Edwards EV1000 Operator's Manual
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Edwards EV1000 Operator's Manual

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EV1000 Clinical Platform NI
Operator's Manual

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  • Page 1 Edwards Lifesciences EV1000 Clinical Platform NI Operator’s Manual...
  • Page 2 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.
  • Page 3 Using This Manual Chapter Description The Edwards Lifesciences EV1000 Clinical Platform NI Demonstration Mode and Data Download: Operator’s Manual is comprised of 14 chapters, seven Describes how to use the EV1000 Clinical Platform NI for training and demonstration and Appendices and an Index. Figures in this manual are how to download monitored data to a USB drive.

  • Page 4: Table Of Contents

    Applicable Standards ..........2-9 EV1000 NI Essential Performance ....... . . 2-9 Documentation and Training .
  • Page 5 Chapter 7: Methodology and Monitoring EV1000 Noninvasive System Methodology ......7-1 Volume Clamp Method ......... . 7-1 Physiocal Method .
  • Page 6 EV1000 Table Stand ........
  • Page 7 EV1000 Pump-Unit Bracket ........
  • Page 8 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 .
  • Page 9 Figure 13-1 EV1000 Table Stand ........
  • Page 10 Table 2-3 Applicable Standards ........2-9 Table 3-1 EV1000 NI Main Components ......3-1 Table 5-1 Intervention Events .

  • Page 11: Monitored Parameters

    Number of arterial blood pressure pulses per minute Stroke Volume (SV) Volume of blood pumped with each The EV1000 Clinical Platform NI consists of the EV1000 heart beat Monitor in conjunction with the EV1000 Noninvasive Stroke Volume Index (SVI) Stroke volume relative to body...

  • Page 12: Edwards Ev1000 Clinical Platform Ni Operator's Manual

    “Warnings” section of this manual before using the platform. Goal Directed Therapy WARNING Hospital Information Systems Use of the EV1000 Clinical Platform NI is restricted to Hemoglobin one patient at a time. Heart Reference Sensor Mean Arterial Pressure Partial pressure of arterial oxygen...

  • Page 13: Safety Identifying Symbols

    WARNING manual or on product labels, including those used to Use of the EV1000 Clinical Platform NI is restricted to identify warnings, cautions, and notes. A list of all one patient at a time.
  • Page 14 Do not use the Ethernet cable to connect anything to Perform New Patient or clear the patient data profile the Pump-Unit other than the Monitor. whenever a new patient is connected to the EV1000 Clinical Platform NI. Failure to do so may result in (Chapter 3) previous patient data in the historical displays.
  • Page 15 Portable and mobile RF communication equipment can potentially affect all electronic medical equipment, WARNING including the EV1000. Do not use the EV1000 Clinical Platform NI as a heart Guidance on maintaining appropriate separation rate monitor. between communications equipment and the EV1000 is (Chapter 7) provided in Table F-3.

  • Page 16: Cautions

    (Chapter 3) defaults. Any settings changes or customizations will be CAUTION permanently lost. Do not restore defaults while monitoring a patient. Do not expose the EV1000 Clinical Platform NI to dirty (Chapter 6) or dusty environments. (Chapter 3) CAUTION CAUTION The effectiveness of EV1000 Noninvasive System has not been evaluated in patients under 18 years of age.
  • Page 17 Edwards sales representative and is different from (Appendix F) 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.

  • Page 18: Monitor Display Symbols

    Safety and Symbols Monitor Display Symbols Table 2-1 Monitor Display Symbols (Continued) Symbol Description Table 2-1 Monitor Display Symbols Zero and waveform icon on Clinical Actions menu Symbol Description Audible alarm silence button CVP manual entry button on Clinical Actions menu Monitoring pause exit button Derived value calculator button on Clinical Actions menu...

  • Page 19: Symbols On Product Labels

    Symbols on Product Labels Clock/Waveform icon that allows user to view historical data This section provides the symbol descriptions for symbols that are on the EV1000 Pump-Unit, EV1000 monitor, Arterial Waveform Display button on graphical EV1000 accessories, and/or shipping container. trend screen...
  • Page 20 Safety and Symbols Table 2-2 Symbols on Product Labels (Continued) Table 2-2 Symbols on Product Labels (Continued) Symbol Description Symbol Description Indicates “ON” condition for part of the equipment Use by Identifies a control that returns the device to its initial state Lot Number Consult instructions for use.

