EV1000 Clinical Platform Operator’s Manual Ver 1.10 Oct 2016

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Edwards Lifesciences EV1000 Clinical Platform 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. Issued by

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686 Made in USA

Trademarks

Edwards, Edwards Lifesciences, the stylized E logo, EV1000, FloTrac, PediaSat, PreSep, Swan, Swan-Ganz, TruWave, Vigilance, Vigilance II, Vigileo, and VolumeView are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Copyright ©2016 Edwards Lifesciences LLC. All rights reserved. Version 1.3, Release Date: October 15, 2016 Software Version 1.10, Release Date: October 15, 2016

Edwards Lifesciences Services GmbH Edisonstr. 6 85716 Unterschleissheim, Germany

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Using This Manual The Edwards Lifesciences EV1000 Clinical Platform Operator’s Manual is comprised of 16 chapters, seven 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.

Chapter

Description

12

Clinical Actions and Analysis: Describes information about using the EV1000 system to calculate the percentage of change of monitored values, perform intervention analyses, and review events.

13

Demonstration Mode and Data Download: Describes how to use the EV1000 platform for training and demonstration and how to download monitored data to a USB drive.

Description

14

1

EV1000 Overview: Provides an overview of the EV1000 system.

Help and Troubleshooting: Describes how to use the help system and lists faults and alerts.

15

2

Safety and Symbols: Includes WARNINGS, CAUTIONS, and NOTES that are found in the manual, as well as illustrations of labels found on the monitor and Databox surfaces.

EV1000 System Accessories: Describes accessories available for use with the EV1000 Clinical Platform.

16

EV1000 Advanced Features: Describes features available for upgrade.

. Chapter

3

4

5

6

Unpacking and Initial Setup: Provides information about setting up the EV1000 platform and cables and for the first time you turn on the system. EV1000 Quick Start: Provides experienced clinicians and users of bedside monitors instructions for immediate monitor use. Navigating the EV1000: Provides information on how to use the touch screen and monitoring cables. Monitor Display Options: Provides information about the various monitor display settings including patient information, language and international units, alarm volume, system time, and system date. It also provides instructions for selecting the monitor screen appearance.

7

FloTrac Continuous Monitoring: Describes procedures for setup and operation of cardiac output, stroke volume, stroke volume variation, and systemic vascular resistance calculation.

8

VolumeView Monitoring: Intermittent TPTD and Continuous Calibrated Cardiac Output: Describes procedures for setup and operation of TPTD, and derived parameters monitoring, when it is used in conjunction with the VolumeView system.

9

Oximetry Monitoring: Describes procedures for calibration and operation of oximetry (oxygen saturation) measurement.

10

Physiology and Physio Relationship Monitoring Screens: The Physiology screen and Physio Relationship monitoring screens provide a graphic display of monitored parameters and their relationship to each other.

11

Enhanced Parameter Tracking: The EV1000 Clinical Platform provides tools to aid in Goal Directed Therapy.

Appendix

Description

A

Specifications

B

Equations for Calculated Patient Parameters

C

Monitor Settings and Defaults

D

EV1000 Unit Conversions

E

System Care, Service and Support

F

Guidance and Manufacturer's Declaration

G

Glossary

Index

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Contents Chapter 1: EV1000 Overview Monitored Parameters... 1-1 FloTrac: Continuous Calculations... 1-1 VolumeView: Intermittent Calculations... 1-1 VolumeView Sensor: Continuous Calculations... 1-2 Intravascular Oximetry... 1-2 Indications for Use... 1-3 FloTrac Arterial Pressure Autocalibrated Cardiac Output (FT-CO)... 1-3 VolumeView Transpulmonary Thermodilution (TPTD)... 1-3 VolumeView Calibrated Cardiac Output (VV-CO)... 1-3 Intravascular Oximetry... 1-3 Edwards EV1000 Clinical Platform Operator's Manual... 1-4 Acronyms and Abbreviations... 1-4

Chapter 2: Safety and Symbols Safety Identifying Symbols... 2-1 Warnings... 2-1 Cautions... 2-3 Monitor Display Symbols... 2-5 Symbols on Product Labels... 2-6 Applicable Standards... 2-7

Chapter 3: Unpacking and Initial Setup Unpacking... 3-1 Contents List... 3-2 Parameter Monitoring Accessories... 3-2 Monitor Installation... 3-3 Mounting Recommendations... 3-3 Connecting the Monitor... 3-4 Connecting the Patient Cables... 3-4 Initial Startup... 3-6 Select Language... 3-6

Chapter 4: EV1000 Quick Start FloTrac System and Pressure Monitoring... 4-1 Zero FloTrac Sensor or Arterial Pressure and Central Venous Pressure... 4-2 Central Venous Pressure Manual Entry (For SVR and SVRI calculations) . . 4-2 VolumeView Calibrated Cardiac Output and Intermittent TPTD Monitoring . 4-3 Central Venous Pressure Manual Entry (For SVR and SVRI calculations) . . 4-4 Oximetry Monitoring... 4-4 In vitro Calibration... 4-4 In vivo Calibration... 4-4

