Edwards EV1000 Clinical Platform User manual

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EV1000 Clinical Platform NI
Edwards Lifesciences
Operator’s Manual

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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 trade-
marks 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
1EV1000 Clinical Platform NI Overview:
Provides an overview of the EV1000 Clinical
Platform NI.
2Safety 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.
3Unpacking 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.
4EV1000 Clinical Platform NI Quick Start:
Provides experienced clinicians and users of
bedside patient monitors instructions for
immediate monitor use.
5Navigating the EV1000 Clinical Platform NI:
Provides information on how to use the touch
screen and monitoring cables.
6Monitor 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.
7Methodology 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.
8Physiology 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.
9Enhanced 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.
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
ASpecifications
BEquations for Calculated Patient
Parameters
CMonitor Settings and Defaults
DEV1000 Unit Conversions
ESystem Care, Service and Support
FGuidance and Manufacturer's Declaration
GGlossary
Index
Chapter Description

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

viii
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

ix
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

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

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.
Edwards EV1000 Clinical
Platform NI Operator's
Manual
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.
Acronyms and
Abbreviations
The following acronyms and abbreviations are used in this
manual.
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.
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.
WARNING
Use of the EV1000 Clinical Platform NI is restricted to
one patient at a time.
Table 1-2 Acronyms and Abbreviations
Abbreviation Definition
A/D Analog/Digital
AP Arterial Pressure
ART Brachial Arterial Waveform
BP Blood Pressure
BSA Body Surface Area
CI Cardiac Index
CO Cardiac Output
CPO Cardiac Power Output
CPI Cardiac Power Index
CVP Central Venous Pressure
DO2Oxygen Delivery
DO2IOxygen Delivery Index
DIA Diastolic Pressure
EV1000 NI EV1000 Clinical Platform NI
GDT Goal Directed Therapy
HIS Hospital Information Systems
HGB Hemoglobin
HRS Heart Reference Sensor
MAP Mean Arterial Pressure
PaO2Partial pressure of arterial oxygen
PC2 Pressure Controller
PM Bedside Patient Monitor
PMP Pump-Unit
PR Pulse Rate
ScvO2Central venous oxygen saturation
SpO2Peripheral arterial oxygen saturation
SV Stroke Volume
SVI Stroke Volume Index
SvO2Mixed 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
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.
This chapter also includes a list of relevant standards to which
the EV1000 Clinical Platform NI complies.
Safety Identifying Symbols
The terms warnings, cautions, and notes are graphically
identified and have specific meanings as used in this manual.
 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
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.
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)
T
WARNING
Use of the EV1000 Clinical Platform NI is restricted to
one patient at a time.
(Chapter 1)
WARNING
No modification of the EV1000 Clinical Platform NI is
allowed.
(Chapter 3, Appendix F)
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
Use of accessories, sensors, and cables other than
those specified may result in increased electromagnetic
emissions or decreased electromagnetic immunity.
(Chapter 3, Appendix F)
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
Do not use the Ethernet cable to connect anything to
the Pump-Unit other than the Monitor.
(Chapter 3)
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
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
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
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
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
Do not touch system connectors of the EV1000 Clinical
Platform NI and the patient at the same time.
(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
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)
WARNING
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
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:
•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
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
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
Do not apply strong shock to or drop the instrument.
(Chapter 3)
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)
CAUTION
Improper ClearSight Finger Cuff placement or sizing
can lead to inaccurate monitoring.
(Chapter 4,7)
CAUTION
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
The effectiveness of EV1000 Noninvasive System has
not been evaluated in patients under 18 years of age.
(Chapter 7)
CAUTION
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 2-5
CAUTION
Inaccurate noninvasive measurements can be caused
by factors such as:
• Improperly zeroed and/or leveled HRS
• Excessive variations in blood pressure. Some con-
ditions 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)
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)
CAUTION
Conduct periodic inspections of all cables for defects.
Do not coil cables tightly when storing.
(Appendix E)
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)

2-6
Safety and Symbols
Monitor Display Symbols
Table 2-1 Monitor Display Symbols
Symbol Description
Audible alarm silence button
Monitoring pause exit button
Symbol used to indicate the audible alarm indicator
for the parameter has been disabled.
Symbol used to indicate the audible alarm indicator
for the parameter has been enabled.
Vertical scroll buttons
Horizontal scroll buttons
Enter button
Keypad enter key
Keypad backspace key
Move cursor left by 1 character
Move cursor right by 1 character
Keypad cancel key
Item enabled
Item not enabled
GDT Tracking button
Monitor screen selection button
Clinical Actions menu button
Zero and waveform icon on Clinical Actions menu
CVP manual entry button on Clinical Actions menu
Derived value calculator button on Clinical Actions
menu
Event review button on Clinical Actions menu
Cuff Options button on Clinical Actions menu
Advanced Options button on Clinical Actions menu
Historical Data button on Clinical Actions menu
Settings menu button
Screen capture button
Start Monitoring button
Stop Monitoring button
Resume Monitoring button
Return to main monitoring screen
Return to previous menu
Cancel
HIS enabled icon on information bar
Battery life indicator icons on information bar
Table 2-1 Monitor Display Symbols (Continued)
Symbol Description

Safety and Symbols 2-7
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.
Battery information is unavailable.
Physiocal Interval ≥30 beats
Physiocal Interval < 30 beats
Physiocal Interval status not available
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
Intervention analysis button
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
Add Target button on GDT Tracking Screen
Target Value button on GDT Tracking Screen
Table 2-1 Monitor Display Symbols (Continued)
Symbol Description
Exit Target Selection button on GDT Tracking
Screen
Edit Target button on GDT Tracking Screen
Time In Target symbol on GDT Tracking Screen
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
Clinical indicator:
SVV slope
Table 2-2 Symbols on Product Labels
Symbol Description
Manufacturer
Date of Manufacture
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
Direct current only
Unit network indicator or connection
Table 2-1 Monitor Display Symbols (Continued)
Symbol Description

2-8
Safety and Symbols
Indicates “ON” condition for part of the equipment
Identifies a control that returns the device to its
initial state
Consult instructions for use.
Consult instructions for use.
Caution
Intertek ETL
Class II
Video equipment output control
Connector: Serial COM output
Keep contents dry
Fragile. Handle with care
This end up
Keep away from direct sunlight.
Catalogue number
Quantity
Serial Number
Table 2-2 Symbols on Product Labels (Continued)
Symbol Description
Use by
Lot Number
Non-sterile
Single Use
Authorized representative in the European
Community
Magnetic resonance unsafe
CE conformity marking per European Council
Directive 93/42/EEC of 14 June 1993 concerning
medical devices.
No serviceable parts inside
Type BF applied part
Alarm, general (Pump-Unit)
Battery Status
AC Mains Status
Equipotentiality
Continuous, noninvasive arterial blood pressure
Indoor use only
Analog output
ClearSight Finger Cuff Size (S=Small, M=Medium,
L=Large)
Warehouse Storage Temperature Limitations
(X = lower limit, Y = upper limit)
Table 2-2 Symbols on Product Labels (Continued)
Symbol Description