Edwards HemoSphere Vita Operator's Manual
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Edwards HemoSphere Vita Operator's Manual

Edwards HemoSphere Vita Operator's Manual

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Summary of Contents for Edwards HemoSphere Vita

  • Page 1 HemoSphere HemoSphere Advanced Monitor Vita 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 Using This Manual The Edwards HemoSphere Vita monitor operator’s manual is comprised of twelve chapters and seven appendices. 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 ForeSight tissue oximetry monitoring Advanced Features: Describes the advanced monitoring features that are currently available for upgrade with the HemoSphere Vita 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: Table Of Contents

    1.6 HemoSphere Vita Monitor Hemodynamic Technology Connections ..1.6.1 HemoSphere Vita Technology Module ......19 1.6.1.1 HemoSphere Vita Technology Module and ForeSight Oximeter Cable...
  • Page 6 3.3 HemoSphere Vita Monitor Installation ....... 3.3.1 Mounting Options and Recommendations ......42 3.3.2 Battery Installation .
  • Page 7 9 HemoSphere VitaWave Module Non-Invasive Monitoring 9.1 HemoSphere Vita Non-Invasive System Methodology ....9.1.1 Volume Clamp Method ........94 9.1.2 Physiocal Method .
  • Page 8 9.1.8 Methodology References ........96 9.2 Connecting the HemoSphere Vita Non-Invasive System ....
  • Page 9 12.4 Pressure Controller Communication ....... . 138 12.5 HemoSphere Vita Monitor Error Messages ......
  • Page 10 E.4 Service and Support ..........E.5 Edwards Lifesciences Regional Headquarters ......
  • Page 11 Figure 5-1 HemoSphere Vita monitor screen features ....... . .
  • Page 12 Figure 10-14 Connecting a sensor to the ForeSight oximeter cable – channel status LED . . . 128 Figure 12-1 HemoSphere Vita monitor LED indicators ......136 Figure 12-2 ForeSight oximeter cable LED indicators .
  • Page 13 Table 3-1 HemoSphere Vita monitoring components ....... . . 37...
  • Page 14 Table B-1 HemoSphere Vita monitor components ........
  • Page 15 Equipment and the HemoSphere Vita monitor ........

  • Page 16: Introduction

    Expected Clinical Benefit ..............19 HemoSphere Vita Monitor Hemodynamic Technology Connections......19 Manual style conventions .

  • Page 17: Indications For Use

    The HemoSphere Vita monitor when used with the HemoSphere VitaWave module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment.

  • Page 18: Intended Use Statement

    No other contraindications were known at the time this operator’s manual was published. 1.4 Intended Use Statement The HemoSphere Vita monitoring platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting.

  • Page 19: Expected Clinical Benefit

    1.6 HemoSphere Vita Monitor Hemodynamic Technology Connections The HemoSphere Vita monitor is equipped with three technology expansion module slots (two standard size and one large [L-Tech] size). Module and cable connection points are located on the left side panel. See figure 1-1.

  • Page 20: Hemosphere Vitawave Module

    ForeSight oximeter cable (FSOC) may also be labeled as FORE-SIGHT ELITE tissue oximeter module (FSM). ForeSight sensors or ForeSight Jr sensors may also be labeled as FORE-SIGHT ELITE tissue oximetry sensors. Table 1-3 HemoSphere Vita technology module with ForeSight oximeter cable parameters description Parameter Description...

  • Page 21: Manual Style Conventions

    HemoSphere Roll Stand Instructions for Use • Instructions for Use are included with HemoSphere Vita Monitor components. See table B-1, “HemoSphere Vita monitor components,” on page 160. For more information on how you can receive training or available documentation for the HemoSphere Vita monitor, contact your local Edwards representative or Edwards Technical Support.

  • Page 22: Table 1-6 Acronyms, Abbreviations

    POST power-on self test pulse rate oxygen saturation signal quality indicator surface temperature tissue oxygen saturation systemic arterial systolic blood pressure Touch Interact with the HemoSphere Vita monitor by touching the screen. Universal Serial Bus...

  • Page 23: Safety And Symbols

    HemoSphere Vita Monitor Essential Performance ........

  • Page 24: Warnings

    2 Safety and Symbols 2.2 Warnings The following are warnings that are used in the HemoSphere Vita 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 Vita •...
  • Page 25 Portable RF communications equipment (including peripherals such as antenna cables and external • antennas) should be used no closer than 30 cm (12 inches) to any part of the HemoSphere Vita monitor, including cables specified by the manufacturer. Otherwise, degradation of the performance this equipment could result.
  • Page 26 Improper finger cuff placement or sizing can lead to inaccurate monitoring. (chapter 9) • Do not use the HemoSphere Vita non-invasive system as a heart rate monitor. (chapter 9) • If using the instrument during full body irradiation, keep all HemoSphere Vita non-invasive system •...
  • Page 27 Inspect all of the ForeSight oximeter cable connections for damage prior to installation. If any • damage is noted, the cable must not be used until it has been serviced or replaced. Contact Edwards Technical support. There is a risk that damaged parts could reduce the performance of the cable or present a safety hazard.
  • Page 28 Testing of the ForeSight oximeter cable operation should be done at least once every 6 months, as • described in HemoSphere Vita service manual. Failure to comply may lead to injury. If the cable fails to respond, it must not be used until it has been inspected and serviced or replaced. See technical support contact information on inside cover.

  • Page 29: Cautions

    Guidance on maintaining appropriate separation between communications equipment and the HemoSphere Vita monitor is provided in table F-3. The effects of other RF emitters are unknown and may interfere with the function and safety of the HemoSphere monitoring platform.
  • Page 30 Make sure that the HRS is correctly applied so that it can be leveled to the phlebostatic axis. • (chapter 9) The HemoSphere Vita non-invasive system is not intended for use as an apnea monitor. (chapter 9) • In patients with extreme contraction of the smooth muscle in the arteries and arterioles in the lower •...
  • Page 31 If any of the ForeSight oximeter cable LEDs fail to turn on, the cable must not be used until it has • been serviced or replaced. Contact Edwards Technical Support. There is a risk that damaged parts could reduce the performance of the cable. (chapter 12)

  • Page 32: User Interface Symbols

    Do not attempt to open cable or module housing or use if the housing has been damaged. (appendix E) Do not pour or spray liquid on any portion of the HemoSphere Vita monitor, accessories, modules, • or cables. (appendix E) Do not use any disinfecting solution other than the types specified.

