Download
Share
Print this page
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:

Advertisement

Quick Links

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

Advertisement

loading
Need help?

Need help?

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

Questions and answers

Related Manuals for Edwards HemoSphere

Summary of Contents for Edwards HemoSphere

  • Page 1 HemoSphere HemoSphere Advanced Monitor Advanced Monitor Operator’s manual...
  • 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 Using This Manual The Edwards HemoSphere advanced monitor operator’s manual is comprised of eleven chapters, eight appendices, and an index. Figures in this manual are intended for reference only and may not be an exact replication of the screens as a result of continuous software improvements.
  • Page 4 Chapter Description Advanced Features: Describes the advanced monitoring features that are currently available for upgrade with the HemoSphere advanced monitoring platform Help and Troubleshooting: Describes the Help menu and provides a list of faults, alerts, and messages, with causes and suggested actions...
  • Page 5 1.5.3 HemoSphere Oximetry Cable ........25...
  • Page 6 4.2.2 Zero Pressure Cable......... . . 56 4.3 HemoSphere Oximetry Cable Monitoring ......
  • Page 7 5.4.2 Historical Graphical Trends ........80 5.4.3 CVP Entry .
  • Page 8 9 HemoSphere Swan-Ganz Module Monitoring 9.1 Connecting the HemoSphere Swan-Ganz Module ..... 9.1.1 Patient CCO Cable Test........119 9.2 Continuous Cardiac Output .
  • Page 9 11.6 HGB Update ..........11.7 HemoSphere Oximetry Cable Reset ....... .
  • Page 10 ..... A.5 HemoSphere Pressure Cable Specifications ......
  • Page 11 F.3 Cleaning the Platform Cables ........F.3.1 Cleaning the HemoSphere Oximetry Cable ..... . . 213 F.3.2 Cleaning the Patient CCO Cable and Connector.
  • Page 12 Figure 3-1 HemoSphere advanced monitor front view ....... . 43...
  • Page 13 Figure 12-9 GDT Active Tracking ..........165 Figure 13-1 HemoSphere advanced monitor LED indicators ......169...
  • Page 14 Table 2-3 Applicable standards ........... 40 Table 3-1 HemoSphere advanced monitoring components ......41 Table 3-2 Cables and catheters required for monitoring parameters with HemoSphere Swan-Ganz module .
  • Page 15 Table 13-4 System faults/alerts ..........170 Table 13-5 HemoSphere advanced monitor warnings ....... . 173 Table 13-6 Numeric keypad errors .
  • Page 16 Equipment and the HemoSphere advanced monitor ....... . . 221...
  • Page 17 Intended Use Statement ..............18 HemoSphere Advanced Monitor Hemodynamic Technology Connections......22 Manual style conventions .
  • Page 18 The HemoSphere advanced monitor has no contraindications for use. 1.4 Intended Use Statement The HemoSphere advanced monitoring platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz...
  • Page 19 HemoSphere Advanced Monitor 1 Introduction 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. Table 1-1 HemoSphere Swan-Ganz module available parameters list Abbreviation Definition...
  • Page 20 *HPI parameters are available when using a FloTrac IQ sensor and if the HPI feature is activated. Activation is only available in certain areas. Please contact your local Edwards representative for more information on enabling this advanced feature.
  • Page 21 1 Introduction A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere pressure cable and oximetry cable are listed below in table 1-5. Table 1-5 HemoSphere pressure cable with oximetry cable available parameters list...
  • Page 22 9, HemoSphere Swan-Ganz Module Monitoring. Currently available cables include the HemoSphere pressure cable, introduced below and described in detail in chapter 10, Monitoring with the HemoSphere Pressure Cable, and the HemoSphere oximetry cable, introduced below and described in detail in chapter 11, Oximetry Monitoring.
  • Page 23 The HemoSphere pressure cable plugs into a monitoring cable port. For more information, see chapter 10, Monitoring with the HemoSphere Pressure Cable. Table 1-7 lists the parameters available while using the HemoSphere pressure cable.
  • Page 24 Truwave pressure transducer *HPI parameters are available when using a FloTrac IQ sensor and if the HPI feature is activated. Activation is only available in certain areas. Please contact your local Edwards representative for more information on enabling this advanced feature. NOTE...
  • Page 25 Instructions for Use are included with HemoSphere Advanced Monitor components. See table B-1, “HemoSphere advanced monitor components,” on page 195. For more information on how you can receive training or available documentation for the HemoSphere advanced monitor, contact your local Edwards...
  • Page 26 HemoSphere Advanced Monitor 1 Introduction 1.6 Manual style conventions Table 1-9 lists the style conventions used in this manual. Table 1-9 Operator’s manual style conventions Convention Description Bold Bold text indicates a software term. This word or phrase will appear on the screen as shown.
