Vigilance II Monitor Operators Manual 2005

Vigilance II Monitor Operator’s Manual

PREFACE

Edwards Lifesciences Vigilance II Monitor Operator’s Manual 2005 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

Patents

This product is manufactured and sold under one or more of the following US patent(s): US Patent No. 4,507,974; 4,651,741; 5,146,414; 5,305,760; 5,553,622; 5,634,470; 5,701,908; 5,755,670; 5,588,438; 5,687,733; 5,720,293; 6,045,512; 6,371,923; and corresponding foreign patents. Additional patents pending.

Trademarks

Edwards Lifesciences, the stylized E logo, Vigilance, Edwards, and Vigilance II are trademarks of Edwards Lifesciences Corporation; Co-Set and Vigilance are registered in the United States patent and trademark office. Flexport and PCMS are trademarks of SpaceLabs, Inc.

Copyright

©2005 Edwards Lifesciences LLC. All rights reserved. Printed in the United States of America. 2005

Edwards Lifesciences Services GmbH Edisonstr. 6 D-85716 Unterschleissheim, Germany Caution:

i

Federal (USA) law restricts this device to sale by or on the order of a physician.

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Using This Manual The Vigilance II monitor Operator’s Manual includes 14 chapters and 9 Appendices. Each chapter provides all information relevant for a specified monitoring function or input/output processing in only one chapter. Although this results in some duplication from chapter to chapter, the manual design minimizes the look-up time for setup and operation of any monitoring feature. A brief description of the chapter contents follows. Each chapter in the manual is introduced with detailed lists of contents, illustrations, and tables. 1.

Introduction: Includes an overview of the Vigilance II monitor modes, functions and interfaces between the monitor accessories.

2. Safety and Symbols: Includes definitions of WARNINGS, CAUTIONS, and NOTES that are found in the manual, as well as illustrations of labels found on surfaces of the monitor. 3. Quick-Start Guide to Operation: Provides experienced clinicians and users of bedside monitors an immediate use of the monitor. 4. Unpacking, Installing, and Performing Power-On Self Test: Provides information about the different accessories and options that may be used with the Vigilance II monitor. Includes a description of the Power-On Self Test performance check of critical hardware components. 5. Monitor Displays, Controls, Alarms and Indicators: Provides details of the monitor display screen layouts, keypad buttons, navigation knob, front and rear panel labels, how to customize the displays, and instructions for disabling, enabling and silencing alarms. 6. Initial Setup, Entering Patient Data: Provides step-by-step procedures for entering initial setups prior to normal operation. 7. CCO Monitoring Mode: Provides instructions for operating the monitor when using the Continuous Cardiac Output (CCO) mode. Includes instrument setup, screen configurations, error messages, and use of the Patient CCO Cable Test. Includes descriptions of STAT and the diagnostic screen. Also provides a guide to operator troubleshooting when in the CCO mode. 8. ICO Monitoring Mode: Provides instructions for operating the monitor when using the Intermittent Cardiac Output (ICO) mode. Includes instrument setup, screen configurations, and error messages. Also provides a guide to operator troubleshooting when in ICO mode. 9. CEDV/RVEF Monitoring: Describes the CEDV/RVEF monitoring function of the Vigilance II monitor. Includes setup instructions for connecting the bedside ECG monitor to the Vigilance II monitor rear-panel connector. Describes screen configurations, error messages, and STAT displays. Also includes a guide to operator troubleshooting for CEDV/RVEF monitoring. 10. Oximetry Monitoring: Describes the oximetry (oxygen saturation, SvO2) function of the Vigilance II monitor. Provides instructions for use of the Optical Module and its connector. Includes instructions for in vivo and in vitro calibration, Recall OM Data, and assessing the system’s signal quality. Includes a guide to operator troubleshooting when in the oximetry monitoring mode.