  • Page 33: Table 2-1 Monitor Display Symbols

    HemoSphere Vita Monitor 2 Safety and Symbols Table 2-1 Monitor display symbols Table 2-1 Monitor display symbols (continued) Symbol Description Symbol Description Navigation Bar Icons BP Calibration (VitaWave BP) (HemoSphere VitaWave module) start non-invasive monitoring (HemoSphere VitaWave module) HRS Calibration...
  • Page 34 HemoSphere Vita Monitor 2 Safety and Symbols Table 2-1 Monitor display symbols (continued) Table 2-1 Monitor display symbols (continued) Symbol Description Symbol Description clock/waveform - allows user to view intervention analysis type indicator for historical data or intermittent data positional challenge (purple)

  • Page 35: Symbols On Product Labels

    HemoSphere Vita Monitor 2 Safety and Symbols 2.5 Symbols on Product Labels This section provides the symbols that are on the HemoSphere Vita monitor and other available HemoSphere Vita monitoring platform accessories. Table 2-2 Symbols on product labels Table 2-2 Symbols on product labels (continued)

  • Page 36: Applicable Standards

    Specifications 2.7 HemoSphere Vita Monitor Essential Performance The platform shall provide non-invasive measurement of arterial blood pressure with a compatible Edwards finger cuff according to the specifications provided in appendix A. The platform shall provide display of with a compatible oximetry module and sensor according to the specifications provided in appendix A.

  • Page 37: Installation And Setup

    HemoSphere Vita Monitor Connection Ports ........

  • Page 38: Table 3-2 Finger Cuff Options For Monitoring Parameters With Hemosphere Vitawave Module

    Finger cuff options (one required) SYS/DIA/MAP • • VitaWave finger cuff • • ClearSight/Acumen IQ finger cuff Table 3-3 Accessories required for monitoring parameters with HemoSphere Vita technology module Tissue oximetry (StO Required accessory • ForeSight oximeter cable • ForeSight/ForeSight Jr sensor...

  • Page 39: Hemosphere Vita Monitor Connection Ports

    3 Installation and Setup 3.2 HemoSphere Vita 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 Vita monitor. 3.2.1 Monitor Front visual alarm indicator ...

  • Page 40: Monitor Rear

    Ethernet port   USB port  COM1 serial port   connector (RS-232) analog input 1   analog input 2  ECG input   pressure output  equipotential  terminal stud Figure 3-2 HemoSphere Vita monitor rear view...

  • Page 41: Monitor Right Panel

    HemoSphere Vita Monitor 3 Installation and Setup 3.2.3 Monitor Right Panel USB port  battery door  Figure 3-3 HemoSphere Vita monitor right panel...

  • Page 42: Monitor Left Panel

    3.3.1 Mounting Options and Recommendations The HemoSphere Vita 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 Vita monitor is available as an optional accessory.

  • Page 43: Battery Installation

    HemoSphere Vita Monitor 3 Installation and Setup The HemoSphere Vita monitor must be positioned in an upright position to ensure IPX1 ingress protection. Do not allow any liquids to splash onto the monitoring screen. Liquid buildup may disable the touchscreen functionality.

  • Page 44: Connecting Power Cord

    Plug power cord into a hospital grade outlet. WARNING Do not use the HemoSphere Vita monitoring platform without an installed power cord entry cover. Failure to do so may result in fluid ingress. Figure 3-5 HemoSphere Vita monitor power entry cover - screw locations...

  • Page 45: Equipotential Connection

    3.3.4 Connecting and Disconnecting a Hemodynamic Monitoring Module The HemoSphere Vita monitor is shipped with two standard expansion modules and one L-Tech expansion module. Before inserting a new monitoring technology module, remove the expansion module by pressing the release button to unlatch and slide the blank module out.

  • Page 46: Initial Start Up

    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 47: Select Device Id

    Select Device ID Upon initial HemoSphere Vita monitor startup, the user can select a Device ID or name for the monitor on the New Patient Data screen. See New Patient on page 76. The Device ID defaults to the monitor serial number but can be changed to any 20 character name.

  • Page 48: Hemosphere Vita Monitor Quick Start

    HemoSphere Vita monitor. Refer to the manual chapters for more detailed information, warnings, and cautions. 4.1 HemoSphere Tissue Oximetry Monitoring The HemoSphere Vita technology module is compatible with a ForeSight oximeter cable and ForeSight/ ForeSight Jr sensors. The HemoSphere Vita technology module fits into a standard module slot. NOTE...

  • Page 49: Connecting The Hemosphere Vita Technology Module

    Insert the HemoSphere Vita technology module into the monitor. The module will click when properly engaged. Press the power button to turn on the HemoSphere Vita monitor. All functions are accessed through the touch screen. Select Continue Same Patient button or New Patient button and enter new patient data.
  • Page 50 HemoSphere Vita Monitor 4 HemoSphere Vita Monitor Quick Start Select the anatomical location of the sensor. See table 10-1 on page 122 for a list of available sensor locations. Touch the home icon to return to the monitoring window. Touch anywhere in the StO...

  • Page 51: Hemosphere Vitawave Module Monitoring

    Insert the HemoSphere VitaWave module into the large technology (L-Tech) slot of monitor. The module will click when properly engaged. Press the power button to turn on the HemoSphere Vita monitor. All functions are accessed through the touch screen. Select Continue Same Patient button or New Patient button and enter new patient data.
  • Page 52 Connect finger cuff to pressure controller. NOTE After 8 hours of accumulated monitoring on the same finger, the HemoSphere Vita non-invasive system will stop monitoring and display a warning to place the cuff on another finger if continued monitoring is desired.

  • Page 53: Navigating The Hemosphere Vita Monitor

    HemoSphere Vita Monitor Screen Appearance ........

