quick Start

NOTE The computation constant is automatically calculated according to injectate system

type, injectate volume and catheter size. If the computation constant is manually entered, the injectate volume and catheter size selections are set to Auto.

• Bolus Mode: Auto or Manual

13 Touch t h e Start Set button.

14 If in automatic bolus mode, Wait appears highlighted ( ) until the thermal baseline is

achieved. If in manual bolus mode, Ready ( ) will appear highlighted when the thermal

baseline is achieved. Touch the Inject button first to start the bolus procedure.

15 When Inject becomes highlighted ( ), use a rapid, smooth, continuous method to inject

the bolus with the volume amount previously selected.

16 Computing is highlighted ( ) and then the resultant iCO measurement is displayed.

17 Repeat steps 14-16 up to six times as desired.

18 Touch t h e Review button and if necessary, edit the bolus series.

19 Touch t h e Accept button.

4.1.3 Continuous End Diastolic Volume Monitoring

Follow steps 1-8 at the start of section 4.1 before proceeding.

9 Attach the thermistor  and thermal filament  Swan-Ganz volumetric catheter connections

(figure 4-1) to the patient CCO cable.

10 Verify that the catheter is properly inserted into the patient.

11 Connect one end of the ECG interface cable to the rear panel of the HemoSphere advanced

monitor and the other end to the bedside monitor’s ECG signal output.

12 Touch the start monitoring icon to begin CO/EDV monitoring.

13 A countdown clock will appear on the stop monitoring icon to indicate the time until the

first CO/EDV value. After approximately 6 to 9 minutes, when sufficient data has been obtained, an EDV and/or RVEF value will appear in the configured parameter globe(s).

14 The time until the next CO measurement is displayed on the information bar. For longer time

spans between calculations, select STAT parameters (sCO, sEDV, and sRVEF) as key parameters. sCO, sEDV, and sRVEF are fast estimates of CO, EDV, and RVEF.

15 Touch the stop monitoring icon to stop CO/EDV monitoring.

Page 46

HemoSphere Advanced Monitor 4 HemoSphere Advanced Monitor Quick Start

 compatible oximetry catheter

 optical connector

 HemoSphere oximetry cable

 HemoSphere advanced monitor









4.2 HemoSphere Oximetry Cable Monitoring

Figure 4-2 Oximetry connection overview

1 Connect the HemoSphere oximetry cable to the left side of the HemoSphere advanced monitor.

See figure 4-2.

2 Press the power button to turn on the HemoSphere advanced monitor. All functions are accessed

through the touch screen.

3 Select Continue Same Patient button or New Patient button and enter new patient data.

4 The HemoSphere oximetry cable must be calibrated before each monitoring session. Continue to

section 4.2.1 for in vitro calibration instructions and section 4.2.2 for in vivo calibration instructions.

4.2.1 In vitro Calibration

1 Remove a section of the catheter tray lid to expose the optical connector.

2 Insert the optical connector of the catheter “TOP” side up into the oximetry cable and snap the

enclosure shut.

3 Touch the clinical actions icon  Oximetry Calibration icon .

4 Select Oximetry Type: ScvO

5 Touch In vitro Calibration button.

or SvO2.

Page 47

HemoSphere Advanced Monitor 4 HemoSphere Advanced Monitor Quick Start

6 Enter either the patient’s hemoglobin (HGB) or hematocrit (Hct) value. A default value may be

used until the patient’s HGB or Hct is available.

7 Touch Calibrate button.

8 When the calibration successfully completes, the following message appears:

In vitro Calibration OK, insert catheter

9 Insert the catheter as described in the catheter directions for use.

10 Touch Start button.

11 If ScvO

outside of any parameter globe to select ScvO

/SvO2 are not current key parameters, touch the displayed parameter label located

/SvO2 as a key parameter from the parameter

popup.

12 Touch within the ScvO

/SvO2 parameter globe to adjust Alarms/Targets.

4.2.2 In vivo Calibration

1 Insert the catheter as described in the catheter directions for use.

2 Insert the optical connector of the catheter “TOP” side up into the oximetry cable and snap the

enclosure shut.

3 Touch clinical actions icon  Oximetry Calibration icon .

4 Select Oximetry Type: ScvO

5 Touch In vivo Calibration button.

If setup is unsuccessful, one of the following messages will be displayed:

Warning: Wa ll Ar tifact or We d g e Detected. Reposition catheter.

6 If a “Wall Artifact or Wedge Detected,” or “Unstable Signal” message appears, attempt to

troubleshoot the problem as instructed in Chapter 10: Help and Troubleshooting and touch Recalibrate button to restart the baseline setup.

Touch Continue button to proceed to the Draw operation.

or SvO2.

Warning: Unstable Signal.

7 When baseline calibration is successful, touch Draw button and then draw the blood sample and

send the blood sample to the lab for measured analysis by co-oximeter.

8 Enter HGB or Hct and ScvO

9 Touch Calibrate button.

10 Touch the monitor screen selection icon to select the desired monitoring screen view.

11 Touch the displayed parameter label located outside of any parameter globe to select ScvO

/SvO2 when lab values are received.

/SvO2

as a key parameter from the parameter popup window.

12 Touch within the ScvO

/SvO2 parameter globe to adjust Alarms/Targets.

Page 48

Navigating the HemoSphere Advanced Monitor

Contents

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

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

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

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

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

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

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

5.1 HemoSphere Advanced Monitor Screen Appearance

All monitoring functions are initiated by touching the appropriate area on the touch screen. The navigation bar, located on the left side of the screen, includes various controls for stopping and starting monitoring, scrolling and selecting screens, performing clinical actions, adjusting system settings, capturing screen shots, and silencing alarms. The main components of the HemoSphere advanced monitor screen are shown below in figure 5-1. The main window displays the current monitoring view or menu screen. For details on monitoring view types, see Monitor Views on page 51 . For details on other screen features, see the referenced sections in figure 5-1.

Page 49

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

Main WindowNavigation Bar

(section 5.2)

Parameter Globe (section 5.3.1)

Information Bar (section 5.5)

Status Bar (section 5.6)

Figure 5-1 HemoSphere advanced monitor screen features

Page 50

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

Start/Stop Monitoring

Monitor Screen Selection

Clinical Actions

Settings

Snapshot

Silence Audible Alarm

5.2 Navigation Bar

The navigation bar is present on most screens. Exceptions are the startup screen and screens indicating the HemoSphere advanced monitor has stopped monitoring.

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

Start CO Monitoring. While monitoring with the HemoSphere Swan-Ganz module, the start CO

monitoring icon allows the user to initiate CO monitoring directly from the navigation bar. See Continuous Cardiac Output on page 98 .

Stop CO Monitoring. The stop monitoring icon indicates that CO monitoring using the HemoSphere Swan-

Ganz module is underway. The user can immediately stop monitoring by touching this icon.

Monitor Screen Selection. The monitor screen selection icon allows the user to select the desired number of

monitored parameters displayed and the type of monitoring view used to display them, which is highlighted in color (see figure 5-3, “Example of monitoring screen selection window,” on page 52). When a monitoring view screen is selected, that monitoring mode is immediately displayed.

To return to the most recent monitoring screen displayed, touch the cancel icon .

Clinical Actions. The clinical actions icon provides access to the following clinical actions:

• Derived Value Calculator

• Event Review

Page 51

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

• iCO (HemoSphere Swan-Ganz module)

• Patient CCO Cable Test (HemoSphere Swan-Ganz module)

• Oximetry Calibration (HemoSphere oximetry cable)

A description of Derived Value Calculator and Event Review can be found in this chapter (see section

5.4.1 on page 65 and section 5.4.2 on page 65 ). For the remaining clinical actions, refer to the specified module or cable chapter for more information.

Settings. The settings icon provides access to configuration screens which include:

• Patient Data: See chapter 6: User Interface Settings

• Monitor Settings: See chapter 6: User Interface Settings

• Advanced Setup: See chapter 7: Alarms / Targets , chapter 7: Adjust Scales , and chapter 8: Data

Export and Connectivity Settings

• Export Data: See chapter 8: Data Export and Connectivity Settings

• Demo Mode: See chapter 7: Demo Mode

• Engineering: See chapter 7: Engineering

• Help: See chapter 11: On Screen Help

Snapshot. The snapshot icon captures an image of the screen at the current time. A USB stick attached to

one of the two USB ports (rear and right panels) of the HemoSphere advanced monitor is required to save the image.

Silence Audible Alarms. This icon silences all alarms for two minutes. New physiological alarms are silenced

during the two minute period. Alarms will resume sounding after the two minutes have elapsed. Faults are silenced until the fault is cleared and re-occurs. If a new fault occurs, the alarm sound will resume.

