Edwards HemoSphere Operator's Manual
  1. Manuals
  2. Brands
  3. Edwards Manuals
  4. Monitor
  5. HemoSphere
  6. Operator's manual

Edwards HemoSphere Operator's Manual

Advanced monitor
Hide thumbs Also See for HemoSphere:
Table of Contents

Advertisement

Quick Links

Download this manual
HemoSphere
HemoSphere
Advanced Monitor
Advanced Monitor
Operator's
manual
Edwards Lifesciences

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the HemoSphere and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Edwards HemoSphere

Summary of Contents for Edwards HemoSphere

  • Page 1 HemoSphere HemoSphere Advanced Monitor Advanced Monitor Operator’s manual Edwards Lifesciences...
  • Page 2 Outside the U.S. and Canada (24 hours)..949.250.2222 Europe ....... . +8001.8001.801 or techserv_europe@edwards.com In the UK.
  • Page 3 Introduction: Provides an overview of the HemoSphere advanced monitor Safety and Symbols: Includes WARNINGS, CAUTIONS, and NOTES that are found in the manual, as well as illustrations of labels found on the HemoSphere advanced monitor and accessories Installation and Setup: Provides information about setting up the HemoSphere...
  • Page 4 Appendix Description Specifications Accessories Equations for Calculated Patient Parameters Monitor Settings and Defaults Thermodilution Computation Constants Monitor Care, Service and Support Guidance and Manufacturer's Declaration Glossary Index...

  • Page 5: Table Of Contents

    1.5.2 HemoSphere Oximetry Cable ........19...
  • Page 6 4.1.3 Continuous End Diastolic Volume Monitoring ..... 45 4.2 HemoSphere Oximetry Cable Monitoring ......
  • Page 7 9 HemoSphere Swan-Ganz Module Monitoring 9.1 Connecting the HemoSphere Swan-Ganz Module ..... . 9.1.1 Patient CCO Cable Test........97...
  • Page 8 10.6 HGB Update ..........10.7 HemoSphere Oximetry Cable Reset ....... .
  • Page 9 ..... A.5 HemoSphere Oximetry Cable Specifications ......
  • Page 10 G.2 Instructions for Use ..........G.3 Wireless Technology Information .
  • Page 11 Figure 3-1 HemoSphere advanced monitor front view ....... . 35...
  • Page 12 Figure 10-1 Oximetry connection overview ........112 Figure 11-1 HemoSphere advanced monitor LED indicators ......119...
  • Page 13 Table 11-3 System faults/alerts ..........120 Table 11-4 HemoSphere advanced monitor warnings ....... . 122 Table 11-5 Numeric keypad errors .
  • Page 14 Equipment and the HemoSphere advanced monitor ....... . . 160...

  • Page 15: Introduction

    Intended Use Statement ..............16 HemoSphere Advanced Monitor Hemodynamic Technology Connections ......18 Manual style conventions .

  • Page 16: Hemosphere Advanced Monitor With Hemosphere Oximetry Cable

    A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Swan-Ganz module are listed below in table 1-1. Only iCO, iCI, iSVR, and iSVRI are available to the pediatric patient population.

  • Page 17: Table 1-2 Hemosphere Oximetry Cable Available Parameters List

    A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere advanced monitor and a connected HemoSphere oximetry cable are listed below in table 1-2. Table 1-2 HemoSphere oximetry cable available parameters list...

  • Page 18: Hemosphere Advanced Monitor Hemodynamic Technology Connections

    (EDV) monitoring is available with slaved in heart rate (HR data from a bedside patient monitor. The HemoSphere Swan-Ganz module fits into a standard module slot. For more information, see chapter 9, HemoSphere Swan-Ganz Module Monitoring. Table 1-4 lists the parameters available while using the HemoSphere Swan-Ganz module.

  • Page 19: Hemosphere Oximetry Cable

    HemoSphere Advanced Monitor 1 Introduction Table 1-4 HemoSphere Swan-Ganz module parameters description (continued) Parameter Description Technology intermittent cardiac output intermittent assessment through the bolus Swan-Ganz thermodilution catheters (iCO) thermodilution method of the volume of blood pumped by the heart measured in...

  • Page 20: Documentation And Training

    Instructions for Use are included with HemoSphere Advanced Monitor components. See table B-1, “HemoSphere advanced monitor components,” on page 137. For more information on how you can receive training or available documentation for the HemoSphere advanced monitor, contact your local Edwards representative or Edwards Technical Support.

  • Page 21: Abbreviations Found In This Manual

    (used when describing certain Swan- SVRI systemic vascular resistance index Ganz catheters and patient CCO cable) Touch Interact with the HemoSphere advanced central venous pressure monitor by touching the screen. oxygen delivery thermodilution oxygen delivery index Universal Serial Bus...

  • Page 22: Safety And Symbols

    HemoSphere Advanced Monitor Essential Performance........

  • Page 23: Warnings

    2 Safety and Symbols 2.2 Warnings The following are warnings that are used in the HemoSphere advanced monitor operator’s manual. They are introduced in the manual where relevant to the function or procedure being described. Read this operator's manual carefully before attempting to use the Edwards Lifesciences •...
  • Page 24 • detachable power cords other than the power cord provided. (chapter 3) To avoid the risk of electric shock, the HemoSphere advanced monitor can only be connected to a • supply mains with grounding (protective earth). Do not use three prong to two prong power adaptors.
  • Page 25 Make sure that Demo Mode is not activated in a clinical setting to ensure that simulated data is not • mistaken for clinical data. (chapter 7) Do not use the HemoSphere advanced monitor as part of a Distributed Alarm System. The • HemoSphere advanced monitor does not support remote alarm monitoring/management systems.

  • Page 26: Cautions

    G-4. (appendix G) 2.3 Cautions The following are cautions that are used in the HemoSphere advanced monitor operator’s manual. They are introduced in the manual where relevant to the function or procedure being described. Federal (USA) law restricts this device to sale by or on the order of a physician.
  • Page 27 • electrocautery equipment and cables from the HemoSphere advanced monitor and plug the power cords into separate AC circuits if possible. If signal quality problems persist, call your local Edwards representative for assistance. (chapter 10) Do not disconnect the oximetry cable while calibration or data recall are in process. (chapter 10)
  • Page 28 If the oximetry cable is being transferred from a HemoSphere advanced monitor to another • HemoSphere advanced monitor, check that the patient height, weight, and BSA are correct prior to beginning monitoring. Re-enter patient data, if necessary. (chapter 10) Clean and store the instrument and accessories after each use. (appendix F) •...

