Edwards HemoSphere User Manual

Edwards HemoSphere

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HemoSphere

Advanced Monitor

HemoSphere

Advanced Monitor

Operator’s

manual

Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14

Table of Contents

List of Figures12
List of Tables14
Introduction17
- 1.1 Intended Purpose of this Manual17
- 1.2 Indications For Use17
- 1.3 Contraindications For Use18
- 1.4 Intended Use Statement18
- 1.5 HemoSphere Advanced Monitor Hemodynamic Technology Connections22
- 1.6 Manual style conventions26
- 1.7 Abbreviations Found in This Manual26
Safety and Symbols28
- 2.1 Safety Signal Words Definitions28
- 2.2 Warnings29
- 2.3 Cautions32
- 2.4 User Interface Symbols36
- 2.5 Symbols on Product Labels38
- 2.6 Applicable Standards40
- 2.7 HemoSphere Advanced Monitor Essential Performance40
Installation and Setup41
- 3.1 Unpacking41
  - 3.1.1 Packaging Contents41
  - 3.1.2 Required Accessories for Platform Modules and Cables42
- 3.2 HemoSphere Advanced Monitor Connection Ports43
- 3.3 HemoSphere Advanced Monitor Installation46
- 3.4 Initial Start Up50
  - 3.4.1 Start Up Procedure50
  - 3.4.2 Select Language50
HemoSphere Advanced Monitor Quick Start52
- 4.1 HemoSphere Swan-Ganz Module Cardiac Output Monitoring53
- 4.2 Monitoring with the HemoSphere Pressure Cable56
  - 4.2.1 Pressure Cable Setup56
  - 4.2.2 Zero Pressure Cable56
- 4.3 HemoSphere Oximetry Cable Monitoring58
  - 4.3.1 In vitro Calibration58
  - 4.3.2 In vivo Calibration59
Navigating the HemoSphere Advanced Monitor61
- 5.1 HemoSphere Advanced Monitor Screen Appearance61
- 5.2 Navigation Bar63
- 5.3 Monitor Views65
- 5.4 Clinical Actions80
- 5.5 Information Bar83
  - 5.5.1 Battery84
  - 5.5.2 Lock Screen85
- 5.6 Status Bar86
- 5.7 Monitor Screen Navigation86
  - 5.7.1 Vertical Scrolling86
  - 5.7.2 Navigation Icons86
User Interface Settings88
- 6.1 Patient Data88
- 6.2 Monitor Settings91
Advanced Settings100
- 7.1 Alarms / Targets100
- 7.2 Adjust Scales107
- 7.3 Serial Port Setup109
- 7.4 Demo Mode109
- 7.5 Engineering110
Data Export and Connectivity Settings111
- 8.1 Export Data111
  - 8.1.1 Data Download111
- 8.2 Clear Data and Settings112
  - 8.2.1 Restore Factory Defaults112
- 8.3 Wireless Settings113
- 8.4 HIS Connectivity114
- 8.5 Cyber Security116
  - 8.5.1 HIPAA116
HemoSphere Swan-Ganz Module Monitoring117
- 9.1 Connecting the HemoSphere Swan-Ganz Module117
  - 9.1.1 Patient CCO Cable Test119
- 9.2 Continuous Cardiac Output120
- 9.3 Intermittent Cardiac Output123
- 9.4 EDV/RVEF Monitoring129
- 9.5 SVR132
Monitoring with the HemoSphere Pressure Cable133
- 10.1 Pressure Cable Overview133
- 10.2 Monitoring Mode Selection135
- 10.3 FloTrac Sensor Monitoring135
- 10.4 Pressure Cable Monitoring with a TruWave DPT139
  - 10.4.1 Connect TruWave DPT139
  - 10.4.2 Zero Intravascular Pressure139
- 10.5 Pressure Cable Monitoring in Swan-Ganz Module Monitoring Mode140
- 10.6 Zero & Waveform Screen141
Oximetry Monitoring143
- 11.1 Oximetry Setup143
- 11.2 In Vitro Calibration144
  - 11.2.1 In Vitro Calibration Error145
- 11.3 In Vivo Calibration145
- 11.4 Signal Quality Indicator147
- 11.5 Recall Oximetry Data147
- 11.6 HGB Update148
- 11.7 HemoSphere Oximetry Cable Reset149
- 11.8 New Catheter149
Advanced Features150
- 12.1 Acumen Hypotension Probability Indicator Software Feature150
- 12.2 Enhanced Parameter Tracking164
Troubleshooting168
- 13.1 On Screen Help168
- 13.2 Monitor Status Lights169
- 13.3 Pressure Cable Communication170
- 13.4 HemoSphere Advanced Monitor Error Messages170
- 13.5 HemoSphere Swan-Ganz Module Error Messages174
- 13.6 Pressure Cable Error Messages181
- 13.7 Oximetry Error Messages186
Specifications189
- A.1 Essential Performance Characteristics189
- A.2 HemoSphere Advanced Monitor Specifications190
- A.3 HemoSphere Battery Pack Specifications192
- A.4 HemoSphere Swan-Ganz Module Specifications192
- A.5 HemoSphere Pressure Cable Specifications194
- A.6 HemoSphere Oximetry Cable Specifications194
Accessories195
- B.1 Accessories List195
- B.2 Additional Accessories Description196
  - B.2.1 Roll Stand196
Equations for Calculated Patient Parameters197
Monitor Settings and Defaults203
- D.1 Patient Data Input Range203
- D.2 Trend Scale Default Limits203
- D.3 Parameter Display and Configurable Alarm/Target Ranges204
- D.4 Alarm and Target Defaults206
- D.5 Alarm Priorities207
- D.6 Language Default Settings*208
Computation Constants209
- E.1 Computation Constant Values209
System Care, Service and Support211
- F.1 General Maintenance211
- F.2 Cleaning the Monitor and Modules212
- F.3 Cleaning the Platform Cables212
- F.4 Service and Support214
- F.5 Edwards Lifesciences Regional Headquarters214
- F.6 Monitor Disposal216
  - F.6.1 Battery Recycling216
- F.7 Preventive Maintenance216
  - F.7.1 Battery Maintenance216
    - F.7.1.1 Battery Conditioning216
    - F.7.1.2 Battery Storage216
- F.8 Testing of Alarm Signals217
- F.9 Warranty217
Guidance and Manufacturer’s Declaration218
- G.1 Electromagnetic Compatibility218
- G.2 Instructions for Use219
- G.3 Wireless Technology Information224
Glossary230

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Edwards HemoSphere Specifications

General

Technology	Advanced hemodynamic monitoring
Connectivity	Ethernet, USB
Power Supply	100–240 VAC, 50/60 Hz
Parameters Measured	Cardiac output, stroke volume, systemic vascular resistance
Trending	Yes
Alarms	Configurable alarms for various parameters
Data Storage	Internal memory
Applications	Critical care
Display	Touchscreen

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