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Edwards HemoSphere Alta Advanced Operator's Manual

Monitoring platform

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HemoSphere Alta Advanced

Monitoring Platform

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Summary of Contents for Edwards HemoSphere Alta Advanced

Page 1 HemoSphere Alta Advanced Monitoring Platform Operator's manual...
Page 2 If, in the normal use of this manual, errors, omissions, or incorrect data are noted, please contact Edwards Technical Support or your local Edwards representative.
Page 3 1.2.1 HemoSphere Alta Advanced Monitoring Platform with Swan-Ganz Technology.......25 1.2.2 HemoSphere Alta Advanced Monitoring Platform with HemoSphere Oximetry Cable....26 1.2.3 HemoSphere Alta Advanced Monitoring Platform with HemoSphere Pressure Cable or HemoSphere Alta Monitor – Pressure Cable......................26 1.2.4 HemoSphere Alta Advanced Monitoring Platform with ForeSight Oximeter Cable......27 1.2.5 HemoSphere Alta Advanced Monitoring Platform with ClearSight Technology.........27...
Page 4 3.4 Initial Start Up....................................85 3.4.1 Start Up Procedure..............................85 3.4.2 Select Device ID................................86 3.5 Power Off and Power Save Mode............................86 4 Navigating the HemoSphere Alta Advanced Monitoring Platform..................... 87 4.1 HemoSphere Alta Advanced Monitor Screen Appearance....................87 4.2 Navigation Bar....................................88 4.3 Monitor Views....................................91 4.3.1 Trend Monitoring View..............................91...
Page 5 HemoSphere Alta Advanced Monitoring Platform Contents 6.1.2 Set Alarm Volume..............................141 6.1.3 Set Targets................................... 141 6.1.4 Patient and Custom Alarm/Targets Settings Screen..................141 6.1.5 Configure All Targets............................... 144 6.1.6 Configure Targets and Alarms for One Parameter..................144 6.2 CVP Settings....................................145 6.3 Parameter Source Settings..............................146 6.3.1 20-Second Flow Parameter Settings........................
Page 6 HemoSphere Alta Advanced Monitoring Platform Contents 9.2.2 Set Averaging Time – FloTrac Sensor Only...................... 176 9.2.3 Zero Arterial Pressure...............................177 9.2.4 SVR Monitoring................................178 9.3 Pressure Cable Monitoring with a TruWave pressure transducer (DPT)..............178 9.3.1 Connect TruWave DPT.............................178 9.3.2 Zero Intravascular Pressure........................... 179 9.4 Pressure Cable Monitoring with an Alta Swan-Ganz patient cable................
Page 7 12.4 Edwards Algorithm for Measurement of Blood Hemoglobin (tHb Algorithm)..........241 12.4.1 Indications for Use..............................242 12.4.2 Intended Use................................242 12.4.3 Inputs and Outputs of Edwards Algorithm for Measurement of Blood Hemoglobin....243 12.4.4 Total Blood Hemoglobin (tHb) Parameter Display..................244 12.4.5 Calibration and Recalibration Steps.........................244 12.4.6 Algorithm Performance Verification........................246...
Page 8 14.3 Pressure Cable Communication............................355 14.4 ForeSight Oximeter Cable Sensor Communication..................... 356 14.5 Pressure Controller Communication..........................357 14.6 HemoSphere Alta Advanced Monitoring Platform Error Messages...............358 14.6.1 System/Monitoring Faults/Alerts........................358 14.6.2 Monitoring Troubleshooting – Numeric Keypad Errors................361 14.6.3 HemoSphere Remote Application Connectivity Errors................361 14.7 HemoSphere Alta Swan-Ganz Patient Cable Error Messages...................362...
Page 9 14.11.3 Total Hemoglobin Faults/Alerts........................393 Appendix A: Specifications and Device Characteristics........................395 A.1 Essential Performance Characteristics..........................395 A.2 HemoSphere Alta Advanced Monitoring Platform Characteristics and Specifications........397 A.3 HemoSphere Alta Monitor Battery Characteristics and Specifications..............399 A.4 HemoSphere Alta Swan-Ganz Patient Cable Characteristics and Specifications..........400 A.5 HemoSphere Pressure Cable Characteristics and Specifications................
Page 10 HemoSphere Alta Advanced Monitoring Platform Contents F.5 Edwards Lifesciences Regional Headquarters........................430 F.6 Monitor Disposal..................................431 F.6.1 Battery Recycling............................... 431 F.7 Preventive Maintenance................................431 F.7.1 Battery Maintenance..............................432 F.7.2 HRS Preventive Maintenance..........................432 F.8 Testing of Alarm Signals................................433 F.9 Warranty......................................433 Appendix G: Guidance and Manufacturer's Declaration........................434 G.1 Electromagnetic Compatibility..............................434...
Page 11: Table Of Contents
Figure 3-3: HemoSphere Alta advanced monitor bottom panel................... 80 Figure 3-4: HemoSphere Alta advanced monitor left panel....................81 Figure 3-5: HemoSphere Alta advanced monitor power entry cover - installation steps..........84 Figure 3-6: Startup screen..................................85 Figure 3-7: Device ID screen................................86 Figure 4-1: HemoSphere Alta advanced monitor screen features..................
Page 12 HemoSphere Alta Advanced Monitoring Platform List of Figures Figure 6-2: Set individual parameter alarms and targets....................... 145 Figure 8-1: HemoSphere Alta Swan-Ganz patient cable connection overview............. 155 Figure 8-2: CO connection overview..............................157 Figure 8-3: iCO connection overview............................161 Figure 8-4: iCO side panel - New set configuration menu..................... 162 Figure 8-5: Thermodilution summary screen..........................