  • Page 29: User Interface Symbols

    2 Safety and Symbols 2.4 User Interface Symbols The following are icons that appear on the HemoSphere advanced monitor screen. For more information about screen appearance and navigation, see chapter 5, Navigating the HemoSphere Advanced Monitor. Certain icons will only appear while monitoring with a specific hemodynamic technology module or cable, as specified.

  • Page 30: Symbols On Product Labels

    2.5 Symbols on Product Labels This section provides the symbols that are on the HemoSphere advanced monitor and other available HemoSphere advanced monitoring platform accessories. Table 2-2 Symbols on product labels...
  • Page 31 HemoSphere Advanced Monitor 2 Safety and Symbols Table 2-2 Symbols on product labels (continued) Table 2-2 Symbols on product labels (continued) Symbol Description Symbol Description Consult instructions for use on USB 3.0 eifu.edwards.com Instructions for use in electronic form is Ethernet connection available by phone or website address.

  • Page 32: Applicable Standards

    Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications 2.7 HemoSphere Advanced Monitor Essential Performance The platform shall provide display of continuous CO and intermittent CO with a compatible Swan-Ganz catheter according to the specifications provided in appendix A. The platform shall provide display of SvO ScvO with a compatible oximetry catheter according to the specifications provided in appendix A.

  • Page 33: Installation And Setup

    HemoSphere Advanced Monitor Connection Ports........

  • Page 34: Required Accessories For Platform Modules And Cables

    Do not twist or bend the connectors. Confirm that all sensors and cables are connected correctly and completely before use. To avoid corruption of data on the HemoSphere advanced monitor, always disconnect the patient CCO cable and oximetry cable from the monitor before using a defibrillator.

  • Page 35: Hemosphere Advanced Monitor Connection Ports

    HemoSphere Advanced Monitor 3 Installation and Setup 3.2 HemoSphere Advanced Monitor Connection Ports The following monitor views illustrate the connection ports and other key features of the front, rear, and side panels of the HemoSphere advanced monitor. 3.2.1 Monitor Front ...

  • Page 36: Monitor Rear

      connector (RS-232)  Analog input 1    Analog input 2  ECG input    pressure output  equipotential terminal stud   Figure 3-2 HemoSphere advanced monitor rear view (shown with HemoSphere Swan-Ganz module)

  • Page 37: Monitor Right Panel

    Figure 3-3 HemoSphere advanced monitor right panel 3.2.4 Monitor Left Panel  L-Tech expansion module slot  expansion module slots (2)   cable ports (2)     Figure 3-4 HemoSphere advanced monitor left panel (shown with no modules)

  • Page 38: Hemosphere Advanced Monitor Installation

    3.3.1 Mounting Options and Recommendations The HemoSphere advanced monitor should be placed on a stable flat surface or securely mounted on a compatible stand, according to your institution’s practices. A roll stand for the HemoSphere advanced monitor is available as an optional accessory. See Additional Accessories Description on page 138 more information.

  • Page 39: Battery Installation

    For information on battery maintenance and conditioning, see Battery Maintenance on page 155. The HemoSphere battery pack is intended as a backup power source during power-loss and can only support monitoring for a limited time period.

  • Page 40: Equipotential Connection

    Do not use extension cords or multiple socket devices to connect the power cord. Do not use detachable power cords other than the power cord provided. To avoid the risk of electric shock, the HemoSphere advanced monitor can only be connected to a supply mains with grounding (protective earth). Do not use three prong to two prong power adaptors.

  • Page 41: Connecting And Disconnecting A Hemodynamic Monitoring Cable

    To turn on and off the monitor, press the power button located on the front panel. After turning on the monitor, the Edwards screen is displayed followed by the Power-On Self Test (POST) screen. The POST verifies the monitor meets basic operating requirements by exercising critical hardware components and is performed each time the system is turned on.

  • Page 42: Select Language

    3.4.2 Select Language Upon initial HemoSphere advanced monitor startup, language options are offered which affect the displayed language, time and date formats, and units of measurement. The language selection screen appears after the software has initialized and POST is complete. Selecting the language also sets the display units and the time and date format to the default settings for that language (see appendix D: Monitor Settings and Defaults).

  • Page 43: Hemosphere Advanced Monitor Quick Start

    Contents HemoSphere Swan-Ganz Module Cardiac Output Monitoring........43 HemoSphere Oximetry Cable Monitoring .

  • Page 44: Continuous Cardiac Output Monitoring

    Ensure that the HemoSphere advanced monitor is off and then insert the HemoSphere Swan- Ganz module into the monitor. The module will click when properly engaged. Press the power button to turn on the HemoSphere advanced monitor. All functions are accessed through the touch screen.

  • Page 45: Continuous End Diastolic Volume Monitoring

    (figure 4-1) to the patient CCO cable. Verify that the catheter is properly inserted into the patient. Connect one end of the ECG interface cable to the rear panel of the HemoSphere advanced monitor and the other end to the bedside monitor’s ECG signal output.

  • Page 46: Hemosphere Oximetry Cable Monitoring

    Connect the HemoSphere oximetry cable to the left side of the HemoSphere advanced monitor. See figure 4-2. Press the power button to turn on the HemoSphere advanced monitor. All functions are accessed through the touch screen. Select Continue Same Patient button or New Patient button and enter new patient data.

  • Page 47: In Vivo Calibration

    HemoSphere Advanced Monitor 4 HemoSphere Advanced Monitor Quick Start Enter either the patient’s hemoglobin (HGB) or hematocrit (Hct) value. A default value may be used until the patient’s HGB or Hct is available. Touch Calibrate button. When the calibration successfully completes, the following message appears: In vitro Calibration OK, insert catheter Insert the catheter as described in the catheter directions for use.

  • Page 48: Navigating The Hemosphere Advanced Monitor

    HemoSphere Advanced Monitor Screen Appearance ........

  • Page 49: Figure 5-1 Hemosphere Advanced Monitor Screen Features

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor Navigation Bar Main Window (section 5.2) Parameter Globe (section 5.3.1) Information Bar (section 5.5) Status Bar (section 5.6) Figure 5-1 HemoSphere advanced monitor screen features...

