EV1000 Clinical Platform NI Operator’s Manual Ver 1.4 Oct 2015

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Edwards Lifesciences EV1000 Clinical Platform NI 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, ClearSight, EV1000, FloTrac, Physiocal, TruWave and VolumeView are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

Copyright ©2015 Edwards Lifesciences LLC. All rights reserved. Version 1.4 Release Date: 10/30/2015

Edwards Lifesciences Services GmbH Edisonstr. 6 85716 Unterschleissheim, Germany

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Using This Manual The Edwards Lifesciences EV1000 Clinical Platform NI Operator’s Manual is comprised of 14 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

1

EV1000 Clinical Platform NI Overview: Provides an overview of the EV1000 Clinical Platform NI.

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 Pump-Unit surfaces.

3

4

Unpacking and Initial Setup: Provides information about setting up the EV1000 Clinical Platform NI and cables as well as information for initial startup of the system. EV1000 Clinical Platform NI Quick Start: Provides experienced clinicians and users of bedside patient monitors instructions for immediate monitor use.

5

Navigating the EV1000 Clinical Platform NI: Provides information on how to use the touch screen and monitoring cables.

6

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

Methodology and Monitoring: Describes the methodology behind ClearSight technology and gives instructions for setup and application of patient monitoring equipment as well as how to measure cardiac output, stroke volume, stroke volume variation, and systemic vascular resistance.

8

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.

9

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

10

Clinical Actions and Analysis: Describes information about using the EV1000 Clinical Platform NI to compute derived parameters, perform event reviews and other advanced options.

Chapter

Description

11

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

12

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

13

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

14

EV1000 Clinical Platform NI Advanced Features: Describes additional features available.

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

Contents Chapter 1: EV1000 Clinical Platform NI Overview Monitored Parameters... 1-1 Indications for Use... 1-1 Edwards EV1000 Clinical Platform NI Operator's Manual... 1-2 Acronyms and Abbreviations... 1-2

Chapter 2: Safety and Symbols Safety Identifying Symbols... 2-1 Warnings... 2-1 Cautions... 2-4 Monitor Display Symbols... 2-6 Symbols on Product Labels... 2-7 Applicable Standards... 2-9 EV1000 NI Essential Performance... 2-9 Documentation and Training... 2-9

Chapter 3: Unpacking and Initial Setup Unpacking... 3-1 Contents List... 3-1 Parameter Monitoring Accessories... 3-1 Monitor and Pump-Unit Installation... 3-1 Mounting Recommendations... 3-2 Connecting the Monitor and Pump-Unit... 3-2 Connecting the Patient Cables... 3-4 Initial Startup... 3-4 Select Language... 3-5

Chapter 4: EV1000 Clinical Platform NI Quick Start ClearSight Technology Blood Pressure and Hemodynamic Monitoring... 4-1 Zero and Apply Heart Reference Sensor (HRS)... 4-2 Alarms and Targets... 4-3 Central Venous Pressure Manual Entry (For SVR and SVRI calculations) . . 4-3

Chapter 5: Navigating the EV1000 Clinical Platform NI Navigation Bar... 5-1 Monitor Views... 5-2 Change Parameters... 5-3 Change Alarm/Target... 5-3 Graphical Trend Monitoring View... 5-3 Tabular Trends... 5-5 Big Numbers... 5-6 Physiology Screen... 5-6 Cockpit Screen... 5-7 Goal Positioning Screen... 5-7

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Physio Relationship... 5-7 Status Indicators... 5-7 Monitor Screen Navigation... 5-8 Vertical Scrolling... 5-8 Information Bar... 5-9 Status Bar... 5-10

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... 6-2 Monitoring Screens Settings... 6-3 Serial Port Setup... 6-4 Restore Monitor Defaults... 6-4 Parameter Settings... 6-4 Alarms / Targets... 6-5 Time Intervals / Averaging... 6-8 Adjust Scales... 6-8 Engineering... 6-9