Page 13 Figure 12-14: Connecting a sensor to the ForeSight oximeter cable - channel status LED........236 Figure 12-15: Tissue Oximetry Physiology Screens........................240 Figure 12-16: Block Diagram of the Edwards algorithm for measurement of blood hemoglobin (tHb Algorithm)......................................243 Figure 12-17: tHb parameter display............................. 244 Figure 12-18: tHb parameter display at the start of monitoring..................244...
Page 14 Figure 13-24: Fluid Responsiveness Test side panel – main menu screen...............347 Figure 13-25: Fluid Responsiveness Test – results screen...................... 350 Figure 14-1: HemoSphere Alta advanced monitoring platform LED indicators............354 Figure 14-2: Pressure cable LED indicator (HEMPSC100 only)....................355 Figure 14-3: ForeSight oximeter cable LED indicators......................356 Figure 14-4: Pressure Controller LED Indicators........................
Page 15 Table 1-18: HemoSphere ClearSight technology key parameters description..............42 Table 1-19: Operator's manual style conventions........................43 Table 1-20: Acronyms, Abbreviations ............................. 43 Table 2-1: Monitor display symbols..............................62 Table 2-2: Symbols on product labels .............................69 Table 2-3: Applicable standards.................................73 Table 3-1: HemoSphere Alta advanced monitoring platform configurations..............75...
Page 16 Table 3-6: Accessories required for monitoring parameters with ForeSight oximeter cable........77 Table 4-1: CVP value prioritization..............................99 Table 4-2: HemoSphere Alta advanced monitoring platform hand gesture commands...........104 Table 4-3: HemoSphere Alta advanced monitoring platform voice commands (English only).......106 Table 4-4: Reviewed events................................110 Table 4-5: Intervention types................................121 Table 4-6: Battery status..................................
Page 17 HemoSphere Alta Advanced Monitoring Platform List of Tables Table 9-6: Performance results of PAOP measurements for patients with valvular disorders, HCP confirmed arrhythmia, catheter flinging, and heart failure*..................189 Table 10-1: 95% Confidence interval (CI) results for repeated blood pressure measurements from the same patient (Bootstrap Re-sampling)...........................200...
Page 18 HemoSphere Alta Advanced Monitoring Platform List of Tables Table 13-11: Patient demographics (minimally-invasive monitored non-surgical patients, N=672)....270 Table 13-12: Analysis dataset length and number of hypotension events (minimally-invasive monitored non-surgical patients)...................................270 Table 13-13: Non-surgical patient characteristics (minimally-invasive, N=672)............270 Table 13-14: Clinical validation study results* (minimally-invasive monitored surgical patients)......271...
Page 19 HemoSphere Alta Advanced Monitoring Platform List of Tables Table 13-38: HPI study - 30 days postoperative composite endpoint components - CC analysis population (pivotal subjects, n=400)................................292 Table 13-39: Length of stay................................292 Table 13-40: GHI display configurations............................295 Table 13-41: GHI value graphical and audible display elements..................295 Table 13-42: Parameter status colors for GHI..........................297...
Page 20 Table 13-70: Transpulmonary thermodilution intermittent parameters................342 Table 13-71: GDT target status indicator colors.........................345 Table 14-1: HemoSphere Alta advanced monitoring platform visual alarm indicator..........354 Table 14-2: HemoSphere Alta advanced monitoring platform power light..............355 Table 14-3: Pressure cable communication light (HEMPSC100 only)................356 Table 14-4: ForeSight oximeter cable LED communication lights..................356...
Page 21 Table 14-31: Tissue oximetry faults/alerts............................390 Table 14-32: Tissue oximetry general troubleshooting......................393 Table 14-33: Total hemoglobin faults/alerts..........................393 Table A-1: HemoSphere Alta advanced monitoring platform essential performance – transient and non- transient electromagnetic phenomena..........................395 Table A-2: HemoSphere Alta advanced monitor physical and mechanical characteristics........397 Table A-3: HemoSphere Alta advanced monitoring platform environmental specifications........397...
Page 22 Table G-4: Wireless coexistence Radiated Anechoic Chamber (RAC) results – Normal Mode (2.4, 5 and 6 GHz WiFi) for HemoSphere Alta advanced monitor (EUT) with unintended signal present......437 Table G-5: Wireless coexistence Radiated Anechoic Chamber (RAC) results – Normal Mode (2.4, 5 and 6 GHz WiFi) for companion device (router) with unintended signal present..............438...
Page 23: Using This Manual
Member State in which the user and/or patient is established. The Edwards HemoSphere Alta advanced monitoring platform operator’s manual is comprised of 14 chapters and 7 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 24 Tissue Oximetry Monitoring: Describes procedures for setup and operation of ForeSight tissue oximetry monitoring Clinical Tools: Describes the HemoSphere Alta advanced monitoring platform clinical tools and algo‐ rithms Help and Troubleshooting: Describes the Help menu and provides a list of faults, alerts, and messages,...
Page 25 HemoSphere Alta Advanced Monitoring Platform Hemodynamic Technology Connections........
Page 26 Refer to the Edwards FloTrac sensor, FloTrac Jr sensor, Acumen IQ sensor, and TruWave disposable pressure transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used.
Page 27 When used in combination with two HemoSphere pressure cables or HemoSphere Alta monitor – pressure cables – one with an Acumen IQ sensor connected to an Edwards Lifesciences femoral arterial catheter and a second with a TruWave disposable pressure transducer connected to a central venous catheter – the Transpulmonary Thermodilution algorithm uses transpulmonary thermodilution (TPTD) to measure parameters related to blood flow, fluid volume, and organ function.
Page 28: Contraindications For Use
1.3.2 HemoSphere Alta Advanced Monitoring Platform with ClearSight Technology The HemoSphere Alta advanced monitor while used with a compatible finger cuff(s) is contraindicated in some patients with extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand, such as may be present in patients with Raynaud’s disease.