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Contents

Chapter 5: Navigating the EV1000 Navigation Bar... 5-1 Monitor Views... 5-2 Change Parameters... 5-2 Change Alarm/Target... 5-3 Graphical Trend Monitoring View... 5-3 Arterial Waveform (ART) Display... 5-3 Intervention Events... 5-3 Graphical Trend Scroll Mode... 5-5 Tabular Trends... 5-5 Tabular Trend Scroll Mode... 5-6 Big Numbers... 5-6 Physiology Screen... 5-6 Cockpit Screen... 5-7 Physio Relationship... 5-7 Status Indicators... 5-7 Monitor Screen Navigation... 5-8 Vertical Scrolling... 5-8 Information Bar... 5-9 Lock Screen... 5-9 Status Bar... 5-10

Chapter 6: Monitor Display Options Patient Data... 6-1 New Patient... 6-1 Continue Monitoring Patient... 6-2 View Patient Data... 6-2 Monitoring Settings... 6-2 General Monitor Settings... 6-2 Change Language... 6-3 Change Date and Time Display... 6-3 Adjust Date or Time... 6-3 Monitoring Screens Settings... 6-4 Serial Port Setup... 6-4 Restore Monitor Defaults... 6-4 Parameter Settings... 6-5 Alarms / Targets... 6-5 Silence Alarms... 6-5 Set Alarm Volume... 6-5 Set Targets... 6-6 Alarms/Targets Setup Screen... 6-6 Configure All Targets... 6-7 Set Custom Defaults... 6-7 Configure Targets and Alarms for One Parameter... 6-7 Time Intervals and Averaging... 6-8 Adjust Scales... 6-8 Engineering... 6-10

Chapter 7: FloTrac Continuous Monitoring Connect FloTrac Cable... 7-1 Enter Patient Data and select Monitoring Options... 7-3

Contents

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Set Averaging Time... 7-3 Set Targets and Alarm Limits... 7-4 Zero Arterial and Central Venous Pressure... 7-4 Waveform Confirmation... 7-5 Central Venous Pressure Manual Entry... 7-5 Derived Value Calculator... 7-5

Chapter 8: VolumeView Monitoring: Intermittent TPTD and Continuous Calibrated Cardiac Output TPTD Procedure... 8-3 Injectate Syringe and Indicator Solution... 8-3 Edit and View TPTD Values... 8-4 System Restart... 8-4

Chapter 9: Oximetry Monitoring Prepare to Calibrate... 9-1 Signal Quality Indicator... 9-1 Connect the Catheter... 9-2 In vitro Calibration... 9-3 In vitro Calibration Error... 9-4 In vivo Calibration... 9-4 Recall OM Data... 9-5 HGB Update... 9-6 Optical Module Reset... 9-6 New Catheter... 9-6

Chapter 10: Physiology and Physio Relationship Monitoring Screens Physiology Screen... 10-1 SVV Slope Indicator... 10-2 Historic Physiology Screen... 10-2 Physio Relationship Screen... 10-3 Continuous and Historical Modes... 10-3 Parameter Boxes... 10-4 Setting Alarms and Targets... 10-4

Chapter 11: Enhanced Parameter Tracking GDT Tracking... 11-1 Key Parameter and Target Selection... 11-1 Active GDT Tracking... 11-2 Historical GDT... 11-2 SV Optimization... 11-2 GDT Report Download... 11-2

Chapter 12: Clinical Actions and Analysis Zero and Waveform... 12-1 Oximetry Calibration... 12-1 Thermodilution... 12-1 Derived Value Calculator... 12-1 Central Venous Pressure Manual Entry... 12-1

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Event Review... 12-2 Hypotension Probability... 12-3

Chapter 13: Demonstration Mode and Data Download Data Download... 13-2

Chapter 14: Help and Troubleshooting On Screen Help... 14-1 Databox Communication and Power... 14-2 System Errors... 14-3 Numeric Keypad Errors... 14-3 CO/SV Faults and Alerts... 14-4 CO/SV Troubleshooting... 14-6 TPTD Messages and Troubleshooting... 14-6 Oximetry Faults and Alerts... 14-8 CVP Faults / Alerts... 14-10

Chapter 15: EV1000 System Accessories Stands... 15-1 EV1000 Table Stand... 15-1 EV1000 Monitor Bracket... 15-1 EV1000 Monitor Types... 15-2 EV1000 Databox Bracket... 15-2 EV1000 Power Adapter Mounting Bracket... 15-2 EV1000 Databox Transducer Holder... 15-3

Chapter 16: EV1000 Advanced Features HIS Connectivity... 16-1 Patient Demographic Data... 16-1 Patient Physiological Data... 16-2 Physiological Alarms and Device Faults... 16-2 Goal Positioning Screen... 16-2 Parameter Selection... 16-2 Trend, Target and Alarm Customization... 16-2 Hypotension Probability Indicator Feature... 16-3 Hypotension Probability P(↓BP)... 16-3 P(↓BP) as a Key Parameter... 16-3 P(↓BP) Alarm... 16-4 P(↓BP) in Information Bar... 16-4 Disable P(↓BP) Information Bar Indicator... 16-5 P(↓BP) High Alert Popup... 16-5 HPI Secondary Screen... 16-5