  • Page 21: Applicable Standards

    EV1000 Clinical Platform NI Instructions for Use • IEC 60601-2-57:2011 Medical electrical equipment - Part 2- Instructions for Use are included with EV1000 Clinical 57: Particular requirements for the Platform NI components. See Table A-4, “EV1000 Clinical basic safety and essential performance Platform NI Components,”...

  • Page 22: Unpacking

    Specifications. delivered separately. We recommend you confirm receipt of all ordered equipment. WARNING No modification of the EV1000 Clinical Platform NI is Examine the contents of the shipping container. Perform a allowed. visual inspection of the Pump-Unit, Pressure Controller, HRS WARNING and all cables.

  • Page 23: Mounting Recommendations

    1 After the Monitor and Pump-Unit are securely mounted, CAUTION attach the main power cable supplied with the system to Do not expose the EV1000 Clinical Platform NI to dirty or dusty environments. the back panel of the Pump-Unit. Use the DC output...

  • Page 24: Figure 3-1 Ev1000 Clinical Platform Ni Cable Connections

     3 Connect the main plug from the Pump-Unit to a hospital grade outlet. The EV1000 Clinical Platform NI is rated for power voltages from 100 to 240VAC. The Pump-Unit is equipped with a battery to allow uninterrupted monitoring during power loss. There are four See Appendix A: Specifications for physical, electrical, indicator lights on the Pump-Unit.

  • Page 25: Connecting The Patient Cables

    3 Press the power button on the Monitor and wait for the Ethernet light to turn green on the Pump- Unit.  The power button can be located on the front or back of the Monitor. See “EV1000 Monitor Types” on page 13-2.

  • Page 26: Select Language

    System Error Screen will replace the Startup screen. See Chapter 12: Help and Troubleshooting or Appendix E: System Care, Service and Support. Otherwise, call your Edwards Lifesciences representative for assistance. Select Language The language selection screen appears after the software has initialized and the self test is complete.

  • Page 27: Clearsight Technology Blood Pressure And Hemodynamic Monitoring

    2 Connect the Pressure Controller to the Pump-Unit. 3 Connect the Pump-Unit to AC mains. 4 Turn on power to the EV1000 Clinical Platform NI by pressing the power button on the EV1000 Monitor. Figure 4-1 EV1000 Noninvasive System Cable...

  • Page 28: Zero And Apply Heart Reference Sensor (Hrs)

    EV1000 Clinical Platform NI Quick Start 10 Line the finger up between the two green lines on the cuff. Figure 4-4 ClearSight Finger Cuff Placement Figure 4-2 Patient Data Entry Screen 11 Wrap the ClearSight Finger Cuff tightly around the finger.

  • Page 29: Alarms And Targets

    EV1000 Clinical Platform NI Quick Start Alarms and Targets 2 Touch Zero & Waveform. 1 To change alarms and targets, touch inside the globe and use the arrows or buttons to adjust the upper and lower alarm limits. 2 Touch the Enter button.

  • Page 30: Navigation Bar

    To return to the most recent monitoring screen displayed, touch the Cancel button. The Navigation Bar is present on most screens. Exceptions are the startup screen and screens indicating the EV1000 has stopped monitoring, for example when Demo Mode ends. Clinical Actions. The Clinical Actions button...

  • Page 31: Monitor Views

    Navigating the EV1000 Clinical Platform NI Start Monitoring. The Start Monitoring button 1 Touch the Monitor Screen Selection allows the user to initiate noninvasive hemody- button.The Monitor Screen Navigation Bar namic monitoring directly from the Navigation contains buttons that are based upon the look bar.

  • Page 32: Change Parameters

    Navigating the EV1000 Clinical Platform NI Change Parameters Graphical Trend Monitoring View 1 Touch outside the globe of a displayed parameter to The graphical trend screen displays the current status and history of monitored parameters and the continuous, real- change it to a different parameter.

  • Page 33: Figure 5-4 Graphical Trend Screen - Arterial Waveform Display

    Navigating the EV1000 Clinical Platform NI  2 Select Detail from right menu tab. Unspecified is set as a If there are 4 Key Parameters being displayed when the default. ART display button is touched, display of the 4th key...

  • Page 34: Tabular Trends

    Navigating the EV1000 Clinical Platform NI 2 Touch the Edit button on the information While in Scroll Mode the user can scroll to data older than the current time scale displays. Scroll Mode also allows display balloon. of the exact value of a point on the graph (indicated by the 3 To change the time of the selected intervention, touch on centered cursor).

