Edwards Lifesciences

EV1000 Clinical Platform Operator’s Manual 2011

Operator’s Manual

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Edwards Lifesciences

EV1000 Clinical Platform Operator’s Manual

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

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 13 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

EV1000 Overview: Provides an overview of the EV1000 system.

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.

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.

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

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.

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

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.

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.

Chapter

Description

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.

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

Appendix

Description

Specifications

Equations for Calculated Patient Parameters

Monitor Settings and Defaults

EV1000 Unit Conversions

System Care, Service and Support

Guidance and Manufacturer's Declaration

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... 2-6 Monitor Case Symbols... 2-7 Shipping Container Symbols... 2-7 Standards Compliance... 2-8

Chapter 3: Unpacking and Initial Setup Unpacking... 3-2 Contents List... 3-2 Parameter Monitoring Accessories... 3-2 Monitor Installation... 3-3 Mounting Recommendations... 3-3 Connecting the Monitor... 3-3 Connecting the Patient Cables... 3-4 Initial Startup... 3-5 Select Language... 3-5

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

Chapter 5: Navigating the EV1000 Navigation Bar... 5-1 Monitor Views... 5-2 Change Parameters... 5-2 Change Alarm/Target... 5-2 Graphical Trend Monitoring View... 5-2 Tabular Trends... 5-3 Scroll Mode... 5-4 Big Numbers... 5-4 Physiology Screen... 5-5 Cockpit Screen... 5-5 Physio Relationship... 5-5 Status Indicators... 5-6 Monitor Screen Navigation... 5-7 Vertical Scrolling... 5-7 Information Bar... 5-8 Status Bar... 5-8 ... 5-8

Chapter 6: Monitor Display Options Patient Data... 6-1 New Patient... 6-1 Continue Monitoring Patient... 6-1 View Patient Data... 6-2 Monitoring Settings... 6-2 General Monitor Settings... 6-2 Change Date and Time Display... 6-3 Select Monitoring Screens and Monitor Settings... 6-3 Serial Port Setup... 6-4 Restore Monitor Defaults... 6-5 Parameter Settings... 6-5 Alarms / Targets... 6-5 Time Intervals and Averaging... 6-8 Engineering... 6-9

Chapter 7: FloTrac Continuous Monitoring Connect FloTrac Cable... 7-1 Enter Patient Data and select Monitoring Options... 7-3 Set Averaging Time... 7-3 Set Targets and Alarm Limits... 7-4 Zero Arterial and Central Venous Pressure... 7-4 Waveform Confirmation... 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 Edwards Lifesciences © Copyright 2011 All rights reserved.

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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... 9-7 New Catheter... 9-7

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: Clinical Actions and Analysis Zero and Waveform... 11-1 Intervention Analysis... 11-1 Intervention Monitoring... 11-2 Oximetry Calibration... 11-2 Thermodilution... 11-2 Derived Value Calculator... 11-2 Event Review... 11-3

Chapter 12: Demonstration Mode and Data Download Data Download... 12-2

Chapter 13: Help and Troubleshooting On Screen Help... 13-1 Databox Communication and Power... 13-2 System Errors... 13-3 Numeric Keypad Errors... 13-3 CO/SV Faults and Alerts... 13-4 CO/SV Troubleshooting... 13-5 TPTD Messages and Troubleshooting... 13-5 Oximetry Faults and Alerts... 13-8 CVP Faults / Alerts... 13-10