Appendix A: Specifications Parameters

... A-1

Accessories... A-2

Contents

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Appendix B: Equations for Calculated Patient Parameters Appendix C: Monitor Settings and Defaults Patient Data Input Range... C-1 Trend Scale Default Limits... C-1 Parameter Display and Configurable Alarm/Target Ranges... C-2 Alarm and Target Defaults... C-3 Language Default Settings*... C-3

Appendix D: EV1000 Unit Conversions lbs vs. kg... D-1 inches vs. cm... D-1 mmHg vs. kPa... D-1 g/dL vs. mmol/L (hemoglobin)... D-1 °F vs. °C... D-1

Appendix E: System Care, Service and Support Cleaning the Monitor... E-1 Cleaning the System Cables... E-1 Cleaning the Optical Module... E-1 Cleaning the Cable and Connector... E-2 Service and Support... E-2 Edwards Lifesciences Regional Headquarters... E-3 Monitor Disposal... E-3 Preventive Maintenance... E-3 Testing of Alarm Signals... E-3 Warranty... E-3

Appendix F: Guidance and Manufacturer's Declaration Electromagnetic Compatibility... F-1 Instructions for Use... F-1

Appendix G: Glossary Index

List of Figures Figure 3-1 EV1000 Packaging Contents... 3-1 Figure 3-2 EV1000 Cable Connections... 3-5 Figure 3-3 Startup Screen... 3-6 Figure 3-4 Language Selection Screen... 3-6 Figure 4-1 FT-CO FloTrac Connections... 4-1 Figure 4-2 Parameter Settings... 4-1 Figure 4-3 Patient Data Entry Screen... 4-1 Figure 4-4 Set Alarms and Targets... 4-2 Figure 4-5 Clinical Actions... 4-2 Figure 4-6 Zero & Waveform... 4-2 Figure 4-7 TPTD Monitoring Diagram... 4-3 Figure 4-8 VolumeView CVC Thermistor Manifold... 4-3 Figure 4-9 Oximetry Cable Connection... 4-4 Figure 5-1 Navigation Bar... 5-1 Figure 5-2 Example of Monitoring Screen Selection Window... 5-2 Figure 5-3 Change Monitored Parameter... 5-2 Figure 5-4 Graphical Trend Screen- Arterial Waveform Display... 5-3 Figure 5-5 Graphical Trend- Intervention... 5-4 Figure 5-6 Graphical Trend Screen - Intervention information Balloon... 5-4 Figure 5-7 Tabular Trend Screen... 5-5 Figure 5-8 Tabular Increment Popup... 5-6 Figure 5-9 Big Numbers Monitoring Screen... 5-6 Figure 5-10 Physiology Screen... 5-6 Figure 5-11 Cockpit Monitoring Screen... 5-7 Figure 5-12 Physio Relationship Screen... 5-7 Figure 5-13 Parameter Globe... 5-7 Figure 5-14 Vertical Scrolling Review List... 5-8 Figure 5-15 Vertical Scrolling Selection List... 5-8 Figure 5-16 Information Bar... 5-9 Figure 5-17 Information Bar - FloTrac Mode... 5-9 Figure 5-18 Information Bar - VolumeView Mode... 5-9 Figure 5-19 Lock Screen... 5-10 Figure 5-20 Screen Locked... 5-10 Figure 5-21 Status Bar... 5-10 Figure 6-1 New or Continuing Patient Screen... 6-1 Figure 6-2 Monitor Settings... 6-2 Figure 6-3 General Monitor Settings... 6-3 Figure 6-4 Time / Date Settings... 6-3 Figure 6-5 Monitor Settings... 6-4 Figure 6-6 Serial Port Setup... 6-4 Figure 6-7 Parameter Settings... 6-5 Figure 6-8 Alarms / Targets Configuration... 6-6 Figure 6-9 Set Custom Default Alarms / Targets... 6-7 Figure 6-10 Set Alarms and Targets... 6-8 Figure 6-11 Time Intervals / Averaging... 6-8 Figure 6-12 Graphical Trend Screen... 6-9 Figure 6-13 Adjust Scales... 6-9 Figure 6-14 Tabular Increment Popup... 6-9