Page 29: Table 1-1: Hemosphere Alta Swan-Ganz Patient Cable Available Parameters List
A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere Alta advanced monitoring platform and a connected HemoSphere oximetry cable are listed below in Table 1-2 on page 30.
Page 30: Table 1-2: Hemosphere Oximetry Cable Available Parameters List
A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere Alta advanced monitoring platform and both a connected HemoSphere Alta Swan-Ganz patient cable and oximetry cable are listed below in Table 1-3 on page 30.
Page 31: Table 1-5: Hemosphere Alta Swan-Ganz Patient Cable With Two Hemosphere Pressure Cables Or Hemosphere Alta Monitor - Pressure Cables Available Parameters List
20-second stroke volume index right ventricular stroke volume index 20-second flow parameters are only available if the 20s flow parameter feature is enabled. Please contact your local Edwards representative for more information on enabling this advanced feature. RVP and RVCO parameters are available when using a Swan-Ganz IQ catheter.
Page 32: Table 1-6: Hemosphere Pressure Cable / Hemosphere Alta Monitor - Pressure Cable Available Parameters List
A list of Acumen Assisted Fluid Management (AFM) outputs available for surgical patients ≥18 years of age while monitoring with the HemoSphere Alta advanced monitoring platform and a connected HemoSphere pressure cable or pressure cable - HemoSphere Alta monitor are listed below in Table 1-7 on page 33.
Page 33: Table 1-7: Hemosphere Pressure Cable / Hemosphere Alta Monitor - Pressure Cable Available Afm Output List
ScvO₂ is being monitored Tissue oxygen saturation, StO₂, can be monitored with the HemoSphere Alta advanced monitoring platform and a connected ForeSight oximeter cable as listed below in Table 1-9 on page 33. Table 1-9: ForeSight oximeter cable available parameters list...
Page 34: Table 1-10: Hemosphere Pressure Cable Or Hemosphere Alta Monitor - Pressure Cable With Foresight Oximeter Cable Available Parameters List
CAI parameter is available when using a ForeSight IQ sensor and if the CAI feature is enabled. A comprehensive list of parameters available while monitoring with the HemoSphere Alta advanced monitoring platform and a connected pressure controller are listed below in Table 1-11 on page 34.
Page 35: Table 1-12: Hemosphere Clearsight Technology With Oximetry Cable Available Parameters List
WARNING Improper use of the HemoSphere Alta advanced monitoring platform could present a hazard to the patient. Carefully read the "warnings" section of this manual, located in chapter 2, before using the platform. The HemoSphere Alta advanced monitoring platform is intended for use only in patient assessment. This instrument must be used in conjunction with a bedside physiological monitor and/or patient clinical signs and symptoms.
Page 36: Figure 1-1: Hemosphere Alta Advanced Monitoring Platform Hemodynamic Technology Connections
HemoSphere Alta Advanced Monitoring Platform Introduction monitoring technologies of the HemoSphere Alta advanced monitoring platform provide a quick setup and stability. All technology cable connection points are located on the right side panel. See Figure 1-1 on page 36. 1. common cable ports (5) 3.
Page 37: Table 1-14: Hemosphere Alta Swan-Ganz Patient Cable Parameters Description
ClearSight monitoring technology is introduced below and in detail in chapter 10, HemoSphere Alta ClearSight Technology on page 192. The HemoSphere Alta advanced monitoring platform is also equipped with a depth camera for gesture commands and a microphone for voice commands. For more on gesture see HemoSphere Alta Advanced Monitoring Platform Gesture Commands on page 103.
Page 38: Table 1-15: Hemosphere Pressure Cable Key Parameters Description
The HemoSphere Alta pressure cable (HEMAPSC200) and HemoSphere pressure cable (HEMPSC100) enable vascular pressure monitoring with a compatible Edwards pressure transducer/sensor and catheter. A connected FloTrac, FloTrac Jr, or Acumen IQ sensor provides continuous cardiac output (CO) and associated hemodynamic parameters.
Page 39 HemoSphere Alta Advanced Monitoring Platform Introduction Parameter Description Technology systolic slope (dP/dt)* maximum upslope of the arterial pres‐ Acumen IQ sensor sure waveform measured from a periph‐ eral artery* dynamic arterial elastance (Ea measure of afterload to the left ventricle...
Page 40: Table 1-16: Hemosphere Oximetry Cable Parameters Description
**Continuous calibrated CO, CI, SV and SVI measurements are also available by calibration using the transpulmonary thermodilution (TPTD) procedure with a connected Acumen IQ sensor at an Edwards Lifesciences femoral arterial catheter line and a TruWave pressure transducer at a central venous catheter line.
Page 41: Table 1-17: Foresight Oximeter Cable Parameters Description
(ΔO2Hb and ΔHHb) 1.6.5 HemoSphere ClearSight Technology The HemoSphere Alta advanced monitoring platform with a connected compatible pressure controller and finger cuff(s) enables non-invasive measurement of a patient’s arterial pressure waveform and calculation of continuous cardiac output (CO) and associated hemodynamic parameters. The pressure controller plugs into the ClearSight...
Page 42: Table 1-18: Hemosphere Clearsight Technology Key Parameters Description
HemoSphere Alta Advanced Monitoring Platform Introduction Table 1-18: HemoSphere ClearSight technology key parameters description Parameter Description Technology continuous cardiac output (CO) continuous assessment of the volume of ClearSight, ClearSight Jr, or Acumen IQ blood pumped by the heart measured in cuff liters per minute using the monitored ar‐...
Page 43: Documentation And Training
An arrow is shown between two on-screen menu options that are selected consecutively by the operator. An icon is a touch screen access point for the menu or navigation graphic shown. See Table 2-1 on page 62 for full list of menu icons shown on the HemoSphere Alta advanced monitoring platform. Venous Oximetry icon Bold text with a menu icon indicates an icon that is paired with a software term or phrase appearing on the screen.