Audible Alarms Silenced. Indicates that alarms are temporarily silenced. A two minute countdown timer and

“Alarms Paused” appear.

Monitoring Pause Exit. When the silence audible alarms button is touched for 3 consecutive seconds, a

monitoring pause confirmation popup will appear asking the user to confirm suspension of monitoring operations. This function is used when the user wishes to pause monitoring. After confirmation, the silence audible alarm button on the navigation bar will switch to the monitoring pause exit button and a “Monitoring Pause” banner will be displayed. To return to monitoring, touch the monitoring pause exit button.

5.3 Monitor Views

There are six monitoring views: graphical trend, tabular trend, graphical/tabular trend split screen, physiology, cockpit, and physio relationship. Up to four monitored parameters can be displayed on these screens at one time.

To select a monitoring view:

Page 52

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

1 Touch the monitor screen selection icon . The monitor screen selection menu contains icons

that are based upon the look of the monitoring screens.

Figure 5-3 Example of monitoring screen selection window

2 Touch the circled number, 1, 2, 3, or 4, that represents the number of key parameters to be

displayed on the monitoring screens.

3 Select and touch a monitor view button to display the key parameters in that screen format.

5.3.1 Parameter Globes

Parameter globes are located on the right side of most monitoring screens. The cockpit monitoring view is composed of larger format parameter globes which function identically as described below.

5.3.1.1 Change Parameters

1 Touch the displayed parameter label located outside the globe to change it to a different parameter.

Page 53

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

2 A popup window will show the selected parameter highlighted in color and other parameters

currently being displayed outlined in color. Available parameters appear on the screen without highlights. Figure 5-4 shows the popup window that will appear while selecting continuous parameters and monitoring with the HemoSphere Swan-Ganz module.

Figure 5-4 Example of key parameter

selection popup window

3 Touch an available parameter to select the replacement parameter.

5.3.1.2 Change Alarm/Target

The Alarms / Targets popup screen lets the user view and set up alarm and target values for the selected parameter or enable/disable the audible alarm and target settings. Additionally, the target settings can be adjusted with a numbered key pad or with the scroll buttons when a minor adjustment is needed. This popup screen is accessed by touching anywhere inside a monitored parameter globe or through the parameter settings screen. For more information, see Alarms / Targets on page 79.

NOTE There is a two minute inactivity timer associated with the popup screen.

Page 54

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

Audible alarm indicator

Continuous % Change Indicator

Target Status Indicator

Parameter Value

Units

Parameter Name

5.3.1.3 Status Indicators

The lantern at the top of each parameter globe indicates the patient’s current status. The color changes as the patient’s status changes. The globes may display additional information:

Figure 5-5 Parameter globe

Fault. When a fault condition occurs, the fault message(s) will be displayed on the status bar until the fault

condition is cleared. When there is more than one fault, alert or alarm, the message is cycled every two seconds.

When a fault condition occurs, parameter calculations are stopped, and each affected parameter globe displays the last value, time, and date at which the parameter was measured.

Continuous % Change Indicator. This indicator displays the percentage of change, followed by the time

period over which it changed. See Time Intervals / Averaging on page 75 for configuration options.

Target Status Indicators. The colored indicator at the top of each monitoring globe indicates the patient’s

clinical status. For indicator colors and their clinical indications, See table 7-2, “Target status indicator colors,” on page 81.

5.3.2 Graphical Trend Monitoring View

The graphical trend screen displays the current status and history of monitored parameters. The amount of history shown for monitored parameters can be configured by adjusting the time scale.

When the target range for the parameter is enabled, the graph color codes the plot line, green indicating within the target range, yellow indicating the value is outside the target range but within the physiological alarm range, and red indicating the value is outside the alarm range. When the target range is disabled for

Page 55

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

the parameter the plot line is white. The colors match those of the clinical target indicator (lantern) on the key parameter globes in the graphical trend graph when targets are enabled for the parameter. The alarm limits for each parameter are displayed as colored arrows on the graph y-axis.

Figure 5-6 Graphical trend screen

To change the time scale of a displayed parameter, touch outside of the plot area along the x or y-axis, and a scale popup menu will appear. Touch the value side of the Graphical Trend Time button to select a different time period.

5.3.2.1 Graphical Trend Scroll Mode

Up to 72 hours of monitored parameter data can be viewed by scrolling back. The date appears above the parameter data during scrolling. Two dates will appear when appropriate. To start scrolling, touch the appropriate scroll mode button. Keep touching the scroll mode button to increase the scroll speed. The screen will return to live mode two minutes after the scroll button has been touched, or if the back button is touched. The scroll rate will appear below the scroll buttons.

Table 5-1 Graphical trend scroll rates

Scroll setting Description

>>> Scrolls at two times the current time scale

>> Scrolls at the current time scale (one graph

width)

> Scrolls at half the current time scale (one-half

graph width)

While in scroll mode the user can scroll to data older than the current time scale displays.

NOTE It is not possible to touch past the most recent data or before the oldest data. The graph

will scroll only as far as data is available.

Page 56

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

5.3.2.2 Intervention Events

While in the graphical trend screen, selecting the intervention icon provides a menu of intervention types, details and a notes section.

Figure 5-7 Graphical trend- intervention window

To ent er a New Intervention:

1 Select the Intervention type from the New Intervention menu on left.

2 Select Detail from right menu tab. Unspecified is set as a default.

3 Select the keyboard icon to enter notes (optional).

4 Touch the enter icon .

To enter a previously used Intervention:

1 Select the Intervention from the Recents list tab.

2 To add, edit, or remove a note, touch the keyboard icon .

3 Touch the enter icon .

Page 57

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

Table 5-2 Intervention events

Intervention Indicator Type

Intervention

(green)

Positional

(purple)

Fluids

(blue)

Custom

(gray)

Inotrope

Vasodilator

Vasopressor

PEEP

Passive Leg Raise

Trendelenburg

Red Blood Cells

Colloid

Crystalloid

Custom Event

After selection of the intervention type, markers indicating the intervention are visually displayed on all graphs. These markers can be selected for more information. Upon touching the marker, an information balloon will appear. See figure 5-8: "Graphical trend screen - intervention information balloon". The information balloon displays the specific intervention, date, time, and notes pertaining to the intervention. Touching the edit button allows the user to edit intervention time, date, and note. Touching the exit button closes the balloon.

NOTE The intervention information balloon has a 2 minute time out.

Intervention Editing. The time, date, and associated note for each intervention can be edited after initial

entry:

1 Touch the intervention event indicator associated with the intervention to be edited.

2 Touch the edit icon located on the information balloon.

3 To change the time of the selected intervention, touch on Time Adjust, and enter the updated

time on keypad.

4 To change the date, touch on Date Adjust, and enter the updated date on keypad.

5 Touch the keyboard icon to enter or edit notes.

6 Touch the enter icon .

Figure 5-8 Graphical trend screen - intervention information balloon

Page 58

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

5.3.3 Tabular Trends

The tabular trends screen displays selected key parameters and their history in a tabular format.

Figure 5-9 Tabular trend screen

1 To change the interval between values, touch inside the table.

2 Select a value on the Tabular Increment popup.

Figure 5-10 Tabular increment popup

5.3.3.1 Tabular Trend Scroll Mode

Up to 72 hours of data can be viewed by scrolling back. The scroll mode is based on the number of cells. Three scroll speeds are available: 1x, 6x, and 40x.

Page 59

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

While the screen scrolls, the date appears above the table. If the time period overlaps two days, both dates will appear on the screen.

1 To start scrolling, touch and hold one of the gray arrows. The scroll rate will appear above the

scroll icons.

Table 5-3 Tabular trend scroll rates

Setting Time Speed

1X one cell Slow

6X six cells Moderate

40X forty cells Fast

2 To exit scroll mode, stop touching the scrolling arrow or touch the return icon .

NOTE The screen will return to live mode two minutes after the last touch of the scroll arrow

icon or if the return icon is touched.

5.3.4 Graphical/Tabular Trends Split

The graphical/tabular trends split screen displays a combination of the graphical trend and tabular trend monitoring views. This display is useful for viewing the current status and history of selected monitored parameters in graphical format and other selected monitored parameters in tabular format at the same time.