Chapter 7: Methodology and Monitoring EV1000 Noninvasive System Methodology... 7-1 Volume Clamp Method... 7-1 Physiocal Method... 7-1 Waveform Reconstruction and Hemodynamic Analysis (ClearSight Algorithm) 7-1 Heart Reference Sensor... 7-1 Discoloration, Numbness, or Tingling of the Fingertip... 7-1 Single Cuff Monitoring... 7-2 Double Cuff Monitoring... 7-2 Connect the Patient Sensors... 7-2 Apply the Pressure Controller... 7-4 Select ClearSight Finger Cuff Size... 7-4 Apply the ClearSight Finger Cuff... 7-4 Enter Patient Data... 7-5 Zero and Apply Heart Reference Sensor and Start Monitoring... 7-5 Set Targets and Alarm Limits... 7-7 Central Venous Pressure Manual Entry... 7-8 Continuous Waveform Display... 7-8 Output Signal to Patient Monitor... 7-8 Derived Value Calculator... 7-8 Cuff Options... 7-8 Cuff Pressure Release Mode... 7-9 Cardiac Output Calibration... 7-9

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Physiocal Control... 7-10

Chapter 8: Physiology and Physio Relationship Monitoring Screens Physiology Screen... 8-1 SVV Slope Indicator... 8-2 Physio Relationship Screen... 8-2 Continuous and Historical Modes... 8-2 Parameter Boxes... 8-3 Physio Relationship Alarms/Targets and Historical Data Screens... 8-3

Chapter 9: Enhanced Parameter Tracking GDT Tracking... 9-1 Key Parameter and Target Selection... 9-1 Active GDT Tracking... 9-2 Historical GDT... 9-2 SV Optimization... 9-2 GDT Report Download... 9-2

Chapter 10: Clinical Actions and Analysis Zero & Waveform... 10-1 Zero Heart Reference Sensor (HRS)... 10-1 Analog Pressure Out... 10-1 Central Venous Pressure Manual Entry... 10-1 Derived Value Calculator... 10-1 Event Review... 10-1 Cuff Options... 10-2 Advanced Options... 10-2 Historical Data... 10-3

Chapter 11: Demonstration Mode and Data Download Data Download... 11-2

Chapter 12: Help and Troubleshooting On Screen Help... 12-1 Graphical Steps Help Screen... 12-2 Pump-Unit Communication and Power... 12-3 Pressure Controller Communication... 12-4 System Errors... 12-6 Numeric Keypad Errors... 12-7 ClearSight Faults and Alerts... 12-8 ClearSight Warnings and Troubleshooting... 12-13 CVP Troubleshooting... 12-14

Chapter 13: EV1000 Clinical Platform NI Accessories Stands... 13-1 EV1000 Table Stand... 13-1 EV1000 Roll Stand... 13-1

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EV1000 Monitor Bracket... 13-2 EV1000 Monitor Types... 13-2 EV1000 Pump-Unit Bracket... 13-3

Chapter 14: EV1000 Clinical Platform NI Advanced Features HIS Connectivity... 14-1 Goal Positioning Screen... 14-2 Technology Selection... 14-3 EV1000 NI Databox Adaptor Cable Connection... 14-3 Technology Selection Screen... 14-3

Appendix A: Specifications Accessories... A-2

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-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 EV1000 Clinical Platform NI... E-1 Cleaning the Monitor and Pump-Unit... E-1 Cleaning the System Cables and Accessories... E-1 Cleaning the Patient Cables and Connectors... E-2 Service and Support... E-2 Edwards Lifesciences Regional Headquarters... E-3 System Disposal... E-3 Preventive Maintenance... E-3 Warranty... E-4

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

Appendix G: Glossary

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List of Figures Figure 3-1 EV1000 Clinical Platform NI Cable Connections... 3-3 Figure 3-2 Startup Screen... 3-4 Figure 3-3 Language Selection Screen... 3-5 Figure 4-1 EV1000 Noninvasive System Cable Connection... 4-1 Figure 4-3 EV1000 Pressure Controller Attachments... 4-2 Figure 4-2 Patient Data Entry Screen... 4-2 Figure 4-4 ClearSight Finger Cuff Placement... 4-2 Figure 4-5 Zero HRS... 4-3 Figure 4-6 Set Alarms and Targets... 4-3 Figure 5-1 Navigation Bar... 5-1 Figure 5-2 Example of Monitoring Screen Selection Window... 5-2 Figure 5-3 Change Monitored Parameter... 5-3 Figure 5-4 Graphical Trend Screen - Arterial Waveform Display... 5-4 Figure 5-5 Graphical Trend- Intervention... 5-4 Figure 5-6 Graphical Trend Screen - Intervention information balloon... 5-5 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 Lock Screen... 5-10 Figure 5-18 Screen Locked... 5-10 Figure 5-19 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... 6-2 Figure 6-4 Date / Time Settings... 6-3 Figure 6-5 Monitor Screens... 6-3 Figure 6-6 Serial Port Setup... 6-4 Figure 6-7 Parameter Settings... 6-4 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... 6-7 Figure 6-11 Time Intervals / Averaging... 6-8 Figure 6-12 Graphical Trend Screen... 6-8 Figure 6-13 Adjust Scales... 6-8 Figure 6-14 Tabular Increment Popup... 6-9 Figure 7-1 Physiocal During Blood Pressure Measurement... 7-1 Figure 7-2 EV1000 Noninvasive System Connections... 7-3 Figure 7-3 Cuff size selection... 7-4 Figure 7-4 ClearSight Finger Cuff Placement... 7-4 Figure 7-5 Settings Screen... 7-5 Figure 7-6 Zero & Waveform Screen... 7-6