  • Page 54: Figure 5-1 Hemosphere Vita Monitor Screen Features

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor Status Bar (section 5.6) Main Window/Monitor Views (section 5.3) ① ④ Information Bars (section 5.5) Navigation Bar (section 5.2) ② ⑤ Parameter Tile (section 5.3.2) ③ Figure 5-1 HemoSphere Vita monitor screen features...

  • Page 55: Navigation Bar

    5 Navigating the HemoSphere Vita Monitor 5.2 Navigation Bar The navigation bar is present on most screens. Exceptions are the startup screen and screens indicating the HemoSphere Vita monitor has stopped monitoring. All available icons are described in detail below. Additional Icons Start/Stop Monitoring...
  • Page 56 HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor This icon allows the user to display the blood pressure waveform during Display Blood Pressure Waveform. non-invasive monitoring. See Live Blood Pressure Waveform Display on page 64. This icon allows the user to hide the blood pressure waveform.

  • Page 57: Monitor Views

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor Advanced Setup: See chapter 7: Alarms/Targets, chapter 7: Adjust Scales, and chapter 8: Data Export • and Connectivity Settings Export Data: See chapter 8: Data Export and Connectivity Settings • Demo Mode: See chapter 7: Demo Mode •...

  • Page 58: Change Monitor Views

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor 5.3.1 Change Monitor Views Touch the settings icon Select Screens tab . 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 parameter tiles on monitoring screens.

  • Page 59: Change Alarm/Target

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor Oximetry parameters include tissue oximetry (StO OXIMETRY. Figure 5-4 Example of key parameter selection tile configuration menu Touch an available parameter to select the replacement parameter. To change the order of any key parameter, touch and hold the parameter tile until the tile appears with a blue outline.

  • Page 60: Status Indicators

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor 5.3.2.3 Status Indicators A parameter tile is outlined in color to indicate the patient’s current status. The color changes as the patient’s status changes. Items on the tile that appear underlined can be touched to access a configuration menu. The...

  • Page 61: Graphical Trend Monitoring View

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor The SQI bar is a reflection of the signal quality during tissue oximetry or non-invasive SQI Bar. monitoring. Signal quality is based on the near-infrared light tissue perfusion index for tissue oximetry, see table 10-5, “Signal quality indicator levels,”...

  • Page 62: Graphical Trend Scroll Mode

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor 5.3.3.1 Graphical Trend Scroll Mode Up to 72 hours of monitored parameter data can be viewed scrolling back. To start scrolling, swipe to the right/left or touch the appropriate scroll mode button as shown above.

  • Page 63: Table 5-2 Intervention Events

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor Select the keyboard icon to enter notes (optional). 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...

  • Page 64: Live Blood Pressure Waveform Display

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor NOTE The intervention information balloon has a 2 minute time out. Intervention Editing. The time, date, and associated note for each intervention can be edited after initial entry: Touch the intervention event indicator associated with the intervention to be edited.

  • Page 65: Tabular Trends

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor 5.3.4 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 66: Clinical Tools

    The screen will return to live mode two minutes after the last touch of the scroll arrow icon or if the cancel icon is touched. 5.4 Clinical Tools The following clinical actions are available on the HemoSphere Vita monitor. 5.4.1 Event Review Use Event Review to view parameter-related and system events that occurred during monitoring.
  • Page 67 HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor Table 5-4 Reviewed events (continued) Event When time logged BP Calibration Successful Blood pressure calibration is successfully completed where {0} is the user- REFERENCE: SYS {0}, entered reference value for SYS and {1} is the user-entered value for DIA...

  • Page 68: Information Bar

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor Table 5-4 Reviewed events (continued) Event When time logged Monitoring Stopped as Single Monitoring for 8 continuous hours on a single cuff has occurred Cuff Use Has Exceeded 8 Hours Positioning Mode: <mode>...

  • Page 69: Battery

    5.5.1 Battery The HemoSphere Vita 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 43. 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 70: Screen Brightness

    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 Vita monitor is required to save the image. Touch the snapshot icon located on the information bar 5.5.5...

  • Page 71: Status Bar

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor Touch the time that the screen will remain locked on the Lock Screen popup. Figure 5-12 Lock screen popup A red lock icon will appear on the information bar. To unlock the screen, touch the red lock icon and touch Unlock Screen on the Lock Screen menu.

  • Page 72: Navigation Icons

    HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor If selecting from a list, the vertical scroll arrows move up or down one item at a time. 5.7.2 Navigation Icons There are some buttons that always perform the same function: Home.
  • Page 73 HemoSphere Vita Monitor 5 Navigating the HemoSphere Vita Monitor Touch the keys on the keypad to enter numeric data. Keypad. data type units backspace cancel enter Keyboard. Touch the keys on the keyboard to enter alphanumeric data. data type backspace...

  • Page 74: User Interface Settings

    Monitoring will remain active. In the event of forgotten passwords, contact your local Edwards representative. Two settings menu options are password protected: Advanced Setup and Export Data.

  • Page 75: Changing Passwords

    HemoSphere Vita Monitor 6 User Interface Settings Table 6-2 Advanced setup menu navigation and password protection (continued) Advanced setup Super Secure Edwards Sub-menu selection menu selection User User User • • Manage Features no access • • Service System Status no access •...

  • Page 76: New Patient

    WARNING Perform New Patient or clear the patient data profile whenever a new patient is connected to the HemoSphere Vita 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 New Patient and continue to step 6.

  • Page 77: Figure 6-2 New Patient Data Screen

    HemoSphere Vita Monitor 6 User Interface Settings NOTE If the user skips entering patient demographics, only the following limited parameters can be monitored: StO , ∆ctHb, SYS , DIA , MAP, and PR. Touch Patient Data icon Touch End Session button.

  • Page 78: Continue Monitoring Patient

    The HemoSphere Vita monitor interface is available in several languages. A language selection screen appears the first time the HemoSphere Vita monitor is started. See figure 3-7, “Language selection screen,” on page 47. The language screen will not appear again, but the display language can be changed at any time.

