EV1000 Clinical Platform NI Service Manual Oct 2015

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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, Physiocal and ClearSight are trademarks of Edwards Lifesciences Corporation.

Released Date: 2015-10-29

Edwards Lifesciences EV1000 Clinical Platform NI Technical Service Manual

All other trademarks are the property of their respective owners. Copyright ©2015 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 1.2 Release Date: 06/15/2015

Contents Introduction... 1-1 EV1000 Clinical Platform NI Product Overview... 1-1 Indications for Use... 1-1 EV1000 System Description... 1-2 EV1000 Monitor... 1-2 EV1000 Pump-Unit... 1-3 EV1000 Pressure Controller... 1-4

Chapter 2: Safety and Symbols General Safety... 2-1 Safety Identifying Symbols... 2-1

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Chapter 1: EV1000 Clinical Platform NI Overview

Warnings... 2-1 Operator’s Warnings... 2-1 Service Warnings... 2-3 Cautions... 2-4 Operator’s Cautions... 2-4 Service Cautions... 2-6 Notes... 2-6 Monitor Display Symbols... 2-7

Documentation and Training... 2-10

Chapter 3: Setup, Installation and System Configuration Unpacking... 3-1 Contents List... 3-1 Minimally Invasive Contents... 3-2 Site Preparation Guidelines... 3-2 Power Source... 3-2 Monitor and Pump-Unit Installation... 3-2 Mounting Recommendations... 3-3 Connecting the Monitor and Pump-Unit... 3-3 Connecting the Patient Cables... 3-5 Optional Minimally-Invasive Setup... 3-5 EV1000 Monitor Types... 3-5 EV1000 Monitor Configuration... 3-6 Monitor Bottom View: Power, Controls and Interfaces... 3-8 The EV1000 Clinical Platform NI Recurrent Testing and Maintenance... 3-9

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Applicable Standards... 2-10 EV1000 NI Essential Performance... 2-10

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Symbols on Product Labels... 2-8 Equipment / Technician Safety... 2-10

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Before Every Use... 4-1 Inspection of the EV1000 Monitor... 4-1 Inspection of EV1000 Pump-Unit... 4-3 Inspection of Pressure Controller... 4-4 Inspection of Accessories... 4-4 Databox and Associated Accessories... 4-5

Chapter 5: EV1000 Clinical Platform NI Safety and Functional Testing Tooling... 5-1 Safety Testing... 5-2 Protective Earth Resistance Testing... 5-2 Equipment Leakage Current Testing... 5-4 Equipment Leakage Current Test with Databox... 5-6 Applied Part Leakage Current Testing... 5-7 Applied Part Leakage Test with Databox... 5-8 Local Area Network (LAN) Leakage Test... 5-8

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Chapter 4: Visual Inspection

Functional Testing... 5-9 EV1000 NI: Pressure Calibration Test... 5-11 Battery Test... 5-12 Heart Reference Sensor: Offset Test... 5-13

Chapter 6: Preventive Maintenance and Repair Preventive Maintenance... 6-1 Maintenance by Edwards Service Centers... 6-1 Cleaning the EV1000 Clinical Platform NI... 6-1 Cleaning the Monitor, Pump-Unit and Databox... 6-2 Cleaning the System Cables and Accessories... 6-2 System Disposal... 6-2

Chapter 7: Help and Troubleshooting Symptomatic Troubleshooting... 7-1 On Screen Help... 7-1 Graphical Steps Help Screen... 7-2 Pump-Unit Communication and Power... 7-3 Pressure Controller Communication... 7-4

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Repair... 6-1

System Errors... 7-5 Numeric Keypad Errors... 7-6 ClearSight Faults and Alerts... 7-6 CVP Troubleshooting... 7-12

Chapter 8: Data Download and Diagnostics Logs Data Download... 8-1 Engineering Diagnostic Export and Software Versions... 8-1

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ClearSight Warnings and Troubleshooting... 7-11

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Appendix A: Specifications Accessories... A-2

Appendix C: Service and Support Service and Support... C-1 Edwards Lifesciences Regional Headquarters... C-2 Warranty... C-2