Appendix A: Specifications Parameters

... A-1

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Accessories... A-2

Appendix B: Equations for Calculated Patient Parameters Appendix C: Monitor Settings and Defaults Patient Data... C-1 Trend Scale Limits... C-1 Alarm Limits... C-2 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 and Sterilizing 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 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... 3-4 Figure 3-3 Startup Screen... 3-5 Figure 3-4 Language Selection Screen... 3-5 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 Continuous and Intermittent Data... 5-3 Figure 5-5 Tabular Trend Screen... 5-4 Figure 5-6 Tabular Increment Popup... 5-4 Figure 5-7 Big Numbers Monitoring Screen... 5-4 Figure 5-8 Physiology Screen... 5-5 Figure 5-9 Cockpit Monitoring Screen... 5-5 Figure 5-10 Physio Relationship Screen... 5-6 Figure 5-11 Parameter Globe... 5-6 Figure 5-12 Vertical Scrolling Review List... 5-7 Figure 5-13 Vertical Scrolling Selection List... 5-7 Figure 5-14 Information Bar – U.S. Units... 5-8 Figure 5-15 Lock Screen... 5-8 Figure 5-16 Screen Locked... 5-8 Figure 5-17 Status Bar... 5-8 Figure 6-1 New or Continuing Patient Screen... 6-1 Figure 6-2 Monitor Settings... 6-2 Figure 6-3 General Monitor Settings... 6-2 Figure 6-4 Time / Date Settings... 6-3 Figure 6-5 Monitor Settings... 6-3 Figure 6-6 Monitor Screens... 6-4 Figure 6-7 Serial Port Setup... 6-4 Figure 6-8 Parameter Settings... 6-5 Figure 6-9 Alarms / Targets Configuration... 6-6 Figure 6-10 Configure All Alarms / Targets... 6-7 Figure 6-11 Set Custom Default Alarms / Targets... 6-7 Figure 6-12 Set Alarms and Targets... 6-8 Figure 6-13 Time Intervals / Averaging... 6-8 Figure 6-14 Graphical Trend Screen... 6-9 Figure 6-15 Adjust Scales... 6-9 Figure 6-16 Tabular Increment Popup... 6-9 Figure 7-1 CO Monitoring Globes... 7-1 Figure 7-2 FloTrac Sensor Connection... 7-2 Edwards Lifesciences © Copyright 2011 All rights reserved.

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... 9-6 Figure 9-9 HGB Update Screen... 9-6 Figure 9-10 Optical Module Reset... 9-7 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 Clinical Actions Screen... 11-1 Figure 11-2 Intervention Analysis... 11-1 Figure 11-3 Derived Value Calculator... 11-2 Figure 11-4 Event Review... 11-3 Figure 12-1 Settings Screen... 12-1 Figure 12-2 Demo Mode... 12-1 Figure 12-3 Data Download... 12-2 Figure 13-1 Main Help Screen... 13-1 Figure 13-2 Category Help Screen... 13-1 Figure 13-3 Secondary Help Screen... 13-1 Figure 13-4 Help Screen... 13-2 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... 2-6 Table 2-2 Monitor Case Symbols... 2-7 Table 2-3 Shipping Container Symbols... 2-7 Table 2-4 Standards Compliance... 2-8 Table 3-1 Parameter Monitoring Accessories... 3-2 Table 3-2 Parameter Monitoring Accessories – Venous Oxygen Saturation . . . 3-2 Table 5-1 Graphical Trend Scroll Rates... 5-3 Table 5-2 Tabular Trend Scroll Rates... 5-4 Table 5-3 SQI Level Indicators... 5-6 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 Intervention Analysis Types... 11-2 Table 11-2 Reviewed Events... 11-3 Table 13-1 Databox Communication and Power Lights... 13-2 Table 13-2 System Errors... 13-3 Table 13-3 Numeric Keypad Errors... 13-3 Table 13-4 CO/SV Faults and Alerts... 13-4 Table 13-5 CO/SV Troubleshooting... 13-5 Table 13-6 TPTD Faults and Alerts... 13-5 Table 13-7 TPTD Warnings... 13-7 Table 13-8 Oximetry Faults/Alerts... 13-8 Table 13-9 Oximetry Warnings... 13-9 Table 13-10 Oximetry General Troubleshooting... 13-9 Table 13-11 CVP Faults/Alerts... 13-10 Table 13-12 CVP Troubleshooting... 13-10 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 Oximetry... A-1 Table A-5 TPTD... A-1 Table A-6 Other Parameters... A-1 Table A-7 In vivo Calibration ScvO2/SvO2/HGB/Hct Ranges and Defaults... A-2 Table A-8 EV1000 System Accessories... A-2 Table A-9 Technical Specifications... A-3 Table B-1 Cardiac Profile Equations... B-1 Table C-1 Patient Information... C-1 Table C-2 Graphical Trend Parameter Scale Limits and Defaults... C-1 Table C-3 Parameter Alarm Red Zone and Target Defaults... C-2 Table C-4 Language Default Settings... C-3 Edwards Lifesciences © Copyright 2011 All rights reserved.