  • Page 79: Change Date And Time Display

    HemoSphere Vita Monitor 6 User Interface Settings Touch the General button. Figure 6-3 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.

  • Page 80: Monitoring Screens Settings

    HemoSphere Vita Monitor 6 User Interface Settings Touch General button. To change the date, touch the value section of the Date Adjust button and enter the date on the keypad. To change the time, touch the value section of the Time Adjust button and enter the time.

  • Page 81: Alarms/Targets

    Demo Mode ................88 7.1 Alarms/Targets There are two types of alarms on the HemoSphere Vita 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 82: Advanced Settings

    HemoSphere Vita Monitor 7 Advanced Settings Oximetry: 2 seconds • NOTE Arterial blood pressure (ART) related physiological and technical alarms will only sound after ART is zeroed and mean arterial pressure (MAP) has 10 continuous readings above 10 mmHg. All alarms are logged and stored for the given patient and can be accessed via the Data Download function (see Data Download on page 90).

  • Page 83: Set Alarm Volume

    HemoSphere Vita Monitor 7 Advanced Settings 7.1.2 Set Alarm Volume The alarm volume ranges from low to high with a default of medium. It applies to physiological alarms, technical faults, and alerts. Alarm volume can be changed at any time.

  • Page 84: 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 85: Configure All Targets

    Defaults.” appears. 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’...

  • Page 86: Figure 7-2 Set Individual Parameter Alarms And Targets

    HemoSphere Vita Monitor 7 Advanced Settings Use the arrows to adjust the zone settings or touch the value button to open a numeric keypad. Figure 7-2 Set individual parameter alarms and targets When the values are correct, touch the enter icon...

  • Page 87: Adjust Scales

    HemoSphere Vita 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 88: Demo Mode

    Demonstration Mode is used to display simulated patient data to assist in training and demonstration. Demonstration mode displays data from a stored set and continually loops through a predefined data set. During Demo Mode, the HemoSphere Vita monitoring platform user interface retains the same...
  • Page 89 HemoSphere VitaWave module and Non-Invasive monitoring mode. Touch Yes on the Demo Mode confirmation screen. The HemoSphere Vita monitoring platform must be restarted prior to monitoring a patient. WARNING Make sure that Demo Mode is not activated in a clinical setting to ensure that simulated...

  • Page 90: Data Export And Connectivity Settings

    Cybersecurity................92 8.1 Export Data The Export Data screen lists a number of data export features of the HemoSphere Vita monitor. This screen is password protected. From this screen clinicians can export diagnostic reports, delete monitoring sessions, or export monitoring data reports.

  • Page 91: Monitoring Data

    A Diagnostics Export option within the Export Data settings menu is provided where this information can be downloaded for diagnostic purposes. This information may be requested by Edwards service personnel to help troubleshoot issues. In addition, this engineering section provides detailed software revision information of connected platform components.

  • Page 92: Cybersecurity

    This chapter outlines ways in which patient data can be transferred to and from the HemoSphere Vita monitor. It is important to note that any facility using the HemoSphere Vita 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 policies for managing this information.

  • Page 93: Cybersecurity Incident Response

    8.2.3 Cybersecurity Incident Response If there is or has been a suspected cybersecurity incident(s) that has affected the HemoSphere Vita monitor, please contact your local Edwards representative or Edwards Technical Support. It is recommended that an internal cybersecurity incident response plan be in place which includes – but is not limited to – an incident response policy, incident response procedures, short and long term goals for the organization, and metrics for measuring the success of the plan.

  • Page 94: Hemosphere Vitawave Module Non-Invasive Monitoring

    Connecting the HemoSphere Vita Non-Invasive System ........

  • Page 95: Physiocal Method

    HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring 9.1.2 Physiocal Method The Physiocal method, developed by K.H. Wesseling (K.H. Physiocal Wesseling et al. 1995) , is short for physiological calibration. Physiocal adjusts for changes in the “un-stretched” volume during a normal measurement period. Cuff pressure is kept constant for one or more heart beats and blood pressure measurement is momentarily interrupted to observe the physiological properties of the finger artery.

  • Page 96: Single Cuff Monitoring

    9.1.6 Single Cuff Monitoring A single compatible Edwards finger cuff can be used for accumulated monitoring of the same patient for up to 8 hours on a single finger. During single cuff monitoring, the HemoSphere Vita non-invasive system will automatically release the pressure in the cuff at regular user selected intervals (30 minutes, 2 hours, and 4 hours).

  • Page 97: Figure 9-1 Hemosphere Vita Non-Invasive System Connection Overview

    HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring Align and insert the HemoSphere VitaWave module into an large technology (L-Tech) module slot on the left panel of the HemoSphere Vita monitor. The module will click in place when properly engaged. CAUTION Do not force the module into the slot.
  • Page 98 WARNING Do not sterilize any components of the HemoSphere Vita non-invasive system. The HemoSphere Vita non-invasive system is provided non sterile. Refer to cleaning instructions. Do not disinfect the instrument by autoclave or gas sterilization.

  • Page 99: Apply The Pressure Controller

    HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring 9.2.1 Apply the Pressure Controller The pressure controller is worn on the patient’s wrist and connects to the HemoSphere VitaWave module, HRS and finger cuff(s). See figure 9-2.  pressure controller ...

  • Page 100: Select Finger Cuff Size

    9.2.3 Apply Finger Cuff(s) Refer to the product IFU for detailed instructions on proper compatible Edwards finger cuff placement and actual device illustrations. Single Patient Use. The VitaWave and Acumen IQ finger cuffs are designed for single patient use. Upon starting a measurement, the finger cuff will expire after 72 hours for a single patient.

  • Page 101: Apply The Heart Reference Sensor

    HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring 9.2.4 Apply the Heart Reference Sensor The Heart Reference Sensor (HRS) should always be used in conscious patients, freely moving patients or those patients that will be frequently re-positioned during the case. Follow the on-screen prompts or the steps below to connect the HRS.