  • Page 35: Big Numbers

    Navigating the EV1000 Clinical Platform NI Big Numbers 2 Select a value on the Tabular Increment popup. The big numbers screen displays parameters in a larger size than the other screens. This makes it easier for clinicians and other personnel to see the values from a distance.

  • Page 36: Physio Relationship

    The Goal Positioning Screen allows the user to monitor and track the relationship of two key parameters by plotting them Units against each other on an XY plane. See Chapter 14, "EV1000 Clinical Platform NI Advanced Features" , for more infor- Parameter Name mation.

  • Page 37: Monitor Screen Navigation

    Navigating the EV1000 Clinical Platform NI SVV Filtering Exceeded Indicator. The SVV Filtering Exceeded Indicator symbol appears if a high degree of pulse rate variability is detected that could affect the SVV value. Fault. When a fault condition occurs, the fault message(s) will be displayed on the Status Bar until the fault condition is cleared.

  • Page 38: Information Bar

    Navigating the EV1000 Clinical Platform NI Information Bar On some screens, for example Patient Data, there is no cancel button. As soon as you enter the patient’s data, it is stored by The information bar appears on all active monitoring screens the system.

  • Page 39: Status Bar

    The system power status information, including battery information, is only displayed on EV1000 Monitor when following screen shot. the Pump-Unit is connected to the EV1000 Monitor with the supplied Ethernet cable. Figure 5-18 Screen Locked 4 To unlock the screen, touch and hold the lock icon.

  • Page 40: Chapter 6: Monitor Display Options

    Perform New Patient or clear the patient data profile demographics and patient ID will be displayed when the whenever a new patient is connected to the EV1000 Clinical Platform NI. Failure to do so may result in system is turned on. When monitoring of the last patient is previous patient data in the historical displays.

  • Page 41: View Patient Data

    Monitor Display Options  View Patient Data If power is lost and restored to the EV1000, the system 1 Touch the Settings button. settings prior to the power loss, including alarm settings, 2 Touch Patient Data to see patient data. The alarm volume, target settings, monitoring screen, screen will also include a New Patient button.

  • Page 42: Monitoring Screens Settings

    Monitor Display Options 3 Touch Date / Time. 4 To change the date, touch the value section of the Date Adjust button and enter the date on the keypad. 5 To change the time, touch the value section of the Time Adjust button and enter the time.

  • Page 43: Serial Port Setup

    Serial Port Setup Restore Monitor Defaults Use Serial Port Setup Menu to configure the serial port for When the defaults are restored, the EV1000 platform stops all digital data transfer. functions and restores the system to a factory default state.

  • Page 44: Alarms / Targets

    Alarms can be silenced directly from the monitoring screen. have target ranges set. The audible alarm is silenced for two minutes. EV1000 monitors that are configured to a non-English (US) language, except Japanese, will sound an audible tone for 3 Table 6-1 Target Status Indicator Colors seconds every 3 minutes when alarm is disabled for any of the key parameters.

  • Page 45: Figure 6-8 Alarms / Targets Configuration

    Custom Defaults.” appears. 8 Touch Continue on the confirmation popup to confirm the restore. 9 To restore all settings to the Edwards defaults, touch Restore All to Edwards Defaults. The message, “This action will restore ALL Alarms and Targets to the Edwards’...

  • Page 46: Figure 6-9 Set Custom Default Alarms / Targets

    Monitor Display Options Set Custom Defaults Configure Targets and Alarms for One Parameter When custom defaults are set up, they can be enabled or disabled at any time through the Configure All or individual The Alarm Target Popup lets the user set up alarm and target Alarms/Targets Settings screen.

  • Page 47: Time Intervals / Averaging

    Monitor Display Options Time Intervals / Averaging Adjust Scales The Time Intervals / Averaging Screen lets the user select the The graphical trend data fills the graph from left to right with continuous % change time interval. the most recent data at the right. The parameter scale is on the vertical axis with the time scale on the horizontal.

  • Page 48: Engineering

    Monitor Display Options Engineering 4 For each parameter, touch the Lower button to enter the minimum value to appear the vertical axis. Touch the The engineering function can only be operated by a system Upper button to enter the maximum value. engineer and is password protected.

