EV1000 Clinical Platform Service Manual May 2014

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Because of continuing product improvement, prices and specifications are subject to change without notice. Changes to this manual, either in response to user input or to continuing product improvements, are accomplished through reissue. If, in the normal use of this manual, errors, omissions, or incorrect data are noted, please contact Edwards Technical Support or your local Edwards representative. Issued by

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

Trademarks

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

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Edwards Lifesciences EV1000 Clinical Platform Technical Service Manual

All other trademarks are the property of their respective owners. Copyright ©2014 Edwards Lifesciences LLC. All rights reserved.

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Edwards Lifesciences Services GmbH Edisonstr. 6 85716 Unterschleissheim, Germany

Printed Date: 2017-01-24

Version 1.1 Release Date: 5/31/2014

Contents Introduction... 1-1 EV1000 Product Overview... 1-1 Indications for Use... 1-1 EV1000 System Description... 1-2 EV1000 Monitor... 1-2 EV1000 Databox... 1-4

Chapter 2: Safety and Symbols General Safety... 2-1 Safety Identifying Symbols... 2-1 Warnings... 2-1 Operator’s Warnings... 2-1 Service Warnings... 2-3

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Chapter 1: EV1000 Overview

Cautions... 2-3 Service Cautions... 2-5 Notes... 2-5 Monitor Display Symbols... 2-6 Symbols on Product Labels... 2-7

Applicable Standards... 2-10

Chapter 3: Setup and Installation Unpacking... 3-2 Contents List... 3-2 Site Preparation Guidelines... 3-2 Power Source... 3-3 Monitor Installation... 3-3 Mounting Recommendations... 3-3 Connecting the Monitor... 3-4

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Procedural Background Information... 2-9 Equipment / Technician Safety... 2-9

Connecting the Patient Cables... 3-5

EV1000 Databox Requirements... 3-10 Power On Self Test (POST) Function... 3-10 SW Upgrade Function... 3-10 Databox Software Download... 3-10

Chapter 4: Help and Troubleshooting Symptomatic Troubleshooting... 4-1 Unit Fails to Turn “On” with On/Standby button... 4-1

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EV1000 Monitor Requirements... 3-6 Software Startup and Updating Requirements... 3-6 Panel PC (Monitor) Software Installation... 3-10

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On Screen Help... 4-1 Databox Communication and Power... 4-3 Numeric Keypad Errors... 4-4 CO/SV Faults and Alerts... 4-4 CO/SV Troubleshooting... 4-5 TPTD Messages and Troubleshooting... 4-6 Oximetry Faults and Alerts... 4-8 CVP Faults / Alerts... 4-10

Chapter 5: EV1000 System Configuration EV1000 Monitor Types... 5-1 EV1000 Monitor Configuration... 5-1 Monitor Front View... 5-3 Monitor Bottom View... 5-3 Calibrating the Touch Screen... 5-4

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System Errors... 4-3

EV1000 Databox Configuration... 5-5 Controls and Indicators... 5-5 Calibrating the Databox... 5-5

Chapter 6: Demonstration Mode and Data Download Data Download... 6-2 Engineering Diagnostic Data and Clinical Data Export... 6-2 Repair and Validation Procedure... 7-1 Inspecting the Monitor... 7-1 Maintenance... 7-1 Preventive Maintenance... 7-2 Cleaning the Monitor... 7-2 Monitor Disposal... 7-2 Cleaning the System Cables... 7-3 Cleaning Patient Cables and Connectors... 7-3 Cleaning the Optical Module... 7-3

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Chapter 7: Preventative Maintenance and Repair

Chapter 8: EV1000 Drawings and Part Numbers EV1000 Monitor... 8-2 EV1000 Databox... 8-9 Parameters

... A-1

Accessories... A-2

Appendix B: Monitor Settings and Defaults Patient Data Input Range... B-1 Trend Scale Limits... B-1

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Appendix A: Specifications

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Alarm Limits... B-2 Language Default Settings*... B-3