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11. Trend Graph, STAT Graph, Data Relationship Plot and Scrolling: Contains detailed descriptions of the setup requirements for the Trend Graph, STAT Graph, and Data Relationship Plot, and use of the Scroll Mode. 12. Receiving and Transmitting Analog Data: Contains descriptions of the rear panel ports through which analog signals are received by or transmitted from the Vigilance II monitor. Includes instructions for configuring the ports and for calibrating/scaling the input or output signals. 13. Transmitting and Receiving Digital Data: Contains descriptions of the two rear panel serial digital (RS-232) communication ports and the USB port for print functions. Includes instructions for configuring each port. 14. Troubleshooting: Lists all instrument error messages and their appropriate references for suggested operator action. Appendices A Specifications B Equations for Calculated Patient Parameters C Monitor Settings and Defaults D Computation Constants E

Units Conversions

F

System Care, Service and Support

G Guidance and Manufacturer’s Declaration H Glossary I

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Index

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Table of Contents

TABLE OF CONTENTS Table of Contents List of Figures... xii List of Tables...xv Chapter 1 Introduction 1.1 General... 1-2 1.1.1 Continuous Cardiac Output (CCO)... 1-2 1.1.2 Intermittent Cardiac Output (ICO)... 1-2 1.1.3 Continuous End Diastolic Volume (EDV)... 1-2 1.1.4 Oximetry (SvO2, ScvO2)... 1-2 1.1.5 Derived Hemodynamic and Oxygenation Parameters... 1-3 1.2 Purpose... 1-3 1.3 Scope... 1-3 1.4 Vigilance II Monitor Operational Environment Overview... 1-4 1.5 Abbreviations... 1-4 1.6 Symbols and Icons... 1-5 Chapter 2 Safety and Symbols 2.1 General... 2-2 2.2 Safety Identifying Symbols... 2-2 2.2.1 Warnings... 2-2 2.2.2 Cautions... 2-5 2.3 Monitor Case Symbols... 2-8 2.4 Other Symbols... 2-11 2.5 Standards... 2-12 Chapter 3 Quick-Start Guide to Operation 3.1 General... 3-2 3.2 Scope... 3-2 3.3 Procedure... 3-2 Chapter 4 Unpacking, Installing and performing power-on self test 4.1 General... 4-2 4.2 Unpacking... 4-2 4.3 System Operating Environment... 4-2 4.4 Accessories... 4-2 4.5 Mounting Recommendations... 4-3 4.6 Mounting Options... 4-3 4.7 Installation Requirements... 4-4 4.8 Initial Start-up... 4-5 4.8.1 General... 4-5 iv

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4.8.2

Start-up Procedure... 4-5

Chapter 5 Monitor Display, Controls, Alarms and Indicators 5.1 General... 5-3 5.2 Front Panel Display, Controls, and Connectors... 5-3 5.2.1 Vigilance II Front Panel... 5-3 5.2.2 Vigilance II Rear Panel... 5-5 5.3 Monitoring Modes... 5-7 5.3.1 CCO Screen Frames... 5-7 5.3.2 ICO (Bolus) Screen Frames... 5-9 5.4 Using the Navigation Knob... 5-10 5.5 Large Parameter Frames (CCO Mode)... 5-11 5.5.1 How to Configure the Large Parameter Frames... 5-12 5.5.1.1 Selecting a Parameter... 5-13 5.5.1.2 Disabling/Enabling the Alarm... 5-13 5.5.1.3 Configuring the Trend Scale for the Graphical Frame 5-14 5.5.1.4 Configuring the Alarm Limits... 5-14 5.6 Large Parameter Frames (ICO Mode)... 5-15 5.7 BT Frame... 5-16 5.8 IT Frame (ICO Mode Only)... 5-16 5.9 Small Parameter Frame... 5-16 5.9.1 How to Configure Groups for the Small Parameter Frame... 5-16 5.9.2 Applying to a Group to the Small Parameter Frame... 5-18 5.10 Time/Date Frame... 5-19 5.11 Toolbar Frames... 5-19 5.12 Secondary Frame... 5-21 5.12.1 Cardiac and Oxygenation Profile... 5-21 5.12.2 STAT Boxes... 5-21 5.12.3 Diagnostic Graph... 5-22 5.12.4 Data Relationship Plot... 5-22 5.12.5 Bolus Review... 5-22 5.13 Graphical Frame... 5-22 5.13.1 Trend Graph... 5-22 5.13.2 STAT Graph... 5-22 5.13.3 ICO (Bolus) Graph... 5-22 5.14 Message Frame... 5-23 5.15 Keypad Function... 5-23 5.15.1 ON/OFF... 5-23 5.15.2 CO Start/Stop... 5-23 5.15.3 CCO/ICO Mode Select... 5-23 5.15.4 Patient Data... 5-23 5.15.5 Trend Scroll... 5-23 5.15.6 Alarm Silence... 5-23