Page 44 HemoSphere Alta Advanced Monitoring Platform Introduction Abbreviation Definition blood temperature cerebral autoregulation index CaO₂ arterial oxygen content cardiac function index cardiac index 20-second cardiac index right ventricular cardiac index cardiac output 20-second cardiac output right ventricular cardiac output continuous cardiac output (used when describing certain Swan-Ganz catheters and...
Page 45 HemoSphere Alta Advanced Monitoring Platform Introduction Abbreviation Definition goal directed therapy GEDV global end-diastolic volume GEDI global end-diastolic volume index global ejection fraction global hypoperfusion index hematocrit HEMPC pressure controller hospital information systems hemoglobin Acumen Hypotension Prediction Index heart rate...
Page 46 HemoSphere Alta Advanced Monitoring Platform Introduction Abbreviation Definition PAOP pulmonary artery occlusion pressure PAWP pulmonary artery wedge pressure pulmonary blood volume predicted blood volume pulse pressure variation POST power-on self test pulse rate right ventricular pulse rate PvO₂ partial pressure of venous oxygen...
Page 47 Touch Interact with the HemoSphere Alta advanced monitor by touching the screen. thermodilution injectate temperature TPTD transpulmonary thermodilution Universal Serial Bus VO₂...
Page 48: Safety And Symbols
HemoSphere Alta Advanced Monitoring Platform Essential Performance ........
Page 49 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the HemoSphere Alta advanced monitoring platform, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Page 50 (chapter 3) • To avoid the risk of electric shock, the HemoSphere Alta advanced monitoring platform can only be connected to a supply mains with grounding (protective earth). Do not use three prong to two prong power adaptors.
Page 51 Do not leave the catheter in a permanent wedge position. Furthermore, avoid lengthy balloon inflation while the catheter is in a wedge position; this occlusive maneuver may result in pulmonary infarction. (chapter 9) • Do not use the HemoSphere Alta advanced monitoring platform as a pulse rate or blood pressure monitor. (chapter 9) •...
Page 52 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. (chapter 12) •...
Page 53 Use only Edwards supplied accessories with the ForeSight oximeter cable. Edwards accessories ensure patient safety and preserve the integrity, accuracy, and electromagnetic compatibility of the ForeSight oximeter cable. Connecting a non-Edwards sensor will cause an appropriate alert on that channel and no StO₂ values will be recorded. (chapter 12) •...
Page 54 (appendix F) • Shock or fire hazard! Do not immerse the HemoSphere Alta advanced monitoring platform or monitor cables in any liquid solution. Do not allow any fluids to enter the instrument. (appendix F) •...
Page 55 When moving the instrument, be sure to turn off the power and remove the connected power cord. (chapter 3) • Do not use the voice command function in the vicinity of other HemoSphere Alta advanced monitoring platforms. Doing so may unintentionally initiate voice commands with those other monitors. (chapter 4) •...
Page 56 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols • Excessive dropping of the HemoSphere pressure cable may result in cable damage and/ or malfunction. (chapter 9) • The effectiveness of FT-CO measurements in pediatric patients under 12 years of age has not been evaluated.
Page 57 The SQI signal is sometimes affected by the use of electrosurgical units. Attempt to distance electrocautery equipment and cables from the HemoSphere Alta advanced monitoring platform 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) •...
Page 58 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols • Do not lift or pull the ForeSight oximeter cable by any cable connections, or place the ForeSight oximeter cable in any position that might present a risk that the cable may fall on the patient, bystander or operator. (chapter •...
Page 59 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols • Inaccurate GHI values may be caused by: • Inaccurate cardiac output measurements • Inaccurate SvO₂ measurements • Incorrect placement or position of the catheter • Excessive variations in pulmonary artery blood temperature. Some examples that cause BT variations...
Page 60 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 14)
Page 61 The HemoSphere Alta advanced monitoring platform and monitor cables are electrostatic discharge (ESD) sensitive. Do not attempt to open cable housing or use if the housing has been damaged. (appendix F) • Do not pour or spray liquid on any portion of the HemoSphere Alta advanced monitoring platform, accessories, or cables. (appendix F) •...
Page 62: User Interface Symbols
Mobile Satellite systems. (appendix G) 2.4 User Interface Symbols The following are icons that appear on the HemoSphere Alta advanced monitoring platform screen. For more information about screen appearance and navigation, see chapter 4, Navigating the HemoSphere Alta Advanced Monitoring Platform on page 87.
Page 63 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols Symbol Description Navigation Bar Icons patient data menu (end session) patient data menu (demographics skipped) zero pressure (HemoSphere pressure cable and ClearSight technology) select monitoring mode (multi-sensor mode disabled) begin CO monitoring...
Page 64 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols Symbol Description Navigation Bar Icons voice interaction disabled help menu settings menu Clinical Tools Side Panel Menu Icons Assisted Fluid Management Derived Value Calculator iCO Thermodilution (intermittent cardiac output) (HemoSphere Alta Swan-Ganz patient cable) Events &...
Page 65 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols Clinical Tools Side Panel Menu Icons TPTD (transpulmonary thermodilution) Menu Navigation Icons exit or return to main monitoring screen return to previous menu cancel enter keypad backspace key move cursor left move cursor right...
Page 66 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols Menu Navigation Icons item disabled (toggle button) Parameter Tile Icons parameter audible alarm indicator: paused parameter audible alarm indicator: indefinitely silenced signal quality indicator bar See Signal Quality Indicator on page 215...