  • Page 102: General Troubleshooting Of Hemosphere Vita Non-Invasive System

    WARNING Do not use the HemoSphere Vita non-invasive system as a heart rate monitor. If using the instrument during full body irradiation, keep all HemoSphere Vita non- invasive system monitoring components out of the irradiation field. If a monitoring component is exposed to the irradiation, the readings may be affected.
  • Page 103 HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring CAUTION The HemoSphere Vita non-invasive system is not intended for use as an apnea monitor. CAUTION In patients with extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand, such as may be present in patients with Raynaud’s disease, blood pressure measurement can become impossible.

  • Page 104: Optional Hrs

    HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring 9.3 Optional HRS Optional HRS is a feature that must be enabled. If this feature is enabled, steps vary from how described previously in Heart Reference Sensor on page 95. The HemoSphere non-invasive system finger cuff algorithm must account for differences in pressure due to the change in vertical level of the monitored finger relative to the heart.

  • Page 105: Update Offset Value During Monitoring

    HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring NOTE If an HRS is connected a popup screen with the message “Alert: HRS Detected” is displayed. To start monitoring with the HRS, touch Yes and proceed to step 2 under Apply the Heart Reference Sensor on page 101.

  • Page 106: Change Patient Positioning Mode

    9.4 SQI A signal quality indicator (SQI) is present on all non-invasive parameter tiles during HemoSphere Vita non- invasive system monitoring. SQI level is calculated with each parameter update every 20 seconds. See table 9- 2 below for a description of arterial waveform SQI levels.

  • Page 107: Physiocal Display

    HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring Table 9-2 Arterial waveform SQI levels (continued) Appearance Level Indication Poor (possible alert status causing limited signal) Unacceptable (possible alert status causing extremely limited or no signal; see table 12-8 on page 142 for a list of...

  • Page 108: Calibrate The Heart Reference Sensor

    HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring Double Cuff. For double cuff monitoring, select a switching time interval from the available option list. Optional HRS. The optional heart reference sensor (HRS) feature can be enabled or disabled from this toggle button. This menu option is an advanced feature and must be enabled. If the Optional HRS feature is enabled, the user has the option of manually entering a vertical offset value between the hand and heart instead of using an HRS.

  • Page 109: Cuff Pressure Release Mode

    9.6.2 Cuff Pressure Release Mode During single cuff monitoring, the HemoSphere Vita non-invasive system will automatically release pressure from the finger cuff at regular intervals. When ≤ 5 minutes remain until Cuff Pressure Release Mode, a white countdown timer icon will appear on the information bar along with the time remaining until pressure release.

  • Page 110: Figure 9-9 Bp Calibration Screen

    HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring NOTE BP Calibration is not available during double cuff monitoring. CAUTION Do not perform a BP calibration during monitoring periods when blood pressure appears unstable. This may result in inaccurate blood pressure measurements.

  • Page 111: Output Signal To Patient Monitor

    The HemoSphere pressure-out cable is a reusable accessory that enables the user to output arterial pressure monitored by the HemoSphere Vita monitor to a compatible patient monitor for standard pressure monitoring. Device performance, including functional characteristics, have been verified in a comprehensive series of testing to support the safety and performance of the device for its intended use when used in accordance with the established Instructions For Use.

  • Page 112: Figure 9-11 Transmit Arterial Pressure Waveform To Patient Monitor

    HemoSphere Vita Monitor 9 HemoSphere VitaWave Module Non-Invasive Monitoring Plug the 18-pin connector of the HemoSphere pressure-out cable (see in figure 9-10) into the  rear panel of the monitor at the pressure-out port denoted by the analog out symbol .

  • Page 113: Hemosphere Tissue Oximetry Monitoring

    ForeSight Oximeter Cable Overview ........... . .114 Connecting the HemoSphere Vita Technology Module and ForeSight Oximeter Cable ... . .118 10.1 HemoSphere Tissue Oximetry Monitoring...

  • Page 114: Foresight Oximeter Cable Overview

    HemoSphere Vita Monitor 10 HemoSphere Tissue Oximetry Monitoring NOTE The following components may have alternative labeling conventions: ForeSight oximeter cable (FSOC) may also be labeled as FORE-SIGHT ELITE tissue oximeter module (FSM). ForeSight sensors or ForeSight Jr sensors may also be labeled as FORE-SIGHT ELITE tissue oximetry sensors.

  • Page 115: Foresight Oximeter Cable Mounting Solutions

    HemoSphere Vita Monitor 10 HemoSphere Tissue Oximetry Monitoring 10.2.1 ForeSight Oximeter Cable Mounting Solutions The ForeSight oximeter cable is packaged with a mounting clip. Figure 10-3 and figure 10-4 identify attachment points on the mounting clip and cable housing.  mounting clip slot ...

  • Page 116: Attaching The Mounting Clip Horizontally

    HemoSphere Vita Monitor 10 HemoSphere Tissue Oximetry Monitoring On the rear of the cable housing, position the mounting clip with the slot facing the mounting clip slide. Slide the mounting clip towards the top of the cable housing, until the mounting clip retaining tab locks in to the vertical mounting clip retaining recess.

  • Page 117: Removing The Mounting Clip

    HemoSphere Vita Monitor 10 HemoSphere Tissue Oximetry Monitoring NOTE You may attach the mounting clip with the opening facing the left or right side.  mounting clip retaining  mounting clip retaining recess (horizontal) Figure 10-6 Attaching the mounting clip horizontally 10.2.3 Removing the Mounting Clip...

  • Page 118: Connecting The Hemosphere Vita Technology Module And Foresight Oximeter Cable

    10.3 Connecting the HemoSphere Vita Technology Module and ForeSight Oximeter Cable The HemoSphere Vita technology module is compatible with a ForeSight oximeter cable and ForeSight/ ForeSight Jr sensors. The HemoSphere Vita technology module fits into a standard module slot. NOTE...

  • Page 119: Figure 10-8 Tissue Oximetry Monitoring Connection Overview

    The ForeSight oximeter cable can remain connected to the patient during cardiac defibrillation. The HemoSphere Vita technology module is shipped with ESD covers for the ForeSight oximeter cable connection ports. After removing them when using the system for the first time, it is recommended that they be kept and used to protect the electrical connection points when the ports are not in use.
  • Page 120 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 Vita monitor. All functions are accessed through the touch screen. Ensure proper orientation, then plug the ForeSight oximeter cable into the technology module.