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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

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, afterload, and contractility. In addition, the EV1000 can assess Extra Vascular Lung Water (EVLW) as an indicator of pulmonary edema. The continuous parametric measurements provided from an arterial line via an Edwards CO sensor include cardiac output (CO), 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 system 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). The following hemodynamic parameters can be measured and displayed on the EV1000 monitor.

Monitored Parameters FloTrac: Continuous Calculations 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).

Stroke Volume (SV)

Volume of blood pumped with each heart beat.

Table 1-1 FloTrac Auto-Calibrated Continuous Parameters Parameter

Description

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.

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.

Extravascular Lung Water Index (ELWI)

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

Global Ejection Fraction (GEF)

Estimated ejection fraction using GEDV.

Global End-Diastolic Volume (GEDV)

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

Global End-Diastolic Volume Index (GEDI)

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

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.

1-2

EV1000 Overview

Table 1-2 VolumeView Intermittent Parameters Parameter

Description

Stroke Volume (iSV)

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

Stroke Volume Index (iSVI)

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

Systemic Vascular Resistance (iSVR)

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

Systemic Vascular Resistance Index (iSVRI)

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

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).

Stroke Volume (SV)

Volume of blood pumped with each heart beat.

Table 1-3 VolumeView Calibrated Continuous Parameters Parameter

Description

Stroke Volume Index (SVI)

Stroke volume relative to body surface area.

Systemic Vascular Resistance (SVR)

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.

Stroke Volume Variation (SVV)

The percent difference between SVmin, max and mean.

Intravascular Oximetry Table 1-4 Intravascular Oximetry Parameters Parameter

Description

Central Venous Oximetry (ScvO2)

Venous oxygen saturation as measured in the superior vena cava.

Mixed Venous Oximetry (SvO2)

Venous oxygen saturation as measured in the pulmonary artery.

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.

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).

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. 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 Platform may be used in all settings in which critical care is provided.

FloTrac Arterial Pressure

 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.

 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.

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 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. Edwards Lifesciences © Copyright 2011 All rights reserved.

1-3

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.

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

1-4

EV1000 Overview

Edwards EV1000 Clinical Platform Operator's Manual 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.