List of Figures

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Figure 7-1 CO Monitoring Globes... 7-1 Figure 7-2 FloTrac Sensor Connection... 7-2 Figure 7-3 Settings Screen... 7-3 Figure 7-4 Parameter Settings... 7-3 Figure 7-5 Time Intervals / Averaging... 7-3 Figure 7-6 Alarms / Targets... 7-4 Figure 7-7 Zero and Waveform – Zero All... 7-4 Figure 8-1 EV1000 Clinical Platform VolumeView Set... 8-2 Figure 8-2 Clinical Actions Screen... 8-3 Figure 8-3 TPTD Start Set... 8-3 Figure 8-4 TPTD – Wait for Thermal Baseline... 8-3 Figure 8-5 TPTD – Review Set... 8-4 Figure 8-6 TPTD – Accept Set... 8-4 Figure 9-1 Oximetry Cable Connection... 9-2 Figure 9-2 Oximetry Calibration Menu Screen... 9-3 Figure 9-3 Oximetry In vitro Calibration Data Entry... 9-3 Figure 9-4 In vitro Calibration OK... 9-3 Figure 9-5 In vivo Setup In Progress... 9-4 Figure 9-6 In vivo Calibration Draw... 9-4 Figure 9-7 In vivo Calibration Data Entry... 9-5 Figure 9-8 Recall OM Data... 9-5 Figure 9-9 HGB Update Screen... 9-6 Figure 9-10 Optical Module Reset... 9-6 Figure 9-11 New Catheter... 9-7 Figure 10-1 Physiology Screen... 10-1 Figure 10-2 Heart Variation... 10-1 Figure 10-3 Lung Water Variation... 10-1 Figure 10-4 Systemic Vascular Resistance... 10-2 Figure 10-5 SVV Slope Indicator... 10-2 Figure 10-6 Physiology Screen... 10-2 Figure 10-7 Physio Relationship Screen... 10-3 Figure 10-8 Physio Relationship Historical Data Screen... 10-3 Figure 10-9 Physio Relationship Parameter Boxes... 10-4 Figure 10-10 Physio Relationship Target Popup... 10-4 Figure 11-1 GDT Menu Screen - Key Parameter Selection... 11-1 Figure 11-2 GDT Menu Screen - Target Selection... 11-1 Figure 11-3 GDT Active Tracking... 11-1 Figure 12-1 Derived Value Calculator... 12-1 Figure 12-2 Event Review... 12-2 Figure 13-1 Settings Screen... 13-1 Figure 13-2 Demo Mode... 13-1 Figure 13-3 Data Download... 13-2 Figure 14-1 Main Help Screen... 14-1 Figure 14-2 Category Help Screen... 14-1 Figure 14-3 Secondary Help Screen... 14-1 Figure 14-4 Help Screen... 14-2 Figure 15-1 EV1000 Table Stand... 15-1 Figure 15-2 EV1000 Monitor Bracket... 15-1 Figure 15-3 EV1000 Monitor and Monitor Bracket... 15-1 Figure 15-4 EV1000 Monitor Appearance and Location of Power Button... 15-2 Figure 15-5 EV1000 Monitor Cable Connections... 15-2

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List of Figures

Figure 15-6 EV1000 Databox Bracket... 15-2 Figure 15-7 EV1000 Databox and Bracket... 15-2 Figure 15-8 EV1000 Power Adapter Bracket... 15-3 Figure 15-9 EV1000 Power Adapter Bracket... 15-3 Figure 15-10 EV1000 Databox Transducer Holder... 15-3 Figure 15-11 EV1000 Databox and Transducer Holder... 15-3 Figure 16-1 HIS- Patient Query... 16-1 Figure 16-2 HIS- New Patient Data Screen... 16-1 Figure 16-3 Goal Positioning Screen... 16-3 Figure 16-4 P(↓BP) Key Parameter Globe... 16-4 Figure 16-5 P(↓BP) Key Parameter Cockpit Screen... 16-4 Figure 16-6 P(↓BP) Key Parameter Shortcut Button... 16-4 Figure 16-7 Information Bar with P(↓BP)... 16-4 Figure 16-8 “Always Alert when P(↓BP) is High” Setting... 16-5 Figure 16-9 P(↓BP) High Alert Popup... 16-5 Figure 16-10 Hypotension Probability Secondary Screen... 16-6 Figure 16-11 Clinical Actions Menu... 16-6 Figure E-1 Startup Screen... E-2

List of Tables Table 1-1 FloTrac Auto-Calibrated Continuous Parameters... 1-1 Table 1-2 VolumeView Intermittent Parameters... 1-1 Table 1-3 VolumeView Calibrated Continuous Parameters... 1-2 Table 1-4 Intravascular Oximetry Parameters... 1-2 Table 1-5 Acronyms, Abbreviations... 1-4 Table 2-1 Monitor Display Symbols... 2-5 Table 2-2 Symbols on Product Labels... 2-6 Table 2-3 Applicable Standards... 2-7 Table 3-1 Parameter Monitoring Accessories... 3-2 Table 3-2 Parameter Monitoring Accessories – Venous Oxygen Saturation . . . 3-3 Table 5-1 Intervention Events... 5-4 Table 5-2 Graphical Trend Scroll Rates... 5-5 Table 5-3 Tabular Trend Scroll Rates... 5-6 Table 5-4 SQI Level Indicators... 5-8 Table 6-1 Target Status Indicator Colors... 6-6 Table 6-2 Target Defaults... 6-6 Table 8-1 Recommended Injectate Volumes... 8-3 Table 9-1 Signal Quality Indicator Levels... 9-1 Table 9-2 In vitro Calibration Options... 9-3 Table 9-3 In vivo Calibration Options... 9-4 Table 11-1 GDT Target Status Indicator Colors... 11-2 Table 12-1 Reviewed Events... 12-2 Table 14-1 Databox Communication and Power Lights... 14-2 Table 14-2 System Errors*... 14-3 Table 14-3 Numeric Keypad Errors... 14-3 Table 14-4 CO/SV Faults and Alerts... 14-4 Table 14-5 CO/SV Troubleshooting... 14-6 Table 14-6 TPTD Faults and Alerts... 14-6 Table 14-7 TPTD Warnings... 14-8 Table 14-8 Oximetry Faults/Alerts... 14-8 Table 14-9 Oximetry Warnings... 14-9 Table 14-10 Oximetry General Troubleshooting... 14-9 Table 14-11 CVP Faults/Alerts... 14-10 Table 14-12 CVP Troubleshooting... 14-10 Table 16-1 P(↓BP) Display Configurations... 16-3 Table 16-2 P(↓BP) vs. Other Key Parameters Similarities... 16-3 Table 16-3 P(↓BP) vs. Other Key Parameters Differences... 16-4 Table 16-4 Parameter Status Colors for P(↓BP)... 16-4 Table A-1 Physical and Mechanical Specifications... A-1 Table A-2 Environmental Specifications... A-1 Table A-3 Base Parameters... A-1 Table A-4 FloTrac/VolumeView... A-1 Table A-5 Oximetry... A-2 Table A-6 TPTD... A-2 Table A-8 In vivo Calibration ScvO2/SvO2/HGB/Hct Ranges and Defaults... A-2 Table A-7 Other Parameters... A-2 Table A-9 EV1000 System Accessories... A-2 Table A-10 Technical Specifications... A-3