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Table of Contents

Chapter 6 Initial Setup, Entering Patient Data 6.1 General... 6-2 6.2 Start-Up... 6-2 6.2.1 Initial Screens and Self Test Performance... 6-2 6.3 Entering Patient Information... 6-4 6.3.1 Patient Data Entry-Height and Weight... 6-4 6.3.2 Patient Data Entry - BSA... 6-5 6.4 Setting Time and Date... 6-6 6.4.1 Accessing the Time/Date Frame Menu... 6-6 6.4.2 Selecting the Time Display Format... 6-7 6.4.3 Selecting the Date Display Format... 6-7 6.4.4 Setting the Time and Date... 6-8 6.5 Selecting Display Format Settings... 6-9 6.6 Vigilance II Monitor Default Settings... 6-10 6.7 Updating Cardiac and Oxygenation Profiles... 6-11 6.7.1 General... 6-11 6.7.2 Cardiac Profile... 6-11 6.7.3 Oxygenation Profile... 6-13 6.7.4 Additional Options... 6-15 Chapter 7 CCO Monitoring Mode 7.1 General... 7-2 7.2 Instrument Setup... 7-3 7.3 Running the CCO Monitoring Process... 7-4 7.3.1 Initiating the Monitoring Process... 7-4 7.3.2 Thermal Signal Conditions During CCO Monitoring... 7-5 7.3.3 CCO STAT Boxes... 7-6 7.3.4 Diagnostic Graph – CCO Mode... 7-7 7.4 CCO/CCI Troubleshooting Messages... 7-7 7.4.1 Accessing Help for CCO... 7-8 7.4.2 Accessing Message Information... 7-9 7.4.3 Accessing Graphic Aid... 7-10 7.4.4 Return, Exit... 7-11 7.4.5 Switching to ICO (Bolus) Mode... 7-11 7.4.6 Patient CCO Cable Test... 7-11 7.4.7 CCO and CCI Message Listings... 7-11 7.4.7.1 Faults... 7-12 7.4.7.2 Alerts... 7-12 7.4.7.3 General Troubleshooting... 7-12 Chapter 8 ICO Monitoring Mode 8.1 General... 8-3 8.2 Instrument Setup... 8-3 8.2.1 Connecting the Patient CCO Cable... 8-3 8.2.2 Probe Selection... 8-5 vi

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8.3

8.4

8.5 8.6

Selecting Configuration Settings... 8-5 8.3.1 Selecting the Parameter... 8-6 8.3.2 Selecting the Mode... 8-7 8.3.3 Selecting the Injectate Volume... 8-7 8.3.4 Selecting the Catheter Size... 8-8 8.3.5 Selecting the Comp Constant... 8-8 Bolus Measurement Modes... 8-8 8.4.1 ICO (Bolus) Automatic Measurement Mode... 8-8 8.4.2 ICO (Bolus) Manual Measurement Mode... 8-12 Bolus Review... 8-16 ICO (Bolus) Troubleshooting Messages... 8-16 8.6.1 Accessing Help for ICO (Bolus) Cardiac Measurement... 8-17 8.6.2 Accessing Message Information... 8-18 8.6.3 Accessing Graphic Aid... 8-19 8.6.4 Return, Exit... 8-20 8.6.5 Patient CCO Cable Test... 8-20 8.6.6 ICO (Bolus) Message Listing... 8-20 8.6.6.1 Faults... 8-20 8.6.6.2 Alerts... 8-20 8.6.6.3 General Troubleshooting... 8-20

Chapter 9 CEDV/RVEF Monitoring 9.1 Overview... 9-2 9.2 Instrument Setup... 9-3 9.2.1 Connecting the Patient CCO Cable... 9-3 9.2.2 Connecting the ECG Interface Cable... 9-4 9.3 CEDV/RVEF Monitoring... 9-5 9.3.1 Initiating the Monitoring Process... 9-5 9.3.2 On-Going CEDV Monitoring... 9-6 9.3.3 EDV and RVEF STAT Boxes... 9-8 9.4 CEDV Troubleshooting Messages... 9-9 9.4.1 Accessing Help for RVEF and CEDV... 9-9 9.4.2 Accessing Message Information... 9-10 9.4.3 Accessing Graphic Aid... 9-11 9.4.4 Return, Exit... 9-12 9.4.5 Patient CCO Cable Test... 9-12 9.4.6 CEDV Message Listing... 9-12 9.4.6.1 Alerts... 9-12 9.4.6.2 General Troubleshooting... 9-12 Chapter 10 Oximetry Monitoring 10.1 General... 10-3 10.2 Oximetry Setup... 10-3 10.2.1 Catheter Preparation... 10-3 10.3 In vitro Calibration... 10-4 Edwards Lifesciences