  • Page 27 SVRI systemic vascular resistance index systolic blood pressure Touch Interact with the HemoSphere advanced monitor by touching the screen. thermodilution Universal Serial Bus oxygen consumption oxygen consumption index estimation of oxygen consumption...
  • Page 28 HemoSphere Advanced Monitor Essential Performance ........
  • Page 29 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 HemoSphere advanced •...
  • Page 30 • 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 31 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 32 G-3. (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 33 Confirm that all sensors and cables are connected correctly and completely before use. (chapter 3) 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. (chapter 3) Do not expose the HemoSphere advanced monitor to extreme temperatures.
  • Page 34 • 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 11) Do not disconnect the oximetry cable while calibration or data recall are in process. (chapter 11)
  • Page 35 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 11) Exercise caution when using dP/dt in patients with severe aortic stenosis, since the stenosis may •...
  • Page 36 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 37 See table 5-5 on page 84 enter CO countdown (HemoSphere Swan-Ganz module) keypad enter key averaged heart rate (HemoSphere Swan-Ganz module with ECG input) keypad backspace key Wi-Fi signal See table 8-1 on page 113 move cursor left by 1 character...
  • Page 38 HemoSphere Advanced Monitor 2 Safety and Symbols 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 Table 2-2 Symbols on product labels (continued)
  • Page 39 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 Defibrillation proof type CF applied part or This end up connection ECG input from external monitor...
  • Page 40 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 intravascular blood pressure with a compatible FloTrac or FloTrac IQ sensor or compatible TruWave DPT according to the specifications provided in appendix A.
  • Page 41 HemoSphere Advanced Monitor Connection Ports ........
  • Page 42 Required Accessories for Platform Modules and Cables The following tables identify accessories required to display specific monitored and calculated parameters for the specified hemodynamic technology module or cable: Table 3-2 Cables and catheters required for monitoring parameters with HemoSphere Swan-Ganz module Monitored and calculated parameters...
  • Page 43 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 44   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 45 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 46 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. The operator should be positioned in front of the monitor and at close proximity during use. The device is intended to be used by only one user at a time. A roll stand for the HemoSphere advanced monitor is available as an optional accessory.
  • Page 47 For information on battery maintenance and conditioning, see Battery Maintenance on page 216. 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 48 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 49 3.3.6 Connecting Cables from External Devices The HemoSphere advanced monitor utilizes slaved-in monitored data to calculate certain hemodynamic parameters. This includes data from the pressure input data ports and ECG monitor input port. All slaved- in cable connections are located on the rear panel of the monitor (figure 3-2). See Required Accessories for Platform Modules and Cables on page 42 for a list of calculated parameters available with certain cable connections.
  • Page 50 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 51 HemoSphere Advanced Monitor 3 Installation and Setup When the language selection screen appears, touch the desired language for use. Figure 3-7 Language selection screen NOTE Figure 3-6 and figure 3-7 are examples of startup and language selection screens.
  • Page 52 Contents HemoSphere Swan-Ganz Module Cardiac Output Monitoring........53 Monitoring with the HemoSphere Pressure Cable .
  • Page 53 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 54 HemoSphere Advanced Monitor 4 HemoSphere Advanced Monitor Quick Start 4.1.1 Continuous Cardiac Output Monitoring Attach the thermistor  and thermal filament  Swan-Ganz CCO catheter connections (figure 4-1) to the patient CCO cable. Verify that the catheter is properly inserted into the patient.
  • Page 55 (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 56 Pressure Cable Setup Connect the opposite end of the pressure cable to the HemoSphere advanced monitor. 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 57 HemoSphere Advanced Monitor 4 HemoSphere Advanced Monitor Quick Start Use the Select Pressure panel to select the type/location of pressure sensor being used. The choices for Pressure Transducer are: • ART • CVP • PAP This step can be skipped while monitoring with a FloTrac or FloTrac IQ sensor. If a FloTrac or FloTrac IQ sensor is connected ART is the only available pressure option and is automatically selected.
  • Page 58 Connect the HemoSphere oximetry cable to the left side of the HemoSphere advanced monitor. See figure 4-3. 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 59 HemoSphere Advanced Monitor 4 HemoSphere Advanced Monitor Quick Start Touch the clinical actions icon Oximetry Calibration icon  Select Oximetry Type: ScvO or SvO Touch In vitro Calibration button. 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.
  • Page 60 HemoSphere Advanced Monitor 4 HemoSphere Advanced Monitor Quick Start Touch the displayed parameter label located outside of any parameter globe to select ScvO /SvO as a key parameter from the parameter popup window. Touch within the ScvO /SvO parameter globe to adjust Alarms/Targets.
  • Page 61 HemoSphere Advanced Monitor Screen Appearance ........
  • Page 62 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor Navigation Bar Main Window 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 63 CO monitoring directly from the navigation bar. See Continuous Cardiac Output on page 120 . 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 64 The snapshot icon captures an image of the screen at the current time. A USB stick attached to Snapshot. one of the two USB ports (rear and right panels) of the HemoSphere advanced monitor is required to save the image.