Page 67 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols Information Bar Icons alarm volume lock screen screen capture beat-to-beat heart rate (HemoSphere Alta Swan-Ganz patient cable with ECG input) time until cuff pressure release mode (HemoSphere Alta ClearSight technology, see Cuff Pressure Release Mode on page 205)
Page 68 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols AFM Icons start or re-start Assisted Fluid Management (AFM) session pause Assisted Fluid Management (AFM) session edit end time or bolus volume Time-in-Target displayed on SVV parameter tile (automatic GDT session) AFM settings...
Page 69: Table 2-2: Symbols On Product Labels
HPI side panel icon 2.5 Symbols on Product Labels This section provides the symbols that are on the HemoSphere Alta advanced monitoring platform and other available HemoSphere Alta advanced monitoring platform accessories, including platform cables. Table 2-2: Symbols on product labels...
Page 70 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols Symbol Description Instructions for use in electronic form is available by phone or website address. Intertek ETL Model number Serial number Unique device identifier MR unsafe Batch code Quantity Lead-free Underwriters Laboratories product certification mark...
Page 71 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols Symbol Description Importer EMVCo Contactless Indicator Connector Identification Labels Equipotential terminal stud USB 2.0 Ethernet connection Pressure (DPT) output Caution: Consult Instructions for use for important cautionary information Defibrillation proof type CF applied part or connection...
Page 72 HemoSphere Alta Advanced Monitoring Platform Safety and Symbols Connector Identification Labels ECG input from external monitor High-Definition Multimedia Interface output Connector: serial COM output (RS232) Additional Packaging Labels Fragile, handle with care This end up Lithium ion batteries packed with or contained in equipment...
Page 73: Table 2-3: Applicable Standards
A. The platform shall provide noninvasive 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 StO₂ with a compatible oximeter cable and sensor according to the specifications provided in appendix A. The platform shall provide alarm, alert, indicator, and/or system status when unable to provide accurate measurement of the applicable hemodynamic parameter.
Page 74: Installation And Setup
HemoSphere Alta Advanced Monitoring Platform Connection Ports ........
Page 75: Table 3-1: Hemosphere Alta Advanced Monitoring Platform Configurations
HemoSphere Alta Advanced Monitoring Platform Installation and Setup Table 3-1: HemoSphere Alta advanced monitoring platform configurations HemoSphere Alta advanced HemoSphere Alta advanced HemoSphere Alta advanced monitoring platform cardiac kit monitoring platform smart recovery monitoring platform all-on-one kit • HemoSphere Alta cardiac monitor •...
Page 76: Table 3-3: Sensor Options For Monitoring Parameters With Hemosphere Pressure Cable/Hemosphere Alta Monitor - Pressure Cable
HemoSphere Alta Advanced Monitoring Platform Installation and Setup Monitored and calculated parameters † Required cable/catheter RVEF ‡ *20-second flow parameters are only available while monitoring with a CCOmbo V catheter (models 777F8 and 774F75) and require a pulmonary artery pressure signal through a HemoSphere pressure cable connection. See 20-Second Flow Parameters on page 159.
Page 77: Table 3-5: Catheters Required For Monitoring Parameters With Hemosphere Oximetry Cable
Confirm that all sensors and cables are connected correctly and completely before use. To avoid corruption of data on the HemoSphere Alta advanced monitoring platform, always disconnect the HemoSphere Alta Swan-Ganz patient cable and oximetry cable from the monitor before using a defibrillator.
Page 78: Monitor Front
HemoSphere Alta Advanced Monitoring Platform Installation and Setup 3.2.1 Monitor Front 1. visual alarm indicator 3. microphone for voice command 2. camera for gesture 4. power button Figure 3-1: HemoSphere Alta advanced monitor front view...
Page 79: Monitor Rear
Installation and Setup 3.2.2 Monitor Rear 1. mains power cord connection 5. COM1 serial port connector, RS-232 (2) 2. Ethernet port 6. ECG input 3. HDMI port 7. EQP terminal 4. USB port (3) Figure 3-2: HemoSphere Alta advanced monitor rear view...
Page 80: Figure 3-3: Hemosphere Alta Advanced Monitor Bottom Panel
HemoSphere Alta Advanced Monitoring Platform Installation and Setup 3.2.3 Monitor Bottom Panel 1. vent (2) 3. roll stand bracket (4 screw attachment) 2. battery door Figure 3-3: HemoSphere Alta advanced monitor bottom panel...
Page 81: Figure 3-4: Hemosphere Alta Advanced Monitor Left Panel
3.3 HemoSphere Alta Advanced Monitoring Platform Installation 3.3.1 Mounting Options and Recommendations The HemoSphere Alta advanced monitoring platform 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.
Page 82 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the HemoSphere Alta advanced monitoring platform, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Page 83: Connecting Power Cord
Manufacturer RRC located in Germany) integrated into the HemoSphere Alta advanced monitor's design. WARNING Only use Edwards approved batteries with the HemoSphere Alta advanced monitoring platform. Do not charge the battery pack outside of the monitor. Doing so can damage the battery or injure the user.
Page 84: Figure 3-5: Hemosphere Alta Advanced Monitor Power Entry Cover - Installation Steps
To avoid the risk of electric shock, the HemoSphere Alta advanced monitoring platform can only be connected to a supply mains with grounding (protective earth). Do not use three prong to two prong power adaptors.
Page 85: 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 86: Figure 3-7: Device Id Screen
3.4.2 Select Device ID Upon initial HemoSphere Alta advanced monitoring platform startup, the user can select a Device ID or name for the monitor on the Welcome screen. The Device ID defaults to the monitor serial number but can be changed to any 20 character name.
Page 87 HemoSphere Alta Advanced Monitoring Platform Gesture Commands........
Page 88: Figure 4-1: Hemosphere Alta Advanced Monitor Screen Features
The navigation bar is present on most screens. Exceptions are the startup screen and screens indicating the HemoSphere Alta advanced monitoring platform has stopped monitoring. The example shown below for Figure 4-2 on page 89 is with non-invasive and invasive monitoring technologies connected with multi-sensor mode enabled.