If two key parameters are selected, the first key parameter is displayed in graphical trend format, and the second in tabular trend format. Key parameters can be changed by touching the parameter label located on the parameter globe. If more than two key parameters are selected, the first two parameters are displayed in graphical trend format, and the third and fourth — if a fourth is selected — are displayed in tabular trend format. The time scale for data displayed on any key parameter graphical trend view(s) is independent of the time scale displayed on the tabular trend view(s). For more information on the graphical trend view see Graphical Trend Monitoring View on page 54. For more on tabular trend view, see Tabular Trends on page 58.

Page 60

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

5.3.5 Physiology Screen

The Physiology screen is an animation depicting the interaction between the heart, blood, and vascular system.

Continuous parameter values are displayed in association with the animation.

Figure 5-11 Physiology screen

In the physiology screen the image of the beating heart is a visual representation of the heart rate and is not an exact representation of beats per minute. Key features of this screen are numbered shown in figure 5-11. This example is of the continuous physiology screen during active monitoring with the HemoSphere SwanGanz module and slaved-in ECG, MAP, and CVP signals.

1 ScvO

/SvO2 parameter data and signal quality indicator (SQI) are displayed here while the

HemoSphere oximetry cable is connected and actively monitoring venous oxygen saturation

2 Cardiac output (CO/CI) is indicated on the arterial side of the vascular system animation. The

blood flow animation rate will adjust based on the CO/CI value and the low/high target ranges selected for that parameter.

3 Systemic Vascular Resistance, indicated in the center of the vascular system animation, is available

while monitoring CO/CI and utilizing MAP and CVP analog pressure signal inputs from a connected patient monitor, as SVR =[(MAP-CVP)/CO]*80. The level of constriction shown in the vessel will adjust based on the derived SVR value, and the low/high target ranges selected for that parameter.

NOTE The alarms/targets settings can be adjusted through the Alarms / Targets setting screen

(see Alarms / Targets Setup Screen on page 82 ) or by selecting the desired parameter as a key parameter, and accessing the parameter Alarms/Targets popup window by touching inside of the parameter globe.

4 From the continuous mode, touch the clock/waveform icon at the upper left, to go to the

intermittent physiology screen. This button only appears when there is historical intermittent data available. See 5.3.5.1 Historic Physiology Screen, below.

5 Touch the syringe to go to the iCO screen to shoot bolus cardiac output.

Page 61

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

5.3.5.1 Historic Physiology Screen

The historic physiology screen displays both intermittent bolus data and a snapshot of continuous data overlaid on a visual representation of the heart and circulatory system. The circulatory system has several variations to illustrate the patient’s condition at the time of the bolus set — for example, the vessels constrict.

Up to 36 historic physiology records may be viewed via the horizontal tabs composite along the top of the screen.

5.3.6 Cockpit Screen

This monitoring screen, shown in figure 5-12, displays large parameter globes with the values of the parameter being monitored. Cockpit parameter globes graphically indicate alarm/target ranges and values, and utilize needle indicators to show where the current parameter value falls. Similar to standard parameter globes, the value within the globe will flash when the parameter is alarming.

Figure 5-12 Cockpit monitoring screen

The key parameter globes shown on the cockpit screen display a more complex target and alarm indicator than the standard parameter globe. The full display range of the parameter is used to create a gauge from the graphical trends minimum to maximum settings. A needle is used to indicate the current value on the circular gauge scale. When target ranges are enabled, red (alarm zone), yellow (warning target zone), and green (acceptable target zone) are used to indicate the target and alarm regions within the circular gauge. When target ranges are not enabled, the circular gauge area is all gray in color and target or alarm indicators are removed. The value indicator arrow changes to indicate when the values are out of the gauge scale limits.

5.3.7 Physio Relationship

The physio relationship screen depicts the balance between oxygen delivery (DO2) and oxygen consumption (VO

). It automatically updates as parameter values change so the values are always current. The connecting

lines highlight the relationship of the parameters to each other.

Page 62

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

5.3.7.1 Continuous and Historical Modes

The physio relationship screen has two modes: continuous and historical. When in continuous mode, the intermittent and derived values are always displayed as unavailable.

Figure 5-13 Physio relationship screen

1 The vertical lines above and below the parameters appear in the same color as the parameter

lantern.

2 Vertical lines that directly connect two parameters will appear in the same color as the parameter

lantern below (for example, between SVRI and MAP).

3 The horizontal lines are the same color as the line above them.

4 The left bar appears after a bolus set is performed. Touch the clock/waveform icon to display

historical data (see figure 5-13).

5 Touch the iCO icon to open the thermodilution new set configuration screen.

Page 63

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

NOTE Before a thermodilution set is performed and before any values are entered (see 5.3.7.2

Parameter Boxes below)

the clock/waveform and iCO icons do not appear. Only the

available continuous parameters are displayed.

Figure 5-14 Historic physio relationship data screen

NOTE The historic physio relationship screen displays most of the parameters available on the

system at a point in time. The screen displays lines connecting the parameters, highlighting the relationship of the parameters to each other. The historic physio relationship screen displays the configured (1-4) key parameters on the right hand side of the screen. There is a horizontal tab composite at the top that allows the user to navigate through the database of historic records. The record times correspond to thermodilution bolus sets and derived value calculations.

The historic physio relationship screen allows the user to enter parameters used to calculate derived parameters DO

and VO2, on only the most recent record. The values

entered are for the time of the record and not the current time.

The historic physio relationship screen is accessed through the clock/waveform icon

on the continuous physio relationship screen. Touch the return icon to return to

the continuous physio relationship screen. There is no 2 minute time-out for this screen.

To calc u lat e DO

oxygen is required. For the historic physio relationship screen, a PaO

of zero (0) is used. To calculate DO

and VO2, the partial pressure of arterial (PaO2) and venous (PvO2)

and PvO2 value

and VO2 using values other than zero (0) for PaO2

and PvO2, use the Derived Value Calculator (see section 5.4.1 on page 65 ).

Page 64

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

Parameter

Units Value

Target status indicator

Faulted or value not available

5.3.7.2 Parameter Boxes

Each small parameter box displays:

• Parameter name

• Parameter units

• Parameter value (if available)

• Clinical target status indicator (if a value is available)

If the parameter is in a fault state, the value is blank, indicating it is or was unavailable at the time of the display.

Figure 5-15 Physio relationship parameter boxes

5.3.7.3 Setting Targets and Entering Parameter Values

To change the target settings or enter a value, touch a parameter to bring up the target/enter popup. The physio relationship target/enter popup will be displayed when the following physio relationship small parameter boxes are touched:

• HGB

• SpO

• SvO

• CVP (when analog pressure signal input not configured)

• MAP (when analog pressure signal input not configured)

• HRavg (when ECG signal input not configured)

/ScvO2 (when no HemoSphere oximetry cable measurement is available)

Figure 5-16 Physio relationship target/enter popup

When the value is accepted, a new time-stamped historic physio relationship record is created. It includes:

The historic physio relationship screen is shown with the newly created record; you can then enter the rest of the manually entered values to calculate any derived values.

• Current continuous parameter data

• The entered value and any derived calculated values.

Page 65

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

5.4 Clinical Actions

Most options on the clinical actions menu are related to the current monitoring mode (e.g., while monitoring with the HemoSphere Swan-Ganz module). The following clinical actions are available across all monitoring modes.

5.4.1 Derived Value Calculator

The Derived Value Calculator allows the user to compute certain hemodynamic parameters and provides a convenient way to display these parameters for one-time calculation.

Calculated parameters include: DO

1 Touch the clinical actions icon  Derived Value Calculator icon .

2 Enter the required values and the derived calculations will automatically display.

3 Touch the home icon to return to the monitoring screen.

, VO2, SVR, LVSWI and RVSWI.

5.4.2 Event Review

Use Event Review to view parameter-related and system events that occurred during monitoring. Up to 72 hours of events are recorded in order with the most recent event at the top.

1 Touch the clinical actions icon  Event Review icon .

2 To scroll up or down, touch the arrow keys.

3 Touch the home icon to return to the monitoring screen.

The following events are included in the clinical event review log.