  • Page 50: Navigation Bar

    CO monitoring directly from the navigation bar. See Continuous Cardiac Output on page 98 . The stop monitoring icon indicates that CO monitoring using the HemoSphere Swan- Stop CO Monitoring. Ganz module is underway. The user can immediately stop monitoring by touching this icon.

  • Page 51: Monitor Views

    Snapshot. The snapshot icon captures an image of the screen at the current time. A USB stick attached to one of the two USB ports (rear and right panels) of the HemoSphere advanced monitor is required to save the image.

  • Page 52: Parameter Globes

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor Touch the monitor screen selection icon . The monitor screen selection menu contains icons that are based upon the look of the monitoring screens. Figure 5-3 Example of monitoring screen selection window Touch the circled number, 1, 2, 3, or 4, that represents the number of key parameters to be displayed on the monitoring screens.

  • Page 53: Change Alarm/Target

    Available parameters appear on the screen without highlights. Figure 5-4 shows the popup window that will appear while selecting continuous parameters and monitoring with the HemoSphere Swan-Ganz module. Figure 5-4 Example of key parameter selection popup window Touch an available parameter to select the replacement parameter.

  • Page 54: Status Indicators

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor 5.3.1.3 Status Indicators The lantern at the top of each parameter globe indicates the patient’s current status. The color changes as the patient’s status changes. The globes may display additional information:...

  • Page 55: Graphical Trend Scroll Mode

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor the parameter the plot line is white. The colors match those of the clinical target indicator (lantern) on the key parameter globes in the graphical trend graph when targets are enabled for the parameter. The alarm limits for each parameter are displayed as colored arrows on the graph y-axis.

  • Page 56: Intervention Events

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor 5.3.2.2 Intervention Events While in the graphical trend screen, selecting the intervention icon provides a menu of intervention types, details and a notes section. Figure 5-7 Graphical trend- intervention window To enter a New Intervention: Select the Intervention type from the New Intervention menu on left.

  • Page 57: Figure 5-8 Graphical Trend Screen - Intervention Information Balloon

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor Table 5-2 Intervention events Intervention Indicator Type Intervention Inotrope Vasodilator Vasopressor (green) PEEP Positional Passive Leg Raise Trendelenburg (purple) Fluids Red Blood Cells Colloid Crystalloid (blue) Custom Custom Event (gray) After selection of the intervention type, markers indicating the intervention are visually displayed on all graphs.

  • Page 58: Tabular Trends

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor 5.3.3 Tabular Trends The tabular trends screen displays selected key parameters and their history in a tabular format. Figure 5-9 Tabular trend screen To change the interval between values, touch inside the table.

  • Page 59: Graphical/Tabular Trends Split

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor While the screen scrolls, the date appears above the table. If the time period overlaps two days, both dates will appear on the screen. To start scrolling, touch and hold one of the gray arrows. The scroll rate will appear above the scroll icons.

  • Page 60: Physiology Screen

    Key features of this screen are numbered shown in figure 5-11. This example is of the continuous physiology screen during active monitoring with the HemoSphere Swan- Ganz module and slaved-in ECG, MAP, and CVP signals.

  • Page 61: Historic Physiology Screen

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor 5.3.5.1 Historic Physiology Screen The historic physiology screen displays both intermittent bolus data and a snapshot of continuous data overlaid on a visual representation of the heart and circulatory system. The circulatory system has several variations to illustrate the patient’s condition at the time of the bolus set —...

  • Page 62: Continuous And Historical Modes

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor 5.3.7.1 Continuous and Historical Modes The physio relationship screen has two modes: continuous and historical. When in continuous mode, the intermittent and derived values are always displayed as unavailable. Figure 5-13 Physio relationship screen The vertical lines above and below the parameters appear in the same color as the parameter lantern.

  • Page 63: Figure 5-14 Historic Physio Relationship Data Screen

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor NOTE Before a thermodilution set is performed and before any values are entered (see 5.3.7.2 Parameter Boxes below) the clock/waveform and iCO icons do not appear. Only the available continuous parameters are displayed.

  • Page 64: Parameter Boxes

    • • /ScvO (when no HemoSphere oximetry cable measurement is available) • CVP (when analog pressure signal input not configured) • MAP (when analog pressure signal input not configured) •...

  • Page 65: Clinical Actions

    5 Navigating the HemoSphere Advanced Monitor 5.4 Clinical Actions Most options on the clinical actions menu are related to the current monitoring mode (e.g., while monitoring with the HemoSphere Swan-Ganz module). The following clinical actions are available across all monitoring modes. 5.4.1...

  • Page 66: Information Bar

    The HemoSphere advanced monitor allows for uninterrupted monitoring during power loss when the HemoSphere battery pack is installed. Battery life is indicated on the information bar by the symbols shown in table 5-5. For more information on battery installation, see Battery Installation on page 39. To ensure that the battery charge status displayed on the monitor is correct, it is recommended to perform periodic checks of battery health through battery conditioning.

  • Page 67: Lock Screen

    The battery is not installed. WARNING To prevent any interruptions to monitoring during power loss, always use the HemoSphere advanced monitor with the battery inserted. In cases of power failure and battery depletion, the monitor will go through a controlled shut off procedure.

  • Page 68: Status Bar

    HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor 5.6 Status Bar The status bar appears at the bottom of all active monitoring screens. It displays faults, alarms, alerts, some warnings and notifications. When there is more than one fault, alert or alarm, the message is cycled every two seconds.
  • Page 69 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor In these cases, touching anywhere on the button reveals a list of selectable items. The right side of the button displays the current selection. Some screens have square buttons as shown below. Touch the button to display a keypad.

  • Page 70: User Interface Settings

    User Interface Settings Contents Patient Data................70 Monitor Settings .

  • Page 71: Figure 6-2 New Patient Data Screen

    WARNING Perform New Patient or clear the patient data profile whenever a new patient is connected to the HemoSphere advanced monitor. Failure to do so may result in previous patient data in the historical displays. After turning on the monitor, the new or continuing patient screen appears (figure 6-1). Touch...