Page 89: Figure 4-2: Navigation Bar And Icons
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform 1. silence audible alarm 7. clinical tools 2. patient entry 8. monitoring screen 3. zero pressure 9. gesture 4. start Swan-Ganz monitoring 10. help 5. start ClearSight technology monitoring 11.
Page 90 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Select Monitoring Mode. Touch here to switch between monitoring modes when multi-sensor mode is disabled. See Multi-Sensor Advanced Monitoring Mode on page 121. The current monitoring mode will be displayed under this icon on the navigation bar.
Page 91: Monitor Views
Touch the Screen icon on the navigation bar. • • Use the gesture command (see HemoSphere Alta Advanced Monitoring Platform Gesture Commands on page 103). 4.3.1 Trend Monitoring View The Trend screen displays the current status and history of monitored parameters. The trend of parameter values can be viewed in graphical or tabular format.
Page 92: Figure 4-3: Graphical Trend Screen
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform 1. graphical trend plot 4. blood pressure waveform display 2. y-axis with threshold data labels 5. graphical trend tile (touch here to access parameter configuration menu) 3. time range 6.
Page 93: Figure 4-4: Tabular Trend Screen
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform 1. tabular trend cells 4. blood pressure waveform display 2. oldest tabular trend cell 5. tabular trend tile (touch here to access parameter con‐ figuration menu) 3. time point 6.
Page 94 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform red indicating the value is outside the alarm range. When the target range is disabled for the parameter the plot line is white. Color plotting can be disabled through general settings.
Page 95: Change Parameters
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform the center. Drag the gray value boxes on any parameter trend plot to move the time frame. Scroll back or forward to move the time frame over the monitoring time period. To lock the selection, touch the unlock icon at the bottom of the screen.
Page 96: Figure 4-5: Example Of Key Parameter Selection Tile Configuration Menu
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Acumen. Parameters listed here are only available with a connected Acumen IQ sensor or cuff. This includes HPI, Ea , and dP/dt. Venous Oximetry. Venous oximetry parameters include venous oximetry (SvO₂/ScvO₂) and GHI (global hypoperfusion index).
Page 97: Status Indicators
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Note The alarms limits and target ranges for the Acumen Hypotension Prediction Index parameter, HPI, are not adjustable. 4.3.2.3 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.
Page 98 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform SVV Filtering Exceeded Indicator. The SVV filtering exceeded indicator symbol appears on the SVV parameter tile if a high degree of pulse rate variability is detected that could affect the SVV value.
Page 99: Table 4-1: Cvp Value Prioritization
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform When multiple sources for CVP are available, the monitor will prioritize the values according to Table 4-1 on page 99. Table 4-1: CVP value prioritization Priority CVP value used...
Page 100: Figure 4-7: Split Screen With Large Scale Physiology Selection
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Figure 4-7: Split screen with large scale physiology selection Touch the magnification icon to view an animation depicting the interaction between the heart, blood, and vascular system. Continuous parameter values are displayed in association with the animation.
Page 101 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform ScvO₂/SvO₂ parameter data and signal quality indicator (SQI) are displayed here while the HemoSphere oximetry cable is connected and actively monitoring venous oxygen saturation. Cardiac output (CO/CI), pulse rate (PR), and mean arterial pressure (MAP) is indicated on the arterial side of the vascular system animation.
Page 102: Figure 4-9: Goal Positioning Screen
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform 4.3.3.2 Goal Positioning Screen 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. Touch the goal positioning icon on the right side of the Physio monitoring screen to display this plot.
Page 103: Cockpit Screen
4.4 HemoSphere Alta Advanced Monitoring Platform Gesture Commands The HemoSphere Alta advanced monitoring platform has gesture command capability and will deliver audio responses to simple gesture commands. There are two main gesture commands: Silence audio alarms...
Page 104: Table 4-2: Hemosphere Alta Advanced Monitoring Platform Hand Gesture Commands
After completing the hand gesture command, listen and watch monitor for expected result. 4.5 HemoSphere Alta Advanced Monitoring Platform Voice Commands The HemoSphere Alta advanced monitoring platform has voice command capability and will deliver audio responses to simple voice commands.
Page 105: Figure 4-11: Voice Listening State (English Only)
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform → Enable the Voice interaction setting through the Interactivity setting screen. Touch settings icon Advanced Settings button → Interactivity button. This menu requires a Secure user password. Contact your hospital administrator or IT department for passwords.
Page 106: Table 4-3: Hemosphere Alta Advanced Monitoring Platform Voice Commands (English Only)
Navigating the HemoSphere Alta Advanced Monitoring Platform CAUTION Do not use the voice command function in the vicinity of other HemoSphere Alta advanced monitoring platforms. Doing so may unintentionally initiate voice commands with those other monitors. Table 4-3: HemoSphere Alta advanced monitoring platform voice commands (English only)
Page 107 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Command Command options Expected result Give a parameter read‐ Audible response with • [parameter ] num‐ • show me [parame‐ • what is [her/his/ current parameter val‐ ter]* their/my/the] [pa‐...
Page 108 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Command Command options Expected result • readout my/the • show me my/the • what was patient's [parame‐ patient's [technol‐ her/his/my/the/ ] [time] ago ] [parameter] their [technology] •...
Page 109: Derived Value Calculator
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform 4.6.1 HPI Secondary Screen The Acumen Hypotension Prediction Index (HPI) software can be activated with an Acumen IQ sensor connected or with an Acumen IQ cuff and heart reference sensor (HRS) connected. For more information, see Acumen Hypotension Prediction Index (HPI) Software Feature on page 250.
Page 110: Event Scrolling
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Enter the required values and the derived calculations will automatically display. Touch the Log Values button to enter values in system for future review of them through the Events &...