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

Appendix E: Service Documentation EV1000 Clinical Platform NI Recurrent Test Report... E-1

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Appendix B: Making a ClearSight Pressure Calibration Adaptor

Appendix F: Packing For Shipment Repacking the Original Carton... F-1 Monitor Packaging... F-1 EV1000 NI Upgrade Packing... F-1 Packing In A Different Carton... F-2

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Index

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Figure 1-1 EV1000 System Context Diagram... 1-3 Figure 1-2 EV1000 Pump-Unit and Pressure Controller Context Diagram... 1-4 Figure 1-3 EV1000 NI Databox Adaptor Cable Power Connections... 1-5 Figure 3-1 Pump-Unit LED Indicators... 3-4 Figure 3-2 EV1000 Cable Connections... 3-4 Figure 3-3 EV1000 NI Databox Adaptor Cable Power Connections... 3-5 Figure 3-4 EV1000 Monitor Appearance and Location of Power Button... 3-6 Figure 3-5 EV1000 Monitor Overview - Kontron Model... 3-6 Figure 3-6 EV1000 Monitor Overview - Advantech Model... 3-7 Figure 3-7 EV1000 Monitor Front View... 3-7 Figure 3-8 EV1000 Monitor Bottom View - Kontron Model... 3-8 Figure 3-9 EV1000 Panel Bottom View - Advantech Model... 3-8 Figure 4-1 Monitor PC, Front View... 4-1 Figure 4-2 Monitor PC, Rear View... 4-1 Figure 4-3 Monitor PC, Labeling... 4-2 Figure 4-4 Monitor Bracket on Monitor... 4-2 Figure 4-5 Pump-Unit, Front, Rear and Side Views... 4-3 Figure 4-6 Labeling on Rear of Pump-Unit... 4-3 Figure 4-7 Pump-Unit Bracket on Pump-Unit... 4-3 Figure 4-8 Pressure Controller Housing and Ports... 4-4 Figure 4-9 Pressure Controller Labeling... 4-4 Figure 4-10 Heart Reference Sensor (HRS)... 4-4 Figure 4-11 EVHRS Use By Date Label... 4-4 Figure 4-12 Databox, Front View... 4-5 Figure 4-13 Databox, Rear View... 4-5 Figure 4-14 Databox, Side View... 4-5 Figure 4-15 Databox Bracket... 4-5 Figure 4-16 Databox Bracket Installation... 4-5 Figure 4-17 Transducer Holder... 4-6 Figure 4-18 Databox with Transducer Holder... 4-6 Figure 4-19 FloTrac Cable... 4-6 Figure 4-20 Use By Date Label Indication... 4-6 Figure 4-21 VolumeView Cable... 4-7 Figure 4-22 Use By Date Label Indication... 4-7 Figure 5-1 Measurement device for leakage measurements per IEC 62353 . . . 5-2 Figure 5-2 Measurement Circuit for Protective Earth Resistance... 5-2 Figure 5-3 Protective Earth Resistance Test Setup... 5-3 Figure 5-4 Equipment Leakage Current Circuit Direct Method... 5-4 Figure 5-5 Leakage Test Setup. Wrap components indicated in foil... 5-4 Figure 5-6 Equipment Leakage Current Test Setup... 5-5 Figure 5-7 EV1000NI System with Databox for Electrical Safety Tests... 5-6 Figure 5-8 Equipment Leakage Current Test (Direct Method)... 5-6 Figure 5-9 Applied Part Leakage Current Circuit Direct Method... 5-7 Figure 5-10 Applied Part Leakage Current Test Setup... 5-7 Figure 5-11 Applied Part Leakage Current Test (Direct Method)... 5-8 Figure 5-12 Patient Data... 5-9 Figure 5-13 Language Setting... 5-9 Figure 5-14 ClearSight Mode Indicator and Monitoring Mode Button... 5-10