  • Page 72: Continue Monitoring Patient

    HemoSphere Advanced Monitor 6 User Interface Settings Touch the home icon and refer to instructions for starting monitoring with the desired hemodynamic monitoring technology. NOTE The home icon is disabled until all patient data is entered. 6.1.2 Continue Monitoring Patient If the last patient’s data is less than 12 hours old, the patient’s demographics and patient ID will be displayed...

  • Page 73: Change Language

    The HemoSphere advanced monitor interface is available in several languages. A language selection screen appears the first time the HemoSphere advanced monitor is started. See figure 3-7, “Language selection screen,” on page 42. The language screen will not appear again, but the display language can be changed at any time.

  • Page 74: Adjust Date Or Time

    Any retained data is updated to reflect the time change. NOTE The time clock of the HemoSphere advanced monitor does not automatically adjust for daylight saving time (DST). This adjustment needs to made using the following instruc- tions.

  • Page 75: Monitoring Screens Settings

    6.2.5 Analog Pressure Signal Input While performing CO monitoring, the HemoSphere advanced monitor can also calculate SVR by utilizing analog pressure signal inputs from a connected patient monitor. NOTE Connecting to external input devices allows additional information to be displayed. For example, when MAP and CVP are available continuously from a bedside monitor, SVR is displayed if configured in a parameter globe.
  • Page 76 Please contact your local Edwards representative to obtain the correct HemoSphere advanced monitor analog input interface cable for your bedside monitor. The following procedure describes how to configure the analog input ports of the HemoSphere advanced monitor. Touch the settings icon Touch Monitor Settings button.

  • Page 77: Calibration

    6.2.5.1 Calibration The calibration option is required when default values are incorrect, or the voltage range is not known. The calibration process configures the HemoSphere advanced monitor with the analog signal received from the bedside monitor. NOTE...
  • Page 78 The accuracy of continuous SVR depends upon the quality and accuracy of the MAP and CVP data transmitted from the external monitors. Since MAP and CVP analog signal quality from the external monitor cannot be validated by the HemoSphere advanced monitor, actual values and the values (including all derived parameters) displayed by the HemoSphere advanced monitor may not be consistent.

  • Page 79: Advanced Settings

    Engineering ................88 7.1 Alarms / Targets There are two types of alarms on the HemoSphere advanced monitor: Physiological alarms: These are set by the clinician and signify the upper and/or lower alarm ranges for configured key continuous parameters.

  • Page 80: Silence Alarms

    For physiological alarms, the delay is the amount of time it takes to calculate the next physiological parameter: HemoSphere Swan-Ganz module continuous CO and associated parameters: varies, but is typically •...

  • Page 81: Set Targets

    HemoSphere Advanced Monitor 7 Advanced Settings Touch the settings icon Touch Monitor Settings button. Touch General button. Touch the right side of the Alarm Volume list button to select the desired volume. Touch the home icon to return to the monitoring screen...

  • Page 82: Alarms / Targets Setup Screen

    The currently configured key parameters are the first set of key parameters displayed. The remaining key parameters are displayed in a defined order. The parameters also indicate what the target ranges are based on: Custom Default, Edwards Default, and Modified.

  • Page 83: Configure All Targets

    • Set Custom Defaults for all parameter alarm and target settings. • Restore all parameter alarm and target settings to Custom Defaults. • Restore all parameter alarm and target settings to Edwards Defaults. • Enable or disable audible alarms for all applicable parameters.

  • Page 84: Set Custom Defaults

    7 Advanced Settings Touch Continue button on the confirmation popup to confirm the restore. 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’ Defaults.”...

  • Page 85: Configure Targets And Alarms For One Parameter

    HemoSphere Advanced Monitor 7 Advanced Settings 7.1.7 Configure Targets and Alarms for One Parameter The Alarms/Targets popup lets the user set up alarm and target values for the selected parameter. The user can also enable or disable the audible alarm. Adjust the target settings by using the numbered keypad or by using the scroll buttons when a minor adjustment is needed.

  • Page 86: Adjust Scales

    HemoSphere Advanced Monitor 7 Advanced Settings 7.2 Adjust Scales The graphical trend data fills the graph from left to right with the most recent data at the right. The parameter scale is on the vertical axis with the time scale on the horizontal.

  • Page 87: Serial Port Setup

    HemoSphere Advanced Monitor 7 Advanced Settings For each parameter, touch the Lower button to enter the minimum value to appear the vertical axis. Touch the Upper button to enter the maximum value. Use the horizontal scroll icons to view additional parameters.

  • Page 88: Demo Mode

    Demonstration mode displays data from a stored set and continually loops through a predefined data set. During Demo Mode, the HemoSphere advanced monitoring platform user interface retains the same functionality as a fully operational platform. Simulated patient demographics must be entered to demonstrate Swan-Ganz technology functions.

  • Page 89: Data Export And Connectivity Settings

    Cyber Security ............... . .94 8.1 Export Data The Export Data screen lists a number of data export features of the HemoSphere advanced monitor. This screen is password protected. From this screen clinicians can export diagnostic reports, delete monitoring sessions, or export monitoring data reports.

  • Page 90: Clear Data And Settings

    8.2.1 Restore Factory Defaults When the defaults are restored, the HemoSphere advanced monitor stops all functions and restores the system to a factory default state. CAUTION Restore Defaults replaces all settings with factory defaults. Any settings changes or customizations will be permanently lost.

  • Page 91: His Connectivity

    Use a compatible interface to access this feature. The HemoSphere advanced monitor HL7 communication protocol, also referred to as HIS Connectivity, facilitates the following types of data exchanges between the HemoSphere advanced...

  • Page 92: Patient Demographic Data

    Patient Query screen allows the user to search for a patient based on name, patient ID or room and bed information. The Patient Query screen can be used to retrieve patient demographics data when starting a new patient or to associate the patient physiological data being monitored on the HemoSphere advanced monitor with a patient record retrieved from HIS.

  • Page 93: Patient Physiological Data

    . Once patient data is saved, the HemoSphere advanced monitor generates unique identifiers for the selected patient and sends out this information in outbound messages with physiological data to the enterprise applications.

  • Page 94: Cyber Security

    8 Data Export and Connectivity Settings 8.5 Cyber Security This chapter outlines ways in which patient data can be transferred to and from the HemoSphere advanced monitor. It is important to note that any facility using the HemoSphere advanced monitor must take measures to protect the privacy of a patients personal information in accordance with country specific regulations, and consistent with the facility’s polices for managing this information.