Table 5-4 Reviewed events

Event Log time

CO Monitoring Started When CO Monitoring is started

CO Monitoring Stopped When the user or system stops CO monitoring

CO Cable Test Passed When the Patient CCO Cable Test was performed and

passed

Draw Blood The Draw option is selected in the In vivo Calibration

Draw Screen

HGB Update Oximetry cable update completes following the HGB

update process

iCO Bolus Performed When an iCO bolus is performed

In vitro Calibration When oximetry cable update completes following the

In vitro calibration process

In vivo Calibration When oximetry cable update completes following In

vivo calibration process

Light Out of Range When the Oximetry Light Range Fault occurs

Monitoring Paused Active monitoring paused to prevent audible alarms

and parameter monitoring

Monitoring Resumed Normal monitoring resumed. Audible alarms and

parameter monitoring are active

Page 66

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

Time Date

Battery

Monitoring

Mode

Averaged

Heart Rate

Blood

Temperature

HIS Status

Wi-Fi Status

Lock

Screen

Table 5-4 Reviewed events (continued)

Event Log time

Oximetry Disconnected An oximetry cable disconnection is detected

Recall Oximetry Data When recalled oximetry calibration data is accepted by

the user

System Restart Recovery When the system has resumed monitoring without

being prompted following a power cycle

Time Change The system clock is updated

5.5 Information Bar

The information bar appears on all active monitoring screens and most clinical action screens. It displays the current time, date, monitoring mode, battery status, and the lock screen symbol. While monitoring with the HemoSphere Swan-Ganz module, the CO countdown, blood temperature, and slaved in heart rate may also be displayed. When the monitor has a HIS or Wi-Fi connection, the status will be displayed. See table 8-1 on page 91 for Wi-Fi status symbols and table 8-2 on page 92 for HIS connectivity status symbols. Figure 517 shows an example of an information bar while monitoring with the HemoSphere Swan-Ganz module with a slaved in ECG heart rate.

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

NOTE Figure 5-17 is an example of an information bar with U.S. standard defaults. To see the

defaults for all languages, see table D-6, “Language default settings,” on page 148.

5.5.1 Battery

The HemoSphere advanced monitor allows for uninterrupted monitoring during power loss when the HemoSphere battery pack is installed. Battery life is indicated on the information bar by the symbols shown in table 5-5. For more information on battery installation, see Battery Installation on page 39. To ensure that the battery charge status displayed on the monitor is correct, it is recommended to perform periodic checks of battery health through battery conditioning. For information on battery maintenance and conditioning, see Battery Maintenance on page 155.

Table 5-5 Battery status

Battery symbol

Indication

The battery has greater than 50% charge remaining.

The battery has less than 50% charge remaining.

Page 67

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

Table 5-5 Battery status (continued)

Battery symbol

Indication

The battery has less than 20% charge remaining.

The battery is charging and connected to mains power.

The battery is fully charged and connected to mains power.

The battery is not installed.

WARNING To prevent any interruptions to monitoring during power loss, always use the

HemoSphere advanced monitor with the battery inserted.

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

5.5.2 Lock Screen

If the monitor is being cleaned or moved, lock the screen. For cleaning instructions refer to Cleaning the Monitor and Modules on page 152. The screen will automatically unlock once the internal timer has counted

down.

1 Touch the lock screen icon.

2 Touch the time that the screen will remain locked on the Lock Screen popup.

Figure 5-18 Lock screen

3 A large lock icon will appear to the right of the information and status bar.

4 To unlock the screen, touch and hold the large lock icon .

Page 68

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

5.6 Status Bar

The status bar appears at the bottom of all active monitoring screens. It displays faults, alarms, alerts, some warnings and notifications. When there is more than one fault, alert or alarm, the message is cycled every two seconds.

Figure 5-19 Status bar

5.7 Monitor Screen Navigation

There are several standard navigational procedures on the screen.

5.7.1 Vertical Scrolling

Some screens will have more information than fits on the screen at one time. If vertical arrows appear on a review list, touch the up or down arrow to see the next set of items.

If selecting from a list, the vertical scroll arrows move up or down one item at a time.

5.7.2 Navigation Icons

There are some buttons that always perform the same function:

Home. The home icon takes you to the most recently viewed monitoring screen and stores any modification

made to data on the screen.

Return. The return icon takes you to the previous menu screen and stores any modification made to data on

the screen.

Cancel. The cancel icon causes any entries to be discarded.

On some screens, for example Patient Data, there is no cancel button. As soon as a patient’s data is entered, it is stored by the system.

List buttons. Some of the screens have buttons that appear to be split in two.

Page 69

HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor

backspace

cancel

enter

decimal

cancel

enter

backspace

cursor left

cursor right

In these cases, touching anywhere on the button reveals a list of selectable items. The right side of the button displays the current selection.

Value button. Some screens have square buttons as shown below. Touch the button to display a keypad.

Toggle button. When an option exists between two choices, such as on/off, a toggle button appears.

Touch on the opposite side of the button to switch the choice.

Keypad. Touch the keys on the keypad to enter numeric data.

Keyboard. Touch the keys on the keyboard to enter alphanumeric data.

Page 70

User Interface Settings

Contents

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

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

6.1 Patient Data

After the system is turned on, the user has the option to either continue monitoring the last patient or to start monitoring a new patient. See figure 6-1 below.

NOTE If data for the last patient monitored is 12 hours or older, the only option is to start a

new patient.

Figure 6-1 New or continuing patient screen

6.1.1 New Patient

Starting a new patient clears all previous patient data. The alarm limits and continuous parameters are set to their default values.

WARNING 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.

Page 71

HemoSphere Advanced Monitor 6 User Interface Settings

The user has the option of entering a new patient upon initial startup of the system or while the system is running.

WARNING 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.

1 After turning on the monitor, the new or continuing patient screen appears (figure 6-1). Touch

New Patient

and continue to step 6.

If the monitor is already on, touch the settings icon and continue to step 2.

2 Touch Patient Data button.

3 Touch New Patient button.

4 Touch Ye s button on the confirmation screen to start a new patient.

5 The New Patient Data screen appears. See figure 6-2.

Figure 6-2 New Patient Data screen

6 Touch the enter key on the keypad/keyboard to save each patient demographic selection value

and return to the patient data screen.

7 Touch Patient ID button and use the keyboard to enter the patient’s hospital ID.

8 Touch Height button and use the keypad to enter the patient’s height. The unit default for your

language is at the upper right of the keypad. Touch it to change the unit of measurement.

9 Touch Age and use the keypad to enter the patient’s age.

10 Touch Weight and use the keypad to enter the patient’s weight. The unit default for your language

is at the upper right of the keypad. Touch it to change the unit of measurement.

11 Tou ch Gender and select Male or Female.

12 The BSA is calculated from the height and weight using the DuBois formula.

Page 72

HemoSphere Advanced Monitor 6 User Interface Settings

13 Touch the home icon and refer to instructions for starting monitoring with the desired

hemodynamic monitoring technology.

NOTE The home icon is disabled until all patient data is entered.

6.1.2 Continue Monitoring Patient

If the last patient’s data is less than 12 hours old, the patient’s demographics and patient ID will be displayed when the system is turned on. When monitoring of the last patient is continued, the patient’s data is loaded and the trend data is retrieved. The most recently viewed monitoring screen is displayed. Touch Continue Same Patient.

6.1.3 View Patient Data

1 Touch settings icon .

2 Touch Patient Data button to see patient data. The screen will also include a New Patient

button.

3 Touch the return icon to return to the settings screen.

6.2 Monitor Settings

The Monitor Settings screen allows the user to change several monitor related settings.

Figure 6-3 Monitor Settings

NOTE The screen will return to the monitoring view after two minutes of inactivity.

6.2.1 General Monitor Settings

The General Monitor Settings are those that affect every screen. These are the display language, units used, alarm volume, and snapshot sound.

Page 73

HemoSphere Advanced Monitor 6 User Interface Settings

The HemoSphere advanced monitor interface is available in several languages. A language selection screen appears the first time the HemoSphere advanced monitor is started. See figure 3-7, “Language selection screen,” on page 42. The language screen will not appear again, but the display language can be changed at any time.

The selected language determines the default time and date format. These can also be changed independently of the language selected.

NOTE If power is lost and restored to the HemoSphere advanced monitor, the system settings

prior to the power loss, including alarm settings, alarm volume, target settings, monitoring screen, parameter configuration, language and unit selection, are automatically restored to last configured settings.

6.2.1.1 Change Language

1 Touch the settings icon .

2 Touch the Monitor Settings button.

3 Touch General button.

Figure 6-4 General Monitor Settings

4 Touch the value section of the Language button and select the desired display language.

5 Touch the home icon to return to the monitoring screen.

NOTE See appendix D for all language default settings.

6.2.2 Change Date and Time Display

English (US) dates default to MM/DD/YYYY, and the time defaults to a 12 Hour clock.

When an international language is selected, the date defaults to the format found in appendix D: Monitor Settings and Defaults, and the time defaults to a 24 hour clock.