xiv List of Tables

Table B-1 Cardiac Profile Equations... B-1 Table C-1 Patient Information... C-1 Table C-2 Graphical Trend Parameter Scale Defaults... C-1 Table C-3 Configurable Parameter Alarm and Display Ranges... C-2 Table C-4 Parameter Alarm Red Zone and Target Defaults... C-3 Table C-5 Language Default Settings... C-3 Table F-1 List of Accessories, Cables and Sensors Necessary for Compliance F-1 Table F-2 Electromagnetic Emissions... F-1 Table F-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the EV1000 Platform... F-2 Table F-4 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)... F-2 Table F-5 Electromagnetic Immunity (RF Radiated and Conducted)... F-3

Chapter 1: EV1000 Overview

T

he EV1000 is a monitoring platform that displays both intermittent and continuous hemodynamic measurements related to the assessment of the essential components of oxygen delivery as well as the balance of oxygen delivery against consumption. The EV1000 system assists the clinician in assessing the patient’s status and supports clinical decisions related to the optimization of oxygen delivery through the management of preload, after load, and contractility. In addition, the EV1000 can assess extra vascular lung water (EVLW) as an indicator of pulmonary edema.

FloTrac: Continuous Calculations

The continuous parametric measurements provided from an arterial line via an Edwards CO sensor include cardiac output (CO), pulse rate (PR), stroke volume (SV), and stroke volume variation (SVV). When combined with a TruWave transducer for monitoring central venous pressure, the Edwards CO sensor is also able to measure continuous systemic vascular resistance (SVR). Continuous venous oximetry is a valuable tool for monitoring the balance between oxygen delivery and consumption. Continuous oximetry measurements are performed using any Edwards oximetry catheter. The intermittent parametric measurements require use of a VolumeView catheter in a femoral artery, a CVC (central venous catheter) thermistor manifold, and a central venous pressure measurement. The intermittent parameters include cardiac output (iCO), stroke volume (iSV), systemic vascular resistance (iSVR), global end-diastolic volume (GEDV) and extravascular lung water (EVLW). Hypotension Probability Indicator (HPI), when activated and when using a FloTrac sensor, connected to a radial arterial catheter, notifies the clinician when the Hypotension Probability parameter, P(↓BP), reaches a pre-set upper threshold, indicating that the patient may be at risk for trending toward a hypotensive event (MAP<65 mmHg). HPI also provides for convenient navigation to a secondary screen of hemodynamic parameters, including mean arterial pressure (MAP). (See Chapter 16 for details of the HPI feature.)

Monitored Parameters The following hemodynamic parameters can be measured and displayed on the EV1000 monitor.

Table 1-1 FloTrac Auto-Calibrated Continuous Parameters Parameter

Description

Cardiac output (CO)

Continuous assessment of the volume of blood pumped by the heart measured in liters per minute

Cardiac Index (CI)

Cardiac output relative to body surface area (BSA)

Diastolic Pressure (DIA)

Diastolic blood pressure

Hypotension Probability (P(BP))

Probability that patient may be trending toward a hypotensive event (MAP < 65 mmHg), displayed as a percentage*

Mean Arterial Pressure (MAP)

Averaged systemic blood pressure over one cardiac cycle

Pulse Rate (PR)

Number of arterial blood pressure pulses per minute

Stroke Volume (SV)

Volume of blood pumped with each heart beat

Stroke Volume Index (SVI)

Stroke volume relative to body surface area (BSA)

Systemic Vascular Resistance (SVR)

The resistance that the left ventricle must overcome to eject stroke volume with each beat

Systemic Vascular Resistance Index (SVRI)

SVR relative to body surface area

Stroke Volume Variation (SVV)

The percent difference between SVmin, max and mean

Systolic Pressure (SYS)

Systolic blood pressure

* The P(BP) parameter is available if the HPI feature is activated.