  • Page 49: Chapter 7: Methodology And Monitoring

    Chapter 7: Methodology and Monitoring Waveform Reconstruction and Hemodynamic he EV1000 Clinical Platform NI continuously measures the patient’s arterial pressure waveform and Analysis (ClearSight Algorithm) calculates Cardiac Output along with other key The arterial blood pressure waveform is known to gradually hemodynamic parameters.

  • Page 50: Single Cuff Monitoring

    WARNING different sized ClearSight Finger Cuffs. Failure to select the Do not touch the system connectors of the EV1000 Clinical Platform NI and the patient at the same time. correct finger cuff can result in measurement inaccuracy.

  • Page 51: Figure 7-2 Ev1000 Noninvasive System Connections

    Ed that in normal use neces- should not be placed in a location where the patient may come into contact with the component. sarily comes into physical contact with the patient for the EV1000 Clinical Platform NI to perform its function.

  • Page 52: Apply The Pressure Controller

    The Pressure Controller is worn on the patient’s wrist and connects to the Pump-Unit, HRS and ClearSight Finger Cuff(s). See Figure 7-2, “EV1000 Noninvasive System Connections,” on page 7-3. 1 Wrap the Pressure Controller band around the patient’s wrist.

  • Page 53: Enter Patient Data

    Upon starting a measurement, the Finger Cuff will expire after 72 hours for a single patient. Double Cuff Application. The EV1000 NI allows two ClearSight Finger Cuffs to be connected simultaneously to alternate the measurement between two fingers. This feature...

  • Page 54: Figure 7-6 Zero & Waveform Screen

    Methodology and Monitoring  3 Touch Zero & Waveform. If the patient is rotated or moved, the phlebostatic axis will rotate or move with the patient. If necessary, be sure to reapply the heart end of the HRS to ensure that it is still at the same vertical level as the heart in the patient’s new position.

  • Page 55: Set Targets And Alarm Limits

    MR image, and the MRI unit may affect the accuracy of the measurements. CAUTION The EV1000 Noninvasive System is not intended for use as an apnea monitor. CAUTION In patients with extreme contraction of the smooth...

  • Page 56: Central Venous Pressure Manual Entry

    Pump-Unit to the patient monitor cable. alarms are silenced. WARNING 2 Touch the Zero patient monitor button and Do not use the EV1000 Clinical Platform NI as a heart then zero the patient monitor. rate monitor. 3 Touch the Signal button of the Pressure...

  • Page 57: Cuff Pressure Release Mode

    Cuff Pressure Release Mode The CO averaging time indicates how much monitored data is averaged to generate a calibration value. During single cuff monitoring, the EV1000 Noninvasive System will automatically release pressure from the finger cuff at regular intervals. Figure 7-10 Finger Cuff Pressure Release Icon and Timer When ≤...

  • Page 58: Physiocal Control

    7-10 Methodology and Monitoring Physiocal Control 4 To disable Physiocal, toggle the Physiocal button from enabled to disabled. Physiocal will automatically be Physiocal can be observed on the ART display as a stepwise enabled after 1 minute. increase in pressure upon startup and as brief interruptions 5 Toggle the Physiocal button to enabled to turn Physiocal throughout monitoring.To accurately account for changes in back on.

  • Page 59: Physiology Screen

    Chapter 8: Physiology and Physio Relationship Monitoring Screens he Physiology Screen and the Physio Relationship 3 Systemic Vascular Resistance, indicated in the center of monitoring screens provide a graphic display of the vascular system animation, is available with manual monitored parameters and their relationship to each input of CVP with continuous calculation as SVR = other.

  • Page 60: Svv Slope Indicator

    Physiology and Physio Relationship Monitoring Screens SVV Slope Indicator 1 The vertical lines above the parameters appear in the same color as the parameter lantern. The SVV Slope Indicator is a visual representation of the Frank-Starling curve used when assessing the Stroke Volume 2 The vertical lines below the parameter appear in the same Variation value.

  • Page 61: Parameter Boxes

    Physiology and Physio Relationship Monitoring Screens The Historic Physio Relationship screen allows the user to Touching HGB, SpO or ScvO brings up a small popup allowing the user to change the target settings or enter a value. enter parameters used to calculate derived parameters DO and VO e, on only the most recent record.

