Edwards EV1000 - Page 114

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Caution: Federal (USA) law restricts this device to

sale by or on the order of a physician. See

instructions for use for full prescribing information.

Edwards Lifesciences devices placed on the

European market meeting the essential

requirements referred to in Article 3 of the Medical

Device Directive 93/42/EEC bear the CE marking

of conformity.

Edwards, Edwards Lifesciences, the stylized E

logo, ClearSight, EV1000, FloTrac, Physiocal,

TruWave and VolumeView are trademarks of

Edwards Lifesciences Corporation or its affiliates.

All other trademarks are the property of their

respective owners.

Main Page

Default Chapter4
- Table of Contents4
Monitored Parameters11
Chapter 1 : EV1000 Clinical Platform ni Overview11
Indications for Use11
- Table 1-1 EV1000 Clinical Platform ni Parameters11
Edwards EV1000 Clinical Platform ni Operator's Manual12
Acronyms and Abbreviations12
- Table 1-2 Acronyms and Abbreviations12
Chapter 2 : Safety and Symbols13
Safety Identifying Symbols13
Warnings13
Cautions16
Monitor Display Symbols18
- Table 2-1 Monitor Display Symbols18
Symbols on Product Labels19
- Table 2-2 Symbols on Product Labels19
Applicable Standards21
- EV1000 ni Essential Performance21
Documentation and Training21
- Table 2-3 Applicable Standards21
Chapter 3 : Unpacking and Initial Setup22
Unpacking22
- Contents List22
- Parameter Monitoring Accessories22
Monitor and Pump-Unit Installation22
- Table 3-1 EV1000 ni Main Components22
Connecting the Patient Cables25
Initial Startup25
- Figure 3-2 Startup Screen25
  - Select Language26
  - Figure 3-3 Language Selection Screen26
Chapter 4 : EV1000 Clinical Platform ni Quick Start27
Clearsight Technology Blood Pressure and Hemodynamic Monitoring27
- Figure 4-1 EV1000 Noninvasive System Cable Connection27
Chapter 5 : Navigating the EV1000 Clinical Platform ni30
Navigation Bar30
- Figure 5-1 Navigation Bar30
Monitor Views31
- Figure 5-2 Example of Monitoring Screen Selection Window31
Status Indicators36
- Figure 5-11 Cockpit Monitoring Screen36
- Figure 5-12 Physio Relationship Screen36
- Figure 5-13 Parameter Globe36
Monitor Screen Navigation37
- Vertical Scrolling37
- Figure 5-14 Vertical Scrolling Review List37
- Figure 5-15 Vertical Scrolling Selection List37
- Information Bar38
- Figure 5-16 Information Bar38
- Table 5-4 Physiocal Interval Status38
- Status Bar39
- Figure 5-17 Lock Screen39
- Figure 5-18 Screen Locked39
- Figure 5-19 Status Bar39
- Table 5-5 Pump-Unit Battery Status39
Chapter 6: Monitor Display Options40
Patient Data40
- New Patient40
- Continue Monitoring Patient40
- Figure 6-1 New or Continuing Patient Screen40
- View Patient Data41
Monitoring Settings41
- General Monitor Settings41
- Change Date and Time Display41
- Figure 6-2 Monitor Settings41
- Figure 6-3 General Monitor Settings41
- Monitoring Screens Settings42
- Figure 6-4 Date / Time Settings42
- Serial Port Setup43
- Restore Monitor Defaults43
Parameter Settings43
- Figure 6-6 Serial Port Setup43
Chapter 7: Methodology and Monitoring49
EV1000 Noninvasive System Methodology49
- Volume Clamp Method49
- Physiocal Method49
- Waveform Reconstruction and Hemodynamic Analysis (Clearsight Algorithm)49
- Heart Reference Sensor49
- Discoloration, Numbness, or Tingling of the Fingertip49
- Figure 7-1 Physiocal During Blood Pressure Measurement49
- Single Cuff Monitoring50
- Double Cuff Monitoring50
Connect the Patient Sensors50
- Figure 7-2 EV1000 Noninvasive System Connections51
Enter Patient Data53
Zero and Apply Heart Reference Sensor and Start Monitoring53
- Figure 7-5 Settings Screen53
- Figure 7-6 Zero & Waveform Screen54
- Figure 7-7 Alignment of HRS54
Set Targets and Alarm Limits55
- Figure 7-8 Parameter Settings55
- Figure 7-9 Alarms / Targets55
Central Venous Pressure Manual Entry56
Continuous Waveform Display56
Output Signal to Patient Monitor56
Derived Value Calculator56
Cuff Options56
- Cuff Pressure Release Mode57
Cardiac Output Calibration57
- Figure 7-10 Finger Cuff Pressure Release Icon and Timer57
- Figure 7-11 Advanced Options Screen57
- Figure 7-12 Advanced Options Screen - CO Calibration57
Physiocal Control58
Chapter 8 : Physiology and Physio Relationship Monitoring Screens59
- Physiology Screen59
Physio Relationship Screen60
- Continuous and Historical Modes60
- Figure 8-3 SVV Slope Indicator60
- Figure 8-4 Physio Relationship Screen60
- Figure 8-5 Physio Relationship Historical Data Screen60
- Parameter Boxes61
- Physio Relationship Alarms/Targets and Historical Data Screens61
- Figure 8-6 Physio Relationship Parameter Boxes61