VolumeView: Intermittent Calculations Table 1-2 VolumeView Intermittent Parameters Parameter

Description

Cardiac Function Index (CFI)

Cardiac function index is provided by transpulmonary thermodilution and serves as an indicator of left ventricular systolic function

Cardiac Output (iCO)

Intermittent assessment through thermodilution of the volume of blood pumped by the heart measured in liters per minute

Cardiac Index (iCI)

Intermittent assessment through thermodilution of cardiac output relative to body surface area

Extravascular Lung Water (EVLW)

Extravascular water content of the lung tissue

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EV1000 Overview

Table 1-2 VolumeView Intermittent Parameters

Table 1-3 VolumeView Calibrated Continuous Parameters (Continued)

Parameter

Description

Extravascular Lung Water Index (ELWI)

Extravascular water content of the lung tissue relative to predicted body weight (PBW)

Parameter

Description

Stroke Volume Index (SVI)

Stroke volume relative to body surface area

Global Ejection Fraction (GEF)

Estimated ejection fraction using GEDV

Systemic Vascular Resistance (SVR)

Global End-Diastolic Volume (GEDV)

Estimated combined volume of the RAEDV, RVEDV, LAEDV, and LVEDV

The resistance to flow that must be overcome to push blood through the circulatory system

Systemic Vascular Resistance Index (SVRI)

SVR relative to body surface area

Global End-Diastolic Volume Index (GEDI)

Estimated combined volume of the RAEDV, RVEDV, LAEDV, and LVEDV relative to body surface area

Stroke Volume Variation (SVV)

The percent difference between SVmin, max and mean

Systolic Pressure (SYS)

Systolic blood pressure

Intrathoracic Blood Volume (ITBV)

Estimated combined volume of the heart and the pulmonary blood volume (PBV)

Pulmonary Vascular Permeability Index (PVPI)

Ratio of the extravascular lung water and the estimated volume of pulmonary blood

Parameter

Description

Stroke Volume (iSV)

Intermittent assessment through thermodilution of the volume of blood pumped with each heart beat

Central Venous Oximetry (ScvO2)

Venous oxygen saturation as measured in the superior vena cava

Stroke Volume Index (iSVI)

Intermittent assessment through thermodilution of the stroke volume relative to body surface area

Mixed Venous Oximetry (SvO2)

Venous oxygen saturation as measured in the pulmonary artery

Systemic Vascular Resistance (iSVR)

Intermittent assessment through thermodilution of the resistance to flow that must be overcome to push blood through the circulatory system

Oxygen Consumption (VO2)

The amount of oxygen used by the body per minute

Estimated Oxygen Consumption (VO2e)

An estimate of the amount of oxygen used by the body per minute

Systemic Vascular Resistance Index (iSVRI)

Intermittent assessment through thermodilution of the SVR relative to body surface area

Oxygen Consumption Index (VO2I)

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

Estimated Oxygen Consumption Index (VO2Ie)

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

VolumeView Sensor: Continuous Calculations Table 1-3 VolumeView Calibrated Continuous Parameters Parameter

Description

Cardiac Output (CO)

Cardiac output as calculated by the VolumeView sensor and calibrated against a known cardiac output value from the TPTD cardiac output measurement

Cardiac Index (CI)

Calibrated cardiac output relative to body surface area (BSA)

Diastolic Pressure (DIA)

Diastolic blood pressure

Mean Arterial Pressure (MAP)

Averaged systemic blood pressure over one cardiac cycle

Pulse Rate (PR)

Number of arterial blood pressure pulses per minute

Stroke Volume (SV)

Volume of blood pumped with each heart beat

Intravascular Oximetry Table 1-4 Intravascular Oximetry Parameters

EV1000 Overview

Indications for Use The EV1000 Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics.The EV1000 Clinical Platform may be used in all settings in which critical care is provided. WARNING The EV1000 platform is intended for use only as an adjunct in patient assessment. This instrument must be used in conjunction with a bedside physiologic monitor.

WARNING Read this manual carefully before attempting to use the Edwards Lifesciences EV1000 platform.

1-3

ventilated with a fixed rate and tidal volume, and no spontaneous breaths. SVV is always used best in conjunction with stroke volume or cardiac output assessment.

VolumeView Transpulmonary Thermodilution (TPTD) A thermal washout curve is measured using a thermistor via a femoral artery catheter. Transpulmonary thermodilution (TPTD) measures parameters related to blood flow, fluid volume, and organ function. The EV1000 platform measures TPTD and derived parameters when it is used in conjunction with the VolumeView disposable set. TPTD is measured when an indicator solution of known temperature and volume is injected into the central venous circulation. It then passes through the pulmonary vascular system, the left heart, and finally into the arterial system. A thermal washout curve is measured using a thermistor in a femoral arterial catheter.

WARNING Improper use of the EV1000 platform could present a hazard to the patient. Carefully read the “Warnings” section of this manual before using the platform.

WARNING Use of the EV1000 platform is restricted to one patient at a time.

FloTrac Arterial Pressure Autocalibrated Cardiac Output (FT-CO) The EV1000 platform, in conjunction with the FloTrac sensor, uses the patient’s arterial pressure waveform to continuously measure cardiac output. With the input of the patient’s height, weight, age, and gender, a specific vascular compliance is determined. The FloTrac algorithm’s Automatic Vascular Tone Adjustment recognizes and adjusts for changes in vascular resistance and compliance. Cardiac output is displayed on a continuous basis by multiplying the pulse rate and calculated stroke volume as determined from the pressure waveform. The FloTrac sensor measures variations of arterial pressure proportional to stroke volume. The EV1000 platform, in conjunction with the FloTrac sensor, also uses the patient’s existing arterial pressure waveform to continuously measure stroke volume variation (SVV). SVV is a sensitive indicator of the patient’s preload responsiveness when the patient is 100% mechanically

VolumeView Calibrated Cardiac Output (VV-CO) The EV1000 platform, in conjunction with the VolumeView sensor and VolumeView catheter, uses the patients’s arterial pressure waveform and a known cardiac output value from the TPTD algorithm, to continuously display a calibrated cardiac output. The VolumeView CO algorithm is based on a static cardiac output calibration (TPTD) and the constant evaluation of physiologic variables.