  • Page 95: Hemosphere Swan-Ganz Module Monitoring

    Connecting the HemoSphere Swan-Ganz Module........

  • Page 96: Figure 9-1 Hemosphere Swan-Ganz Module Connection Overview

    Do not force the module into the slot. Apply even pressure to slide and click the module into place. Press the power button to turn on the HemoSphere advanced monitor and follow steps for entering patient data. See Patient Data on page 70. Connect the patient CCO cable to the...

  • Page 97: Patient Cco Cable Test

    Patient CCO Cable Test To test the integrity of the Edwards patient CCO cable, perform a cable integrity test. It is recommended to test the integrity of the cable as part of a troubleshooting process. This does not test the injectate temperature probe connection of the cable.

  • Page 98: Continuous Cardiac Output

    HemoSphere Swan-Ganz module. 9.2 Continuous Cardiac Output The HemoSphere advanced monitor measures cardiac output continuously by introducing small pulses of energy into the blood stream and measuring blood temperature via a pulmonary artery catheter. The maximum surface temperature of the thermal filament used to release these pulses of energy within the blood is 48 °C.

  • Page 99: Initiating Monitoring

    HemoSphere Advanced Monitor 9 HemoSphere Swan-Ganz Module Monitoring Verify that the CCO catheter is properly inserted into the patient.  Swan-Ganz CCO  patient CCO cable catheter  HemoSphere Swan-  thermal filament Ganz module connection  HemoSphere advanced  thermistor connection...

  • Page 100: Thermal Signal Conditions

    CO value. Table 9-2 shows the alert/fault messages that appear on the screen at different time points while the signal stabilizes. Refer to table 11-6, “HemoSphere Swan-Ganz module CO faults/alerts,” on page 123 for more information on CO faults and alerts.

  • Page 101: Intermittent Cardiac Output

    9.3.1 Connecting Patient Cables Connect the patient CCO cable to the inserted HemoSphere Swan-Ganz module as previously described in section 9.1. Attach the catheter end of the patient CCO cable to the thermistor connector on the Swan-Ganz...

  • Page 102: Probe Selection

    9.3.2 Configuration Settings The HemoSphere advanced monitor provides the operator with the choice of entering a specific computation constant, or configuring the HemoSphere Swan-Ganz module to allow it to automatically determine the computation constant by selecting the injectate volume and catheter size. The operator can...

  • Page 103: Select Injectate Volume

    If the computation constant differs, enter the desired compu- tation constant manually. NOTE The HemoSphere Swan-Ganz module will automatically sense the type of temperature probe in use (ice bath or in-line). The module will use this information to determine the computation constant.

  • Page 104: Select Computation Constant

    9.3.3 Instructions for Bolus Measurement Modes The HemoSphere Swan-Ganz module factory default setting for bolus measurement is Auto mode. In this mode, the HemoSphere advanced monitor highlights an Inject message upon achieving a baseline blood temperature. During Manual mode, the operator will initiate when to inject by touching the Inject button.
  • Page 105 ( ) and the resultant iCO measurement is displayed. When the thermal washout curve is complete the HemoSphere advanced monitor will highlight Wait and then Inject – or Ready during manual mode – when a stable thermal baseline is reached again.

  • Page 106: Thermodilution Summary Screen

    HemoSphere Advanced Monitor 9 HemoSphere Swan-Ganz Module Monitoring A red “X” appears over the waveform removing it from the averaged CO/CI value. Waveforms that are irregular or questionable will have an next to the waveform data set. If desired, touch the cancel icon to delete the bolus set.

  • Page 107: Edv/Rvef Monitoring

    9.4.1 Connecting Patient Cables Connect the patient CCO cable to the inserted HemoSphere Swan-Ganz module as previously described in section 9.1. Attach the catheter end of the patient cable to the thermistor and thermal filament connectors on the Swan-Ganz CCOmbo V catheter.
  • Page 108 Connect the other end of the interface cable to the bedside monitor’s ECG signal output. This will provide an average heart rate (HR ) measure to the HemoSphere advanced monitor for EDV and RVEF measurements. For compatible ECG interface cables, contact your local Edwards representative.

  • Page 109: Initiating Measurement

    HemoSphere Advanced Monitor 9 HemoSphere Swan-Ganz Module Monitoring 9.4.3 Initiating Measurement WARNING CO monitoring should always be discontinued when blood flow around the thermal filament is stopped. Clinical situations where CO monitoring should be discontinued include, but are not limited to: •...

  • Page 110: Stat Edv And Rvef

    The accuracy of continuous EDV and RVEF determinations is dependent upon a consistent ECG signal from the bedside monitor. For additional troubleshooting, see table 11-7, “HemoSphere Swan-Ganz module EDV and SV faults/alerts,” on page 124 and table 11-10, “HemoSphere Swan-Ganz module general troubleshooting,” on page 128.

  • Page 111: Oximetry Setup

    HemoSphere Oximetry Cable Reset ........

  • Page 112: Oximetry Monitoring

    NOTE Appearance of catheter shown in figure 10-1 is for example only. Actual appearance may vary depending on catheter model. The HemoSphere oximetry cable and any attached compatible catheter is an APPLIED PART. CAUTION Make sure that the oximetry cable is securely stabilized to prevent unnecessary movement of the attached catheter.

  • Page 113: In Vitro Calibration Error

    Insert the catheter as described in the catheter instructions for use. Touch Start button. 10.2.1 In Vitro Calibration Error If the HemoSphere advanced monitor is unable to perform an in vitro calibration, an error popup screen appears. Touch In vitro Calibration button to repeat the oximetry calibration process.

  • Page 114: Table 10-2 In Vivo Calibration Options

    HemoSphere Advanced Monitor 10 Oximetry Monitoring Signal quality is displayed during in vivo calibration. It is recommended that calibration be performed only when the SQI level is 1 or 2. See Signal Quality Indicator on page 115. Touch clinical actions icon Oximetry Calibration icon ...

  • Page 115: Signal Quality Indicator

    Recall Oximetry Data can be used to recall data from the oximetry cable after a patient has been transported away from the HemoSphere advanced monitor. This allows the patients last calibration to be recalled along with the patients demographic data for immediate oximetry monitoring. Calibration data within the oximetry cable must be less than 24 hours old to use this function.