Warranty... C-2

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

Index

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Edwards Lifesciences Regional Headquarters... C-2

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Service and Support... C-1

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Appendix C: Service and Support

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Figure 1-1 EV1000 System Context Diagram... 1-3 Figure 1-2 EV1000 Databox Context Diagram... 1-4 Figure 3-1 EV1000 Packaging Contents... 3-1 Figure 3-2 Example of EV1000 Mounting System... 3-3 Figure 3-3 Databox Ethernet Communication... 3-4 Figure 3-4 EV1000 Cable Connections... 3-5 Figure 3-5 Startup Flowchart... 3-6 Figure 3-6 Language Selection Screen... 3-7 Figure 3-7 BIOS Screen... 3-7 Figure 3-8 Startup Screen... 3-8 Figure 3-9 Query Update Screen... 3-8 Figure 3-10 Updating Screen... 3-9 Figure 4-1 Main Help Screen... 4-1 Figure 4-2 Category Help Screen... 4-2 Figure 4-3 Secondary Help Screen... 4-2 Figure 4-4 Help Screen... 4-2 Figure 5-1 EV1000 Monitor Appearance and Location of Power Button... 5-1 Figure 5-3 EV1000 Monitor Overview - Advantech Model... 5-2 Figure 5-2 EV1000 Monitor Overview Kontron Model... 5-2 Figure 5-4 EV1000 Monitor Front View... 5-3 Figure 5-5 EV1000 Monitor Bottom View - Kontron Model... 5-3 Figure 5-6 EV1000 Monitor Bottom View - Advantech Model... 5-3 Figure 5-7 Calibration Control Panel... 5-4 Figure 5-8 Databox Indicator Lights... 5-5 Figure 6-1 Settings Screen... 6-1 Figure 6-2 Demo Mode... 6-1 Figure 6-3 Data Download... 6-2 Figure 8-1 EV1000 Monitor and Databox... 8-1 Figure 8-2 EV1000 Monitor Frontal View (Kontron model)... 8-2 Figure 8-3 EV1000 Monitor: Rear and Left Side View (Kontron model)... 8-2 Figure 8-4 EV1000 Monitor System Dimensions (Advantech model)... 8-3 Figure 8-5 VolumeView Thermodilution Cable or ICO Cable... 8-5 Figure 8-6 FloTrac CVP Cable or DPT Cable... 8-6 Figure 8-7 Power Adapter, Bifurcation... 8-7 Figure 8-8 EV1000 Monitor: Mounting Bracket... 8-8 Figure 8-9 EV1000 Databox: Front and Bottom View... 8-9 Figure 8-10 EV1000 Databox: Rear View... 8-9 Figure 8-11 EV1000 Device (Transducer) Holder (Item #5)... 8-10 Figure 8-12 EV1000 Databox: Exploded View... 8-11 Figure 8-13 EV1000 Databox: Rear Housing... 8-12 Figure 8-14 EV1000 Databox: Front Housing... 8-13 Figure 8-15 EV1000 Databox: CPU Board... 8-14 Figure 8-16 EV1000 Databox: ISO Board... 8-14 Figure 8-17 EV1000 Databox: Pole Mount... 8-15 Figure C-1 Startup Screen... C-1