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Figure 7-7 Alignment of HRS... 7-6 Figure 7-8 Parameter Settings... 7-7 Figure 7-9 Alarms / Targets... 7-7 Figure 7-10 Finger Cuff Pressure Release Icon and Timer... 7-9 Figure 7-11 Advanced Options Screen... 7-9 Figure 7-12 Advanced Options Screen - CO Calibration... 7-9 Figure 8-1 Physiology Screen... 8-1 Figure 8-2 Systemic Vascular Resistance... 8-1 Figure 8-3 SVV Slope Indicator... 8-2 Figure 8-4 Physio Relationship Screen... 8-2 Figure 8-5 Physio Relationship Historical Data Screen... 8-2 Figure 8-6 Physio Relationship Parameter Boxes... 8-3 Figure 8-7 Physio Relationship Target Popup... 8-3 Figure 9-1 GDT Menu Screen - Key Parameter Selection... 9-1 Figure 9-2 GDT Menu Screen - Target Selection... 9-1 Figure 9-3 GDT Active Tracking... 9-1 Figure 10-1 Derived Value Calculator... 10-1 Figure 10-2 Event Review... 10-1 Figure 11-1 Settings Screen... 11-1 Figure 11-2 Demo Mode... 11-1 Figure 11-3 Live Demo Banner... 11-1 Figure 11-4 Data Download... 11-2 Figure 12-1 Main Help Screen... 12-1 Figure 12-2 Category Help Screen... 12-1 Figure 12-3 Secondary Help Screen... 12-1 Figure 12-4 Help Screen... 12-2 Figure 12-5 Graphical Steps Help Screen... 12-2 Figure 12-6 Example of Detailed Graphical Steps Help Screen... 12-2 Figure 12-7 EV1000 Pump-Unit and Monitor LED Indicators... 12-3 Figure 12-8 Pressure Controller LED Indicators... 12-4 Figure 13-1 EV1000 Table Stand... 13-1 Figure 13-2 EV1000 Roll Stand... 13-1 Figure 13-3 EV1000 Monitor Bracket... 13-2 Figure 13-4 EV1000 Monitor and Monitor Bracket... 13-2 Figure 13-5 EV1000 Monitor Appearance and Location of Power Button... 13-2 Figure 13-6 EV1000 Monitor Cable Connections... 13-2 Figure 13-7 EV1000 Pump-Unit Bracket... 13-3 Figure 14-1 HIS- Patient Query... 14-1 Figure 14-2 HIS- New Patient Data Screen... 14-1 Figure 14-3 Goal Positioning Screen... 14-2 Figure 14-4 EV1000 NI Databox Adaptor Cable Power Connections... 14-3 Figure A-1 Spectral Irradiance... A-1 Figure A-2 Location of Light Emission Aperture... A-1 Figure E-1 Startup Screen... E-2