  • Page 116: Hgb Update

    Re-enter patient data, if necessary. NOTE Keep the time and date of all HemoSphere advanced monitors current. If the date and/ or time of the HemoSphere advanced monitor being transported “from” differs from the HemoSphere advanced monitor being transported “to” the following message may appear: “Patient data in oximetry cable more than 24 hours old - Recalibrate.”...

  • Page 117: Hemosphere Oximetry Cable Reset

    10.7 HemoSphere Oximetry Cable Reset Use HemoSphere oximetry cable reset when the SQI level is continuously high. An oximetry cable reset may stabilize the signal quality. It should be performed only after attempting other actions to resolve the high SQI as defined in Troubleshooting.

  • Page 118: Troubleshooting

    HemoSphere Swan-Ganz Module Error Messages ........

  • Page 119: Monitor Status Lights

    11 Troubleshooting 11.2 Monitor Status Lights The HemoSphere advanced monitor has a visual alarm indicator to alert the user to alarm conditions. See Alarm Priorities on page 147 for more information on medium and high priority physiological alarm conditions. The monitor power button has an integrated LED to indicate the power status at all times.

  • Page 120: Hemosphere Advanced Monitor Error Messages

    HemoSphere Advanced Monitor 11 Troubleshooting 11.3 HemoSphere Advanced Monitor Error Messages 11.3.1 System Faults/Alerts Table 11-3 System faults/alerts Message Possible causes Suggested actions Fault: Module Slot 1 – Module 1 is not inserted properly Reinsert the module Hardware Failure Connection points on slot or module are...
  • Page 121 If problem persists, contact Edwards Technical Support Fault: Battery Depleted The battery is depleted and the system will Connect the HemoSphere advanced monitor to an shut down in 1 minute if not plugged in alternate source of power to avoid loss of power and...

  • Page 122: System Warnings

    Suggested actions Battery Needs Conditioning Gas gauge is not synched to actual To ensure uninterrupted measurement, make certain the battery capacity status HemoSphere advanced monitor is connected to electrical outlet Condition the battery (ensure a measurement is not active): •...

  • Page 123: Hemosphere Swan-Ganz Module Error Messages

    HemoSphere Advanced Monitor 11 Troubleshooting 11.4 HemoSphere Swan-Ganz Module Error Messages 11.4.1 CO Faults/Alerts Table 11-6 HemoSphere Swan-Ganz module CO faults/alerts Message Possible causes Suggested actions Fault: CO – Blood Temp Out of Monitored blood temperature is <31 °C or Verify proper catheter position in the pulmonary artery: Range (<31 °C or >41 °C)

  • Page 124: Edv And Sv Faults/Alerts

    Temporarily turn off sequential compression device per hospital procedure 11.4.2 EDV and SV Faults/Alerts Table 11-7 HemoSphere Swan-Ganz module EDV and SV faults/alerts Message Possible causes Suggested actions Alert: EDV – Heart Rate Signal Patient’s time-averaged heart rate out of...
  • Page 125 HemoSphere Advanced Monitor 11 Troubleshooting Table 11-7 HemoSphere Swan-Ganz module EDV and SV faults/alerts (continued) Message Possible causes Suggested actions Alert: EDV – Exceeding HR Patient’s time-averaged heart rate out of Wait until average heart rate is within range Threshold Limit range (HR <30 or >200 bpm)

  • Page 126: Ico Faults/Alerts

    HemoSphere Advanced Monitor 11 Troubleshooting 11.4.3 iCO Faults/Alerts Table 11-8 HemoSphere Swan-Ganz module iCO faults/alerts Message Possible causes Suggested actions Fault: iCO – Check Injectate Injectate temperature probe not detected Verify connection between patient CCO cable and Probe Connection injectate temperature probe...

  • Page 127: Svr Faults/Alerts

    HemoSphere Advanced Monitor 11 Troubleshooting Table 11-8 HemoSphere Swan-Ganz module iCO faults/alerts (continued) Message Possible causes Suggested actions Alert: iCO – Warm Injectate Injectate temperature within 8 °C of blood Use cooler injectate fluid temperature Change injectate temperature probe Injectate temperature probe malfunction...

  • Page 128: General Troubleshooting

    Possible causes Suggested actions Connect HemoSphere Swan- Connection to the HemoSphere Swan- Insert the HemoSphere Swan-Ganz module into slot 1 or Ganz module for CO monitoring Ganz module has not been detected slot 2 of the monitor Remove and re-insert module...

  • Page 129: Oximetry Error Messages

    HemoSphere Advanced Monitor 11 Troubleshooting Table 11-10 HemoSphere Swan-Ganz module general troubleshooting (continued) Message Possible causes Suggested actions HemoSphere Advanced Monitor External monitor not optimally configured Stop CO monitoring and verify heart rate is the same for HRavg ≠ External Monitor HR...

  • Page 130: Oximetry Warnings

    If the cable body feels warm, allow it to cool before operating again If problem persists, contact Edwards Technical Support Fault: Oximetry Cable Internal system malfunction Power monitor off and on to restore platform...

  • Page 131: Oximetry General Troubleshooting

    Patient data in oximetry cable Last oximetry cable calibration >24 hours Perform in vivo calibration more than 24 hours old — Synchronize date and time on all Edwards’ monitors at Recalibrate Date and time on Edwards’ monitors at facility facility differ...

  • Page 132: Essential Performance Characteristics

    HemoSphere Swan-Ganz Module Specifications ........

  • Page 133: Hemosphere Advanced Monitor Specifications

    Alarm if oxygen saturation outside of alarm ranges. Table A-2 identifies the minimum performance for transient electromagnetic phenomena, such as electrical fast transients and surges, according to IEC 60601-1-2. Table A-2 HemoSphere advanced monitor essential performance – transient electromagnetic phenomena Parameter Essential Performance After the transient electromagnetic phenomena, the system shall return to an operational state within 10 seconds.

  • Page 134: Table A-5 Hemosphere Advanced Monitor Technical Specifications

    Table A-5 HemoSphere advanced monitor technical specifications Input/Output Touch screen Projective capacitive touch RS-232 serial port (1) Edwards proprietary protocol; Maximum data rate = 57.6 kilo baud USB ports (2) one USB 2.0 (rear) and one USB 3.0 (side) RJ-45 Ethernet port HDMI port Analog inputs (2) Input voltage range: 0 to 10V;...