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List of Figures

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Table 2-1 Monitor Display Symbols... 2-6 Table 2-2 Symbols on Product Labels... 2-7 Table 2-3 Applicable Standards... 2-10 Table 3-1 EV1000 Packaging Contents... 3-2 Table 4-1 Databox Communication and Power Lights... 4-3 Table 4-2 System Errors... 4-3 Table 4-3 Numeric Keypad Errors... 4-4 Table 4-4 CO/SV Faults and Alerts... 4-4 Table 4-5 CO/SV Troubleshooting... 4-5 Table 4-6 TPTD Faults and Alerts... 4-6 Table 4-7 TPTD Warnings... 4-8 Table 4-8 Oximetry Faults/Alerts... 4-8 Table 4-9 Oximetry Warnings... 4-9 Table 4-10 Oximetry General Troubleshooting... 4-10 Table 4-11 CVP Faults/Alerts... 4-10 Table 4-12 CVP Troubleshooting... 4-10 Table 5-1 LED System Power Status... 5-3 Table 7-1 Maintenance Frequency Recommendations... 7-2 Table 8-1 Monitor Part Number Reference... 8-1 Table 8-2 EV1000 System Part Number Reference... 8-4 Table 8-3 EV1000 Databox Assembly... 8-10 Table 8-4 Assembly and Testing Reference Documents... 8-16 Table A-1 Physical and Mechanical Specifications... A-1 Table A-2 Environmental Specifications... A-1 Table A-3 Base Parameters... A-1 Table A-4 Oximetry... A-1 Table A-5 TPTD... A-2 Table A-6 Other Parameters... A-2 Table A-7 In vivo Calibration ScvO2/SvO2/HGB/Hct Ranges and Defaults... A-2 Table A-8 EV1000 System Accessories... A-2 Table A-9 Technical Specifications... A-3 Table B-1 Patient Information... B-1 Table B-2 Graphical Trend Parameter Scale Limits and Defaults... B-1 Table B-3 Parameter Alarm Red Zone and Target Defaults... B-2 Table B-4 Language Default Settings... B-3 Table D-1 List of Accessories, Cables and Sensors Necessary for Compliance D-1 Table D-2 Electromagnetic Emissions... D-1 Table D-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the EV1000 Platform... D-2 Table D-4 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field) D-2 Table D-5 Electromagnetic Immunity (RF Radiated and Conducted)... D-3

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List of Tables

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This manual is written for the use of Edward's-qualified service personnel to troubleshoot and repair Edwards EV1000 Critical Care Platforms. This manual was written assuming the service person(s) are familiar with the operation of the monitor as described in the EV1000 Operator's Manual. It is the user's responsibility to ensure that the product is properly maintained and that the monitor and Databox are in safe and proper operating conditions before use. Before servicing the EV1000 Platform, see the operator's manual for the instructions necessary to operate the equipment in accordance with its function and intended use.

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SOP’s referenced in this manual do not include a revision number history. For the most current revision, contact Edwards Technical Support. A reference table of all relevant SOP’s and procedures are provided in Chapter 8.

EV1000 Product Overview The EV1000 is a monitoring platform that displays both intermittent and continuous hemodynamic measurements related to the assessment of the essential components of oxygen delivery as well as the balance of oxygen delivery against consumption. The EV1000 system assists the clinician in assessing the patient’s status and supports clinical decisions related to the optimization of oxygen delivery through the management of preload, afterload, and contractility. In addition, the EV1000 can assess Extra Vascular Lung Water (EVLW) as an indicator of pulmonary edema. The continuous parametric measurements provided from an arterial line via an Edwards CO sensor include cardiac output (CO), stroke volume (SV), and stroke volume variation (SVV). When combined with a TruWave transducer for monitoring central venous pressure, the Edwards CO sensor is also able to measure continuous systemic vascular resistance (SVR).

Refer to the EV1000 Clinical Platform Operator’s Manual for a list of hemodynamic parameters that can be measured and displayed on the EV1000 monitor. Contact your Edwards Representative for the most recent version of the EV1000 Operator's Manual.

Indications for Use The EV1000 Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Platform may be used in all settings in which critical care is provided.

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This manual provides the service technician with the necessary information to maintain and service the EV1000 Panel Monitoring Device and Databox. It includes an overall description of how the system operates and provides detailed service support procedures such as repair and replace, troubleshooting, validation, and calibration.

The intermittent parametric measurements require use of a VolumeView catheter in a femoral artery, a CVC (central venous catheter) thermistor manifold, and a central venous pressure measurement. The intermittent parameters include cardiac output (iCO), stroke volume (iSV), systemic vascular resistance (iSVR), global end-diastolic volume (GEDV) and extravascular lung water (EVLW).