  • Page 65 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor This icon silences all alarms for two minutes. New physiological alarms are silenced Silence Audible Alarms. during the two minute period. Alarms will resume sounding after the two minutes have elapsed. Faults are silenced until the fault is cleared and re-occurs.
  • Page 66 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 67 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 68 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor NOTE When using the Acumen Hypotension Probability Indicator parameter, P( BP), the ↓ patient status indicators differ from those described. Refer to Acumen Hypotension Proba- bility Indicator Software Feature on page 150 for the patient status indicators available when using the Acumen Hypotension Probability Indicator feature.
  • Page 69 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor 5.3.2.1 Graphical Trend Scroll Mode Up to 72 hours of monitored parameter data can be viewed by scrolling back. The date appears above the parameter data during scrolling. Two dates will appear when appropriate. To start scrolling, touch the appropriate scroll mode button.
  • Page 70 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor Touch the enter icon To enter a previously used Intervention: Select the Intervention from the Recents list tab. To add, edit, or remove a note, touch the keyboard icon Touch the enter icon...
  • Page 71 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor Touch the enter icon Figure 5-8 Graphical trend screen - intervention information balloon 5.3.2.3 Live Arterial Waveform (ART) Display To display the real-time blood pressure waveform while in FloTrac sensor monitoring mode, touch the display arterial waveform icon .
  • Page 72 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor Select a value on the Tabular Increment popup. Figure 5-10 Tabular increment popup 5.3.3.1 Tabular Trend Scroll Mode Up to 72 hours of data can be viewed by scrolling back. The scroll mode is based on the number of cells.
  • Page 73 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor If two key parameters are selected, the first key parameter is displayed in graphical trend format, and the second in tabular trend format. Key parameters can be changed by touching the parameter label located on the parameter globe.
  • Page 74 Key features of this screen are numbered shown in figure 5-12. 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 75 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor 5.3.6.2 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 76 Touch the iCO icon, when available, to open the thermodilution new set configuration screen. NOTE The example shown in figure 5-14 is while monitoring with a HemoSphere Swan-Ganz module. Differences in appearance and parameters will occur with other monitoring modes. For example, while monitoring within FloTrac sensor monitoring mode, HR is replaced by PR, PPV and SVV appear (if configured), and EDV and RVEF are not shown.
  • Page 77 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor NOTE Before a thermodilution set is performed and before any values are entered (see 5.3.8.2 Parameter Boxes below) the clock/waveform and iCO icons do not appear. Only the available continuous parameters are displayed.
  • Page 78 • • /ScvO (when no HemoSphere oximetry cable measurement is available) • Figure 5-17 Physio relationship target/enter popup When the value is accepted, a new time-stamped historic physio relationship record is created. It includes: Current continuous parameter data •...
  • Page 79 The Goal Positioning Screen allows the user to monitor and track the relationship of two key parameters by plotting them against each other on an XY plane. This screen feature is available through the advanced setup menu, which is passcode protected. Please contact your local Edwards Representative for more information on enabling this advanced feature.
  • Page 80 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 Select Monitoring Mode The Select Monitoring Mode page allows the user to switch between monitoring modes.
  • Page 81 CVP entry is not available when an analog input signal is used to display CVP data (see Analog Pressure Signal Input on page 95) or when the HemoSphere pressure cable and a TruWave transducer are monitoring CVP (see Pressure Cable Monitoring with a TruWave DPT on page 139).
  • Page 82 HemoSphere Advanced Monitor 5 Navigating the HemoSphere Advanced Monitor To scroll up or down, touch the arrow keys. Touch the home icon to return to the monitoring screen. The following events are included in the clinical event review log. Table 5-4 Reviewed events...
  • Page 83 Select Monitoring Mode on page 80. While monitoring with the HemoSphere Swan-Ganz module, blood temperature and slaved in heart rate may also be displayed. While monitoring with the HemoSphere pressure cable, in FloTrac sensor monitoring mode, the CO/pressure averaging time and P( BP) may also be displayed.
  • Page 84 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 47. 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 85 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 86 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 87 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 88 User Interface Settings Contents Patient Data ................88 Monitor Settings .
  • Page 89 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 90 HemoSphere Advanced Monitor 6 User Interface Settings Touch the enter icon NOTE The enter icon is disabled until all patient data is entered. Review the patient demographics on the confirmation window and touch the Yes button if they are correct.
  • Page 91 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 51. The language screen will not appear again, but the display language can be changed at any time.
  • Page 92 HemoSphere Advanced Monitor 6 User Interface Settings Touch General button. Figure 6-4 General Monitor Settings Touch the value section of the Language button and select the desired display language. Touch the home icon to return to the monitoring screen. NOTE See appendix D for all language default settings.