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List of Tables Table 1-1 EV1000 Clinical Platform NI Parameters... 1-1 Table 1-2 Acronyms and Abbreviations... 1-2 Table 2-1 Monitor Display Symbols... 2-6 Table 2-2 Symbols on Product Labels... 2-7 Table 2-3 Applicable Standards... 2-9 Table 3-1 EV1000 NI Main Components... 3-1 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 Physiocal Interval Status... 5-9 Table 5-5 Pump-Unit Battery Status... 5-10 Table 6-1 Target Status Indicator Colors... 6-5 Table 6-2 Target Defaults... 6-6 Table 9-1 GDT Target Status Indicator Colors... 9-2 Table 10-1 Reviewed Events... 10-2 Table 12-1 Pump-Unit Communication and Power Lights... 12-3 Table 12-2 Pressure Controller Communication Lights... 12-4 Table 12-3 System Errors... 12-6 Table 12-4 Numeric Keypad Errors... 12-7 Table 12-5 ClearSight Faults and Alerts... 12-8 Table 12-6 ClearSight Warnings... 12-13 Table 12-7 ClearSight Troubleshooting... 12-13 Table 12-8 CVP Troubleshooting... 12-14 Table A-1 Physical and Mechanical Specifications... A-1 Table A-2 Environmental Specifications... A-2 Table A-3 Base Parameters... A-2 Table A-4 EV1000 Clinical Platform NI Components... A-2 Table A-5 EV1000 Monitor Technical Specifications... A-3 Table A-6 EV1000 Pump-Unit 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 Defaults... C-1 Table C-3 Ranges for Key Parameters... C-2 Table C-4 Parameter Alarm Red Zone and Target Defaults... C-2 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-2 Table F-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the EV1000 Clinical Platform NI... F-2 Table F-4 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field) F-3 Table F-5 Electromagnetic Immunity (RF Radiated and Conducted)... F-4

Chapter 1: EV1000 Clinical Platform NI Overview

T

he EV1000 Clinical Platform NI monitors key hemodynamic parameters derived from continuous noninvasive measurement of the arterial pressure waveform. The EV1000 Clinical Platform NI assists the clinician in assessing the patient’s physiologic status and supports clinical decisions related to hemodynamic optimization. CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician.

ClearSight™ Technology Noninvasive Arterial Pressure and Cardiac Output Monitoring The EV1000 Clinical Platform NI consists of the EV1000 Monitor in conjunction with the EV1000 Noninvasive System, which is comprised of the EV1000 Pump-Unit (PMP), Pressure Controller (PC2), Heart Reference Sensor (HRS) and ClearSight Finger Cuff. The ClearSight Finger Cuff has a built in plethysmograph sensor to noninvasively measure the continuous finger arterial blood pressure using Volume Clamp and Physiocal™ methods. The brachial arterial pressure waveform is then reconstructed from the measured finger blood pressure pulsations to monitor Systolic (SYS), Diastolic (DIA) and Mean Arterial (MAP) pressures. Hemodynamic parameters, Cardiac Output (CO), Cardiac Index (CI), Stroke Volume (SV), Stroke Volume Index (SVI), Stroke Volume Variation (SVV), and Pulse Rate (PR) are calculated using a novel pulse contour method (ClearSight Algorithm). Systemic Vascular Resistance (SVR) and Systemic Vascular Resistance Index (SVRI) can also be calculated after the user manually inputs a CVP value. In addition, the Heart Reference Sensor is used to compensate for hydrostatic pressure differences due to changes in height of the finger relative to the heart, with one end placed at the level of the patient’s finger and the other at heart level.

Monitored Parameters The following hemodynamic parameters can be measured noninvasively, using ClearSight technology, and displayed on the EV1000 Monitor.

Table 1-1 EV1000 Clinical Platform NI Parameters Parameter

Description

Cardiac Output (CO)

Continuous measurement 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

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

Indications for Use Intended Medical Indication. The EV1000 Clinical Platform NI and ClearSight™ Finger Cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform NI and ClearSight™ finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

1-2

EV1000 Clinical Platform NI Overview

User Profile(s). The EV1000 Clinical Platform NI is intended for use by trained clinicians in a hospital setting. Intended Conditions of Use. The system is intended for use in the hospital environment or other appropriate clinical setting. Contraindications. In some patients with extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand, such as may be present in patients with Raynaud's disease, blood pressure measurement can become impossible.

Acronyms and Abbreviations The following acronyms and abbreviations are used in this manual. Table 1-2 Acronyms and Abbreviations Abbreviation

Definition

A/D

Analog/Digital

AP

Arterial Pressure

ART

Brachial Arterial Waveform

BP

Blood Pressure

WARNING

BSA

Body Surface Area

The EV1000 Clinical Platform NI is intended for use only as an adjunct in patient assessment. This instrument should be used in conjunction with a bedside physiologic monitor. If the accuracy of any reading is questionable, first check the patient’s vital signs by alternate means.