  • Page 135: Hemosphere Battery Pack Specifications

    HemoSphere Advanced Monitor A Specifications Table A-5 HemoSphere advanced monitor technical specifications (continued) Input/Output (continued) Electrical Rated supply voltage 100 to 240 Vac; 50/60 Hz Rated input 1.5 to 2.0 Amps Fuses T 2.5AH, 250V; High breaking capacity; Ceramic Alarm...

  • Page 136: Hemosphere Oximetry Cable Specifications

    HemoSphere Advanced Monitor A Specifications Table A-10 HemoSphere Swan-Ganz module parameter measurement specifications Parameter Specification Continuous Cardiac Output Range 1 to 20 L/min (CO) ±6% or 0.1 L/min, whichever is greater Reproducibility <10 mins (for CCO catheters) Average response time <14 mins (for CCO volumetric catheters)

  • Page 137: Appendix B: Accessories

    Additional Accessories Description............138 B.1 Accessories List WARNING Only use approved HemoSphere advanced monitor accessories, cables and or compo- nents that have been supplied and labeled by Edwards. Using unapproved accessories, cables and or components may affect patient safety and measurement accuracy.

  • Page 138: Additional Accessories Description

    B.2 Additional Accessories Description B.2.1 Roll Stand The HemoSphere advanced monitor roll stand is intended for use with the HemoSphere advanced monitor. Follow included instructions for roll stand assembly and warnings. Place the assembled roll stand on the floor, ensuring that all wheels are in contact with the floor, and securely mount the monitor to the roll stand...

  • Page 139: Appendix C: Equations For Calculated Patient Parameters

    Equations for Calculated Patient Parameters This section describes the equations used to calculate continuous and intermittent patient parameters displayed on the HemoSphere advanced monitor. NOTE Patient parameters are calculated to more decimal places than are displayed on the screen. For example, a screen CO value of 2.4 may actually be a CO of 2.4492. Conse-...
  • Page 140 HemoSphere Advanced Monitor C Equations for Calculated Patient Parameters Table C-1 Cardiac and oxygenation profile equations (continued) Parameter Description and formula Units Venous Oxygen Content = (0.0138 x HGB x SvO ) + (0.0031 x PvO ) (mL/dL) mL/dL = [0.0138 x (HGB x 1.611) x SvO...
  • Page 141 HemoSphere Advanced Monitor C Equations for Calculated Patient Parameters Table C-1 Cardiac and oxygenation profile equations (continued) Parameter Description and formula Units ESVI End Systolic Volume Index mL/m ESVI = EDVI – SVI where: EDVI – End Diastolic Volume Index(mL/m SVI –...
  • Page 142 HemoSphere Advanced Monitor C Equations for Calculated Patient Parameters Table C-1 Cardiac and oxygenation profile equations (continued) Parameter Description and formula Units RVSWI Right Ventricular Stroke Work Index g-m/m /beat RVSWI = SVI x (MPAP – CVP) x 0.0136 RVSWI = SVI x (MPAP –...
  • Page 143 HemoSphere Advanced Monitor C Equations for Calculated Patient Parameters Table C-1 Cardiac and oxygenation profile equations (continued) Parameter Description and formula Units Estimated Oxygen Consumption Index e/ BSA mL O /min/m Ventilation Perfusion Index {1.38 x HGB x (1.0 - (SaO /100))+ (0.0031 x PAO...

  • Page 144: Appendix D: Monitor Settings And Defaults

    Appendix Monitor Settings and Defaults D.1 Patient Data Input Range Table D-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 145: Parameter Display And Configurable Alarm/Target Ranges

    D Monitor Settings and Defaults NOTE The HemoSphere advanced monitor will not accept a setting of an upper scale setting that is less than the lower scale setting. Nor will it accept a lower scale setting that is higher than the upper scale setting.

  • Page 146: Alarm And Target Defaults

    HemoSphere Advanced Monitor D Monitor Settings and Defaults D.4 Alarm and Target Defaults Table D-4 Parameter alarm red zone and target defaults EW default EW default lower alarm EW default EW default upper alarm (red zone) lower target upper target...

  • Page 147: Alarm Priorities

    HemoSphere Advanced Monitor D Monitor Settings and Defaults D.5 Alarm Priorities Table D-5 Parameter alarm red zone priorities Lower alarm Upper alarm (red zone) (red zone) Parameter priority priority CO/CI/sCO/sCI High Medium SV/SVI High Medium SVR/SVRI Medium Medium ScvO /SvO...

  • Page 148: Language Default Settings

    HemoSphere Advanced Monitor D Monitor Settings and Defaults D.6 Language Default Settings* Table D-6 Language default settings Default display units CO trend Time averaging Language Height Weight format Date format time English (US) mmHg g/dL 12 hour MM/DD/YYYY 20 seconds...

  • Page 149: Computation Constant Values

    Computation Constants E.1 Computation Constant Values In iCO mode, the HemoSphere Swan-Ganz module computes cardiac output employing either a bath probe setup or an in-line temperature probe using the computation constants listed in the following tables. The HemoSphere Swan-Ganz module automatically senses the type of injectate temperature probe being used, and the corresponding injectate temperature, catheter size, and injectate volume define the computation constant to be used.

  • Page 150: Table E-2 Computation Constants For In-Line Temperature Probe

    HemoSphere Advanced Monitor E Computation Constants Table E-2 Computation constants for in-line temperature probe Injectate Injectate Catheter size (French) temperature volume range* (°C) (mL) Room temp. 0.601 0.599 0.616 0.616 0.624 22.5–27 °C 0.294 0.301 0.311 0.307 0.310 Room temp.

  • Page 151: General Maintenance

    Edwards Lifesciences Regional Headquarters........

  • Page 152: Cleaning The Monitor And Modules

    Do not allow any fluids to enter the instrument. The HemoSphere advanced monitor and modules can be cleaned using a lint-free cloth dampened with cleaning agents that are based on the following chemical content: 70% isopropyl •...