  • Page 62: Gdt Tracking

    Chapter 9: Enhanced Parameter Tracking he EV1000 Clinical Platform provides tools for performing Goal Directed Therapy (GDT), enabling a user to track and manage key parameters in the optimal range. With enhanced parameter tracking, clinicians have the ability to create and monitor customized protocols.

  • Page 63: Active Gdt Tracking

    Enhanced Parameter Tracking Active GDT Tracking Historical GDT During active GDT tracking, the plot area of the parameter Press the Historical Data button to display recent trend graph within targeted range appears shaded in blue. See GDT tracking sessions. A blue “Viewing Historical Figure 9-3, “GDT Active Tracking,”...

  • Page 64: Zero & Waveform

    4 Touch the Home button to return to the patients. These include tools to compute derived monitoring screen. parameters, perform event reviews and review patient data history from other EV1000 technologies. Access all of these screens by touching the Clinical Actions button. Zero & Waveform Zero Heart Reference Sensor (HRS) The Zero &...

  • Page 65: Cuff Options

    10-2 Clinical Actions and Analysis 3 To scroll up or down, touch the arrow keys. Table 10-1 Reviewed Events 4 Touch the Home button to return to the Event Log Time monitoring screen. Intervention Analysis (IA) When user edits a previously Updated entered intervention time, date, or The following events are included in the Event...

  • Page 66: Historical Data

    3 Touch Historical Data button. 4 Historic graphical trend data will display from before the This screen displays historical trend data for the technology switch. same patient from previous EV1000 technology  measurements when available. Actively monitored values will not be displayed when 1 Touch the Clinical Actions button.

  • Page 67: Figure 11-1 Settings Screen

    The Pump-Unit and Databox Ethernet cables must be discon- nected from the EV1000 Monitor in order to enter demon- stration mode. The system will not run Demo Mode when there is communication with the Pump-Unit and/or Databox.

  • Page 68: Data Download

    Figure 11-4 Data Download All monitored patient data may be cleared by the user if patient monitoring is stopped. Touch the Clear All button and 2 Make sure an approved Edwards USB device has been confirm to clear. inserted. 3 Touch Data Download.

  • Page 69: On Screen Help

    Chapter 12: Help and Troubleshooting se the information in this chapter to determine the cause and solution for error messages. This chapter also describes the Graphical Steps Help Screens which provide on screen instructions for device setup and monitoring. On Screen Help The main help screen allows the user navigate to specific help for ClearSight technology issues.

  • Page 70: Graphical Steps Help Screen

    12-2 Help and Troubleshooting Figure 12-5 Graphical Steps Help Screen Figure 12-4 Help Screen Touch the number that corresponds with the specific To capture a screen image, touch the Snapshot component of the system for which help is needed to view button.

  • Page 71: Pump-Unit Communication And Power

    The internal battery will charge automatically when the Pump-Unit is plugged into mains.      Figure 12-7 EV1000 Pump-Unit and Monitor LED Indicators   Pump-Unit alert AC power status   Ethernet communication status Monitor status ...

  • Page 72: Pressure Controller Communication

    None. The connected ClearSight Finger Cuff is actively monitoring. Defective ClearSight Finger Cuff Amber Flashing ON/OFF Verify that an Edwards Finger Cuff has been used. connected Disconnect and reconnect the ClearSight Finger Cuff. Expired ClearSight Finger Cuff Replace the finger cuff with a genuine Edwards Cuff.

  • Page 73: System Errors

    Pump-Unit. powered by the same Pump-Unit. Databox connected to the EV1000 Monitor Ensure Databox connected to the EV1000 monitor that is that is powered by a Pump-Unit, is not powered by a Pump-Unit, is powered by the same Pump- powered by the same Pump-Unit.

  • Page 74: Numeric Keypad Errors

    12-6 Help and Troubleshooting Numeric Keypad Errors Table 12-4 Numeric Keypad Errors Message Possible Causes Suggested Actions Value out of range (xx-yy) The entered value is either higher or lower Displayed when the user enters a value that is out of than the allowed range.