CI

Cardiac Index

CO

Cardiac Output

WARNING

CPO

Cardiac Power Output

CPI

Cardiac Power Index

CVP

Central Venous Pressure

DO2

Oxygen Delivery

DO2I

Oxygen Delivery Index

Read this Manual carefully before attempting to use the Edwards Lifesciences EV1000 Clinical Platform NI. Improper use of the EV1000 Clinical Platform NI could present a hazard to the patient. Carefully read the “Warnings” section of this manual before using the platform.

DIA

Diastolic Pressure

EV1000 NI

EV1000 Clinical Platform NI

GDT

Goal Directed Therapy

WARNING

HIS

Hospital Information Systems

Use of the EV1000 Clinical Platform NI is restricted to one patient at a time.

HGB

Hemoglobin

HRS

Heart Reference Sensor

MAP

Mean Arterial Pressure

PaO2

Partial pressure of arterial oxygen

Edwards EV1000 Clinical Platform NI Operator's Manual

PC2

Pressure Controller

The EV1000 Clinical Platform NI Operator’s Manual is intended for use with the Edwards Lifesciences EV1000 Clinical Platform NI by trained clinicians in a hospital setting. 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 Clinical Platform NI can be installed. This includes connections and communications to devices and monitors within that environment.

PM

Bedside Patient Monitor

PMP

Pump-Unit

PR

Pulse Rate

ScvO2

Central venous oxygen saturation

SpO2

Peripheral arterial oxygen saturation

SV

Stroke Volume

SVI

Stroke Volume Index

SvO2

Mixed Venous Oxygen Saturation

SVR

Systemic Vascular Resistance

SVRI

Systemic Vascular Resistance Index

SVV

Stroke Volume Variation

SYS

Systolic Pressure

Touch

Interact with the EV1000 system by touching the monitor screen.

USB

Universal Serial Bus

VO2e

Estimated oxygen consumption

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 in this chapter.

WARNING

This chapter also includes a list of relevant standards to which the EV1000 Clinical Platform NI complies.

No modification of the EV1000 Clinical Platform NI is allowed. (Chapter 3, Appendix F)

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 NI Operator’s Manual where relevant to the function or procedure being described. WARNING The EV1000 Clinical Platform NI is intended for use only as an adjunct in patient assessment. This instrument should be used in conjunction with a bedside physiologic monitor. If the accuracy of any reading is questionable, first check the patient’s vital signs by alternate means. (Chapter 1)

WARNING Read this Manual carefully before attempting to use the Edwards Lifesciences EV1000 Clinical Platform NI. Improper use of the EV1000 Clinical Platform NI 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 Clinical Platform NI is restricted to one patient at a time. (Chapter 1)

WARNING

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

WARNING To avoid the risk of electric shock, the Pump-Unit must only be connected to a supply mains with protective earth. (Chapter 3)

WARNING Grounding reliability can only be achieved in Canada and in the USA when the instrument is connected to a receptacle marked “hospital only”, “hospital grade”, or its equivalent. (Chapter 3)

WARNING In the USA the instrument shall be connected only to a single phase 110-120V supply system. (Chapter 3)

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

WARNING For noninvasive monitoring, the EV1000 Monitor must be powered by the Pump-unit using the EV1000 NI Power Cable. (Chapter 3)

WARNING Shock hazard: Do not attempt to connect/disconnect system cables while hands are wet. Ensure that hands are dry prior to disconnecting system cables. (Chapter 3)

WARNING Only use ClearSight Finger Cuffs, EV1000 Heart NI Reference Sensor and other EV1000 Noninvasive System accessories, cables and or components that have been supplied and labeled by Edwards. Using other unlabeled accessories, cables and or components may affect patient safety and measurement accuracy. (Chapter 3,7,13, Appendix A)

2-2

Safety and Symbols

WARNING

WARNING

Use of accessories, sensors, and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity. (Chapter 3, Appendix F)

Physiological visual and audible physiological 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 and displayed as a key parameter, the audible physiological alarms are silenced. (Chapter 4,6,7,8)

WARNING The EV1000 Clinical Platform NI meets the requirements of IEC 60601-1:2005 for the system configurations described in this manual. Connecting external equipment or configuring the system in a way not described in this manual may not meet this standard. (Chapter 3, 14)

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 4, 11)

WARNING

WARNING

Do not use the Ethernet cable to connect anything to the Pump-Unit other than the Monitor. (Chapter 3)

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

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

WARNING Do not obstruct the EV1000 Clinical Platform NI ventilation openings. (Chapter 3)