Page 74

HemoSphere Advanced Monitor 6 User Interface Settings

1 Touch the settings icon .

2 Touch Monitor Settings button.

3 Touch Date / Time button.

Figure 6-5 Date / Time Settings

4 Touch the value section of the Date Format button and touch the desired format.

5 Touch the value section of the Time Format button and touch the desired format.

6 Touch the home icon to return to the monitoring screen.

6.2.2.1 Adjust Date or Time

The system time can be reset if necessary. When the time or date is changed, trended data is updated to reflect the change. Any retained data is updated to reflect the time change.

NOTE The time clock of the HemoSphere advanced monitor does not automatically adjust for

daylight saving time (DST). This adjustment needs to made using the following instructions.

1 Touch the settings icon .

2 Touch Monitor Settings button.

3 Touch Date / Time.

4 To change the date, touch the value section of the Date Adjust button and enter the date on the

keypad.

5 To change the time, touch the value section of the Time Adjust button and enter the time.

6 Touch the home icon to return to the monitoring screen.

Page 75

HemoSphere Advanced Monitor 6 User Interface Settings

6.2.3 Monitoring Screens Settings

From the Monitoring Screens settings screen, the user can set physiology and physio relationship monitoring screen options.

1 Touch the settings icon .

2 Touch the Monitor Settings button.

3 Touch the Monitoring Screens button.

4 Select the Indexed or Non-Indexed toggle for parameters in the physiology and physio

relationship screens.

6.2.4 Time Intervals / Averaging

The Time Intervals / Averaging screen lets the user select the continuous % change time interval.

NOTE The screen will return to the monitoring view after two minutes of inactivity.

1 Touch the settings icon .

2 Touch Parameter Settings button.

3 Touch Time Intervals / Averaging button.

4 Touch the right side of the Continuous % Change Interval value button and touch one of the

following time interval options:

• None • 15 min

• 5 min • 20 min

• 10 min • 30 min

5 Touch home icon to return to the monitoring screen.

6.2.5 Analog Pressure Signal Input

While performing CO monitoring, the HemoSphere advanced monitor can also calculate SVR by utilizing analog pressure signal inputs from a connected patient monitor.

NOTE Connecting to external input devices allows additional information to be displayed. For

example, when MAP and CVP are available continuously from a bedside monitor, SVR is displayed if configured in a parameter globe. MAP and CVP are displayed on the physio relationship and physiology monitoring screens.

Page 76

HemoSphere Advanced Monitor 6 User Interface Settings

WARNING 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.

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.

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.

CAUTION 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.

Once the bedside monitor has been configured for the desired parameter output, connect the monitor via an interface cable to the selected analog input port on the HemoSphere advanced monitor.

NOTE A compatible bedside monitor must provide an analog output signal.

Please contact your local Edwards representative to obtain the correct HemoSphere advanced monitor analog input interface cable for your bedside monitor.

The following procedure describes how to configure the analog input ports of the HemoSphere advanced monitor.

1 Touch the settings icon .

2 Touch Monitor Settings button.

3 Touch Analog Input button.

4 Select MAP from the Parameter list button for the numbered analog port where MAP is

connected (1 or 2). The default setting values for MAP will be displayed.

NOTE If an analog signal is not detected on the selected port, “Not Connected” will be

displayed below the Port list button.

When an analog input connection or disconnection is first detected, a brief notification message will be displayed on the status bar.

5 Select CVP in the Parameter list button for the numbered analog port where CVP is connected.

The default setting values for CVP will be displayed.

Page 77

HemoSphere Advanced Monitor 6 User Interface Settings

NOTE The same parameter may not be configured on more than one analog input at the same

time.

6 If the default values are correct for the bedside monitor being used, touch the home icon .

If the default values are not correct for the bedside monitor being used (refer to the bedside monitor operator’s manual), the user can modify the voltage range, full scale range, or perform the calibration option described in section 6.2.5.1 of this chapter.

Touch the Full Scale Range value button to change the displayed full scale signal value. Table 61 below shows the allowable input values for full scale range based on the selected parameter.

Table 6-1 Analog input parameter ranges

Parameter Full Scale Range

MAP 0 to 510 mmHg (0 kPa to 68 kPa)

CVP 0 to 110 mmHg (0 kPa to 14.6 kPa)

NOTE A voltage reading of zero is automatically set to a minimum pressure reading of 0

mmHg (0 kPa). The Full Scale Range represents the full scale signal or maximum pressure reading for the selected Volta ge R a ng e.

Touch the Vo lt age R an ge list button to change the displayed voltage range. The selectable voltage ranges available for all of the parameters are:

• 0 - 1 volts

• 0 - 5 volts

• 0 - 10 volts

• Custom (see 6.2.5.1: Calibration)

WARNING 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.

6.2.5.1 Calibration

The calibration option is required when default values are incorrect, or the voltage range is not known. The calibration process configures the HemoSphere advanced monitor with the analog signal received from the bedside monitor.

NOTE If the default values are correct, do not calibrate.

Page 78

HemoSphere Advanced Monitor 6 User Interface Settings

CAUTION Only properly trained personnel should calibrate the HemoSphere advanced monitor

analog ports.

1 Touch the settings icon .

2 Touch Monitor Settings button.

3 Touch Analog Input button.

4 Select the desired port number (1 or 2) from the Port list button and corresponding parameter

(MAP or CVP) from the Parameter list button.

5 Select Custom from the voltage value popup screen. The Analog Input Custom Settings screen

will appear.

6 Simulate a full scale signal from the bedside monitor to the selected analog input port on the

HemoSphere advanced monitor.

7 Set the maximum parameter value equal to the full-scale signal value.

8 Touch Calibrate Maximum button. The Maximum A/D value will appear on the Analog

Input Custom Settings screen.

NOTE If an analog connection is not detected, the Calibrate Maximum and Calibrate

Minimum buttons will be disabled and the Maximum A/D value will be displayed as Not Connected.

9 Repeat the process to calibrate the minimum parameter value.

10 Touch th e Accept button to accept the displayed custom settings and return to the Analog Input

Screen.

11 Repeat steps 4-10 to calibrate another port if needed, or touch the home icon to return to

the monitoring screen.

CAUTION 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.

Page 79

Advanced Settings

Contents

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

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

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

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

Engineering. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88

7.1 Alarms / Targets

There are two types of alarms on the HemoSphere advanced monitor:

1 Physiological alarms: These are set by the clinician and signify the upper and/or lower alarm

ranges for configured key continuous parameters.

2 Technical alarms: This alarm signifies a device fault or alert. Technical alarms are non-latching.

Alarms occur with either Medium or High priority. Only parameters that are displayed (key parameters) will have active visual and audible alarms.

For physiological parameters CO/CI, sCO/sCI, SV/SVI, and ScvO priority is medium and the lower alarm (red zone) priority is high. For the physiological parameters SVR/ SVRI, EDV/sEDV, EDVI/sEDVI, and RVEF/sRVEF the alarm priority is always medium. See Alarm Priorities on page 147.

Among technical alarms, faults are of medium priority, and will halt operation of the related monitoring activity. Alerts are of low priority and will not halt any monitoring activity. As faults are of higher priority than alerts, alerts will not be alarmed if there are any active faults.

All alarms have an associated text displayed on the status bar. The system will actively cycle through every active alarm text on the status bar. In addition, alarms will generate the visual alarm indicator shown in table 7-1 below. For additional information, see table 11-1 on page 119.

Table 7-1 Visual alarm indicator colors

Alarm priority Color Light pattern

High red Flashing ON/OFF

Medium yellow Flashing ON/OFF

Low yellow Solid ON

/SvO2 the upper alarm (red zone)

Page 80

HemoSphere Advanced Monitor 7 Advanced Settings

The visual alarm indicator will indicate the highest active alarm priority. The audible tone associated with the highest priority active alarm will be played. Where the priority levels are the same, physiological alarms take priority over faults and alerts. All technical alarms are generated once detected by the system; there is no inherent delay in alarms from the point of detection. For physiological alarms, the delay is the amount of time it takes to calculate the next physiological parameter:

• HemoSphere Swan-Ganz module continuous CO and associated parameters: varies, but is typically

around 57 seconds (See CO Countdown Timer and STAT CO on page 100).

• Oximetry: 2 seconds

All alarms are logged and stored for the given patient and can be accessed via the Data Download function (see Data Download on page 89). The Data Download log is cleared when initiating a new patient (see New Patient on page 70). The current patient can be accessed from up to 12 hours following a system power-off.

7.1.1 Silence Alarms

7.1.1.1 Physiological Alarms

Physiological alarms can be silenced directly from the monitoring screen by touching the silence audible

alarms icon . The physiological alarm audio tone is silenced for two minutes. No audio tone for any

physiological alarm will be emitted during this two minutes, including new physiological alarms triggered during this time. If a technical alarm is generated during this two-minute period, the audio silence will be cleared, allowing alarm audio tones to resume. The user can also manually clear the two-minute period by pressing the alarm silence button again. Once the two-minute period has elapsed, active physiological alarms will resume audio sound.