  • Page 93 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 94 HemoSphere Advanced Monitor 6 User Interface Settings Touch the settings icon Touch the Monitor Settings button. Touch the Monitoring Screens button. Select the Indexed or Non-Indexed toggle for parameters in the physiology and physio relationship screens. To turn the SVV indicator On or Off, touch the SVV: Physiology and Physio Relationship Screens toggle button.
  • Page 95 Waveform screen (see Zero & Waveform Screen on page 141), the update rate is always 2 seconds. Touch home icon to return to the monitoring screen. 6.2.5 Analog Pressure Signal Input While performing CO monitoring, the HemoSphere advanced monitor can also calculate SVR by utilizing analog pressure signal input from a connected patient monitor.
  • Page 96 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 97 HemoSphere Advanced Monitor 6 User Interface Settings NOTE While in FloTrac sensor monitoring mode, MAP data through analog input is not available. If an analog signal is not detected on the selected port, “Not Connected” will be displayed below the Port list button.
  • Page 98 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 If the default values are correct, do not calibrate.
  • Page 99 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 100 Engineering ................110 7.1 Alarms / Targets There are two types of alarms on the HemoSphere advanced monitor intelligent alarm system: Physiological alarms: These are set by the clinician and signify the upper and/or lower alarm ranges for configured key continuous parameters.
  • Page 101 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 102 HemoSphere Advanced Monitor 7 Advanced Settings WARNING Do not turn off the audible alarms in situations in which patient safety could be compromised. 7.1.1.2 Technical Alarms During an active technical alarm, the user can silence the alarm and clear the visual alarm indicator (medium and low priority) by touching the silence audible alarms icon .
  • Page 103 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 104 • 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 105 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 106 HemoSphere Advanced Monitor 7 Advanced Settings Touch the parameter of interest. Touch the value button for each target setting and enter the desired value. The corresponding indexed or non-indexed value for that parameter will be set automatically. Continue steps 7 and 8 for each parameter. Touch the right or left arrow at the bottom of the screen to display the next or previous set of parameters.
  • Page 107 HemoSphere Advanced Monitor 7 Advanced Settings To cancel, touch the cancel icon WARNING Visual and audible physiological alarms are activated only if the parameter is configured on the screens as a key parameter (1-4 parameters displayed in parameter globes). If a parameter is not selected and displayed as a key parameter, the audible and visual physi- ological alarms are not triggered for that parameter.
  • Page 108 HemoSphere Advanced Monitor 7 Advanced Settings Touch Parameter Settings button Adjust Scales button.  Figure 7-5 Adjust scales NOTE The screen will return to the monitoring view after two minutes of inactivity. For each parameter, touch the Lower button to enter the minimum value to appear the vertical axis.
  • Page 109 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 the selected monitoring mode functions.
  • Page 110 Swan-Ganz: See chapter 9: HemoSphere Swan-Ganz Module Monitoring for details on monitoring with the HemoSphere Swan-Ganz module and Swan-Ganz module monitoring mode. FloTrac: See chapter 10: Monitoring with the HemoSphere Pressure Cable for details on monitoring with the HemoSphere pressure cable and FloTrac sensor monitoring mode.
  • Page 111 Cyber Security ............... .116 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 112 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 Factory Defaults replaces all settings with factory defaults. Any settings changes or customizations will be permanently lost.
  • Page 113 8.3 Wireless Settings The HemoSphere advanced monitor can connect to available wireless networks. Touch the settings icon Touch the Advanced Setup button and enter password. Contact your Edwards representative for more information on this advanced feature. Touch the Wireless button.
  • Page 114 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 115 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 116 Data is logged and transmitted for charting purposes only. 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 117 Connecting the HemoSphere Swan-Ganz Module........
  • Page 118 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 88. Connect the patient CCO cable to the...
  • Page 119 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...
  • Page 120 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 121 HemoSphere Advanced Monitor 9 HemoSphere Swan-Ganz Module Monitoring Attach the catheter end of the patient cable to the thermistor and thermal filament connectors on the Swan-Ganz CCO catheter. These connections are emphasized as numbers  and  in figure 9-3 on page 121.
  • Page 122 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 13-7, “HemoSphere Swan-Ganz module CO faults/alerts,” on page 174 for more information on CO faults and alerts.
  • Page 123 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 124 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 125 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 126 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 127 ( ) 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 128 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 129 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 130 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 cables, contact your local Edwards representative.
  • Page 131 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 132 The accuracy of continuous EDV and RVEF determinations is dependent upon a consistent ECG signal from the bedside monitor. For additional troubleshooting, see table 13-8, “HemoSphere Swan-Ganz module EDV and SV faults/alerts,” on page 175 and table 13-12, “HemoSphere Swan-Ganz module general troubleshooting,” on page 179.
  • Page 133 Zero & Waveform Screen ............. .141 10.1 Pressure Cable Overview The HemoSphere pressure cable acquires and processes a single pressure signal from a compatible Edwards disposable pressure transducers (DPT), such as the TruWave DPT, or a FloTrac sensor. A FloTrac or FloTrac IQ sensor connects to an existing arterial catheter to provide minimally invasive hemodynamic parameters.