  • Page 75: Clearsight Faults And Alerts

    Possible Causes Suggested Actions Fault: Invalid Finger Cuff #1 Non Edwards Finger Cuff #1 detected. Verify that an Edwards Finger Cuff has been used. Connected Defective Finger Cuff #1 connected. Disconnect and reconnect Edwards Finger Cuff #1. Replace Finger Cuff #1 with a genuine Edwards Cuff.
  • Page 76 Restart Measurement. If problem persists, contact Edwards Technical Support. Fault: Invalid HRS Connected Non Edwards HRS detected. Verify that an Edwards HRS has been used. HRS is defective. Disconnect and reconnect Edwards HRS. Replace HRS with a genuine Edwards HRS.
  • Page 77 12-9 Help and Troubleshooting Table 12-5 ClearSight Faults and Alerts (Continued) Message Possible Causes Suggested Actions Alert: Finger Cuff #1 - Light signal too high. Allow System to automatically resolve issue. Plethysmogram Light Out of Warm the hand. Range Apply Finger Cuff to a different finger. Resize Finger Cuff and replace Finger Cuff with different size.
  • Page 78 12-10 Help and Troubleshooting Table 12-5 ClearSight Faults and Alerts (Continued) Message Possible Causes Suggested Actions Alert: Finger Cuff #2 - No The system failed to detect pressure Allow System to automatically resolve issue. Pressure Waveforms Detected waveforms. Check if the blood flow in the arm of the patient is free of Pressure pulsations in finger diminished obstructions.
  • Page 79 Check the arterial waveform for severe hypotension, period of time. severe hypertension, and motion artifact. Systolic pressure too high or diastolic Make sure the heart end of Edwards HRS is aligned with pressure too low. the patient’s phlebostatic axis. Confirm electrical connections of cables.

  • Page 80: Clearsight Warnings And Troubleshooting

    The HRS pressure offset exceeded limit Vertically align the two ends of HRS and re-zero. during the zeroing process. Replace HRS. Defective HRS. If the problem persists, contact Edwards Technical Support HRS Zero Unsuccessful Prior to zero, no HRS movement detected. Disconnect and reconnect HRS.

  • Page 81: Cvp Troubleshooting

    Remove and reapply other BP measurement sensor. Service Battery Battery full charge capacity has dropped To ensure uninterrupted measurement, make certain below recommended level. EV1000 NI is connected to electrical outlet. Battery malfunction. Condition the battery (ensure a measurement is not active): •...

  • Page 82: Stands

    EV1000 Clinical Platform NI offers various acces- sories. This chapter identifies and describes the use of The EV1000 Roll Stand is intended for use with the EV1000 some of the accessories available. Refer to Appendix monitor and EV1000 Pump-Unit. Follow included directions A, Table A-4 for associated model numbers on all for EV1000 Roll Stand assembly and warnings.

  • Page 83: Ev1000 Monitor Bracket

    EV1000 Clinical Platform NI Accessories EV1000 Monitor Bracket EV1000 Monitor Types The EV1000 monitor bracket is intended for use with the EV1000 Monitor appearance and location of EV1000 EV1000 monitor. To install the monitor bracket to the rear Monitor cable connections shown throughout this operator’s panel of the monitor, align the 4-hole mounting pattern in the manual are for example only.

  • Page 84: Ev1000 Pump-Unit Bracket

    EV1000 Clinical Platform NI Accessories EV1000 Pump-Unit Bracket WARNING The EV1000 Pump-Unit bracket is intended for use with the Make sure the EV1000 Clinical Platform NI is securely EV1000 Pump-Unit. The EV1000 Pump-Unit is supplied mounted, and that all cords and accessory cables are with the Pump-Unit Bracket attached.

  • Page 85: His Connectivity

    HIS Connectivity demographics data when starting a new patient or to associate the patient physiological data being monitored on the EV1000 system with a patient record retrieved from HIS. The EV1000 system has the ability to interface with the Hospital Information...

  • Page 86: Goal Positioning Screen

    EV1000 Clinical Platform NI Advanced Features Parameter Selection applications. Continuously monitored and calculated param- eters with the EV1000 Clinical Platform NI can be sent to the The user can select the parameters for the X enterprise application: and Y axis.

  • Page 87: Technology Selection

    Cables to connect the Pump-Unit with the Monitor and the Databox with the Monitor. If the EV1000 Databox fails turn on, when the EV1000 NI is powered on, check the Databox Adapter cable connections. If the problem persists, call Edwards Technical Support.
  • Page 88  To continue, touch the Enter button. The Zero & Waveform screen of the selected technology will Please refer to the EV1000 Clinical Platform Operator’s then appear. Manual for instructions on minimally-invasive monitoring using the EV1000 Databox including cleaning, connection...