If the physiological alarm is a medium priority, the visual alarm indicator (blinking yellow) is also disabled for two minutes. A high priority visual alarm indicator (blinking red) cannot be disabled. For information on physiological alarm priorities, see Alarm Priorities on page 147.

NOTE Physiological parameters can be configured to have no alarms. See sections 7.1.5

and7.1.7.

WARNING Do not turn off the audible alarms in situations in which patient safety could be

compromised.

7.1.1.2 Technical Alarms

During an active technical alarm, the user can silence the alarm and clear the visual alarm indicator (medium

and low priority) by touching the silence audible alarms icon . The visual alarm indicator and audio

tone will remain inactive unless another technical or physiological alarm condition triggers, or the original technical alarm resolves and re-triggers.

7.1.2 Set Alarm Volume

The alarm volume ranges from low to high with a default of medium. It applies to physiological alarms, technical faults, and alerts. Alarm volume can be changed at any time.

Page 81

HemoSphere Advanced Monitor 7 Advanced Settings

1 Touch the settings icon .

2 Touch Monitor Settings button.

3 Touch General button.

4 Touch the right side of the Alarm Volume list button to select the desired volume.

5 Touch the home icon to return to the monitoring screen

WARNING 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.

7.1.3 Set Targets

Targets are visual indicators (lanterns) set by the clinician to indicate if the patient is in the ideal target zone (green), warning target zone (yellow), or alarm zone (red). The use of target zone ranges can be enabled or disabled by the clinician. Alarms (high /low) differ from target zones in that the alarm parameter value flashes and has a audible alarm.

Parameters that can “Alarm” are indicated by a bell icon in the Alarms / Targets settings screen. High/ low alarms by default also become the ranges for the red caution zone for that parameter. Parameters which DO NOT have the ability to set a high/low alarm will not have a bell icon in the Alarms/Targets settings screen for that parameter but can still have target ranges set.

Table 7-2 Target status indicator colors

Color Indication

Green Acceptable – Green target zone is considered

an ideal range for parameter as set by the clinician.

Yellow Yellow target zone is considered a warning

range and visually indicates that the patient has exited the ideal range but has not entered the alarm or caution range as set by the clinician.

Page 82

HemoSphere Advanced Monitor 7 Advanced Settings

Table 7-2 Target status indicator colors

Color Indication

Red Red alarm and/or target zones can be

considered “Alarm” parameters indicated by a bell icon in the Alarms /Targets settings screen. High/low alarms by default also become the range for the red caution zone for that parameter. Parameters which DO NOT have the ability to set a high/low alarm will not have a bell icon in the Alarms /Targets settings screen for that parameter but can still have target ranges set. Ranges for the alarm and/or target zone are to be set by the clinician.

Gray If a target is not set, the status indicator

appears as gray.

7.1.4 Alarms / Targets Setup Screen

The Alarms / Targets Setup Screen allows the clinician to view and set up alarms and targets for each key parameter. From the Alarms/Targets screen, located within the Advanced Setup settings menu, the user can adjust targets and enable/disable audible alarms. Any features accessed through the Advanced Setup settings menu are passcode protected and should only be altered by experienced clinicians. The settings for each key parameter are displayed in a parameter box. The currently configured key parameters are the first set of key parameters displayed. The remaining key parameters are displayed in a defined order. The parameters also indicate what the target ranges are based on: Custom Default, Edwards Default, and Modified.

Table 7-3 Target defaults

Default name Description

Custom Default A custom default target range was set for the parameter and the

parameter target range has not been modified from that default.

Edwards Default The parameter target range has not been changed from the

original settings.

Modified Parameter target range was changed for this patient.

NOTE Visual and audible alarm settings are only applicable to parameters being displayed.

To modify Alarms / Targets:

1 Touch the settings icon .

2 Touch Advanced Setup button and enter the required password.

3 Touch Parameter Settings button  Alarms / Targets button.

Page 83

HemoSphere Advanced Monitor 7 Advanced Settings

4 Touch anywhere in a parameter box to display the Alarms / Targets popup for the parameter.

Figure 7-1 Alarms / Targets configuration

NOTE There is a 2 minute inactivity timer associated with this screen.

The red, yellow and green rectangles are fixed shapes, and don’t change size / shape.

7.1.5 Configure All Targets

Targets can easily be configured or changed all at the same time. From the Configure All screen, the user can:

• Set Custom Defaults for all parameter alarm and target settings.

• Restore all parameter alarm and target settings to Custom Defaults.

• Restore all parameter alarm and target settings to Edwards Defaults.

• Enable or disable audible alarms for all applicable parameters.

• Enable or disable target ranges for all parameters.

1 Touch the settings icon .

2 Touch Advanced Setup button and enter the required password.

3 Touch Parameter Settings button  Alarms / Targets button.

4 Touch the Configure All button.

5 To enable or disable all audible alarms for all parameters, touch the Disable All or Enable All

buttons within the Audible Alarm box.

6 To enable or disable all targets for parameters that support target ranges, touch the Tar ge t O n/

Off toggle button.

7 To restore all settings to your custom defaults, touch Restore All to Custom Defaults. The

message, “This action will restore ALL Alarms and Targets to the Custom Defaults.” appears.

Page 84

HemoSphere Advanced Monitor 7 Advanced Settings

8 Touch Continue button on the confirmation popup to confirm the restore.

9 To restore all settings to the Edwards defaults, touch Restore All to Edwards Defaults. The

message, “This action will restore ALL Alarms and Targets to the Edwards’ Defaults.” appears.

10 Touch Continue button on the confirmation popup to confirm the restore.

7.1.6 Set Custom Defaults

When custom defaults are set up, they can be enabled or disabled at any time through the Configure All or individual Alarms/Targets Settings screen.

1 Touch the settings icon .

2 Touch Advanced Setup button and enter the required password.

3 Touch Parameter Settings button  Alarms / Targets button.

4 Touch the Configure All button.

5 Touch the Set Custom Defaults button.

Figure 7-2 Set custom default Alarms /

Targets

6 The defaults can be displayed as Indexed or Non-Indexed. Choose the desired format on the

Set all parameters according to: toggle button.

7 Touch the parameter of interest.

8 Touch the value button for each target setting and enter the desired value. The corresponding

indexed or non-indexed value for that parameter will be set automatically.

9 Continue steps 7 and 8 for each parameter. Touch the right or left arrow at the bottom of the

screen to display the next or previous set of parameters.

10 When all desired parameters have been modified, touch Confirm All.

Page 85

HemoSphere Advanced Monitor 7 Advanced Settings

7.1.7 Configure Targets and Alarms for One Parameter

The Alarms/Targets popup lets the user set up alarm and target values for the selected parameter. The user can also enable or disable the audible alarm. Adjust the target settings by using the numbered keypad or by using the scroll buttons when a minor adjustment is needed.

1 Touch inside a globe to open the alarms/targets popup for that parameter. The alarms/targets

popup is also available on the physio relationship screen by touching a parameter box.

2 To disable the audible alarm for the parameter, touch the Audible Alarm icon at the top

right of the popup.

NOTE Parameters that DO NOT have the ability to set a high/low alarm will not have an

Audible Alarm icon on the Alarms / Targets popup.

3 To disable visual targets for the parameter, touch the Ta rg et enabled icon at the top left of

the popup. The target indicator for that parameter will appear gray.

4 Use the arrows to adjust the zone settings or touch the value button to open a numeric keypad.

Figure 7-3 Set individual parameter alarms

and targets

5 When the values are correct, touch the enter icon .

6 To cancel, touch the cancel icon .

WARNING 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.

Page 86

HemoSphere Advanced Monitor 7 Advanced Settings

7.2 Adjust Scales

The graphical trend data fills the graph from left to right with the most recent data at the right. The parameter scale is on the vertical axis with the time scale on the horizontal.

Figure 7-4 Graphical trend screen

The scales setup screen allows the user to set up both the parameter and time scales. The key parameters are at the top of the list. Use the horizontal scroll buttons to see additional parameters.

1 Touch the settings icon .

2 Touch Advanced Setup button and enter the required password.

3 Touch Parameter Settings button  Adjust Scales button.

Figure 7-5 Adjust scales

NOTE The screen will return to the monitoring view after two minutes of inactivity.