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List of Figures

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Figure 5-15 Technology Selection screen... 5-10 Figure 5-16 Saving Snapshot Screen... 5-10 Figure 5-17 Pump-Unit LED Indicators... 5-10 Figure 5-18 Databox LED’s... 5-11 Figure 5-19 Pressure Calibration Test... 5-11 Figure 5-20 Battery Charging Icon... 5-12 Figure 5-21 Battery Fully Charged Icon... 5-12 Figure 5-22 Battery Icon: Greater than 50% Charge... 5-12 Figure 5-23 Zero HRS and Offset Reading... 5-13 Figure 5-24 HRS Offset Test... 5-13 Figure 7-1 Main Help Screen... 7-1 Figure 7-2 Secondary Help Screen... 7-2 Figure 7-3 Help Screen... 7-2 Figure 7-4 Graphical Steps Help Screen... 7-2 Figure 7-5 Example of Detailed Graphical Steps Help Screen... 7-2 Figure 7-6 EV1000 Pump-Unit and Monitor LED Indicators... 7-3 Figure 7-7 Pressure Controller LED Indicators... 7-4 Figure 7-8 Graphical Steps Help Screen... 7-13 Figure 7-9 Example of Detailed Graphical Steps Help Screen... 7-13 Figure 8-1 Data Download... 8-1 Figure A-1 Spectral Irradiance... A-1 Figure A-2 Location of Light Emission Aperture... A-1 Figure B-1 Pressure Calibration Adaptor Assembly... B-3 Figure C-1 Startup Screen... C-1 Figure F-1 Unit Carton Diagram- EV1000 NI Upgrade... F-1

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Table 2-1 Monitor Display Symbols... 2-7 Table 2-2 Symbols on Product Labels... 2-8 Table 2-3 Applicable Standards... 2-10 Table 3-1 EV1000 Clinical Platform NI Components... 3-1 Table 3-2 LED System Power Status... 3-7 Table 3-3 EV1000 Clinical Platform NI Tests... 3-9 Table 5-1 Necessary Tooling for EV1000 Clinical Platform NI Functional and Safety Testing... 5-1 Table 7-1 Pump-Unit Communication and Power Lights... 7-3 Table 7-2 Pressure Controller Communication Lights... 7-4 Table 7-3 System Errors... 7-5 Table 7-4 Numeric Keypad Errors... 7-6 Table 7-5 ClearSight Faults and Alerts... 7-6 Table 7-6 ClearSight Warnings... 7-11 Table 7-7 ClearSight Troubleshooting... 7-11 Table 7-8 CVP Troubleshooting... 7-12 Table 7-9 Additional Troubleshooting... 7-13 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 Clinical Platform NI Part Number Reference... A-3 Table A-6 EV1000 Monitor Technical Specifications... A-3 Table A-7 EV1000 Pump-Unit Technical Specifications... A-4 Table D-1 List of Accessories, Cables and Sensors Necessary for Compliance D-1 Table D-2 Electromagnetic Emissions... D-2 Table D-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the EV1000 Clinical Platform NI... D-2 Table D-4 Electromagnetic Immunity (ESD, EFT, Surge, Dips and Magnetic Field) D-3 Table D-5 Electromagnetic Immunity (RF Radiated and Conducted)... D-4

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List of Tables

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

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 non-invasive 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.

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This manual provides the hospital biomed or service technician with the necessary information to maintain and service the EV1000 Clinical Platform NI. It includes an overall description of how the system operates and provides detailed service support procedures for recurrent testing, troubleshooting and validation Any recalibration or repair of the EV1000 Clinical Platform NI must only be performed at an authorized Edwards service center. This manual is written for the use of hospital service personnel to troubleshoot the Edwards EV1000 Clinical Platform NI. This manual was written assuming the service person(s) are familiar with the operation of the EV1000 Monitor, Pump-Unit and EV1000 noninvasive patient sensors as described in the EV1000 Clinical Platform NI Operator's Manual. It is the user's responsibility to ensure that the product is properly maintained and that the EV1000 Clinical Platform NI is in safe and proper operating conditions before use. Before servicing the EV1000 Clinical Platform NI, see the operator's manual for the instructions necessary to operate the equipment in accordance with its function and intended use.