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10.3.1 Procedure... 10-4 10.3.2 Completing the Oximetry Calibration... 10-7 10.3.3 Cancelling the Calibration Process... 10-8 10.4 In vivo Calibration... 10-8 10.5 Recall OM Data... 10-12 10.6 HGB Update... 10-13 10.7 Optical Reset... 10-14 10.8 New Catheter... 10-15 10.9 Oximetry Trend... 10-15 10.10 Signal Quality Indicator (SQI)... 10-15 10.11 Oximetry Troubleshooting Messages... 10-16 10.11.1 Accessing Help for Oximetry Monitoring... 10-16 10.11.2 Accessing Message Information... 10-17 10.11.3 Accessing Graphic Aid... 10-18 10.11.4 Return, Exit... 10-19 10.11.5 Oximetry Message Listing... 10-19 10.11.5.1 Faults... 10-19 10.11.5.2 Alerts... 10-19 10.11.5.3 Warnings... 10-19 10.11.5.4 General Troubleshooting... 10-19 Chapter 11 Trend Graph, STAT Graph, Data Relationship Plot, and Scrolling 11.1 General... 11-2 11.2 Trend Graph Features... 11-2 11.3 Configuring the Trend Graph Display... 11-3 11.3.1 Configuring the Trend Graph... 11-4 11.3.2 Configuring the Time Axis... 11-4 11.3.3 Add an Event to the Trend Graph... 11-4 11.3.4 Reviewing Events... 11-6 11.4 The STAT Graph... 11-7 11.5 Data Relationship Plot... 11-8 11.5.1 Accessing the Data Relationship Plot Screen and Configuration Menu 11-8 11.5.2 Configuration of the Data Relationship Plot... 11-10 11.6 Scroll Mode... 11-15 Chapter 12 Receiving and Transmitting Analog Data 12.1 General... 12-2 12.2 Analog Input Interfaces... 12-2 12.2.1 Configuring an Analog Input Port... 12-2 12.2.1.1 Selecting a Parameter... 12-3 12.2.1.2 Changing Default Values... 12-5 12.2.2 Calibration... 12-6 12.2.2.1 Procedure... 12-7

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12.3

12.4

Analog Output Interfaces... 12-8 12.3.1 Output Voltage Ranges... 12-9 12.3.2 Configuring the Analog Output Port... 12-9 12.3.3 Calibration Process... 12-11 Configuring the ECG Port... 12-12

Chapter 13 Transmitting and Receiving Digital Data 13.1 General... 13-2 13.2 Supported Digital Devices... 13-2 13.2.1 Alarm Delay... 13-3 13.3 Cable Connections... 13-3 13.4 Port Configuration... 13-3 13.4.1 Port Configuring Procedure... 13-3 13.4.2 Modifying IFMout Protocol... 13-5 13.5 Supported USB Devices... 13-5 Chapter 14 Troubleshooting 14.1 General... 14-2 14.2 Troubleshooting Messages... 14-2 14.2.1 CCO/CCI Messages and Troubleshooting... 14-2 14.2.2 SVR/SVRI Messages and Troubleshooting... 14-5 14.2.3 Oximetry Messages and Troubleshooting... 14-6 14.2.4 CEDV Messages and Troubleshooting... 14-8 14.2.5 ICO (Bolus) Messages and Troubleshooting... 14-9 14.3 Catheter Position Graphic Aid (Example) 14-11 14.4 Patient CCO Cable Test... 14-11 Appendix A Specifications A1 General... A-1 A2 Measurement Specifications... A-2 A3 Patient Data Profiles... A-3 A4 Technical Specification... A-4 A5 Environmental Specifications... A-4 A6 Accessories... A-5 Appendix B Equations for Calculated Patient Parameters B1 Overview... B-1 B2 Cardiac Profile Equations... B-1 B3 Oxygenation Profile Equations... B-4 Appendix C Monitor Settings and Defaults C1 Trend Scales... C-1 C1.1 Upper Trend Scale Limits... C-1 C1.2 Lower Trend Scale Limits... C-1