  • Page 153: Cleaning The Patient Cco Cable And Connector

    Moisten a lint-free cotton-tipped applicator with sterile alcohol and apply gentle pressure to clean the optical fibers recessed within the front of the oximetry cable housing. CAUTION Do not steam, radiate, or EO sterilize the HemoSphere oximetry cable. Do not immerse the HemoSphere oximetry cable. F.3.2...

  • Page 154: Edwards Lifesciences Regional Headquarters

    For single use parts and accessories, where not otherwise specified, follow local regulations regarding disposal of hospital waste. F.6.1 Battery Recycling Replace the HemoSphere battery pack when it no longer holds a charge. After removal, follow your local recycling guidelines.

  • Page 155: Preventive Maintenance

    F.8 Testing of Alarm Signals Each time the HemoSphere advanced monitor is powered on, a self test is automatically performed. As a part of the self test, an alarm tone will sound. This indicates that the audible alarm indicators are functioning correctly.
  • Page 156 HemoSphere Advanced Monitor F System Care, Service and Support probes, or oximetry cables used with the HemoSphere advanced monitor. Edwards’ sole obligation and purchaser's exclusive remedy for breach of any warranty shall be limited to repair or replacement of the HemoSphere advanced monitor at Edwards’...

  • Page 157: Appendix G: Guidance And Manufacturer's Declaration

    IEC/EN 60601-1-2:2014-02 and IEC 60601-2-49:2011-02 The HemoSphere advanced monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the HemoSphere advanced monitor should assure that it is used in such an environment. Table G-1 List of accessories, cables and sensors necessary for compliance...

  • Page 158: Table G-2 Electromagnetic Emissions

    Guidance and Manufacturer's Declaration - Electromagnetic Emissions The HemoSphere advanced monitor is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere advanced monitor should assure that it is used in such an environment.

  • Page 159: Equipment

    Meters (V/m) The HemoSphere advanced monitor is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere advanced monitor should ensure that it is used in such an environment. Pulse modulation ² 380 - 390...

  • Page 160: Table G-4 Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Hemosphere Advanced Monitor

    Table G-4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the HemoSphere advanced monitor The HemoSphere advanced monitor 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 HemoSphere advanced monitor as recommended below, according to the maximum output power of the communications equipment.

  • Page 161: Table G-5 Electromagnetic Immunity (Esd, Eft, Surge, Dips And Magnetic Field)

    Level Guidance The HemoSphere advanced monitor is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere advanced monitor should assure that it is used in such an environment. Electrostatic discharge ±8 kV contact ±8 kV...

  • Page 162: Table G-6 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 HemoSphere advanced monitor is used exceeds the applicable RF compliance level above, the HemoSphere advanced monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the HemoSphere advanced monitor.

  • Page 163: Wireless Technology Information

    Wi-Fi connectivity. HemoSphere advanced monitor wireless technology supports IEEE 802.11a/b/g/ n with a fully integrated security supplicant providing 802.11i/WPA2 Enterprise authentication, data encryption. Technical details of the wireless technology implemented in the HemoSphere advanced monitor are provided in the following table. Table G-7 HemoSphere advanced monitor wireless information...
  • Page 164 HemoSphere Advanced Monitor G Guidance and Manufacturer’s Declaration Table G-7 HemoSphere advanced monitor wireless information (continued) Feature Description Maximum Transmit 802.11a Power 6 Mbps 15 dBm (31.623 mW) 54 Mbps 12 dBm (19.953 mW) Maximum Note: 802.11b transmits power 1 Mbps 16 dBm (39.81 mW)

  • Page 165: Quality Of Service For Wireless Technology

    5% total data loss under these conditions. HemoSphere advanced monitor wireless technology has an effective range of 150 feet, line of sight and 75 feet, non-line of sight. The effective range might be affected due to the presence of other wireless emitters.

  • Page 166: Wireless Security Measures

    Edwards recommends securing wireless data transmission by enabling IEEE 802.11i (WPA2) security and FIPS mode. Edwards also recommends implementing network security measures like virtual LANs with firewalls to further secure HemoSphere advanced monitoring platform data in transit to the HIS.

  • Page 167: Industry Canada Statements

    HemoSphere Advanced Monitor G Guidance and Manufacturer’s Declaration FCC requires this product to be used indoors for the frequency range 5.15 to 5.25 GHz to reduce the potential for harmful interference to co-channel Mobile Satellite systems. This device does not permit operations on channels 116-128 (5580 – 5640 MHz) for 11na and 120-128 (5600-5640 MHz) for 11a which overlap the 5600 -5650 MHz band.

  • Page 168: European Union R&Tte Statements

    10 mW EIRP in the frequency range of 2454 – 2483.5 MHz. For detailed information the end-user should contact the national spectrum authority in France. Hereby, Edwards Lifesciences, declares that this monitor is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC.

  • Page 169: Appendix H: Glossary

    The calculated surface area of a human body. End-Diastolic Volume (EDV) Bolus (iCO) Mode The volume of blood in the right ventricle at the end of Functional state of the HemoSphere Swan-Ganz module diastole. in which cardiac output is measured by the bolus End-Diastolic Volume Index (EDVI) thermodilution method.
  • Page 170 Slave Cable Injectate Cable that transfers data to the HemoSphere advanced Fluid used for iCO (bolus thermodilution cardiac output) monitor from another monitor. measurement. STAT Value...
  • Page 171 Battery monitoring with HemoSphere Swan- recommended for equipment installation Ganz module battery required accessories def. maintenance Cockpit monitoring screen equation status on information bar...
  • Page 172 Group 1 RF Emissions monitoring with HemoSphere Swan- def. Ganz module mechanical specifications required accessories message area harmonic emissions model numbers IEC 61000-3-2 def. Module accessories...
  • Page 173 RVEF required accessories def. def. required accessories def. packaging labels RVEF monitoring equation PaO2 RVSWI monitoring with HemoSphere Swan- def. def. Ganz module parameter globe required accessories parameter globes SVR equation parameters SVRI display and alarm ranges scales def.
  • Page 174 Warning Unstable Signal Wall Artifact or Wedge Detected warning def. Warnings oximetry warnings, list of warranty washout curve weight HemoSphere Swan-Ganz module monitor weight, patient data width HemoSphere Swan-Ganz module monitor Windows 7 embedded wireless setup...
  • Page 175 Index Page intentionally left blank...
  • Page 176 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.

Table of Contents

Save PDF