The EV1000 Clinical Platform NI consists of the EV1000 Monitor (EV1000M) in combination with the EV1000 Noninvasive Upgrade Kit (EVNIUPG), which is comprised of the EV1000 Pump-Unit (EVPMP), Pressure Controller (PC2), and Heart Reference Sensor (EVHRS) and used with the 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), and Stroke Volume Variation (SVV) 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. Refer to the EV1000 Clinical Platform NI 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 Clinical Platform NI Operator's Manual.

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Introduction

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Chapter 1: EV1000 Clinical Platform NI Overview

EV1000 Clinical Platform NI Overview

The EV1000 Monitor is comprised of: • A screen: 800x600 LCD display (Kontron model) or 1024x768 LCD display (Advantech model). •

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

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Three USB host ports providing communication with supported portable storage devices.

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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 EV1000 PumpUnit.One of the ports can be used to communicate with the EV1000 Databox (EV1000DB) for minimally invasive monitoring or for integration with Hospital Information Systems (HIS).

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A speaker attached to generate audio feedback to the user.

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.

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

WARNING

Software functions

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. 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

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

EV1000 System Description The EV1000 Clinical Platform NI includes a monitor, comprised of an off-the-shelf single board computer with integrated LCD display and touch screen, a Non-Invasive Upgrade Kit comprising of a pneumatic Pump-Unit, a Pressure Controller worn on the patient’s wrist, and a reusable Heart Reference Sensor, used with a disposable single patient use Finger Cuff.

The EV1000 Monitor software performs the following functions: • Acquires brachial pressure and parameter signal data from the EV1000 Pump-Unit. •

Sends signal to EV1000 Pump-Unit to start/stop monitoring, zero HRS, start/stop physiocal, and send analog pressure signal to bedside patient monitor.

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Displays 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.

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Intended Conditions of Use. The system is intended for use in the hospital environment or other appropriate clinical setting.

EV1000 Monitor

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User Profile(s). The EV1000 Clinical Platform NI is intended for use by trained clinicians in a hospital setting.

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EV1000 Pump-Unit The EV1000 Pump-Unit manages the pneumatic air supply to the pressure controller and calculates key parameters using the finger blood pressure output signal from the Pressure Controller. The Pump-Unit and the Monitor communicate using Ethernet protocols over a dedicated cable. This Ethernet interface is not intended to be connected to a general network connection. The EV1000 Pump-Unit is one component of the EV1000 noninvasive monitoring system and cannot be used as a stand-alone device.

The Pump-Unit software monitors and stores brachial blood pressure parameters through the finger arterial blood pressure measured by the ClearSight Finger Cuff and monitored by the Pressure Controller. In addition, the design incorporates a built in battery to allow for uninterrupted monitoring during power loss. The Pump-Unit also provides mains power to the Pressure Controller and EV1000 Monitor. Figure 1-2, “EV1000 Pump-Unit and Pressure Controller Context Diagram” , depicts the context of the EV1000 Pump-Unit and Pressure Controller devices.

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Figure 1-1 EV1000 System Context Diagram

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EV1000 Clinical Platform NI Overview

EV1000 Clinical Platform NI Overview

Figure 1-2 EV1000 Pump-Unit and Pressure Controller Context Diagram

The EV1000 Pressure Controller interfaces between the Pump-Unit and the EV1000 noninvasive patient sensors. The Pressure Controller regulates air to the ClearSight Finger Cuff(s) and measures the light signal created by the plethysmograph sensor located in the finger cuff to calculate finger pressure parameters. The Pressure Controller also interfaces with the Heart Reference Sensor (HRS) to measure the differential pressure of the finger relative to the heart.

Operational Minimally Invasive Configuration The EV1000 Clinical Platform NI can optionally be configured to operate with the minimally invasive FloTrac, VolumeView, and Oximetry (PreSep, PediaSat) products. The EV1000 Databox (EV1000DB), part of the EV1000 Clinical Platform, can be configured to operate with the Monitor and Pump-Unit with the Databox Adaptor Cable (EVNIDBAC) and an additional Ethernet cable (EVECxFT).