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Table of Contents

C2

C3 C4 C5 C6

C7 C8

Alarm Limits...C-2 C2.1 Alarm Upper Limits...C-2 C2.2 Alarm Lower Limits...C-2 Display Settings...C-3 Small Parameter Frame Groups...C-3 Patient Data Screen Defaults...C-3 Data Relationship Plot...C-4 C6.1 Data Relationship Plot Settings...C-4 C6.2 Data Relationship Plot Scales...C-4 C6.2.1 Upper Data Relationship Plot Scale Limits... C-4 C6.2.2 Lower Data Relationship Plot Scale Limits... C-5 C6.2.3 Upper Red Line Value Limits... C-5 C6.2.4 Lower Red Line Value Limits... C-6 ICO (Bolus) Settings...C-6 Communication Port Default Settings...C-6

Appendix D Computation Constants D1 General... D-1 D2 Bath Temperature Probe Data... D-1 D3 In-Line Temperature Probe Data... D-2 Appendix E Units Conversions E1 lbs vs. Kg...E-1 E2 inches vs. cm...E-1 E3 mmHg vs. kPa...E-1 E4

dn-s/cm5 vs. kPa-s/L...E-1

E5 E6

dn-s-m2/cm5 vs. kPa-s-m2/l...E-2 g/dL vs. mmol/L...E-2

Appendix F System Care, Service and Support F1 General... F-1 F2 Monitor System Cleaning... F-1 F3 Cleaning System Cables... F-2 F4 Cleaning the Optical Module... F-2 F5 How to Obtain Monitor Operations Service and Support... F-2 F6 Disposal of the Monitor... F-3 F7 Preventive Maintenance... F-3 F8 Warranty... F-3 Appendix G Guidance and Manufacturer’s Declaration G1 Electromagnetic Compatibility... G-1 G2 Instructions for Use... G-1

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Appendix H Glossary Index

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List of Figures Figure 1-1 Figure 2-1 Figure 2-2 Figure 3-1 Figure 3-2 Figure 4-1 Figure 4-2 Figure 4-3 Figure 4-4 Figure 4-5 Figure 5-1 Figure 5-2 Figure 5-3 Figure 5-4 Figure 5-5 Figure 5-6 Figure 5-7 Figure 5-8 Figure 5-9 Figure 5-10 Figure 5-11 Figure 5-12 Figure 5-13 Figure 6-1 Figure 6-2 Figure 6-3 Figure 6-4 Figure 6-5 Figure 6-6 Figure 6-7 Figure 6-8 Figure 6-9 Figure 6-10 Figure 6-11 Figure 7-1 Figure 7-2 Figure 7-3 Figure 7-4 Figure 7-5 Figure 7-6 Figure 7-7 Figure 7-8 Figure 7-9 Figure 7-10 Figure 7-11

Vigilance II Monitor Operational Environment Block Diagram... 1-4 Vigilance II Monitor Front Panel Symbols... 2-8 Vigilance II Monitor Rear Panel Symbols... 2-9 Patient Data Entry Screen... 3-3 Large Parameter Frame Menu for Oximetry Parameter... 3-3 Vigilance II Monitor in Operating Environment... 4-2 Vigilance II Adapter Plate... 4-3 Adapter Plate Interfaces with Vigilance II Monitor... 4-4 POST Start-Up Screen... 4-5 Vigilance II Language Selection Display Screen... 4-6 Vigilance II Front Panel Controls and Indicators... 5-3 Vigilance II Rear Panel Connectors and Indicators... 5-5 CCO Monitoring Screen (Home Screen)... 5-7 CCO Monitoring Screen (Split Screen)... 5-7 ICO (Bolus) Monitoring Screen... 5-9 Vigilance II Front Panel Navigation Knob... 5-10 Typical Large Parameter Frame... 5-11 SvO2 Parameter in Large Parameter Frame... 5-11 Large Parameter Frame Menu... 5-13 Large Parameter Frames 1 and 2 in ICO Mode... 5-15 Large Parameter Frame 3 in ICO Mode... 5-16 Small Parameter Frame Submenu Positions and Parameters... 5-17 Vigilance II Screen Toolbar Frame Buttons... 5-19 Vigilance II Start-Up Screen... 6-2 Clear Patient Data Profile Screen... 6-3 Patient Information Screen... 6-4 Patient Information Screen – Calculated BSA for Default Values of Height and Weight... 6-5 Time/Date Frame Menu Screen... 6-6 Accessing Default Settings Option Menu... 6-11 Cardiac Profile Screen... 6-12 Selecting a Cardiac Profile Parameter, Displaying Pop-Up Box Values... 6-13 Accessing the Oxygenation Profile from Cardiac Profile Menu... 6-14 Oxygenation Profile Screen... 6-14 Confirming Change to New Patient Data Updating Actions... 6-16 Typical CCO Monitoring Display... 7-2 Patient CCO Cable Connectors... 7-3 Vigilance II Monitor Front-Panel Cardiac Output and SvO2 Connectors... 7-4 Large Frame Configuration When Monitoring is Stopped... 7-6 Trend Plot with Missing Data Gap... 7-6 STAT Boxes Display... 7-7 Help Screen Menu... 7-8 CCO Help Screen Display... 7-8 A Two-Page Display of CCO Fault Messages... 7-9 CCO Help Screen: Faults, Check Thermal Filament Position... 7-10 Graphic Aid for Suggested Troubleshooting Action Responding to Fault Message “Check Thermal Filament Position”... 7-11 Edwards Lifesciences