WARNING Make sure the EV1000 Clinical Platform NI is securely mounted, and that all cords and accessory cables are appropriately arranged to minimize the risk of injury to patients, users or the equipment. Refer to directions on proper setup. (Chapter 3,13)

WARNING The Monitor must be positioned in an upright position to ensure IPX1 fluid ingress protection. (Chapter 3)

WARNING The Pump-Unit must be positioned in an upright position to ensure IP4X ingress protection. (Chapter 3,13)

WARNING Do not position the Pump-Unit so that it is difficult to disconnect the mains power cord. (Chapter 3)

WARNING Components that are not indicated as APPLIED PARTS should not be placed in as location where the patient may come into contact with the component. (Chapter 4,7)

WARNING Do not apply ClearSight Finger Cuff(s) on a hand/finger when external constriction (that may prevent circulation to the hand/finger) is present. (Chapter 4)

WARNING Do not turn off the audible physiological 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 sterilize any components of the EV1000 Noninvasive System. The EV1000 Noninvasive System is provided non sterile. (Chapter 7)

WARNING Refer to cleaning instructions. Do not disinfect the instrument by autoclave or gas sterilization. (Chapter 7, Appendix E)

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 damaged components/sensors or components/sensors with exposed electrical contacts to prevent patient or user shocks. (Chapter 7, Appendix E)

WARNING The EV1000 Noninvasive System monitoring components are not defibrillation proof. Disconnect the system before defibrillating. (Chapter 7)

Safety and Symbols

2-3

WARNING

WARNING

Do not touch system connectors of the EV1000 Clinical Platform NI and the patient at the same time. (Chapter 7)

The analog output signal from the EV1000 Clinical Platform NI will experience brief interruptions due to Physiocal which will be displayed on the bedside patient monitor. (Chapter 7)

WARNING Always remove EV1000 Noninvasive System sensors and components from the patient and completely disconnect the patient from the instrument before bathing the patient. (Chapter 7)

WARNING Do not overtighten the Pressure Controller Band or ClearSight Finger Cuff(s). (Chapter 7)

WARNING Do not apply the ClearSight Finger Cuff or Pressure Controller on injured skin as this can cause further injury. (Chapter 7)

WARNING Measurement on one finger in contradiction with the instructions for use may affect patient comfort and/or lead to minor injuries. (Chapter 7)

WARNING To reduce the risk of skin irritation and tissue damage, do not monitor longer than 8 hours continuously on a single finger. To continue to monitor, apply the ClearSight Finger Cuff to another finger or use two cuffs to measure more than 8 hours. (Chapter 7)

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 11)

WARNING EV1000 Databox and EV1000 Monitor power must be supplied through the same Pump-Unit when using integrated noninvasive and minimally invasive technologies for patient monitoring. (Chapter 14)

WARNING The EV1000 Clinical Platform NI, cables and sensors contain 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, Pump-Unit, Pressure Controller or Cables in any liquid solution. Do not allow any fluids to enter the instrument. (Appendix E)

WARNING DO NOT:

WARNING

•

Do not use two ClearSight Finger Cuffs simultaneously on the same finger. (Chapter 7)

•

WARNING If using the instrument during full body irradiation, keep all EV1000 Noninvasive System monitoring components out of the irradiation field. If a monitoring component is exposed to the irradiation, the readings may be affected. (Chapter 7)

WARNING Strong magnetic fields may cause malfunction of the instrument and burn wounds to the patient. Do not use the instrument during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns.The device may affect the MR image, and the MRI unit may affect the accuracy of the measurements. (Chapter 7)

WARNING Do not use the EV1000 Clinical Platform NI as a heart rate monitor. (Chapter 7)

Allow any liquid to come in contact with the power connector

Allow any liquid to penetrate connectors or openings in the case 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)

WARNING The EV1000 Clinical Platform NI should not be used adjacent to, or stacked with other equipment. If adjacent or stacked use is necessary, the EV1000 Monitor, Databox and Pump-Unit should be observed to verify normal operation in the configuration in which it is used. (Appendix F)

WARNING Portable and mobile RF communication equipment can potentially affect all electronic medical equipment, including the EV1000. Guidance on maintaining appropriate separation between communications equipment and the EV1000 is provided in Table F-3. (Appendix F)

2-4

Safety and Symbols

Cautions

CAUTION

The following cautions are presented in the Edwards EV1000 Clinical Platform NI Operator’s Manual where relevant to the function or procedure being described.