  • Page 121: Figure 10-9 Foresight Oximeter Cable Status Led

    1 and channel 2 status LEDs should turn on. The group status LED will also turn on, indicating the module channels are group A (connected to port A on inserted technology module) or group B (connected to port B on inserted technology module).  HemoSphere Vita technology  Green module group status module port A...

  • Page 122: Table 10-1 Tissue Oximetry Sensor Locations

    Adult sensor mode is configured for any body weight ≥40 kg. Select the anatomical location of the sensor. See table 10-1 for a list of available sensor locations. The sensor locations are color coded based on the HemoSphere Vita technology module connection port:...

  • Page 123: Attaching Sensors To The Patient

    10 HemoSphere Tissue Oximetry Monitoring • Green: Sensor locations for an ForeSight oximeter cable connected to port A on HemoSphere Vita technology module • Blue: Sensor locations for an ForeSight oximeter cable connected to port B on HemoSphere Vita technology module Touch the home icon to return to the monitoring screen.

  • Page 124: Preparing The Sensor Site

    WARNING Use only Edwards supplied accessories with the ForeSight oximeter cable. Edwards accessories ensure patient safety and preserve the integrity, accuracy, and electromag- netic compatibility of the ForeSight oximeter cable. Connecting a non-Edwards sensor will cause an appropriate alert on that channel and no StO values will be recorded.

  • Page 125: Applying Sensors

    HemoSphere Vita Monitor 10 HemoSphere Tissue Oximetry Monitoring Use an appropriate cleanser to gently clean the intended sensor site. You may use Tegaderm or Mepitel under the sensor in patients with delicate skin or edema. Allow the skin to dry completely before applying the sensors.

  • Page 126: Figure 10-12 Sensor Placement (Non-Cerebral)

    HemoSphere Vita Monitor 10 HemoSphere Tissue Oximetry Monitoring • Arm: Position sensor over the deltoid (shoulder), biceps (upper arm), or brachioradialis muscle. • Leg: Position sensor over the quadriceps (upper leg), gastrocnemius (calf), or tibialis (calf) muscle. Apply the sensor with the connector towards the feet.

  • Page 127: Connecting Sensors To Cables

    HemoSphere Vita Monitor 10 HemoSphere Tissue Oximetry Monitoring WARNING Exercise extreme care when applying sensors. Sensor circuits are conductive and must not come into contact with other grounded, conductive parts other than EEG or entropy monitors. Such contact would bridge the patient’s isolation and cancel the protection provided by the sensor.

  • Page 128: Disconnecting Sensors After Monitoring

    HemoSphere Vita Monitor 10 HemoSphere Tissue Oximetry Monitoring Gently push the sensor connector straight into the sensor cable connector until it snaps into place. Gently pull back on the sensor to verify the sensor is fully inserted into the connector.

  • Page 129: Monitoring Considerations

    (20) seconds thereafter. No separate actions are required when using this equipment with a defibrillator, but only Edwards-supplied sensors must be used for proper protection against the effects of a cardiac defibrillator.

  • Page 130: Table 10-3 Sto2 Validation Methodology

    Testing of the ForeSight oximeter cable operation should be done at least once every 6 months, as described in HemoSphere Vita service manual. Failure to comply may lead to injury. If the cable fails to respond, it must not be used until it has been inspected and serviced or replaced.

  • Page 131: Skin Check Timer

    HemoSphere Vita Monitor 10 HemoSphere Tissue Oximetry Monitoring Table 10-3 StO validation methodology (continued) Patient ForeSight Cerebral Non-cerebral Type Subject weight population sensor reference reference measurement range Small data < 5 kg Pediatric – FORE-SIGHT Co-oximetry of neonates (term, umbilical...

  • Page 132: Set Averaging Time

    ∆ctHb parameters are only available if the ∆ctHb parameter feature is enabled. Please contact your local Edwards representative for more information on enabling this advanced feature. For additional information, see Relative Change in Total Hemoglobin – ∆ctHb on page 133.

  • Page 133: Advanced Features

    ∆ctHb sub-parameter. ∆ctHb parameters are only available if the ∆ctHb parameter feature is enabled. Please contact your local Edwards representative for more information on enabling this advanced feature. 11.1.1 ∆ctHb Value Display To display the value of ∆ctHb on the StO...

  • Page 134: Validation Methodology And Study Results

    HemoSphere Vita Monitor 11 Advanced Features 11.1.4 Validation Methodology and Study Results Table 11-1 summarizes the validation methodology and study results for relative change in hemoglobin (∆ctHb). Table 11-1 Clinical and blood bench validation study results for trending accuracy of relative change in hemoglobin (ΔctHb)

  • Page 135: On Screen Help

    HemoSphere Vita Monitor Error Messages ........

  • Page 136: Monitor Status Lights

    12.2 Monitor Status Lights The HemoSphere Vita monitor has a visual alarm indicator to alert the user to alarm conditions. See Alarm Priorities on page 166 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 137: Foresight Oximeter Cable Sensor Communication

    If any of the ForeSight oximeter cable LEDs fail to turn on, the cable must not be used until it has been serviced or replaced. Contact Edwards Technical Support. There is a risk that damaged parts could reduce the performance of the cable.

  • Page 138: Pressure Controller Communication

    None. The connected finger cuff is actively monitoring. Defective finger cuff connected Amber Flashing ON/OFF Verify that a compatible Edwards finger cuff has been used. Expired finger cuff connected Disconnect and reconnect the finger cuff. Non-compatible Edwards finger cuff connected Replace the finger cuff with a compatible Edwards finger cuff.

  • Page 139: Hemosphere Vita Monitor Error Messages

    HemoSphere Vita Monitor 12 Troubleshooting 12.5 HemoSphere Vita Monitor Error Messages 12.5.1 System/Monitoring Faults/Alerts Table 12-5 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 140 Connection points on cable or port are Check for bent or broken pins damaged Try switching to cable port 2 If problem persists, contact Edwards Technical Support Fault: Cable Port 2 – Cable is not inserted properly Reinsert the cable...