Page 87

HemoSphere Advanced Monitor 7 Advanced Settings

4 For each parameter, touch the Lower button to enter the minimum value to appear the vertical

axis. Touch the Upper button to enter the maximum value. Use the horizontal scroll icons

to view additional parameters.

5 Touch the right side of the Graphical Trend Time value button to set the total amount of time

displayed on the graph. The options are:

• 3 minutes • 1 hour • 12 hours

• 5 minutes • 2 hours (default) • 18 hours

• 10 minutes • 4 hours • 24 hours

• 15 minutes • 6 hours • 48 hours

• 30 minutes

6 Touch the right side of the Tabular Increment value icons to set the amount of time to each

tabbed value. The options are:

• 1 minute (default) • 30 minutes

• 5 minutes • 60 minutes

• 10 minutes

7 To advance to the next set of parameters, touch the arrow at the bottom left.

8 Touch the home icon to return to the monitoring screen.

7.3 Serial Port Setup

Use the Serial Port Setup screen to configure the serial port for digital data transfer. The screen displays

until the return icon is touched

Figure 7-6 Tabular increment popup

Page 88

HemoSphere Advanced Monitor 7 Advanced Settings

1 Touch the settings icon .

2 Touch Advanced Setup button and enter the required password.

3 Touch Serial Port Setup button.

4 Touch the list button of any serial port setup parameter to change the default value shown.

5 Touch the return icon when configuration of serial port settings is complete.

NOTE A RS232 9 pin serial port is available for real time communication to support patient

monitoring systems through the IFMout protocol.

7.4 Demo Mode

Demonstration Mode is used to display simulated patient data to assist in training and demonstration.

Demonstration mode displays data from a stored set and continually loops through a predefined data set. During Demo Mode, the HemoSphere advanced monitoring platform user interface retains the same functionality as a fully operational platform. Simulated patient demographics must be entered to demonstrate Swan-Ganz technology functions. The user can touch the controls as if a patient was being monitored.

When Demo Mode is entered, trended data and events are cleared from being displayed and saved for return to patient monitoring.

1 Touch settings icon .

2 Touch the Demo Mode button.

NOTE When the HemoSphere advanced monitoring platform runs in Demo Mode, all

audible alarms are disabled

3 Touch Ye s on the Demo Mode confirmation screen.

4 See chapter 9: HemoSphere Swan-Ganz Module Monitoring for details on monitoring with the

HemoSphere Swan-Ganz module.

5 The HemoSphere advanced monitoring platform must be restarted prior to monitoring a patient.

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

data is not mistaken for clinical data.

7.5 Engineering

The engineering menu can only be operated by a system engineer and is password protected. If an error is encountered, start by referring to chapter 11: Troubleshooting .

Page 89

Data Export and Connectivity Settings

Contents

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

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

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

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

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

8.1 Export Data

The Export Data screen lists a number of data export features of the HemoSphere advanced monitor. This screen is password protected. From this screen clinicians can export diagnostic reports, delete monitoring sessions, or export monitoring data reports. For more on exporting monitoring data reports, see below.

8.1.1 Data Download

The Data Download screen allows the user to export monitored patient data to a USB device in Windows Excel XML 2003 format.

NOTE The screen will return to the monitoring view after two minutes of inactivity.

1 Touch the settings icon .

2 Touch the Export Data button.

3 Enter password when prompted in Export Data Password popup window.

4 Make sure an approved Edwards USB device has been inserted.

CAUTION Use a virus scan on any USB stick before inserting to prevent a virus or malware

infection.

5 Touch the Data Download button.

Monitoring Data. To generate a spreadsheet of monitored patient data:

Page 90

HemoSphere Advanced Monitor 8 Data Export and Connectivity Settings

1 Touch the value side of the Interval button and select the frequency of the data to download. The

shorter the frequency, the greater the amount of data. Options are:

• 20 seconds (default)

• 1 minute

• 5 minutes

2 Touch the Start Download button.

NOTE Do not disconnect the USB device until the “Download complete” message appears.

If a message appears stating that the USB device is out of space, insert a different USB device and restart the download.

All monitored patient data may be cleared by the user. Touch the Clear All button and confirm to clear.

8.2 Clear Data and Settings

The Clear Data and Settings screen allows the user to restore the factory defaults. For more information on factory defaults, see below.

8.2.1 Restore Factory Defaults

When the defaults are restored, the HemoSphere advanced monitor stops all functions and restores the system to a factory default state.

CAUTION 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.

1 Touch the settings icon .

2 Touch the Advanced Setup button.

3 Enter Advanced Setup Password. See service manual for clinician passcode.

4 Touch Clear Data and Settings button.

5 Touch Restore Factory Defaults button.

6 A confirmation screen appears. Touch Ye s to continue.

7 Turn the monitor power off and then follow the start-up process.

8.3 Wireless Settings

The HemoSphere advanced monitor can connect to available wireless networks.

1 Touch the settings icon .

2 Touch the Advanced Setup button and enter password. See service manual for clinician

passcode.

Page 91

HemoSphere Advanced Monitor 8 Data Export and Connectivity Settings

3 Touch the Wireless button.

4 Select the desired wireless network from the list of available connections and enter the password

if required.

NOTE Do not connect to an unrecognized or unsecured network. See Cyber Security on page 94.

Wi-Fi connection status is indicated on the information bar by the symbols shown in table 8-1.

Table 8-1 Wi-Fi connection status

Wi-Fi Symbol Indication

very high signal strength

medium signal strength

low signal strength

very low signal strength

8.4 HIS Connectivity

The HemoSphere advanced monitor has the ability to interface with the Hospital Information Systems (HIS) to send and receive patient demographics and physiological data. The HemoSphere advanced monitor supports Health Level 7 (HL7) messaging standard and implements Integrating Healthcare Enterprise (IHE) profiles. HL7's version 2.6 messaging standard is the most commonly used means for electronic data exchange in the clinical domain. Use a compatible interface to access this feature. The HemoSphere advanced monitor HL7 communication protocol, also referred to as HIS Connectivity, facilitates the following types of data exchanges between the HemoSphere advanced monitor and external applications and devices:

• Sending of physiological data from the HemoSphere advanced monitor to the HIS and/or medical

devices

• Sending of physiological alarms and device faults from the HemoSphere advanced monitor to the

HIS

no signal strength

no connection

Page 92

HemoSphere Advanced Monitor 8 Data Export and Connectivity Settings

• HemoSphere advanced monitor retrieval of patient data from the HIS.

Figure 8-1 HIS- Patient query screen

HIS connectivity status is indicated on the information bar by the symbols shown in Table 8-2.

Table 8-2 HIS connectivity status

HIS symbol Indication

Connection to all configured HIS actors are good.

Unable to establish communication with configured HIS actors.

Patient ID is set to “Unknown” in all outbound HIS messages.

Intermittent errors are occurring in communications with configured HIS actors.

Persistent errors are occurring in communications with configured HIS actors.

8.4.1 Patient Demographic Data

The HemoSphere advanced monitor, with HIS Connectivity enabled, can retrieve patient demographics data from enterprise application. Once the HIS Connectivity feature is enabled, touch the Query button. The Patient Query screen allows the user to search for a patient based on name, patient ID or room and bed information. The Patient Query screen can be used to retrieve patient demographics data when starting a new patient or to associate the patient physiological data being monitored on the HemoSphere advanced monitor with a patient record retrieved from HIS.

Page 93

HemoSphere Advanced Monitor 8 Data Export and Connectivity Settings

Once a patient is selected form the query results, patient demographics data is displayed in the New Patient Data screen.

Figure 8-2 HIS- New patient data screen

The user can enter or edit patient height, weight, age, gender, room and bed information on this screen. The

selected or updated patient data can be saved by touching the home icon . Once patient data is saved, the HemoSphere advanced monitor generates unique identifiers for the selected patient and sends out this

information in outbound messages with physiological data to the enterprise applications.

8.4.2 Patient Physiological Data

The HemoSphere advanced monitor can send monitored and calculated physiological parameters in outbound messages. Outbound messages can be sent to one or more configured enterprise applications. Continuously monitored and calculated parameters with the HemoSphere advanced monitor can be sent to the enterprise application.

8.4.3 Physiological Alarms and Device Faults

The HemoSphere advanced monitor can send physiological alarms and device faults to configure HIS. Alarms and faults can be sent to one or more configured HIS. Statuses of individual alarms including change in states are sent out to the enterprise application.

For more information on how to receive access to HIS Connectivity, contact your local Edwards representative or Edwards Technical Support.

WARNING 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.