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Introduction

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Chapter 1: EV1000 Overview

The EV1000 system includes a monitor, comprised of an offthe-shelf single board computer with integrated LCD display and touch screen, a Databox subsystem, a reusable patient cable, a disposable pressure sensor arterial line, a disposable pressure-temperature sensor integrated into an arterial catheter, and an Oximetry catheter.

EV1000 Monitor

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A RS232 serial port available for real time communication to supported patient monitoring systems through the IFMout protocol.

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Two LAN ports either of which can provide communication between the EV1000 Monitor and Databox. One of the ports may be used in the future for integration with Hospital Information Systems (HIS).

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A speaker attached to generate audio feedback to the user.

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A VGA port providing connection to a second screen or projector for training.

The EV1000 Monitor is comprised of: •

A screen: 800x600 LCD or 1024x768 LCD (Advantech Model) display.

Software functions

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A touch screen used over the display to enable an easy to use user interface.

The EV1000 Monitor software performs the following functions:

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A real time clock that provides the time and date for the system.

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Acquires pressure, temperature, and light data from the EV1000 Databox.

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Three USB host ports providing communication with supported portable storage devices. (Note: When a USB Device is connected, a drive letter is assigned by the system software to an open drive letter above those used for the basic EV1000 system. The first drive connected is usually but not always assigned to the lowest drive letter available. The EV1000 application software will always access the lowest assigned drive letter that is above those used for the basic EV1000 system for performing snap shots, patient data downloads, and clinical or diagnostic data export).

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Displays intermittent and continuous parameter values.

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Displays trend values over time.

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User configurable settings.

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Multiple language support.

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Field upgrade-ability

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Demonstration mode.

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Data Capture and Download.

General Constraints The software runs on a Windows XPe Operating System.

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EV1000 System Description

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EV1000 Overview

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Figure 1-1 EV1000 System Context Diagram

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EV1000 Overview 1-3

EV1000 Databox The Databox is a part of the EV1000 system consisting of the Databox patient interface component and the EV1000 Monitor (Panel PC) user interface component. The two communicate using Ethernet protocols over a dedicated cable. It is one component of the EV1000 monitoring system and cannot be used as a stand-alone device.

incorporates a previously designed system for Oximetry measurement, and sensor detection using an additional sensor. The Databox is used for patient monitoring and includes an Ethernet interface, but it is not intended to be connected to a general network connection. Figure 1-2: EV1000 Databox Context Diagram, depicts the context of the EV1000 Databox device.

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The Databox software is based on the design of a pre-existing device that monitors temperature and pressure through central arterial and venous catheters. In addition, the design

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EV1000 Overview

Figure 1-2 EV1000 Databox Context Diagram

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1-4

This unit uses Mains power to perform its function and all reasonable precautions that are appropriate for an AC powered device should be taken. Reasonable care must be maintained to ensure there is no risk of electrical shock during diagnostic testing and repair procedures. Circuit Boards and other electronic components are static electricity sensitive and so must be "handled" using good ESD practices as indicated in the Warnings section of this chapter. This device is intended for use under the direct supervision of a licensed and trained health care professional. It is not intended for home use. Parts and accessories used must meet the requirements of the applicable IEC/EN 60601 series safety standards, and/or the system configuration must meet the requirements of the IEC/ EN 60601-1 medical electrical systems standard. Refer to Table 2-3 for a complete list of Applicable Standards.

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.

WARNING An indication of risk of potential Electrostatic Discharge (ESD) damage to Boards.

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

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

The Warnings presented in this chapter are used in both the EV1000 Operator’s Manual and Service Manual.

Operator’s Warnings The following warnings are present in the EV1000 Clinical Platform Operator’s Manual. See the Operator’s Manual for specific chapter locations. WARNING The EV1000 platform is intended for use only as an adjunct in patient assessment. This instrument must be used in conjunction with a bedside physiologic monitor.