  • Page 134 /status LED  color insert for pressure type  HemoSphere advanced monitor  connection Figure 10-1 HemoSphere pressure cable Table 10-1 HemoSphere pressure cable configurations and available key parameters Available Pressure cable configuration FloTrac/ FloTrac/ FloTrac/ TruWave TruWave...
  • Page 135 10.2 Monitoring Mode Selection The primary monitoring mode for the HemoSphere pressure cable is FloTrac sensor monitoring mode. The monitoring mode appears at the center of the information bar. The pressure cable can also be used to collect pulmonary artery pressure (PAP) data while in Swan-Ganz module monitoring mode.
  • Page 136 (dynamic arterial elastance). See Acumen Hypotension Probability Indicator Software Feature on page 150 for more information on the FloTrac IQ sensor and the hypotension probability indicator (HPI) feature. Activation of the HPI feature is only available in certain areas. Please contact your local Edwards representative for more information on enabling this advanced feature.
  • Page 137 HemoSphere Advanced Monitor 10 Monitoring with the HemoSphere Pressure Cable With gravity only (no pressure in Pressure Bag), flush FloTrac sensor holding pressure tubing in upright position as the column of fluid raises through the tubing, pushing air out of the pressure tubing until the fluid reaches the end of the tubing.
  • Page 138 (ART) waveform display. See Live Arterial Waveform (ART) Display on page 71. 10.3.4 SVR monitoring When paired with the FloTrac or FloTrac IQ sensor, the HemoSphere pressure cable can monitor systemic vascular resistance (SVR) and systemic vascular resistance index (SVRI) with a slaved-in CVP pressure signal or if the user manually enters the patient’s CVP value.
  • Page 139 Fast-flush transducer tubing while tapping on tubing and stopcocks to remove any residual bubbles. Use a straight in or out motion to connect the TruWave DPT to the HemoSphere pressure cable. Connect tubing to catheter, and then aspirate and flush system to assure catheter is intra-vascular and remove residual bubbles.
  • Page 140 10.5 Pressure Cable Monitoring in Swan-Ganz Module Monitoring Mode The HemoSphere pressure cable connects to a single Swan-Ganz pulmonary artery pressure port to provide pulmonary artery pressure (PAP). While in HemoSphere Swan-Ganz module monitoring mode, the pressure cable can be connected to a TruWave DPT on a pulmonary artery line.
  • Page 141 HemoSphere Advanced Monitor 10 Monitoring with the HemoSphere Pressure Cable PAP will be automatically selected on the Select Pressure panel. Level the stopcock valve (vent port) just above the TruWave transducer to the patient’s phlebostatic axis position according to the instructions for use.
  • Page 142 The Zero & Waveform screen allows the user to output the pressure waveform to a connected patient monitor. Plug the HemoSphere pressure-out cable into the rear panel of the monitor at the pressure out port. See in figure 3-2 on page 44.
  • Page 143 HemoSphere Oximetry Cable Reset ........
  • Page 144 NOTE Appearance of catheter shown in figure 11-1 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 145 Insert the catheter as described in the catheter instructions for use. Touch Start button. 11.2.1 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 146 HemoSphere Advanced Monitor 11 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 147. Touch clinical actions icon Oximetry Calibration icon ...
  • Page 147 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 148 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 149 11.7 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 150 Advanced Features Contents Acumen Hypotension Probability Indicator Software Feature ....... . .150 Enhanced Parameter Tracking.
  • Page 151 To activate the Acumen HPI software, the platform requires entry of a password to access the Manage Features screen, where an activation key must be entered. Please contact your local Edwards Representative for more information on enabling this Advanced Feature.
  • Page 152 HemoSphere Advanced Monitor 12 Advanced Features 12.1.1 Hypotension Probability P(↓BP) The P(↓BP) value will update every 20 seconds and displays as a percentage equating to the probability that a hypotensive event may occur. The higher the percentage value, the higher the probability that a hypotensive event (MAP <...
  • Page 153 HemoSphere Advanced Monitor 12 Advanced Features 12.1.2 P(↓BP) as a Key Parameter Once the HPI feature is activated, the user can configure P(↓BP) as a key parameter using the steps described in Change Parameters on page 66. The display of P(↓BP) differs in several ways from other key parameters. Display of other key parameters is described in Status Indicators on page 67.
  • Page 154 HemoSphere Advanced Monitor 12 Advanced Features Figure 12-1 P(↓BP) key parameter globe P(↓BP) will be displayed as shown in figure 12-1 when configured as a key parameter in all screens except the cockpit screen (figure 12-2). For more information about the cockpit screen, see Cockpit Screen on page 75.
  • Page 155 HemoSphere Advanced Monitor 12 Advanced Features parameter color (green/yellow/red). As with other available alarms on the HemoSphere advanced monitoring platform, the volume of the P(↓BP) available alarm is adjustable. See Alarms / Targets on page 100 for information about silencing the alarm and configuring the alarm volume. Occurrence of P(↓BP) alarm will be logged in the data download file following an update with P(↓BP) exceeding the alarm...