Intravascular Oximetry The EV1000 system uses a spectrophotometric technique to measure and display oxygen saturation as a percent value. It uses light-emitting diodes (LEDs) to transmit light in the red and infrared spectra through catheter-based fiber-optics inserted intravascularly. The light is reflected from the blood to an optical module through a separate optical fiber in the catheter. The amount of light reflected is primarily dependent on the color of the blood, which is due to the amount of oxygen bound to the hemoglobin. The EV1000 system electrically measures and analyzes the reflected light to determine oximetry values by detecting color changes in the red blood cells. The tip location of the fiber-optic catheter determines the oximetry parameter that the operator configures the monitor to display. Most commonly, central

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EV1000 Overview

venous oximetry (ScvO2) is measured in the superior vena cava (SVC), and mixed venous oximetry (SvO2) is measured in the pulmonary artery.

Table 1-5 Acronyms, Abbreviations (Continued) Abbreviation

Definition

FT-CO

FloTrac Arterial Pressure Auto calibrated Cardiac Output

Edwards EV1000 Clinical Platform Operator's Manual

GDT

Goal Directed Therapy

The EV1000 Operator’s Manual is intended for use with the Edwards Lifesciences EV1000 platform by trained critical care clinicians in any environment where critical care is administered. This manual provides the operator with setup and operating instructions. It also provides instructions for user configurations and describes the operational environment in which the EV1000 platform can be installed. This includes connections and communications to devices and monitors within that environment.

GEDI

Global End-Diastolic Volume Index

GEDV

Global End-Diastolic Volume

GEF

Global Ejection Fraction

Hct

Hematocrit

HIS

Hospital Information Systems

HGB

Hemoglobin

HPI

Hypotension Probability Indicator

iCO

Intermittent cardiac output

iSV

Intermittent stroke volume

ITBI

Intra-thoracic Blood Volume Index

ITBV

Intra-thoracic Blood Volume

LAEDV

Left atrial end-diastolic volume

LVEDV

Left ventricular end-diastolic volume

MAP

Mean Arterial Pressure

The following acronyms and abbreviations are used in this manual.

MTt

Mean transit time

P(BP)

Hypotension Probability parameter

Table 1-5 Acronyms, Abbreviations

PBV

Pulmonary blood volume

PR

Pulse Rate

PVPI

Pulmonary Vascular Permeability Index

Acronyms and Abbreviations

Abbreviation

Definition

A/D

Analog/Digital

AP

Arterial Pressure

BP

Blood Pressure

BSA

Body Surface Area

BT

Blood Temperature

CFI

Cardiac Function Index

CI

Cardiac Index

CO

Cardiac Output

CPO

Cardiac Power Output

RAEDV

Right atrial end-diastolic volume

RUL

Right upper lobectomy

RVEDV

Right ventricular end-diastolic volume

ScvO2

Central venous oximetry

SpO2

Pulse Oximetry

SQI

Signal Quality Indicator

SV

Stroke Volume

SVI

Stroke Volume Index Mixed Venous Oxygen Saturation Systemic Vascular Resistance

CPI

Cardiac Power Index

SvO2

CVC

Central Venous Catheter

SVR

CVP

Central Venous Pressure

SVRI

Systemic Vascular Resistance Index

Device connected to the monitor that measures sensor signals and calculates the data displayed by the EV1000

SVV

Stroke Volume Variation

Databox

SYS

Systolic Pressure

Touch

Interact with the EV1000 system by touching the monitor screen. Thermodilution

DIA

Diastolic Pressure

DO2

Oxygen Delivery

TD

DO2I

Oxygen Delivery Index

TPTD

Transpulmonary Thermodilution

dP/dt

Maximal first derivative with respect to time of arterial pressure waveform

USB

Universal Serial Bus

VO2

Oxygen Consumption

DPT

Disposable Pressure Transducer

VO2I

Oxygen Consumption index

Eadyn

Dynamic Arterial Elastance

VO2e

Estimation of oxygen consumption

ELWI

Extravascular Lung Water Index Extravascular Lung Water

VO2Ie

Estimated oxygen consumption index

EVLW

VV-CO

VolumeView CO

Chapter 2: Safety and Symbols

T

his chapter describes the symbols that appear in the manual or on product labels, including those used to identify warnings, cautions, and notes. A list of all warnings and cautions used in this manual is provided later in the chapter.

WARNING

This chapter also includes a list of relevant standards to which the EV1000 platform complies.

Explosion Hazard! Do not use the EV1000 platform in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. (Chapter 3)

Safety Identifying Symbols

WARNING

The terms warnings, cautions, and notes are graphically identified and have specific meanings as used in this manual. WARNING Advises against certain actions or situations that could result in personal injury or death.