Table 1-5 Acronyms, Abbreviations (Continued) Abbreviation

Definition

FT-CO

FloTrac Arterial Pressure Autocalibrated Cardiac Output

GEDI

Global End-Diastolic Volume Index

GEDV

Global End-Diastolic Volume

GEF

Global Ejection Fraction

Hct

Hematocrit

HGB

Hemoglobin

iCO

Intermittent cardiac output

iSV

Intermittent stroke volume

ITBI

Intra-thoracic Blood Volume Index

Acronyms and Abbreviations

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

PBV

Pulmonary blood volume

PVPI

Pulmonary Vascular Permeability Index

RAEDV

Right atrial end-diastolic volume

RUL

Right upper lobectomy

Table 1-5 Acronyms, Abbreviations Abbreviation

Definition

A/D

Analog/Digital

Arterial Pressure

Blood Pressure

BSA

Body Surface Area

Blood Temperature

CFI

Cardiac Function Index

Cardiac Index

Cardiac Output

CPO

Cardiac Power Output

CPI

Cardiac Power Index

CVC

Central Venous Catheter

CVP

Central Venous Pressure

Databox

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

RVEDV

Right ventricular end-diastolic volume

ScvO2

Central venous oximetry

SpO2

Pulse Oximetry

SQI

Signal Quality Indicator

Stroke Volume

SVI

Stroke Volume Index

SvO2

Mixed Venous Oxygen Saturation

SVR

Systemic Vascular Resistance

SVRI

Systemic Vascular Resistance Index

SVV

Stroke Volume Variation

Touch

Interact with the EV1000 system by touching the monitor screen

Thermodilution

TPTD

Transpulmonary Thermodilution Universal Serial Bus

DO2

Oxygen Delivery

USB

DO2I

Oxygen Delivery Index

VO2

Oxygen Consumption

DPT

Digital Pressure Transducer

VO2I

Oxygen Consumption index

ELWI

Extravascular Lung Water Index

VO2e

Estimation of oxygen consumption

EVLW

Extravascular Lung Water

VO2Ie

Estimated oxygen consumption index

VV-CO

VolumeView CO

Chapter 2: Safety and Symbols

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

Safety Identifying Symbols 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



WARNING

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

 WARNING

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

 WARNING

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)

 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

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

 WARNING

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

 WARNING

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

2-2

Safety and Symbols

 WARNING

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)



WARNING



WARNING



WARNING

Make sure the Databox is mounted so that it can be leveled to the phlebostatic axis. (Chapter 3) The monitor and power adaptors must be positioned in an upright position to ensure IPX1 ingress protection. (Chapter 3) Equipment must be mounted securely to prevent injury or damage. Refer to directions on proper post sizing. (Chapter 3)

 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)

 WARNING

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

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



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)

 WARNING

Do not use the EV1000 platform as a pulse rate or blood pressure monitor. (Chapter 7, 11)

 WARNING

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

 WARNING

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

 WARNING

Make sure that Demo Mode is not activated in a clinical setting to ensure that simulated data is not mistaken for clinical data. (Chapter 12)

 WARNING

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

 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 cardiac output 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)

 WARNING

The EV1000 monitor and EV1000 Databox should not be used adjacent to, or stacked with other equipment. If adjacent or stacked use is necessary, the EV1000 monitor and EV1000 Databox should be observed to verify normal operation in the configuration in which it is used. (Appendix F)

 WARNING

There are minimum amplitudes for the EV1000 platform to measure physiological signals. Operation of the equipment below the minimum amplitudes may cause inaccurate results. (Appendix F)

Safety and Symbols

Cautions The following cautions are presented in the Edwards EV1000 Operator’s Manual where relevant to the function or procedure being described.The SVV Filtering



CAUTION Do not use the EV1000 platform during MRI procedures; refer to the catheter’s “directions for use” for catheter MRI compatibility. (Chapter 3)

 CAUTION

Do not expose the EV1000 platform to extreme temperatures. (Chapter 3)

 CAUTION

Do not obstruct the EV1000 platform ventilation openings. (Chapter 3)

 CAUTION

Use only Edwards-compatible accessories to avoid damage to the platform and to ensure accuracy of patient information. (Chapter 3)

 CAUTION

When connecting the EV1000 platform to any external device, refer to the device's instruction manual for complete instructions. Verify proper operation of the system before clinical use. (Chapter 3)

 CAUTION

Do not use the EV1000 monitor in environments where strong lighting makes the LCD screen difficult to view. (Chapter 3)

 CAUTION

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

 CAUTION

The only way to remove power from the system is to unplug the power cord from its power source. (Chapter 3)

 CAUTION

SVV Filtering Exceeded Indicator (yellow heart) does not display with the SVV value on the SVV Slope Indicator of the Physiology Screen. (Chapter 5)

 CAUTION

Restore Defaults replaces all settings with factory defaults. Any settings changes or customizations will be permanently lost. (Chapter 6)

 CAUTION

Do not restore defaults while monitoring a patient. (Chapter 6)

2-3

 CAUTION

The effectiveness of FT-CO measurements in pediatric patients has not been evaluated. (Chapter 7)