  • Page 89: Figure A-1 Spectral Irradiance

    (0.02 lbs) Base Parameter Specifications LED Spectral Irradiance See Figure A-1 • Max Optical Output 0.013 mWatts Accessories for use with the EV1000 Clinical Platform NI • over treatment area Technical Specifications • Max variation of output over treatment area...

  • Page 90: Accessories

    Edwards. Using other Manual unlabeled accessories, cables and or components may * Please contact your Edwards representative for model and affect patient safety and measurement accuracy. ordering information. **Please contact your Edwards representative for the most current version.

  • Page 91: Table A-5 Ev1000 Monitor Technical Specifications

    Table A-5 EV1000 Monitor Technical Specifications Input/Output Touch Screen Resistive type RS232 Serial Port Edwards proprietary protocol; Maximum data rate = 57.6 kilo baud USB Port Three USB V1.1 compatible type A connectors on the monitor. RJ-45 Ethernet Port VGA Port...

  • Page 92: Table B-1 Cardiac Profile Equations

    Patient parameters are calculated to more decimal EV1000 monitor. places than are displayed on the screen. For example, a screen CO value of 2.4 may actually be a CO of 2.4492.
  • Page 93 Equations for Calculated Patient Parameters Table B-1 Cardiac Profile Equations (Continued) Parameter Description and Formula Units Cardiac Index CI = CO/BSA L/min/m where: CI - Cardiac Index, CO - Cardiac Output, L/min BSA - Body Surface Area, m Cardiac Power Index CPI = MAP x CI x 0.0022 Cardiac Power Output CPO = CO x MAP x K...
  • Page 94 Equations for Calculated Patient Parameters Table B-1 Cardiac Profile Equations (Continued) Parameter Description and Formula Units SVRI Systemic Vascular Resistance Index SVRI = {(MAP - CVP) x 80} /CI dyne-s-m where: MAP - Mean Arterial Pressure, mmHg CVP - Central Venous Pressure, mmHg CI - Cardiac Index, L/min/m Stroke Volume Variation SVV = 100 x (SVmax - SVmin) / mean(SV)

  • Page 95: Patient Data Input Range

    Appendix C: Monitor Settings and Defaults Patient Data Input Range Table C-1 Patient Information Parameter Minimum Maximum Available Units Gender M (Male) / F (Female) years Height 12 in / 30 cm 98 in / 250 cm inches (in) or cm Weight 2 lbs / 1.0 kg 880 lbs / 400.0 kg...

  • Page 96: Parameter Display And Configurable Alarm/Target Ranges

    Monitor Settings and Defaults Parameter Display and Configurable Alarm/Target Ranges Table C-3 Ranges for Key Parameters Parameter Units Range L/min 1.0 to 20.0 0.0 to 20.0 L/min/m mL/b 0 to 300 0 to 200 mL/b/m 0 to 5000 dyne-s/cm SVRI 0 to 9950 dyne-s-m 0 to 99...

  • Page 97: Language Default Settings

    Monitor Settings and Defaults Language Default Settings* Table C-5 Language Default Settings Default Display Units Time Language Height Weight Format Date Format English (US) mmHg g/dL 12 hour MM/DD/YYYY English (UK) mmol/L 24 hour DD.MM.YYYY Français mmol/L 24 hour DD.MM.YYYY Deutsch mmol/L 24 hour...

  • Page 98: Lbs Vs. Kg

    Appendix D: EV1000 Unit Conversions lbs vs. kg   ÷ Conversion factors:   inches vs. cm   Conversion factors: inches inches x 2.54   ÷ inches 2.54 mmHg vs. kPa   m  Newton 1kPa 1kPa ...

  • Page 99: Cleaning The Ev1000 Clinical Platform Ni

    Sensor can be cleaned using the specified disinfectants previ- Cleaning the EV1000 Clinical ously mentioned. Sterile alcohol preps containing 70% alcohol solution can also be used to clean the EV1000 Platform NI Clinical Platform NI and other accessory cables. ...

  • Page 100: Cleaning The Patient Cables And Connectors

    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 If any electrolytic solution, for example NaCl or lactated Ringer’s solution, is introduced into the cable...

  • Page 101: Edwards Lifesciences Regional Headquarters

    São Paulo - SP - Brasil mountings to ensure that they are secure. CEP 04719-002 It is recommended to send the EV1000 Clinical Platform NI 55.11.5567-5337 to a qualified Edwards Service Center for routine service and Edwards (Shanghai) Medical Products Co., Lt preventive maintenance checks every two years.