  • Page 156 HemoSphere Advanced Monitor 12 Advanced Features The HPI feature remains available even when P(↓BP) is not displayed on the screen. If P(↓BP) is configured as a key parameter, the parameter will alarm and alert as described in P(↓BP) Alarm on page 154.
  • Page 157 HemoSphere Advanced Monitor 12 Advanced Features The secondary screen, along with other key parameters on the monitoring screen, can be used to provide potential insight into the cause of a high hypotension probability or hypotension when such an even occurs.
  • Page 158 HemoSphere Advanced Monitor 12 Advanced Features For parameter derivations, see table C-1 in appendix C, Equations for Calculated Patient Parameters. 12.1.8 Clinical Application The Hypotension Probability Indicator (HPI) parameter, P(↓BP), can be configured as a key parameter on the monitoring screen, or it can be displayed only in the Information Bar at the bottom right on the monitoring screen, as described in Acumen Hypotension Probability Indicator Software Feature on page 150.
  • Page 159 HemoSphere Advanced Monitor 12 Advanced Features Dynamic arterial elastance (Ea ), – a measure of the afterload to the left ventricle by the arterial • system (arterial elastance), relative to the left ventricular elastance, computed as the ratio between PPV and SVV [8]. The arterial elastance is an integrative arterial load parameter that incorporates systemic vascular resistance (SVR), total arterial compliance (C) and systolic and diastolic time intervals [9, 10].
  • Page 160 HemoSphere Advanced Monitor 12 Advanced Features SVV, dP/dt and Ea are intended as integrative decision support parameters to guide an interventional treatment of SV or SV and MAP. 12.1.10 Clinical Validation A clinical validation study was undertaken to assess the measurement performance of the P(↓BP) parameter.
  • Page 161 HemoSphere Advanced Monitor 12 Advanced Features Table 12-7 and Table 12-8 provide the hypotensive event occurrence percentage and time-to-event data for a given P(↓BP) Range (%) for patients in the clinical validation study. These data are presented using time windows that have been selected based upon how fast hypotensive events developed on average in OR and ICU patients.
  • Page 162 HemoSphere Advanced Monitor 12 Advanced Features Table 12-8 ICU Time-to-Event in minutes: Median [10 percentile, P(↓BP) Range (%) Event Rate (%) percentile] 10-14 13.8 51.0 [10.0, 104.0] 15-19 17.2 48.7 [10.0, 102.3] 20-24 20.8 51.0 [9.9, 105.3] 25-29 25.1 48.5 [9.3, 104] 30-34 29.6...
  • Page 163 HemoSphere Advanced Monitor 12 Advanced Features Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness. A “gray zone” approach. Anesthesiology 2011; 115: 231-241.
  • Page 164 12 Advanced Features 12.2 Enhanced Parameter Tracking The HemoSphere advanced monitoring 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 165 HemoSphere Advanced Monitor 12 Advanced Features Touch any selected parameter to change it to a different available parameter or touch None on the parameter selection panel to remove it from tracking. To view and select parameter/target settings from a previous GDT tracking session, touch the Recents tab.
  • Page 166 HemoSphere Advanced Monitor 12 Advanced Features Table 12-9 GDT Target Status Indicator Colors Color Indication Tracked parameter is currently below the low alarm limit or above the high alarm limit. Gray Tracked parameter is unavailable, in a fault state, GDT tracking is paused, or a target has not been selected.
  • Page 167 HemoSphere Advanced Monitor 12 Advanced Features Touch the target value icon to accept the displayed target range and initiate GDT tracking. The edit target icon can be touched at anytime after target selection to adjust the SV/SVI target value. The GDT tracking icon can be touched at anytime when GDT mode is active to end the GDT tracking session.
  • Page 168 HemoSphere Swan-Ganz Module Error Messages ........
  • Page 169 13 Troubleshooting 13.2 Monitor Status Lights The HemoSphere advanced monitor has a visual alarm indicator to alert the user to alarm conditions. See Alarm Priorities on page 207 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 170 Refer to the screen to ascertain the type of technical priority technical alarm fault. Use the help menu or tables below for the appropriate suggested action 13.4 HemoSphere Advanced Monitor Error Messages 13.4.1 System Faults/Alerts Table 13-4 System faults/alerts Message...
  • Page 171 Connection points on cable or port are Check for bent or broken pins damaged Try switching to cable port 1 If problem persists, contact Edwards Technical Support Fault: Module Slot 1 – There is a software error with the module Contact Edwards Technical Support...