  • Page 141: System/Monitoring Warnings

    Ensure that the monitor ventilation openings are Monitor ventilation openings are unobstructed and clear of dust obstructed If problem persists, contact Edwards Technical Support Alert: System LED Indicators Visual alarm indicator hardware or Power cycle the system Inoperable...

  • Page 142: Numeric Keypad Errors

    HemoSphere Vita Monitor 12 Troubleshooting Table 12-6 HemoSphere Vita monitor warnings Message Possible causes Suggested actions Service Battery Internal battery fault occurred Power cycle the system If condition persists, replace the battery pack 12.5.3 Numeric Keypad Errors Table 12-7 Numeric keypad errors...
  • Page 143 Restart measurement Fault: Invalid Finger Cuff #1 Non Edwards finger cuff #1 detected Verify that an Edwards finger cuff has been used Connected Defective finger cuff 1 connected Disconnect and reconnect Edwards finger cuff #1 Replace finger cuff #1 with a genuine Edwards cuff...
  • Page 144 Replace pressure controller If problem persists, contact Edwards Technical Support Fault: Invalid Pressure Incompatible pressure controller detected Verify that an Edwards pressure controller has been used Controller Connected Non Edwards pressure controller detected Disconnect and re-connect Edwards pressure controller Defective pressure controller connected...
  • Page 145 Check the arterial waveform for severe hypotension, period of time severe hypertension, and motion artifact Integrity of pressure monitoring line Make sure the heart end of Edwards HRS is aligned with compromised the patient’s phlebostatic axis Systolic pressure too high or diastolic...

  • Page 146: Table 12-9 Hemosphere Vitawave Module Warnings

    Vertically align the two ends of HRS and calibrated HRS incorrectly calibrated Replace HRS HRS is defective Restart measurement If problem persists, contact Edwards Technical Support Alert: No HRS Connected – The patient positioning mode is "Patient Verify that the displayed offset is still accurate Verify Patient Positioning Sedated and Stationary"...
  • Page 147 Pressure Controller not connected Connect Pressure Controller Defective Pressure Controller connected Replace Pressure Controller If problem persists, contact Edwards Technical Support Finger Cuff #1 Expiration in < 5 Finger cuff #1 approaching maximum use Replace finger cuff #1 to ensure uninterrupted...

  • Page 148: Tissue Oximetry Error Messages

    Fault: StO – Technology Internal system malfunction Remove and reinsert module to reset Module If problem persists, contact Edwards Technical Support Fault: StO – ForeSight FSOC A is defective If condition persists, contact Edwards to replace the FSOC Oximeter Cable A...
  • Page 149 Table 12-11 Tissue oximetry faults/alerts (continued) Message Possible causes Suggested actions Fault: StO – ForeSight FSOC B is defective If condition persists, contact Edwards to replace the FSOC Oximeter Cable B Fault: StO – ForeSight The technology module has lost Reconnect the cable...

  • Page 150: Tissue Oximetry General Troubleshooting

    Fault* Replace the FSOC channel Replace the technology module If problem persists, contact Edwards Technical Support Fault: ΔctHb {0} – Out Of ΔctHb went outside of display range Reset ctHb to re-baseline all applicable channels Range* Alert: StO {0} –...
  • Page 151 HemoSphere Vita Monitor 12 Troubleshooting Table 12-12 Tissue oximetry general troubleshooting Message Possible causes Suggested actions {0} - Sensor Temperature Temperature under Sensor < 28°C Verify correct placement of sensor Below Expected Range If patient is cooled intentionally, no action is required *Note: {0} is the sensor channel.

  • Page 152: Essential Performance Characteristics

    Essential Performance Characteristics........... . .152 HemoSphere Vita Monitor Characteristics and Specifications ....... . .153 HemoSphere Battery Pack Characteristics and Specifications .

  • Page 153: Hemosphere Vita Monitor Characteristics And Specifications

    HemoSphere Vita Monitor A Specifications and Device Characteristics Table A-1 HemoSphere Vita monitor essential performance – transient and non-transient electromagnetic phenomena Module or Parameter Essential Performance cable HemoSphere non-invasive blood pressure Measurement of blood pressure within specified accuracy (±1% of full scale with a maximum of ±3 mmHg).

  • Page 154: Table A-4 Hemosphere Vita Monitor Transportation Environmental Specifications

    A-3 and table A- MRI Information. Do not use the HemoSphere Vita monitor or platform modules and cables in an MR environment. The HemoSphere Vita monitoring platform, including all modules and cables, is MR unsafe since the device contains metallic components, which can experience RF- induced heating in the MRI environment.

  • Page 155: Hemosphere Battery Pack Characteristics And Specifications

    Table A-5 HemoSphere Vita monitor technical characteristics 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 156: Hemosphere Tissue Oximetry Characteristics And Specifications

    3.5 in (9.0 cm) Depth 5.4 in (13.6 cm) Ingress protection IPX1 Applied part classification Type BF defibrillation proof NOTE For HemoSphere Vita technology module and ForeSight oximeter cable environmental specifications, see table A-3, HemoSphere Vita monitor environmental specifications, on page 153.

  • Page 157: Table A-10 Foresight Oximeter Cable Physical Characteristics

    Ingress protection IPX4 Applied part classification Type BF defibrillation proof The length of the technology module and sensor cables are nominal lengths Table A-11 HemoSphere Vita technology module with ForeSight oximeter cable parameter measurement characteristics Sensor Parameter Specification (all locations)

  • Page 158: Hemosphere Vitawave Module Characteristics And Specifications

    0 to 300 mmHg accuracy 1% of full scale (max 3 mmHg), zeroing automatically Accuracy tested under laboratory conditions compared to a calibrated pressure gauge Table A-15 Edwards finger cuff characteristics Finger cuff Maximum weight 11 g (0.02 lbs) LED spectral irradiance...