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Figure 8-1 Figure 8-2 Figure 8-3 Figure 8-4 Figure 8-5 Figure 8-6 Figure 8-7 Figure 8-8 Figure 8-9 Figure 8-10 Figure 8-11 Figure 8-12 Figure 8-13 Figure 8-14 Figure 8-15 Figure 8-16 Figure 8-17 Figure 8-18 Figure 9-1 Figure 9-2 Figure 9-3 Figure 9-4 Figure 9-5 Figure 9-6 Figure 9-7 Figure 9-8 Figure 9-9 Figure 9-10 Figure 9-11 Figure 9-12 Figure 10-1 Figure 10-2 Figure 10-3 Figure 10-4 Figure 10-5 Figure 10-6 Figure 10-7 Figure 10-8 Figure 10-9 Figure 10-10 Figure 10-11 Figure 10-12 Figure 10-13 Figure 10-14 Figure 10-15 Figure 10-16 Figure 10-17 xiii

An ICO (Bolus) Display Screen... 8-3 Patient CCO Cable Connectors... 8-4 Vigilance II Monitor Front-Panel Cardiac Output and SvO2 Connectors... 8-4 Large Parameter Frame Menu... 8-6 ICO Large Parameter Frame 2... 8-6 Initial ICO (Bolus) Display Configuration... 8-9 Plotting an Injection Sequence... 8-10 Listing the Results of a Six-Injection Series... 8-11 Selecting Two Injection Measurements for Removal... 8-11 Bolus “Computing” Display and Listing of Computed Results in Large Parameter Frame 3... 8-13 Selecting Two Injection Measurements for Removal... 8-14 Bolus Review Screen... 8-16 Help Screen Menu... 8-17 Help Screen Menu... 8-17 ICO Alert Messages... 8-18 First Page Possible Cause and Suggested Action for “Alert Bolus: Extended Curve” Message... 8-19 Second Page Suggested Action for “Alert Bolus: Extended Curve” Message... 8-19 Catheter Positioning Graphic... 8-20 Typical EDV Monitoring Display... 9-2 Patient Cable Connectors... 9-3 Vigilance II Front Panel Cardiac Output and SvO2 Connectors... 9-4 Vigilance II Rear Panel ECG Connector... 9-5 Large Frame Configuration when Monitoring is Stopped... 9-7 Trend Plot with Missing Data Gap... 9-8 STAT Boxes Display... 9-8 Help Screen Menu... 9-9 CEDV Help Screen Display... 9-10 Display of CEDV Alert Messages... 9-10 CEDV Help Screen Alert: Signal Adapting – Continuing... 9-11 Graphic Aid for Suggested Troubleshooting Action Responding to Alert Message “Signal Adapting – Continuing”... 9-12 Optical Module Storage Location... 10-3 Highlighted Oximetry Frame with Large Parameter Frame Menu... 10-4 Oximetry Large Parameter Frame Menu... 10-5 In vitro Calibration Menu... 10-5 In vitro Calibrating Message... 10-6 Start In vitro Calibration Instruction... 10-7 Calibration Error Screen Display... 10-7 In vivo Calibration In Progress Message... 10-9 Instructions after Successful Baseline Completion... 10-10 Draw Time and Value Display Screen... 10-10 Lab Value Entry Screen... 10-11 Optical Module Update Message... 10-11 Optical Module Calibration Data Display Screen... 10-12 Selecting HGB Update... 10-13 Help Screen Menu... 10-17 Oximetry Help Screen Display... 10-17 Oximetry Help Screens on Two Pages, First Page... 10-18 Edwards Lifesciences

Figure 10-18 Figure 10-19 Figure 11-1 Figure 11-2 Figure 11-3 Figure 11-4 Figure 11-5 Figure 11-6 Figure 11-7 Figure 11-8 Figure 11-9 Figure 11-10 Figure 11-11 Figure 11-12 Figure 11-13 Figure 12-1 Figure 13-1 Figure 14-1 Figure 14-2