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EV1000 Pressure Controller

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EV1000 Clinical Platform NI Overview

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EV1000 Databox EV1000 Monitor EV1000 Pump-Unit Ethernet Cable from Databox to Monitor Ethernet Cable from Pump-Unit to Monitor EV1000 NI Power Cable EV1000 NI Databox Adaptor Cable Mains Power Cable (Detachable Power Cord)

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Figure 1-3 EV1000 NI Databox Adaptor Cable Power Connections

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Please see the EV1000 Clinical Platform Operators Manual for additional details on minimally invasive hemodynamic monitoring.

Operator’s Warnings The following warnings are used in both the EV1000 Clinical Platform NI Operator’s Manual and Service Manual. See the Operator’s Manual for specific chapter locations. WARNING

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. 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.

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



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

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

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.

WARNING No modification of the EV1000 Clinical Platform NI is allowed.

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.

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

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.

WARNING

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General Safety

In the USA the instrument shall be connected only to a single phase 110-120V supply system.

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.

WARNING For Non invasive monitoring, the EV1000 Monitor must be powered by the Pump-Unit using the EV1000 NI Power Cable.

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T

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 Clinical Platform NI complies.

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Chapter 2: Safety and Symbols

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WARNING

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.

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.

WARNING Use of accessories, sensors, and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity.

WARNING

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.

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

The EV1000 Clinical Platform NI meetings the requirements of IEC 60601-1:2005 for the systems 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.

WARNING

WARNING Do not use the Ethernet cable to connect anything to the Pump-Unit other than the Monitor.

Do not Sterilize any components of the EV1000 Noninvasive System. The EV1000 Noninvasive System is provided non sterile.

WARNING

WARNING

All 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.

Refer to cleaning instructions. Do not disinfect the instrument by autoclave or gas sterilization.

WARNING Do not obstruct the EV1000 Clinical Platform NI ventilation openings.

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.

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

WARNING The Pump-Unit must be positioned in an upright position to ensure IP4X ingress protection.

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

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.

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.

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

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

WARNING Do not use damaged components/sensors or components/sensors with exposed electrical contacts to prevent patient or user shocks.

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

WARNING Do not touch system connectors of the EV1000 Clinical Platform NI and the patient at the same time.

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Only use ClearSight Finger Cuffs, Heart 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.

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

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

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

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WARNING

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Safety and Symbols

WARNING

WARNING

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

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.

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.

WARNING Do not use two ClearSight Finger Cuffs simultaneously on the same finger.

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.

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.

WARNING Do not use the EV1000 Clinical Platform NI as a heart rate monitor.

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.

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

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

WARNING EV1000 Databox and EV1000 Monitor power must be supplied through the same Pump-Unit which must be connected by ethernet cable to the EV1000 Monitor when using integrated non-invasive and minimally invasive technologies for patient monitoring.

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.

WARNING DO NOT:

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Allow any liquid to come in contact with the power connector

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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.

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 and Pump-Unit should be observed to verify normal operation in the configuration in which it is used.

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 D-3.

WARNING Do not use a used ClearSight Finger Cuff due to the risk of cross contamination.

WARNING Do not cut the ClearSight Finger Cuff in half when the Finger Cuff is still connected to the Pressure Controller.

Service Warnings The following warnings are present in the EV1000 Clinical Platform NI Service Manual where relevant to the function or procedure being described. WARNING Disconnect the Pump-Unit from the AC source by unplugging Main Power Cable from the AC mains. The On/Standby button on the monitor does not disconnect the system from the AC mains supply.

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WARNING

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Safety and Symbols

WARNING 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.

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WARNING

CAUTION

Disconnect the Pump-Unit from AC power and shutdown the monitor before performing any cleaning.

Improper ClearSight Finger Cuff placement or sizing can lead to inaccurate monitoring.

WARNING

CAUTION

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.

Make sure that the HRS is correctly applied so that it can be leveled to the phlebostatic axis.

Operator’s Cautions The following Cautions are used in both the EV1000 Clinical Platform NI Operator’s Manual and Service Manual. See the Operator’s Manual for specific chapter locations. CAUTION Federal (USA) law restricts this device to sale by or on the order of a physician.

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.