CAUTION Advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.



This is a note. It draws attention to useful information regarding a function or procedure.

Warnings The following warnings are presented in the EV1000 Clinical Platform Operator’s Manual where relevant to the function or procedure being described. WARNING The EV1000 platform is intended for use only as an adjunct in patient assessment. This instrument must be used in conjunction with a bedside physiologic monitor. (Chapter 1)

WARNING Read this Manual carefully before attempting to use the Edwards Lifesciences EV1000 platform. (Chapter 1)

WARNING Improper use of the EV1000 platform could present a hazard to the patient. Carefully read the “Warnings” section of this manual before using the platform. (Chapter 1)

Use of the EV1000 platform is restricted to one patient at a time. (Chapter 1)

WARNING

Do not connect a power supply to the Databox or monitor that is not approved by Edwards. (Chapter 3)

WARNING The EV1000 Databox should not be connected to a patient monitor using an AC or pulsed DC pressure transducer excitation voltages. The patient monitor must be powered on when connected to EV1000. (Chapter 3)

WARNING The EV1000 monitor should only be connected to a single Databox, and that connection can only be done using an Edwards supplied ethernet cable. (Chapter 3)

WARNING Do not use extension cords or multiple socket devices to connect the power adapter. Do not use detachable power cords other than the power cord provided. (Chapter 3)

WARNING Do not use any damaged system components. (Chapter 3)

WARNING Use of accessories, sensors, and cables other than those specified may result in increased emission and/or decreased immunity of the EV1000 platform. (Chapter 3)

WARNING Equipment may be used in the presence of electrosurgery when following the recommended setup procedure (Chapters 7-8) and routine maintenance steps (Appendix E). Inaccurate parameter measurements can be caused by factors such as electrocautery or electrosurgery unit interference. (Chapter 3)

WARNING Do not place any foreign items (unapproved 60601-1 items) in any of the Databox or monitor ports. (Chapter 3)

2-2

Safety and Symbols

WARNING

WARNING

Do not connect anything to the ethernet cable other than the Databox and panel. (Chapter 3)

Do not resterilize or reuse any FloTrac sensor, VolumeView sensor or catheter; refer to the catheter’s “directions for use”. (Chapter 7)

WARNING All IEC/EN 60950 equipment, including printers, must be positioned no closer than 1.5 meters to the patient’s bed. (Chapter 3)

WARNING

WARNING Refer to the directions provided with each accessory for specific instructions on placement and use, and for relevant WARNINGS, CAUTIONS, and specifications. (Chapter 7,9)

Make sure the EV1000 monitor and EV1000 Databox are securely mounted, and that all cords and accessory cables are appropriately arranged to minimize the risk of injury to patients, users or the equipment. (Chapter 3,15)

WARNING

WARNING

Do not use a damaged catheter or one with exposed electrical contacts. (Chapter 9)

Make sure the Databox is mounted so that it can be leveled to the phlebostatic axis. (Chapter 3)

WARNING

Do not use the EV1000 platform as a pulse rate or primary blood pressure monitor. (Chapter 7, 12)

WARNING

WARNING

The monitor and power adaptors must be positioned in an upright position to ensure IPX1 ingress protection. (Chapter 3)

Make sure that Demo Mode is not activated in a clinical setting to ensure that simulated data is not mistaken for clinical data. (Chapter 13)

WARNING

WARNING

Equipment must be mounted securely to prevent injury or damage. Refer to directions on proper post sizing. (Chapter 3)

Equipment must be mounted securely to prevent injury or damage. (Chapter 15)

WARNING

WARNING

Visual and audible alarms are activated only if the parameter is selected and displayed on the screens as a key parameter (1-4 parameters). If a parameter is not selected as a key parameter, the audible alarms are silenced. (Chapter 4,6,7,10)

The Hypotension Probability, P(BP), should not be used exclusively to treat the patient. A review of the patient's hemodynamics is recommended prior to initiating treatment. (Chapter 16)

WARNING

Only connect accessories that have been qualified as part of the EV1000 system. (Appendix A)

Perform New Patient or clear the patient data profile whenever a new patient is connected to the EV1000 system. Failure to do so may result in previous patient data in the historical displays. (Chapter 6)

WARNING Do not turn off the audible alarms in situations in which patient safety could be compromised. (Chapter 6)

WARNING Make sure that the alarm volume is set to a level that allows alarms to be adequately monitored. Failure to do so could result in a situation where patient safety is compromised. (Chapter 6)

WARNING Do not use a FloTrac sensor, VolumeView sensor or catheter that is damaged or that has exposed electrical contacts. (Chapter 7)

WARNING

WARNING The EV1000 platform contains no user-serviceable parts. Removing the cover or any other disassembly will expose you to hazardous voltages. (Appendix E)

WARNING Shock or fire hazard! Do not immerse the EV1000 monitor, Databox or cables in any liquid solution. Do not allow any fluids to enter the instrument. (Appendix E)

WARNING Use of a damaged cable may result in inaccurate measurements or may damage the EV1000 platform. (Appendix E)

WARNING Use of accessories, sensors, and cables other than those specified may result in increased emission and/or decreased immunity of the EV1000 platform. (Appendix F)