CAUTION

CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician. (Chapter 1)

CAUTION Do not use any damaged system components. Use of a damaged system component may result in inaccurate measurements or may damage the EV1000 Clinical Platform NI. (Chapter 3, Appendix E)

CAUTION Do not expose the EV1000 Clinical Platform NI to extreme temperatures. (Chapter 3)

CAUTION Do not expose the EV1000 Clinical Platform NI to dirty or dusty environments. (Chapter 3)

CAUTION

Improper ClearSight Finger Cuff placement or sizing can lead to inaccurate monitoring. (Chapter 4,7) Make sure that the HRS is correctly applied so that it can be leveled to the phlebostatic axis. (Chapter 4,7)

CAUTION Pump-Unit includes a Lithium-Ion battery backup. (Chapter 5)

CAUTION The system power status information, including battery information, is only displayed on EV1000 Monitor when the Pump-Unit is connected to the EV1000 Monitor with the supplied Ethernet cable. (Chapter 5,14)

CAUTION Restore Defaults replaces all settings with factory defaults. Any settings changes or customizations will be permanently lost. Do not restore defaults while monitoring a patient. (Chapter 6)

CAUTION

Do not apply strong shock to or drop the instrument. (Chapter 3)

The effectiveness of EV1000 Noninvasive System has not been evaluated in patients under 18 years of age. (Chapter 7)

CAUTION

CAUTION

Clean and store the instrument and accessories after each use. (Chapter 3, Appendix E)

CAUTION When moving the instrument, be sure to turn off the power and remove the connected power cord. (Chapter 3)

CAUTION The EV1000 Monitor should only be connected to a single Pump-Unit and/or single Databox. (Chapter 3)

CAUTION When connecting the EV1000 Clinical Platform NI 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)

Always grasp the connector, not the cable, when connecting or disconnecting cables. Do not twist or bend the connectors. Confirm that all sensors and cables are connected correctly and completely before use. (Chapter 7)

CAUTION Never bend a finger cuff to a flat shape, it will damage the cuff and affect measurement accuracy (Chapter 7)

CAUTION Excessive ambient light may interfere with ClearSight Finger Cuff measurements. (Chapter 7)

CAUTION The effectiveness of the ClearSight finger cuff has not been established in pre-eclamptic patients. (Chapter 7)

CAUTION The EV1000 Noninvasive System is not intended for use as an apnea monitor. (Chapter 7)

CAUTION In patients with extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand, such as may be present in patients with Raynaud's disease, blood pressure measurement can become impossible. (Chapter 7)

Safety and Symbols

CAUTION

CAUTION

Inaccurate noninvasive measurements can be caused by factors such as: • Improperly zeroed and/or leveled HRS • 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. • Poor blood circulation to the fingers • A bent or flattened ClearSight Finger Cuff • Excessive patient movement of fingers or hands. • Artifacts and poor signal quality • Incorrect placement or position of the ClearSight Finger Cuff • Electrocautery or electrosurgical unit interference (Chapter 7)

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

CAUTION Always disconnect the ClearSight Finger Cuff when it is not wrapped around a finger, to prevent damage by accidental over-inflation. (Chapter 7)

CAUTION The pulsations from intra-aortic balloon support can be additive to the pulse rate on the instrument pulse rate display. Verify patient's pulse rate against the ECG heart rate. (Chapter 7)

CAUTION The pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias.The pulse rate should not be used as a replacement or substitute for ECG based arrhythmia analysis. (Chapter 7)

CAUTION The LIVE DEMO mode can only be initiated by an Edwards sales representative and is different from Demo Mode. If a LIVE DEMO banner appears on the screen, as shown in Figure 11-3, discontinue use the EV1000 Clinical Platform NI and contact your local sales representative. (Chapter 11)

CAUTION Use Windows Embedded Standard 2009 compatible USB devices. (Chapter 11)

CAUTION 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. Do not expose the instrument to excessive moisture. Excessive moisture can cause the device to perform inaccurately or fail. (Appendix E)

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CAUTION If any electrolytic solution, for example NaCl or lactated Ringer’s solution, is introduced into the cable connectors while they are connected to the platform, the excitation voltage can cause electrolytic corrosion and rapid degradation of the electrical contacts. (Appendix E)

CAUTION Do not immerse any cable connectors in fluid or use a hot air gun to dry cable connectors. Refer to cleaning instructions. (Appendix E)

CAUTION This product contains batteries. If you no longer need to use this product, protect the environment by bringing it to your local distributor or designated collection point for proper disposal. (Appendix E)