CAUTION Do not expose the EV1000 Clinical Platform NI to extreme temperatures.

CAUTION Do not expose the EV1000 Clinical Platform NI to dirty or dusty environments.

CAUTION

CAUTION Pump-Unit includes a Lithium-Ion battery backup.

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.

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.

CAUTION The effectiveness of EV1000 Noninvasive System has not been evaluated in patients under 18 years of age.

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.

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

CAUTION Excessive ambient light may interfere with ClearSight Finger Cuff measurements.

Do not apply strong shock to or drop the instrument.

CAUTION

CAUTION

The EV1000 Noninvasive System is not intended for use as an apnea monitor.

Clean and store the instrument and accessories after each use.

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

CAUTION

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.

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Cautions

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Safety and Symbols

The EV1000 Monitor should only be connected to a single Pump-Unit and/or single Databox.

CAUTION

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.

Status = Released

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.

CAUTION

CAUTION

Inaccurate noninvasive measurements can be caused by factors such as: • Improperly zeroed and/or leveled HRS • Excessive variations in blood pressure. Some conditions that cause BP variations include, but are not limited to: * Intra-aortic balloon pumps • Any clinical situation where the arterial pressure is deemed inaccurate or not representative of aortic pressure. • Poor blood circulation to the fingers • A bent or flattened ClearSight Finger Cuff • Excessive patient movement of fingers or hands. • Artifacts and poor signal quality • Incorrect placement or position of the ClearSight Finger Cuff • Electrocautery or electrosurgical unit interference

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

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

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.

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.

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, discontinue use the EV1000 Clinical Platform NI and contact your local sales representative.

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.

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.

CAUTION Do not connect the ClearSight Pressure Calibration Adaptor directly to the Pressure Gauge.

CAUTION Do not use a tube with a bigger inner diameter, because that may cause air leakage in the tube connection and result in incorrect pressure readings.

CAUTION Make sure that you select a tube with sufficient wall thickness and hardness, so that the tube will not kink.

CAUTION

Use Windows Embedded Standard 2009 compatible USB devices.

Make sure that the inner tube of the Pressure Calibration Adaptor does not split when inserting the tube fitting, because this may lead to air leakage and result in incorrect pressure readings.

CAUTION

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.

Reduce the number of tube fittings between the Pressure Calibration Adaptor and the Pressure Gauge, because of potential air leakage.

CAUTION

CAUTION

Printed Date: 2017-01-24

CAUTION

CAUTION

Released Date: 2015-10-29

Safety and Symbols

CAUTION The ClearSight Pressure Adaptor is intended to be used for a static Pressure Calibration Test on the EV1000 NI system only.

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

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.

Status = Released

2-5

Safety and Symbols

2-6

Service Cautions

CAUTION Do not immerse any patient sensors or connectors in these cleaning agents.

Notes



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

Printed Date: 2017-01-24

The Monitor is not completely disconnected from power by turning off via the power button.

Status = Released

CAUTION

Released Date: 2015-10-29

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

Safety and Symbols

Monitor Display Symbols

Table 2-1 Monitor Display Symbols (Continued) Symbol

Table 2-1 Monitor Display Symbols

CVP manual entry button on Clinical actions menu

Audible alarm silence button

Monitoring pause exit button

Derived value calculator button on Clinical actions menu

Event review button on Clinical actions menu

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

Cuff Options button on Clinical actions menu

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

Advanced Options button on Clinical actions menu

Released Date: 2015-10-29

Description

Quick scroll buttons Historical Data button on Clinical actions menu Vertical scroll buttons Horizontal scroll buttons

Settings menu button

Enter button

Screen capture button

Keypad enter key

Start Monitoring button

Keypad backspace key

Stop Monitoring button

Keypad cancel key Resume Monitoring button Item enabled Return to main monitoring screen Item not enabled Return to previous menu

Printed Date: 2017-01-24

Symbol

Description

Monitor screen selection button Cancel Clinical actions menu button Connection to all configured HIS actors are good. Zero and waveform icon on Clinical actions menu

No physical HIS connection to the Ethernet

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

Status = Released

2-7