  • Page 172 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 173 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 174 HemoSphere Advanced Monitor 13 Troubleshooting 13.5 HemoSphere Swan-Ganz Module Error Messages 13.5.1 CO Faults/Alerts Table 13-7 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 175 Temporarily turn off sequential compression device per hospital procedure 13.5.2 EDV and SV Faults/Alerts Table 13-8 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 176 HemoSphere Advanced Monitor 13 Troubleshooting Table 13-8 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 177 HemoSphere Advanced Monitor 13 Troubleshooting 13.5.3 iCO Faults/Alerts Table 13-9 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 178 HemoSphere Advanced Monitor 13 Troubleshooting Table 13-9 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 179 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 180 HemoSphere Advanced Monitor 13 Troubleshooting Table 13-12 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 181 Internal system malfunction If problem persists, contact Edwards Technical Support Fault: Pressure Cable – A non-Edwards sensor has been detected Verify that an Edwards pressure sensor has been used Incompatible Sensor Cable or sensor malfunction Disconnect sensor and check for bent/missing contacts...
  • Page 182 Systolic pressure too high or diastolic stopcocks are properly positioned pressure too low Make sure Edwards CO sensor is aligned with the patient’s phlebostatic axis Zero the Edwards CO sensor on HemoSphere advanced monitor to zero transducer and confirm pressure cable...
  • Page 183 Make sure the arterial catheter is not kinked or clotted Make sure all arterial pressure lines are patent and stopcocks are properly positioned Make sure the Edwards CO sensor is aligned with the patient’s phlebostatic axis Zero the Edwards CO sensor on HemoSphere advanced...
  • Page 184 HemoSphere Advanced Monitor 13 Troubleshooting 13.6.3 SVR Faults/Alert Table 13-15 HemoSphere pressure cable SVR faults/alerts Message Possible causes Suggested actions Alert: SVR – Slaved-In CVP HemoSphere advanced monitor analog Verify correct voltage range and low/high voltage values Pressure Signal Loss...
  • Page 185 HemoSphere Advanced Monitor 13 Troubleshooting Table 13-17 HemoSphere pressure cable MAP faults/alerts (continued) Message Possible causes Suggested actions Alert: MAP – Pressure Arterial waveform is inadequate to Assess Edwards pressure monitoring system starting Waveform Not Stable measure blood pressure accurately...
  • Page 186 HemoSphere Advanced Monitor 13 Troubleshooting Table 13-19 HemoSphere pressure cable general troubleshooting (continued) Message Possible causes Suggested actions Connect pressure sensor for An arterial pressure-dependent key Verify connection between pressure cable and catheter arterial pressure monitoring parameter is configured Disconnect pressure cable and check for missing pins...
  • Page 187 Oximetry cable malfunction Power monitor off and on to restore platform Processing Malfunction Change oximetry cable and recalibrate If problem persists, contact Edwards Technical Support Fault: Oximetry Cable Memory Oximetry cable memory malfunction Disconnect and then reconnect the cable Change oximetry cable and recalibrate...
  • Page 188 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 189 HemoSphere Swan-Ganz Module Specifications ........
  • Page 190 HemoSphere Advanced Monitor A Specifications Table A-1 HemoSphere advanced monitor essential performance – transient and non-transient electromagnetic phenomena (continued) Module or Parameter Essential Performance cable HemoSphere Continuous Cardiac Output Monitors the filament surface temperature and time at temperature. If a time and temperature threshold is exceeded (above 45 °C),...
  • Page 191 Table A-4 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 192 HemoSphere Advanced Monitor A Specifications Table A-4 HemoSphere advanced monitor technical specifications (continued) Input/Output (continued) HRavg display CO Monitoring Off. Averaging time: 57 seconds; Update rate: Per beat; Response time: 40 seconds for step increase from 80 to 120 BPM, 29 seconds for step decrease from 80 to 40 BPM.
  • Page 193 Dimensions Height 1.36 in (3.45 cm) Width 3.53 in (8.96 cm) Depth 5.36 in (13.6 cm) Table A-9 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)
  • Page 194 HemoSphere oximetry cable Weight approximately 0.64 lbs (0.29 kg) Dimensions Length 15 ft (4.6 m) Table A-11 HemoSphere pressure cable parameter measurement specifications Parameter Specification FloTrac cardiac output (CO) Display range 1.0 to 20 L/min ±6% or 0.1 L/min, whichever is greater...
  • Page 195 Additional Accessories Description............196 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 196 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 197 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 198 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 199 HemoSphere Advanced Monitor C Equations for Calculated Patient Parameters Table C-1 Cardiac and oxygenation profile equations (continued) Parameter Description and formula Units Dynamic Arterial Elastance = PPV/SVV where: SVV – Stroke Volume Variation,%: PPV – Pulse Pressure Variation, calculated as:...
  • Page 200 HemoSphere Advanced Monitor C Equations for Calculated Patient Parameters Table C-1 Cardiac and oxygenation profile equations (continued) Parameter Description and formula Units Oxygen Extraction Ratio ER = (Ca-vO / CaO ) x 100 (%) where: – Arterial Oxygen Content, mL/dL Ca-vO –...