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

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

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

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

WARNING Do not connect a power supply to the Databox or monitor that is not approved by Edwards.

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

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General Safety

Warnings

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

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

WARNING Do not use any damaged system components.

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his chapter describes the symbols that appear in the manual or on product labels, including those used to identify warnings, cautions, and notes. This chapter also includes a list of relevant standards to which the EV1000 platform complies.

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Chapter 2: Safety and Symbols

WARNING

WARNING

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

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

WARNING

WARNING

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

Do not use the EV1000 platform as a pulse rate or blood pressure monitor.

WARNING

WARNING

Do not connect anything to the Ethernet cable other than the Databox and Monitor.

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

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

WARNING

WARNING

WARNING

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

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

WARNING

Only connect accessories that have been qualified as part of the EV1000 system.

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

WARNING

Do not use a damaged catheter or one with exposed electrical contacts.

WARNING

WARNING

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

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

WARNING

WARNING

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

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

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

WARNING

WARNING

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

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

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

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.

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

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

Use of a damaged cable may result in inaccurate cardiac output measurements or may damage the EV1000 platform.

WARNING

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

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WARNING

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Safety and Symbols

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

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Safety and Symbols

The Cautions presented in this chapter are used in both the EV1000 Operator’s Manual and Service Manual. .

Disconnect the monitor from the AC source by unplugging the power Cable from the utility power socket. The On/Standby button does not disconnect the monitor from the AC mains supply.

CAUTION

WARNING

CAUTION

To avoid contaminating or infecting personnel, the service environment or other equipment, make sure that equipment which has been used before has been appropriately disinfected and decontaminated.

WARNING Disconnect the monitor from AC power before performing any cleaning.

WARNING Removing the cover or any other disassembly will expose you to hazardous voltages.

Do not use the EV1000 platform during MRI procedures; refer to the catheter’s “directions for use” for catheter MRI compatibility. Do not expose the EV1000 platform to extreme temperatures.

CAUTION Do not obstruct the EV1000 platform ventilation openings.

CAUTION

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WARNING

Cautions

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

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

CAUTION Do not use the EV1000 monitor in environments where strong lighting makes the LCD screen difficult to view.

CAUTION Do not use the monitor as a handheld device.

CAUTION The only way to remove power from the system is to unplug the power cord from its power source.

CAUTION Protection against effects of discharge from a cardiac defibrillator is dependent on proper use of patient cables.

CAUTION Restore Defaults replaces all settings with factory defaults. Any settings changes or customizations will be permanently lost.

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The following warnings are present in the EV1000 Clinical Platform Service Manual where relevant to the function or procedure being described.

CAUTION Do not restore defaults while monitoring a patient.

CAUTION The effectiveness of FT-CO measurements in pediatric patients has not been evaluated.

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Service Warnings

2-3

CAUTION

CAUTION

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

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

Always grasp the connector, not the cable, when connecting or disconnecting the cable.

CAUTION Do not twist or bend the connectors.

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

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

CAUTION The catheter and the calibration cup must be dry for an accurate oximetry in vitro calibration. Flush the catheter lumen only after the in vitro calibration has been completed.

CAUTION Performing an in vitro calibration after the oximetry catheter has been inserted into the patient will yield inaccurate calibration.

CAUTION Do not disconnect the optical module while calibration and patient data are being transferred from the EV1000 system.

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

CAUTION Use Windows Embedded Standard 2009 compatible USB devices.

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

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

CAUTION

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CAUTION

CAUTION

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Safety and Symbols

DO NOT:

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Allow any liquid to come in contact with the power connector

•

Allow any liquid to penetrate connectors or openings in the case

•

Clean the platform rear panels

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.

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Safety and Symbols

DO NOT attempt to clean the rear panels.

CAUTION Conduct periodic inspections of all cables for defects. Do not coil cables tightly when storing.

CAUTION Do not steam, radiate, or EO sterilize the Optical Module. Do not immerse the Optical Module.