Page 111 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Identifying Event message When time logged Icon and Cate‐ gory Fluid bolus {0} ended (user- An AFM session is active and a user-specified bolus has ended specified) {0} is the number identifying the bolus within the current AFM session...
Page 112 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Identifying Event message When time logged Icon and Cate‐ gory Resumed An AFM session is active and the AFM session is resumed from previous‐ ly being paused Started - fluid tracking: {0}, surgery...
Page 113 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Identifying Event message When time logged Icon and Cate‐ gory CO monitoring started – No HRS – The user begins non-invasive system monitoring without an HRS where {0} is the verified height offset between the monitored finger and heart...
Page 114 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Identifying Event message When time logged Icon and Cate‐ gory Bolus started An FRT challenge measurement is started (Fluid challenge type: Fluid Bolus) Bolus cancelled An FRT challenge measurement is cancelled...
Page 115 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Identifying Event message When time logged Icon and Cate‐ gory Started A GDT tracking session is started Paused A GDT tracking session is paused Resumed A GDT tracking session is resumed...
Page 116 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Identifying Event message When time logged Icon and Cate‐ gory Alert acknowledged* Acumen Hypotension Prediction Index, HPI, alert is acknowledged*. [HPI only] Alert cleared (acknowledged)* Acumen Hypotension Prediction Index, HPI, alert is cleared as the HPI value was lower than 75 for the last two consecutive 20-second up‐...
Page 117 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Identifying Event message When time logged Icon and Cate‐ gory System Restart Recovery When the system has resumed monitoring without being prompted following a power cycle Time updated...
Page 118 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Identifying Event message When time logged Icon and Cate‐ gory In Vitro – Calibration started An In vitro calibration process has started In Vitro – Calibration error An error occurs during the In vitro calibration process In Vitro calibration - Wall artifact or The system detects a wall artifact or wedge during the In vitro calibra‐...
Page 119: Figure 4-12: Clinical Tools - Intervention Menu
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Identifying Event message When time logged Icon and Cate‐ gory Sensor off check acknowledged The sensor off check warning popup is acknowledged by touching Acknowledge *Acknowledgment is logged when the user touches either button on the HPI High Alert popup.
Page 120 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Select a detail for the intervention. Options include: Unspecified, Decrease, Increase, Start, or Stop. Fluid intervention types have options of volume amount or unspecified. Touch within the Comments pane to access a keyboard and enter any notes about the intervention (optional).
Page 121: Table 4-5: Intervention Types
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Table 4-5: Intervention types Intervention Indicator Type Intervention Inotrope Vasodilator (green) Vasopressor Positional Passive Leg Raise Trendelenburg (purple) Fluids Red Blood Cells Colloid (blue) Crystalloid Fluid Bolus* Event...
Page 122: Status Bar
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform → Advanced Settings button and enter the Secure User password. All Touch the settings icon passwords are set during system initialization. Contact your hospital administrator or IT department for password.
Page 123: Figure 4-13: Status Bar - Icons
HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform the lock screen symbol. While monitoring with the HemoSphere Alta Swan-Ganz patient cable, the status bar may display blood temperature and heart rate from an analog input. While monitoring with the HemoSphere pressure cable the status bar may display CO/pressure averaging time and HPI parameter values.
Page 124: Figure 4-14: Status Bar Quick Settings Menu
Figure 4-14: Status bar quick settings menu 4.8.3 Battery The HemoSphere Alta advanced monitoring platform allows for uninterrupted monitoring during power loss. Battery life is indicated on the status bar by the symbols shown in Table 4-6 on page 124. 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 125: Figure 4-15: Status Bar
The snapshot icon captures an image of the screen at the current time. A USB stick attached to one of the USB ports (rear panel) of the HemoSphere Alta advanced monitor is required to save the image. Touch the snapshot icon located on the status bar 4.9 Status Bar - Notifications...
Page 126 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Home. The home icon takes you to the most recently viewed monitoring screen and stores any modification made to data on the screen. Return. The return icon takes you to the previous menu screen and stores any modification made to data on the screen.
Page 127 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Keypad. Touch the keys on the keypad to enter numeric data. 1. data type 5. input range (shown when entered value is blank) 2. units (toggle if applicable) 6.
Page 128 HemoSphere Alta Advanced Monitoring Platform Navigating the HemoSphere Alta Advanced Monitoring Platform Keyboard. Touch the keys on the keyboard to enter alphanumeric data. 1. data type 4. cursor right 2. cancel 5. backspace (use to delete existing text) 3. cursor left...
Page 129: User Interface Settings
User Interface Settings Contents Settings Menu Navigation and Password Protection..............129 Patient Data.
Page 130: Figure 5-1: Primary Settings Screen
HemoSphere Alta Advanced Monitoring Platform User Interface Settings Figure 5-1: Primary settings screen The HemoSphere Alta advanced monitoring platform has three levels of password protection. Table 5-1: HemoSphere Alta advanced monitoring platform password levels Level Digits required User description Super User...
Page 131: Table 5-3: Export Data Menu Navigation And Password Protection
HemoSphere Alta Advanced Monitoring Platform User Interface Settings Advanced settings Sub-menu selection Super User Secure User Edwards User menu selection General Date and Time no access • • Units of Measurement no access • • Language no access • •...
Page 132: Patient Data
HemoSphere Alta Advanced Monitoring Platform User Interface Settings → Advanced Settings button. Touch settings icon Enter the Secure User password. Touch Password button. Enter the new Super User and/or Secure User password digits in both value boxes until the Confirm button is active.
Page 133 HemoSphere Alta Advanced Monitoring Platform User Interface Settings WARNING Upon initiation of a new patient session, the default high/low physiological alarm ranges should be checked to ensure that they are appropriate for the given patient. The user has the option of entering a new patient upon initial startup of the system or while the system is running.