  • Page 102: Warranty

    System Care, Service and Support Warranty Sight Finger Cuffs, or any cables used with the EV1000 NI system. Edwards’ sole obligation and purchaser's exclusive remedy for breach of any warranty shall be limited to repair Edwards Lifesciences (Edwards) warrants that the EV1000 or replacement of the EV1000 system at Edwards’...

  • Page 103: Electromagnetic Compatibility

    Reference: IEC/EN 60601-1-2:2007 according to the EMC information provided in the following information and tables. he EV1000 Clinical Platform NI is intended for use in the electromagnetic environment specified below. The customer or the user of the EV1000 Clinical Platform WARNING NI should assure that it is used in such an environment.

  • Page 104: Table F-2 Electromagnetic Emissions

    EV1000 Clinical Platform NI The EV1000 Clinical Platform NI is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. To help prevent electromagnetic interference, maintain a minimum distance between portable and mobile RF communications equipment (transmitters) and the EV1000 Clinical Platform NI as recommended below, according to the maximum output power of the communications equipment.

  • Page 105: Table F-4 Electromagnetic Immunity (Esd, Eft, Surge, Dips And Magnetic Field)

    Compliance Level Electromagnetic Environment -Guidance The EV1000 Clinical Platform NI is intended for use in the electromagnetic environment specified below. The customer or user of the EV1000 Clinical Platform NI should assure that it is used in such an environment.

  • Page 106: Table F-5 Electromagnetic Immunity (Rf Radiated And Conducted

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EV1000 Clinical Platform NI is used exceeds the applicable RF compliance level above, the EV1000 Clinical Platform NI should be observed to verify normal operation.
  • Page 107 A central input of multiple physiologic minimally invasive Oxygen Delivery Index (DO signal sources which communicates with the EV1000 Monitor. The Databox can only be operated separately from Amount of oxygen in milliliters per minute (mL/min/m the Pump-Unit.
  • Page 108 The central input and output for pressure signals from Systolic Pressure (SYS) noninvasive hemodynamic measurement which Systolic pressure measured from the reconstructed brachial communicates with the EV1000 Monitor. arterial waveform. Pulse Rate (PR) Number of arterial blood pressure pulses per minute.
  • Page 109 Index Symbols BSA Change ClearSight Monitoring Resumed 10-2 10-2 Button ClearSight Monitoring Started °F vs. °C 10-2 glossary ClearSight Monitoring Stopped 10-2 list ClearSight Technology Numerics Buttons available parameters 61000-4-3 overview ClearSight Technology noninvasive calculations Cable Clinical actions button cleaning E-1, E-2 def.
  • Page 110 Index Troubleshooting EV1000 Clinical Platform NI Height, monitor 12-14 CVP Cleared Overview Height, patient data 10-2 CVP Entered EV1000 Clinical Platform NI Help, on screen 10-2 12-1 Parameters Hemodynamic parameters EV1000 Power Supply Hemoglobin EV1000 Pump Unit Bracket glossary 13-3...
  • Page 111 Index Intervention Analysis (IA) Monitor Bracket Updated Monitor screen navigation def. 10-2 ISO 13485 Monitor settings 2003/AC General glossary 2009 Monitoring Physical specifications 12-1 Monitoring Pause Physio Relationship 10-2 8-2, 8-3 ISO 14971 Monitoring Pause Exit continuous mode 2007 Monitoring Resumed Physio Relationship monitoring 10-2 ISO 15223-1...
  • Page 112 Index power and communication lights Start Monitoring Button Startup Tabular Increment weight Status bar 5-10 Tabular trend monitoring screen width Status indicators Tabular Trend scroll rates Stop Monitoring Button 5-2, 7-9 Target Stroke Volume change Quick start def. Target status indicators glossary Targets Stroke Volume Index...
  • Page 113 Index VO2I Voltage fluctuation/ Flicker Zero & Waveform 10-1 equation emissions ART display VO2Ie Volume Clamp Method output to PM 1-1, 7-1 equation Voltage Monitor Warnings 2-1, 12-1 Pump-Unit Warranty Waveform confirmation 10-1 Weight, ClearSight Finger Cuff Weight, Heart Reference Sensor Weight, Monitor Weight, patient data Weight, Pressure Controller...
  • Page 114 Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

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