Oximetry Help Screens on Two Pages, Second Page... 10-18 Graphic Aid for Suggested Troubleshooting Action Responding to Alert Message “SQI = 4”... 10-19 Trend Graph with Event Markers and Bolus Dots... 11-3 The Trend Graph Menu... 11-4 Add Event Menu... 11-5 Trend Graph Event Review Display... 11-6 STAT Graph Screen... 11-7 Highlighting the Secondary Frame (Border)... 11-8 Data Relationship Plot Screen... 11-9 Data Relationship Plot Menu... 11-10 Scale Setting in Data Relationship Plot Menu... 11-12 Red Line Setting in Data Relationship Plot Menu... 11-13 Intervention Symbols in Data Relationship Plot Menu... 11-13 Pre-defined Plots in Data Relationship Plot Menu... 11-14 Trend Graph Scroll Mode... 11-15 Vigilance II Rear Panel Analog Connectors... 12-2 Rear Panel Serial Ports Connectors... 13-2 Connecting the Patient CCO Cable for Integrity Test... 14-11 Setup Menu, Patient CCO Cable Test Highlighted... 14-12

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List of Tables Table 1-1 Table 2-1 Table 4-1 Table 5-1 Table 5-2 Table 5-3 Table 5-4 Table 5-5 Table 5-6 Table 6-1 Table 6-2 Table 11-1 Table 11-2 Table 11-3 Table 12-1 Table 12-2 Table 12-3 Table 13-1 Table 14-1 Table 14-2 Table 14-3 Table 14-4 Table 14-5 Table 14-6 Table 14-7 Table 14-8 Table 14-9 Table 14-10 Table 14-11 Table 14-12 Table 14-13 Table 14-14 Table A-1 Table A-2 Table A-3 Table A-4 Table A-5 Table A-6 Table A-7 Table A-8 Table B-1 xv

Definitions of Abbreviations... 1-4 Standards Compliance... 2-12 Accessories Required for Monitoring Parameters... 4-3 Vigilance II Front Panel Controls and Indicators... 5-4 Vigilance II Rear Panel Connectors and Labels... 5-6 CCO Frame Function and Content... 5-8 ICO Frame Function and Content... 5-9 Parameters That May Be Displayed in the Large Parameter Frames... 5-12 Vigilance II Toolbar Buttons... 5-20 Vigilance II Monitor Clear Patient Data Processing... 6-3 Display Format Option Descriptions... 6-9 Parameters That May Be Displayed in the Large Parameter Frames... 11-2 Event Names and Markers... 11-5 Available Plot Parameters... 11-11 Parameter Characteristics... 12-5 Analog Output Parameters... 12-9 Characteristics of the ECG Port... 12-12 IFMout Protocol Communication Characteristics... 13-3 CCO/CCI Faults... 14-2 CCO/CCI Alerts... 14-4 CCO/CCI General Troubleshooting... 14-5 SVR/SVRI Alerts... 14-5 SVR/SVRI General Troubleshooting... 14-5 Oximetry Faults... 14-6 Oximetry Alerts... 14-7 Oximetry Warnings... 14-7 Oximetry General Troubleshooting... 14-8 CEDV Alerts... 14-8 CEDV General Troubleshooting... 14-9 ICO Faults... 14-9 ICO Alerts... 14-10 ICO General Troubleshooting... 14-10 Physical and Mechanical Specifications... A-1 Base Parameters... A-2 Volumetric Parameters... A-2 Oximetry Parameter... A-2 Patient Data Profiles... A-3 Technical Specification... A-4 Environmental Specifications... A-4 Vigilance II Monitor Accessories... A-5 Cardiac Profile Equations... B-1 Edwards Lifesciences

Table B-2 Table D-1 Table D-2 Table G-1 Table G-2 Table G-3 Table G-4

Oxygenation Profile Equations... B-4 Computation Constants for Bath Temperature Probe... D-1 Computation Constants for In-Line Temperature Probe... D-2 Electromagnetic Emissions... G-1 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field)... G-2 Electromagnetic Immunity (RF Radiated and Conducted)... G-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Vigilance II monitor... G-4