CAUTION The instrument has been tested and complies with the limits of IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving device. • Increase the separation between the equipment. • Consult the manufacturer for help. (Appendix F)

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Safety and Symbols

Monitor Display Symbols

Table 2-1 Monitor Display Symbols (Continued) Symbol

Table 2-1 Monitor Display Symbols Symbol

Description Zero and waveform icon on Clinical Actions menu

Description Audible alarm silence button

Monitoring pause exit button

CVP manual entry button on Clinical Actions menu

Derived value calculator button on Clinical Actions menu

Symbol used to indicate the audible alarm indicator for the parameter has been disabled.

Event review button on Clinical Actions menu

Symbol used to indicate the audible alarm indicator for the parameter has been enabled.

Cuff Options button on Clinical Actions menu

Vertical scroll buttons Advanced Options button on Clinical Actions menu Horizontal scroll buttons

Enter button

Historical Data button on Clinical Actions menu

Keypad enter key

Settings menu button

Keypad backspace key

Screen capture button

Move cursor left by 1 character

Start Monitoring button

Move cursor right by 1 character Stop Monitoring button Keypad cancel key

Item enabled

Resume Monitoring button

Item not enabled

Return to main monitoring screen

GDT Tracking button

Return to previous menu

Cancel Monitor screen selection button HIS enabled icon on information bar Clinical Actions menu button Battery life indicator icons on information bar

Safety and Symbols

Table 2-1 Monitor Display Symbols (Continued) Symbol

Description

Table 2-1 Monitor Display Symbols (Continued) Symbol

Description

Battery information is unavailable.

Exit Target Selection button on GDT Tracking Screen

Physiocal Interval ≥ 30 beats

Edit Target button on GDT Tracking Screen

Physiocal Interval < 30 beats

Time In Target symbol on GDT Tracking Screen

Physiocal Interval status not available

Clinical/alarm indicators: Green: In target range Yellow: Out of target range Red: Red alarm and/or target zone Gray: No target set Blue: In GDT target range Black: Out of GDT target range

Time until Cuff Pressure Release Mode

Time until conclusion of Cuff Pressure Release Mode

SVV Filtering Exceeded Indicator: High degree of pulse rate variability may be impacting SVV values. Clock/Waveform icon that allows user to view historical data

Arterial Waveform Display button on graphical trend screen

Arterial Waveform Hide button on graphical trend screen

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Clinical indicator: SVV slope

Symbols on Product Labels This section provides the symbol descriptions for symbols that are on the EV1000 Pump-Unit, EV1000 monitor, EV1000 accessories, and/or shipping container. Table 2-2 Symbols on Product Labels Symbol

Description Manufacturer

Intervention analysis button Date of Manufacture Intervention analysis type indicator for custom event (grey) Intervention analysis type indicator for positional challenge (purple) Intervention analysis type indicator for a fluid challenge (blue) Intervention analysis type indicator for intervention (green) Edit button on intervention information balloon

Federal (USA) law restricts this device to sale by, or on the order of a physician. Extent of protection against vertically falling water

Extent of protection against the ingress of objects and dripping water Separate collection for electrical and electronic equipment in accordance with EC directive 2002/ 96/EC. Connector: USB

Add Target button on GDT Tracking Screen Direct current only Target Value button on GDT Tracking Screen Unit network indicator or connection

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Safety and Symbols

Table 2-2 Symbols on Product Labels (Continued) Symbol

Description

Table 2-2 Symbols on Product Labels (Continued) Symbol

Description

Indicates “ON” condition for part of the equipment

Use by

Identifies a control that returns the device to its initial state

Lot Number

Consult instructions for use. Non-sterile Consult instructions for use.

Single Use

Caution

Authorized representative in the European Community

Intertek ETL

Magnetic resonance unsafe

Class II

CE conformity marking per European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. No serviceable parts inside

Video equipment output control

Type BF applied part

Connector: Serial COM output

Alarm, general (Pump-Unit)

Keep contents dry

Battery Status

Fragile. Handle with care

AC Mains Status Equipotentiality

This end up

Keep away from direct sunlight.

Continuous, noninvasive arterial blood pressure

Indoor use only

Analog output Catalogue number

Quantity

ClearSight Finger Cuff Size (S=Small, M=Medium, L=Large) Warehouse Storage Temperature Limitations (X = lower limit, Y = upper limit)

Serial Number