CAUTION If any electrolytic solution, for example NaCl, Lactated Ringers, is introduced into the cable connectors while they are connected to the platform, and the platform is turned on, the excitation voltage can cause electrolytic corrosion and rapid degradation of the electrical contacts.

CAUTION

Notes

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Notes are presented in the Edwards EV1000 Service Manual where relevant to the function or procedure being described.

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CAUTION

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Do not immerse any cable connectors in detergent, isopropyl alcohol or glutaraldehyde.

CAUTION Do not use a hot air gun to dry cable connectors.

CAUTION

Service Cautions The following cautions are present in the EV1000 Clinical Platform Service Manual where relevant to the function or procedure being described

CAUTION Even when the system is turned off via power button (front or rear) there is still a standby-voltage of 5 V on the SBC board. The system is not completely disconnected from the main power source by turning off via the power button.

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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 this manual.

CAUTION

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Do not immerse the sensor connector in these cleaning agents.

Safety and Symbols

Monitor Display Symbols

Table 2-1 Monitor Display Symbols (Continued) Symbol

Table 2-1 Monitor Display Symbols

Oximetry calibration icon on Clinical actions menu.

Audible alarm silence button

Thermodilution menu option on Clinical actions menu.

Monitoring Pause exit button.

Derived value calculator button.

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

Event review button.

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

Quick Scroll buttons

More actions icon on Clinical actions menu. Additional options displayed include the Derived Value Calculator and Event Review. (Japan only)

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Description

Settings menu button

Vertical scroll buttons Screen capture button Horizontal scroll buttons Return to main monitoring screen Enter button Return to previous menu Keypad enter key Cancel

Keypad backspace key

Signal quality indicator bar

Keypad cancel key

SVV Filtering Exceeded Indicator: High degree of pulse rate variability may be impacting SVV values.

Item enabled

Clock/Waveform icon that allows user to view historical data. Also known as Intermittent indicator.

Item not enabled

Bolus Clock

Monitor screen selection button

Intervention analysis type indicator for custom event (grey)

Clinical actions menu button

Intervention analysis type indicator for positional challenge (purple).

Zero and waveform icon on Clinical actions menu.

Intervention analysis type Indicator for a fluid challenge (blue)

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Symbol

Description

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Safety and Symbols

Description Intervention analysis type Indicator for Intervention (green) Clinical/alarm indicators: Green: In target range Yellow: Out of target range Red: Red alarm and/or target zone Gray: No target set Clinical indicator: SVV slope

Connection to all configured HIS actors are good.

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

Description Caution

Defibrillation proof type CF applied part

Connector: FloTrac cable connector

Manufacturer No physical HIS connection to the Ethernet Date of Manufacturer

Intermittent errors are occurring in communications with configured HIS actors.

Persistent errors are occurring in communications with configured HIS actors.

Federal (USA) law restricts this device to use by, or on the order of a physician. Provides protection against vertically falling water to IPX1 standard. 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.

Indicates “ON” condition for part of the equipment.

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Patient ID is set to “Unknown” in all outbound HIS messages

Identifies a control that returns the device to its initial state. Consult instructions for use.

Consult instructions for use.

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Symbol

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Table 2-1 Monitor Display Symbols (Continued)

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Safety and Symbols

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

Symbol

Description Lot Number

Do Not Use if Damaged Video equipment output control.

Authorized representative in the European Community

Connector: Serial COM output

Keep contents dry.

Fragile. Handle with care.

.

Released Date: 2014-05-21

Intertek ETL

This end up.

Do not expose contents to environments above 95% RH or below 10% RH.

Do not expose contents to temperatures in excess of 70 oC or below -25 oC.

Keep away from direct sunlight.

Catalogue number

Quantity

Printed Date: 2017-01-24

Symbol

Table 2-2 Symbols on Product Labels (Continued)

Non-Sterile

Serial Number

Use By

Status = Released

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