  • Page 159: Figure A-1 Spectral Irradiance And Location Of Light Emission Aperture

    Figure A-1 Spectral Irradiance and location of light emission aperture NOTE The expected useful life of the HemoSphere VitaWave module is 5 years from date of purchase. If your equipment experiences a malfunction, please contact Technical Support or your local Edwards representative for further assistance.

  • Page 160: Accessories List

    Additional Accessories Description............161 B.1 Accessories List WARNING Only use approved HemoSphere Vita monitor accessories, cables and or components that have been supplied and labeled by Edwards. Using unapproved accessories, cables and or components may affect patient safety and measurement accuracy.

  • Page 161: Additional Accessories Description

    B.2 Additional Accessories Description B.2.1 Roll Stand The HemoSphere Vita monitor roll stand is intended for use with the HemoSphere Vita 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 plate as indicated in the directions.

  • Page 162: Figure B-1 Applying Pressure Controller Cover

    HemoSphere Vita Monitor B Accessories Figure B-1 Applying pressure controller cover To remove the pressure controller cover, pull upwards from the front tab. This is indicated by the arrows symbol . Do not remove the pressure controller cover from the side by HRS...

  • Page 163: Table C-1 Cardiac And Oxygenation Profile Equations

    Appendix Equations for Calculated Patient Parameters This section describes the equations used to calculate continuous and intermittent patient parameters displayed on the HemoSphere Vita monitor. Table C-1 Cardiac and oxygenation profile equations Parameter Description and formula Units Body Surface Area (DuBois formula) 0.425...

  • Page 164: Patient Data Input Range

    Appendix Monitor Settings and Defaults Contents Patient Data Input Range............. . .164 Trend Scale Default Limits .

  • Page 165: Parameter Display And Configurable Alarm/Target Ranges

    NOTE The HemoSphere Vita 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 166: Alarm And Target Defaults

    HemoSphere Vita 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 167: Language Default Settings

    HemoSphere Vita Monitor D Monitor Settings and Defaults alarm visual indicator. Most technical faults are medium priority. Alerts and other system messages are low priority. D.6 Language Default Settings Table D-6 Language default settings Default display units CO trend Time...

  • Page 168: General Maintenance

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

  • Page 169: Cleaning The Monitor And Modules

    Do not allow any fluids to enter the instrument. The HemoSphere Vita 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 170 ForeSight oximeter cable while the module is being used to monitor a patient. The monitor must be turned off and the HemoSphere Vita monitor power cord discon- nected, or the cable must be disconnected from the monitor and the sensors removed from the patient.

  • Page 171: Figure E-1 Removing Pressure Controller From Band

    HemoSphere Vita Monitor E System Care, Service and Support Phenolic germicidal detergent solution (per manufacturer’s recommendations) • Quaternary ammonium germicidal detergent solution (per manufacturer’s recommendations) • See the product directions for use and labeling for detailed information on active ingredients and any disinfecting claims.

  • Page 172: Service And Support

    Edwards Lifesciences. Edwards provides HemoSphere Vita 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 Vita monitor’s serial number, located on the rear panel;...

  • Page 173: Monitor Disposal

    It may ignite, explode, leak or get hot, causing serious personal injury or death. E.7.1.2 Battery Storage The battery pack can remain stored in the HemoSphere Vita monitor. Refer to “HemoSphere Vita Monitor Characteristics and Specifications” on page 153 for environmental specifications for storage. NOTE...

  • Page 174: Testing Of Alarm Signals

    E.8 Testing of Alarm Signals Each time the HemoSphere Vita 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 175 Edwards shall not be liable for proximate, incidental, or consequential damages. Edwards shall not be obligated under this warranty to repair or replace a damaged or malfunctioning HemoSphere Vita monitor if such damage or malfunction is caused by the customer’s use of catheters other than those manufactured...
  • Page 176 The HemoSphere Vita monitor is intended for use in the electromagnetic environment specified in this appendix. The customer or the user of the HemoSphere Vita monitor should assure that it is used in such an environment. When connected to the HemoSphere Vita monitor, all accessory cables listed in table B-1 on page 160 comply with the EMC standards listed above.
  • Page 177 HemoSphere Vita monitor. Guidance on maintaining appropriate separation between communications equipment and the HemoSphere Vita monitor is provided in table F-3. The effects of other RF emitters are unknown and may interfere with the function and safety of the HemoSphere monitoring platform.

  • Page 178: Table F-1 Electromagnetic Emissions

    Meters (V/m) The HemoSphere Vita monitor is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere Vita monitor should ensure that it is used in such an environment. Pulse modulation ² 380 - 390...
  • Page 179 Modulation Meters (V/m) The HemoSphere Vita monitor is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere Vita monitor should ensure that it is used in such an environment. Bluetooth, WLAN, 2400 - Pulse modulation ²...
  • Page 180 Table F-3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the HemoSphere Vita monitor The HemoSphere Vita 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 Vita monitor as recommended below, according to the maximum output power of the communications equipment.
  • Page 181 Level Guidance The HemoSphere Vita monitor is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere Vita monitor should assure that it is used in such an environment. Electrostatic discharge ±8 kV contact ±8 kV...
  • Page 182 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the HemoSphere Vita monitor is used exceeds the applicable RF compliance level above, the HemoSphere Vita 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 Vita monitor.
  • Page 183 The calculated surface area of a human body. The unit worn on the patient’s wrist that connects the Button Heart Reference Sensor and compatible Edwards finger A screen image with text that, when touched, initiates an cuffs to the HemoSphere VitaWave module.
  • Page 184 HemoSphere Vita Monitor G Glossary Volume Clamp Method Arterial blood volume is kept constant using the signal from the photo-plethysmograph and a rapidly changing pressure in the air bladder.
  • Page 185 Edwards, Edwards Lifesciences, the stylized E logo, Acumen IQ, ClearSight, FORE-SIGHT, ForeSight, FORE-SIGHT ELITE, ForeSight Jr, HemoSphere, HemoSphere Vita Physiocal, and VitaWave are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. ©2024 Edwards Lifesciences Corporation. All rights reserved. A/W Part No 10058416001/B...

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