Page 94

HemoSphere Advanced Monitor 8 Data Export and Connectivity Settings

8.5 Cyber Security

This chapter outlines ways in which patient data can be transferred to and from the HemoSphere advanced monitor. It is important to note that any facility using the HemoSphere advanced monitor must take measures to protect the privacy of a patients personal information in accordance with country specific regulations, and consistent with the facility’s polices for managing this information. Steps that can be taken to safeguard this information and the general security of the HemoSphere advanced monitor include:

• Physical Access: Limit use of the HemoSphere advanced monitor to authorized users.

• Active Use: Users of the monitor should take measures to limit patient data storage. Patient data

should be removed from the monitor after a patient is discharged and patient monitoring has ended.

• Network Security: The facility must take measures to ensure the security of any shared network

to which the monitor may be connected to.

• Device Security: Users should only use Edwards approved accessories. In addition, ensure that any

connected device is free of malware.

The use of any HemoSphere advanced monitor interface outside of its intended purpose could pose cyber security risks. No HemoSphere advanced monitor connections are meant to control the operations of another device. All available interfaces are shown in HemoSphere Advanced Monitor Connection Ports on page 35 and specifications for these interfaces are listed in table A-5, “HemoSphere advanced monitor technical specifications,” on page 134.

8.5.1 HIPAA

The Health Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the U.S. Department of Health and Human Services, outlines important standards to protect individually identifiable health information. If applicable, these standards should be followed during monitor use.

Page 95

HemoSphere Swan-Ganz Module Monitoring

Contents

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

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

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

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

SVR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .110

9.1 Connecting the HemoSphere Swan-Ganz Module

The HemoSphere Swan-Ganz module is compatible with all approved Edwards Swan-Ganz pulmonary artery catheters. The HemoSphere Swan-Ganz module acquires and processes signals to and from a compatible Edwards Swan-Ganz catheter for CO, iCO and EDV/RVEF monitoring. This section provides an overview of the HemoSphere Swan-Ganz module connections. See figure 9-1.

Page 96

HemoSphere Advanced Monitor 9 HemoSphere Swan-Ganz Module Monitoring

 compatible Swan-Ganz

catheter

 thermal filament

connection

 thermistor connection

 injectate temperature

probe connection

 patient CCO cable

 HemoSphere Swan-

Ganz module

 HemoSphere advanced

monitor

Figure 9-1 HemoSphere Swan-Ganz module connection overview

NOTE Appearance of catheters and injectate systems shown in this chapter are for example

only. Actual appearance may vary depending on catheter and injectate system models.

The patient CCO cable and any attached compatible catheter is an APPLIED PART.

1 Ensure that the HemoSphere advanced monitor is off before inserting the HemoSphere Swan-

Ganz module.

2 Insert the HemoSphere Swan-Ganz module into the HemoSphere advanced monitor. The

module will click when properly engaged.

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

into place.

3 Press the power button to turn on the HemoSphere advanced monitor and follow steps for

entering patient data. See Patient Data on page 70. Connect the patient CCO cable to the HemoSphere Swan-Ganz module.

Page 97

HemoSphere Advanced Monitor 9 HemoSphere Swan-Ganz Module Monitoring

4 Connect the compatible Swan-Ganz catheter to the patient CCO cable. See table 9-1 below for

available parameters and required connections.

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

Parameter Required connection See

CO thermistor and thermal filament connection Continuous Cardiac Output on page 98

iCO thermistor and injectate (bath or in-line) probe Intermittent Cardiac Output on page 101

EDV/RVEF (SV)

SVR thermistor and thermal filament connection

thermistor and thermal filament connection *HR slaved-in by HemoSphere advanced monitor

*MAP and CVP slaved-in by HemoSphere advanced monitor

EDV/RVEF Monitoring on page 107

SVR on page 110

5 Follow the necessary directions for monitoring. See Continuous Cardiac Output on page 98,

Intermittent Cardiac Output on page 101 or EDV/RVEF Monitoring on page 107.

9.1.1 Patient CCO Cable Test

To test the integrity of the Edwards patient CCO cable, perform a cable integrity test. It is recommended to test the integrity of the cable as part of a troubleshooting process. This does not test the injectate temperature probe connection of the cable.

To access the patient CCO cable test window, touch the clinical actions icon

Tes t icon . Refer to figure 9-2 for numbered connections.

Figure 9-2 Patient CCO cable test connections

 Patient CCO Cable

1 Attach the patient CCO cable to the inserted HemoSphere Swan-Ganz module .

2 Attach the patient CCO cable thermal filament connector  and thermistor connector  to their

mating test ports on the HemoSphere Swan-Ganz module.

3 Touch the Start button to begin the cable test. A progress bar will appear.

Page 98

HemoSphere Advanced Monitor 9 HemoSphere Swan-Ganz Module Monitoring

4 Replace the patient CCO cable if it fails the cable test.

5 Touch the enter icon when the cable has passed. Disconnect the patient cable thermal

filament connector and thermistor connector from the HemoSphere Swan-Ganz module.

9.2 Continuous Cardiac Output

The HemoSphere advanced monitor measures cardiac output continuously by introducing small pulses of energy into the blood stream and measuring blood temperature via a pulmonary artery catheter. The maximum surface temperature of the thermal filament used to release these pulses of energy within the blood is 48 °C. Cardiac output is computed using proven algorithms derived from the conservation of heat principles, and indicator dilution curves that are obtained by cross-correlation of energy input and blood temperature waveforms. After initialization, the HemoSphere advanced monitor continuously measures and displays the cardiac output in liters per minute without operator calibration or intervention.

9.2.1 Connecting the Patient Cables

1 Connect the patient CCO cable to the inserted HemoSphere Swan-Ganz module as previously

described in section 9.1.

2 Attach the catheter end of the patient cable to the thermistor and thermal filament connectors on

the Swan-Ganz CCO catheter. These connections are emphasized as numbers  and  in figure 9-3 on page 99.

Page 99

HemoSphere Advanced Monitor 9 HemoSphere Swan-Ganz Module Monitoring

 Swan-Ganz CCO

catheter

 thermal filament

connection

 thermistor connection

 patient CCO cable

 HemoSphere Swan-

Ganz module

 HemoSphere advanced

monitor

3 Verify that the CCO catheter is properly inserted into the patient.

Figure 9-3 CO connection overview

9.2.2 Initiating Monitoring

WARNING 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

When the system is properly connected, touch the start monitoring icon to begin CO monitoring. The

CO countdown timer will appear on the stop monitoring icon. After approximately 3 to 6 minutes, when sufficient data has been obtained, a CO value will appear in the parameter globe. The CO value displayed on the screen will be updated approximately every 60 seconds.

NOTE No CO value will be displayed until sufficient time-averaged data is available.

Page 100

HemoSphere Advanced Monitor 9 HemoSphere Swan-Ganz Module Monitoring

9.2.3 Thermal Signal Conditions

In some situations where patient conditions create large changes in pulmonary artery blood temperature over several minutes, the monitor may take longer than 6 minutes to obtain an initial CO measurement. When CO monitoring is in progress, updating of the CO measurement may also be delayed by unstable pulmonary artery blood temperature. The last CO value and measurement time will be displayed in place of an updated CO value. Table 9-2 shows the alert/fault messages that appear on the screen at different time points while the signal stabilizes. Refer to table 11-6, “HemoSphere Swan-Ganz module CO faults/alerts,” on page 123 for more information on CO faults and alerts.

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

Alert CO Fault CO

Condition

Monitoring Commencing: minutes from

commencement without CO measurement

Monitoring in Progress: minutes from last CO update

Signal Adapting — Continuing

61530

na 6 20

Unstable Blood Temp. — Continuing

Thermal Signal Loss

A fault condition terminates monitoring. A fault condition could result from migration of the catheter tip into a small vessel preventing the thermistor from accurately sensing the thermal signal. Check catheter position and reposition the catheter, if necessary. After verifying patient status and catheter position, CO

monitoring may be resumed by touching the start monitoring icon .

9.2.4 CO Countdown Timer and STAT CO

The CO countdown timer is located on the stop monitoring icon . This timer alerts the user as to when

the next CO measurement will take place. The time to the next CO measurement varies from 60 seconds to 3 minutes or longer. A hemodynamically unstable thermal signal may delay CO calculations. For longer time spans between CO measurements, the STAT CO is available. The STAT CO (sCO) is a fast estimate of the CO value and is updated every 60 seconds. Select sCO as a key parameter to view STAT CO values. Select CO and sCO as key parameters while viewing the graphical/tabular trends split screen and CO monitored data is graphically plotted alongside tabular/numerical data for STAT values of sCO. See Graphical/Tabular Trends Split on page 59.

CAUTION 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)

100