  • Page 201 HemoSphere Advanced Monitor C Equations for Calculated Patient Parameters Table C-1 Cardiac and oxygenation profile equations (continued) Parameter Description and formula Units Systemic Vascular Resistance SVR = {(MAP - CVP) x 80} /CO (dyne-sec/cm dyne-s/cm SVR = {(MAP – CVP...
  • Page 202 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 203 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 204 P(↓BP) 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 205 HemoSphere Advanced Monitor D Monitor Settings and Defaults Table D-3 Configurable parameter alarm and display ranges (continued) Configurable Parameter Units Display Range Range mmHg 0 to 300 0 to 300 MAP (live arterial mmHg -34 to 312 0 to 300...
  • Page 206 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 207 CO and associated FloTrac system parameters, the delay is 2 seconds for 5 second parameter averaging, and 20 seconds for 20 second and 5 minute parameter averaging (see table 6-1 on page 95). For HemoSphere pressure cable with TruWave DPT measured parameters, the delay is 2 seconds.
  • Page 208 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 209 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 210 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 211 Edwards Lifesciences Regional Headquarters........
  • Page 212 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 alcohol •...
  • Page 213 F.3.3 Cleaning the Pressure Cable The HemoSphere pressure cable can be cleaned using the cleaning agents and methods specified for platform cables at the start of this section (section F.3). Disconnect the pressure cable from the monitor to air dry the connector. To blow dry the transducer connector, use clean, dry wall air, canned air, or CO aerosol for at least two minutes.
  • Page 214 Edwards Lifesciences. Edwards provides HemoSphere advanced monitor operations support: Within the United States and Canada, call 1.800.822.9837. • Outside the United States and Canada, contact your local Edwards Lifesciences representative. • E-mail operational support questions to tech_support@edwards.com. • Have the following information before you call: The HemoSphere advanced monitor’s serial number, located on the rear panel;...
  • Page 215 HemoSphere Advanced Monitor F System Care, Service and Support Japan: Edwards Lifesciences Ltd. Australia: Edwards Lifesciences Pty Ltd Nittochi Nishi-Shinjuku Bldg. Unit 2 40 Talavera Road 6-10-1, Nishi-Shinjuku, North Ryde Shinjuku-ku, NSW 2113 Tokyo 160-0023 Japan PO Box 137, North Ryde BC Phone 81.3.6894.0500...
  • Page 216 F.6.1 Battery Recycling Replace the HemoSphere battery pack when it no longer holds a charge. After removal, follow your local recycling guidelines. CAUTION Recycle or dispose of the lithium-ion battery in accordance to all federal, state, and local laws.
  • Page 217 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 218 The HemoSphere advanced monitor is intended for use in the electromagnetic environment specified in this appendix. The customer or the user of the HemoSphere advanced monitor should assure that it is used in such an environment. When connected to the HemoSphere advanced monitor, all accessory cables listed in...
  • Page 219 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 220 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 221 Table G-3 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 222 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 223 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 224 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-6 HemoSphere advanced monitor wireless information...
  • Page 225 HemoSphere Advanced Monitor G Guidance and Manufacturer’s Declaration Table G-6 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 226 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 227 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 228 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 229 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 230 Initial operating conditions assumed by the system. Bolus (iCO) Mode Dynamic Arterial Elastance (Ea Functional state of the HemoSphere Swan-Ganz module Dynamic arterial elastance is the ratio of pulse pressure in which cardiac output is measured by the bolus variation and stroke volume variation (PPV/SVV). It is an thermodilution method.
  • Page 231 Intermittent Cardiac Index (iCI) Slave Cable Intermittent cardiac output adjusted according to body Cable that transfers data to the HemoSphere advanced size. monitor from another monitor. Intervention STAT Value Steps taken to change a patient’s condition.
  • Page 232 HemoSphere Advanced Monitor H Glossary Systemic Vascular Resistance Index (SVRI) Systemic vascular resistance adjusted for body size. Thermal Filament Area on the CCO thermodilution catheter that transfers small amounts of energy into the blood to serve as indicator for trending cardiac output continuously.
  • Page 233 HDMI display size countdown timer display specifications monitoring with HemoSphere Swan- monitor Battery Ganz module disposal, monitor installation required accessories distances battery Cockpit monitoring screen recommended for equipment...
  • Page 234 Grey LVSWI indicator def. Group 1 RF Emissions def. monitoring with HemoSphere Swan- Ganz module maintenance harmonic emissions required accessories IEC 61000-3-2 def. def. mechanical specifications def. IEC 60601-1 message area...
  • Page 235 RVEF monitoring data RVSWI def. data parameters def. equation monitoring with HemoSphere Swan- Ganz module Patient CCO cable test scales required accessories patient data adjust SVR equation SVRI enter def. def. Patient Data in oximetry cable more than...
  • Page 236 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...
  • Page 237 Index Page intentionally left blank...
  • Page 238 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.