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Chapter 1 INTRODUCTION Contents 1.1 General... 1-2 1.1.1 Continuous Cardiac Output (CCO)... 1-2 1.1.2 Intermittent Cardiac Output (ICO)... 1-2 1.1.3 Continuous End Diastolic Volume (EDV)... 1-2 1.1.4 Oximetry (SvO2, ScvO2)... 1-2 1.1.5 Derived Hemodynamic and Oxygenation Parameters... 1-3 1.2 Purpose... 1-3 1.3 Scope... 1-3 1.4 Vigilance II Monitor Operational Environment Overview... 1-4 1.5 Abbreviations... 1-4 1.6 Symbols and Icons... 1-5

Figures Figure 1-1

Vigilance II Monitor Operational Environment Block Diagram... 1-4

Tables Table 1-1

Definitions of Abbreviations

... 1-4

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1-1

Introduction

WARNING Read this manual carefully before attempting to use the Edwards Lifesciences Vigilance II monitor.

1.1

General The Vigilance II monitor measures cardiac output (CO) both continuously (CCO) and intermittently (ICO) using the bolus thermodilution method. The monitor may also be configured to measure continuous oxygen saturation (SvO2, ScvO2) as well as continuous end diastolic volume (EDV). The Vigilance II monitor also calculates hemodynamic and oxygenation parameters. 1.1.1

Continuous Cardiac Output (CCO)

The Vigilance II monitor measures cardiac output continuously by introducing small pulses of energy into the blood stream and measuring blood temperature via a pulmonary artery catheter. Cardiac output is computed using proven algorithms derived from the conservation of heat principles, and indicator dilution curves that are obtained by cross-correlation of energy input and blood temperature waveforms. After initialization, the Vigilance II monitor continuously measures and displays the cardiac output in liters per minute without operator calibration or intervention. 1.1.2

Intermittent Cardiac Output (ICO)

The Vigilance II monitor measures cardiac output intermittently by using the bolus thermodilution technique. A small amount of indicator of known volume and temperature is injected through the catheter injectate port. The resultant decrease in blood temperature is measured by the thermistor in the pulmonary artery (PA). Using algorithms based on the Stewart-Hamilton indicator dilution equation, the Vigilance II monitor plots a curve representing the decrease in blood temperature over time. The area under the thermodilution curve is calculated and the resulting ICO value is displayed in liters per minute. 1.1.3

Continuous End Diastolic Volume (EDV)

The Vigilance II monitor calculates continuous end diastolic volume by using the continuous cardiac output (CCO) technology mentioned above to obtain the indicator dilution curve. Right ventricular ejection fraction (RVEF) is computed based on the curve’s exponential slope, and the continuous average heart rate obtained from the patient’s slaved-in ECG signal. Continuous end diastolic volume (EDV) is then calculated from the right ventricular ejection fraction, continuous cardiac output and heart rate without the need for user calibration or intervention. 1.1.4

Oximetry (SvO2, ScvO2)

The Vigilance II monitor measures oxygen saturation, including but not limited to SvO2 and ScvO2, by a spectrophotometric technique that uses light emitting diodes (LEDs) to transmit light in the red and infrared spectra through an optical fiber in an oximetry catheter to the blood. The light is reflected back from the blood through a separate optical fiber in the catheter to an optical module. The amount of light reflected is primarily dependent on the color, which is due to the amount of oxygen bound to the hemoglobin and the amount of red blood cells present. The reflected light is electrically measured by the Vigilance II monitor and analyzed to determine oxygen saturation by detecting color changes in the red blood cells.

Edwards Lifesciences

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Vigilance II Monitor Operator’s Manual

1.1.5

Derived Hemodynamic and Oxygenation Parameters

The Vigilance II monitor calculates derived parameter values related to hemodynamics and oxygenation with appropriate user input. 1.2

Purpose This manual has been prepared for use with the Edwards Lifesciences Vigilance II monitor by trained critical care clinicians, nurses, and physicians in any hospital environment where critical care is administered; for example, emergency rooms, operating rooms, intensive care units, cath labs, recovery rooms, emergency departments, burn units, etc. The manual provides the operator of the Vigilance II monitor with setup and operating instructions, device interfacing procedures, and limitations.

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Scope The Vigilance II monitor Operator’s Manual provides instructions for all user configurations. The manual also introduces the operational environment in which the Vigilance II monitor may be installed. This includes connections and communications to devices and monitors within that environment. The Vigilance II monitor may be configured to perform CCO, ICO and oximetry measurements, as well as derived continuous EDV, RVEF, SV and SVR when interfaced with appropriate bedside monitors.

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Edwards Lifesciences