- Figure 8-7 Physio Relationship Target Popup61
Chapter 9 : Enhanced Parameter Tracking62
GDT Tracking62
- Key Parameter and Target Selection62
- Figure 9-1 GDT Menu Screen - Key Parameter Selection62
- Figure 9-2 GDT Menu Screen - Target Selection62
- Figure 9-3 GDT Active Tracking62
- Active GDT Tracking63
- Historical GDT63
SV Optimization63
GDT Report Download63
- Table 9-1 GDT Target Status Indicator Colors63
Chapter 10 : Clinical Actions and Analysis64
Zero & Waveform64
- Zero Heart Reference Sensor (HRS)64
- Analog Pressure out64
Central Venous Pressure Manual Entry64
Derived Value Calculator64
Event Review64
- Figure 10-1 Derived Value Calculator64
- Figure 10-2 Event Review64
Cuff Options65
Advanced Options65
- Table 10-1 Reviewed Events65
Historical Data66
- Figure 11-1 Settings Screen67
- Figure 11-2 Demo Mode67
- Figure 11-3 Live Demo Banner67
Chapter 11 : Demonstration Mode and Data Download68
Data Download68
- Figure 11-4 Data Download68
Chapter 12 : Help and Troubleshooting69
On Screen Help69
- Figure 12-1 Main Help Screen69
Pump-Unit Communication and Power71
- Figure 12-7 EV1000 Pump-Unit and Monitor LED Indicators71
- Table 12-1 Pump-Unit Communication and Power Lights71
Pressure Controller Communication72
- Figure 12-8 Pressure Controller LED Indicators72
- Table 12-2 Pressure Controller Communication Lights72
System Errors73
- Table 12-3 System Errors73
Numeric Keypad Errors74
- Table 12-4 Numeric Keypad Errors74
Clearsight Faults and Alerts75
- Table 12-5 Clearsight Faults and Alerts75
Clearsight Warnings and Troubleshooting80
- Table 12-6 Clearsight Warnings80
- Table 12-7 Clearsight Troubleshooting80
CVP Troubleshooting81
- Table 12-8 CVP Troubleshooting81
Chapter 13 : EV1000 Clinical Platform ni Accessories82
Stands82
- EV1000 Table Stand82
- EV1000 Roll Stand82
- Figure 13-1 EV1000 Table Stand82
- Figure 13-2 EV1000 Roll Stand82
- EV1000 Clinical Platform ni Accessories82
EV1000 Monitor Bracket83
EV1000 Monitor Types83
- Figure 13-3 EV1000 Monitor Bracket83
- Figure 13-4 EV1000 Monitor and Monitor Bracket83
- Figure 13-5 EV1000 Monitor Appearance and Location of Power Button83
- Figure 13-6 EV1000 Monitor Cable Connections83
EV1000 Pump-Unit Bracket84
- Figure 13-7 EV1000 Pump-Unit Bracket84
Chapter 14 : EV1000 Clinical Platform ni Advanced Features85
HIS Connectivity85
- Figure 14-1 HIS- Patient Query85
- Figure 14-2 HIS- New Patient Data Screen85
- Goal Positioning Screen86
  - Figure 14-3 Goal Positioning Screen86
Technology Selection87
- EV1000 ni Databox Adaptor Cable Connection87
- Technology Selection Screen87
- Figure 14-4 EV1000 ni Databox Adaptor Cable Power Connections87
- Figure A-1 Spectral Irradiance89
- Figure A-2 Location of Light Emission Aperture89
- Table A-1 Physical and Mechanical Specifications89
Appendix A: Specifications90
Accessories90
- Table A-2 Environmental Specifications90
- Table A-3 Base Parameters90
- Table A-4 EV1000 Clinical Platform ni Components90
- Table A-5 EV1000 Monitor Technical Specifications91
- Table A-6 EV1000 Pump-Unit Technical Specifications91
- Table B-1 Cardiac Profile Equations92
Appendix B: Equations for Calculated Patient Parameters95
Appendix C: Monitor Settings and Defaults95
Patient Data Input Range95
Trend Scale Default Limits95
- Table C-1 Patient Information95
- Table C-2 Graphical Trend Parameter Scale Defaults95
Parameter Display and Configurable Alarm/Target Ranges96
Alarm and Target Defaults96
- Table C-3 Ranges for Key Parameters96
- Table C-4 Parameter Alarm Red Zone and Target Defaults96
Language Default Settings97
- Table C-5 Language Default Settings97
Appendix D: EV1000 Unit Conversions98
Lbs Vs. Kg98
Inches Vs. CM98
Mmhg Vs. Kpa98
G/Dl Vs. Mmol/L (Hemoglobin98
F Vs. °C98
Appendix E: System Care, Service and Support99
Cleaning the EV1000 Clinical Platform ni99
- Cleaning the Monitor and Pump-Unit99
- Cleaning the System Cables and Accessories99
- Cleaning the Patient Cables and Connectors100
Service and Support100
- Figure E-1 Startup Screen100
Edwards Lifesciences Regional Headquarters101
System Disposal101
Preventive Maintenance101
Warranty102
Appendix F: Guidance and Manufacturer's Declaration103
Electromagnetic Compatibility103
Instructions for Use103
- Table F-1 List of Accessories, Cables and Sensors Necessary for Compliance103
- Table F-2 Electromagnetic Emissions104
- Table F-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the EV1000 Clinical Platform ni104
- Table F-4 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)105
- Table F-5 Electromagnetic Immunity (RF Radiated and Conducted106

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