 CAUTION

Inaccurate FT-CO measurements can be caused by factors such as: • Improperly zeroed and/or leveled sensor/transducer • Over- or under-damped pressure lines • Excessive variations in blood pressure. Some conditions that cause BP variations include, but are not limited to: * Intra-aortic balloon pumps • Any clinical situation where the arterial pressure is deemed inaccurate or not representative of aortic pressure, including but not limited to: * Extreme peripheral vasoconstriction which results in a compromised radial arterial pressure waveform * Hyperdynamic conditions as seen in post liver transplant • Excessive patient movement • Electrocautery or electrosurgical unit interference Aortic valve regurgitation may cause an over estimation of Stroke Volume / Cardiac Output calculated depending on the amount of valvular disease and the volume lost back into the left ventricle. (Chapter 7)

 CAUTION

Always grasp the connector, not the cable, when connecting or disconnecting the cable. (Chapter 7)

 CAUTION

Do not twist or bend the connectors. (Chapter 7)

2-4

Safety and Symbols

 CAUTION

Inaccurate TPTD or VolumeView CO measurements can be caused by factors such as: • Improperly zeroed and/or leveled sensor/transducer • Over- or under-damped pressure lines • Any clinical situation where the arterial pressure is deemed inaccurate or not representative of aortic pressure. • Excessive patient movement • Electrocautery or electrosurgical unit interference • Incorrect placement or position of the femoral artery catheter • Excessive variations or interference in blood temperature measurement. Some conditions that cause temperature variations include, but are not limited to: * Post cardiopulmonary bypass surgery status * Centrally administered cooled or warmed solutions of blood products * Clot formation on the thermistor * External heat sources (cooling or heating blankets) placed on the VolumeView catheters thermistor connection. * Electrocautery or electrosurgical unit interference * Rapid changes in cardiac output • Intra-aortic balloon pumps • Anatomical abnormalities (for example, cardiac shunts) (Chapter 8)

 CAUTION

The effectiveness of TPTD and VolumeView CO measurements in pediatric patients has not been evaluated. (Chapter 8)



 CAUTION

If the Optical Module is being transferred from an EV1000 to any Edwards Oximetry monitor, check that the patient height, weight, and BSA are correct prior to beginning monitoring. Re-enter patient data, if necessary. (Chapter 9)

 CAUTION

The Signal Quality Indicator (SQI) bar displays only with the oximetry parameter in the touch space outside the oximetry globe. (Chapter 10)

 CAUTION

Use Windows Embedded Standard 2009 compatible USB devices. (Chapter 12)

 CAUTION

Do not use AC excitation voltages from a bedside monitor for the External CVP connection. The EV1000 platform is designed for use with bedside monitors which use DC excitation voltages only. (Appendix A)

 CAUTION

You can lightly wipe the top, bottom and front surfaces with a cloth, but the monitor screen and its accessories MUST NOT have liquid poured or sprayed directly on them. (Appendix E)

 CAUTION DO NOT:

•

Allow any liquid to come in contact with the power connector

•

Allow any liquid to penetrate connectors or openings in the case

•

Clean the platform rear panels

CAUTION The SQI signal is sometimes affected by the use of electrosurgical units. Attempt to distance electrocautery equipment and cables from the EV1000 platform and plug the power cords into separate AC circuits if possible. If signal quality problems persist, call your local Edwards Representative for assistance. (Chapter 9)

 CAUTION

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 9)

 CAUTION

Performing an in vitro calibration after the oximetry catheter has been inserted into the patient will yield inaccurate calibration. (Chapter 9)

 CAUTION

Do not disconnect the optical module while calibration and patient data are being transferred from the EV1000 system. (Chapter 9)

If any liquid does come in contact with any of the above mentioned items, DO NOT attempt to operate the platform. Disconnect power immediately and call your Biomedical Department or local Edwards Representative. (Appendix E)

 CAUTION

DO NOT attempt to clean the rear panels. (Appendix E)

 CAUTION

Conduct periodic inspections of all cables for defects. Do not coil cables tightly when storing. (Appendix E)

 CAUTION

Do not steam, radiate, or EO sterilize the Optical Module. Do not immerse the Optical Module. (Appendix E)

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