Page 134: Figure 5-3: New Patient Data Screen
HemoSphere Alta Advanced Monitoring Platform User Interface Settings Figure 5-3: New Patient Data screen Touch the check icon on the keypad/keyboard to save each patient demographic selection value and return to the patient data screen. Touch Patient ID button and use the keyboard to enter the patient's hospital ID.
Page 135: General Monitor Settings
Note If power is lost and restored to the HemoSphere Alta advanced monitoring platform, the system settings prior to the power loss, including alarm settings, alarm volume, target settings, monitoring screen, parameter configuration, language and unit selection, are automatically restored to last configured settings.
Page 136 Touch settings icon Note When the HemoSphere Alta advanced monitoring platform runs in Demo Mode, all audible alarms are disabled. A "Demo Mode" banner is displayed across the information bar to alert the user to the use of simulated patient data.
Page 137: Table 5-4: Co/Pressure Averaging Time And Display Update Rates
HemoSphere Alta Advanced Monitoring Platform User Interface Settings • If Reference is selected, the change interval will be calculated from the start of monitoring. This start value can be adjusted under Reference Value. Under the Measured Delta heading, select the format for which the change interval is displayed.
Page 138 HemoSphere Alta Advanced Monitoring Platform User Interface Settings Parameter update rate CO/Pressure Averaging Time menu se‐ 5 sec* 20 sec 5 min* lection When an Acumen IQ sensor/cuff is connected, all Acumen IQ sensor/cuff monitored parameters will be available with 20 second averaging interval / 20 second update rate only.
Page 139: Advanced Settings
Parameter Source Settings................... 146 6.1 Alarms/Targets There are two types of alarms on the HemoSphere Alta advanced monitoring platform intelligent alarm system: •...
Page 140 HemoSphere Alta Advanced Monitoring Platform Advanced Settings • HemoSphere pressure cable arterial blood pressure parameters (SYS/DIA/MAP) while arterial waveform is displayed: 2 seconds • HemoSphere pressure cable with TruWave DPT measured parameters: 2 seconds • HemoSphere Alta ClearSight technology continuous CO and associated hemodynamic parameters: 20 seconds •...
Page 141: Set Alarm Volume
HemoSphere Alta Advanced Monitoring Platform Advanced Settings 6.1.2 Set Alarm Volume The alarm volume ranges in 20% increments from low (20%) to high (100%) with a default of medium-high (80%). It applies to physiological alarms, technical faults, and alerts. Alarm volume can be changed at any time from the status bar (see Status Bar Quick Settings Menu on page 123) or from the main settings page (see General Monitor Settings on page 135).
Page 142: Table 6-3: Patient Versus Custom Alarm/Targets Settings Screen
Not pass code protected Pass code protected Two minute time-out Configure all Configure all targets on/off, audio alarms on/ Restore any custom defaults to Edwards de‐ off, Edwards defaults or custom defaults faults only Parameter order Key parameters first, then predefined order...
Page 143: Figure 6-1: Custom Alarm/Target Settings Screen
Toggle the Target switch for any individual parameter to turn the alarm/target values off for that parameter. Touch Restore Edwards Defaults button to restore all configured custom defaults to Edwards defaults. Touch Restore on confirmation popup to confirm. All targets will be enabled.
Page 144 Custom Default" appears on a confirmation popup. Touch Configure All to confirm the restore. To restore all settings to the Edwards defaults, select the Edwards Default radio button and touch Restore button. The message, "Touch “Configure All” to reset all target parameter settings values for patient to Edwards Default"...
Page 145: Figure 6-2: Set Individual Parameter Alarms And Targets
Use the arrows to adjust the zone settings or touch the value button to open a numeric keypad. Figure 6-2: Set individual parameter alarms and targets To restore alarm/target values back to the Edwards default touch Reset to Default button. To cancel, touch the exit icon...
Page 146 PA (pulmonary artery) pressure signal is also monitored through a connected HemoSphere pressure cable, TruWave DPT, and CCOmbo V catheter (models 777F8 and 774F75). In addition, the 20-second flow parameter feature must be activated. Please contact your local Edwards representative for more information on enabling this advanced feature.
Page 147: Export Data
Cyber Security..................... . 152 7.1 Export Data The Export Data screen lists a number of data export features of the HemoSphere Alta advanced monitoring platform. This screen is password protected. From this screen clinicians can export diagnostic reports or export monitoring data reports.
Page 148: Monitoring Data
HemoSphere Alta Advanced Monitoring Platform Data Export and Connectivity Settings CAUTION Use a virus scan on any USB stick before inserting to prevent a virus or malware infection. Touch the Download button. A popup window will show download progress of each item selected for the data export.
Page 149: Wireless Settings
A Diagnostic Logs 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 150: Table 7-1: Wi-Fi Connection Status
The HemoSphere remote proxy server needs to be correctly installed and provisioned before it can be paired to the HemoSphere Alta advanced monitoring platform. For questions on installation of the HemoSphere Remote server at your site, contact your Edwards representative.
Page 151 Data Export and Connectivity Settings 7.3.2 HemoSphere Remote Pairing The HemoSphere Alta advanced monitoring platform needs to be paired with the HemoSphere Remote server to enable HemoSphere Remote connectivity. → Advanced Settings button and enter the Secure User password. All Touch the settings icon passwords are set during system initialization.
Page 152: Table 7-2: Hemosphere Remote Application Connectivity Status
Data is logged and transmitted for charting purposes only. 7.4 Cyber Security This chapter outlines ways in which patient data can be transferred to and from the HemoSphere Alta advanced monitoring platform. It is important to note that any facility using the HemoSphere Alta advanced monitoring platform must take measures to protect the privacy of a patient's personal information in accordance with country- specific regulations, and consistent with the facility’s policies for managing this information.
Page 153 If a critical and/or highly-exploitable vulnerability is discovered, customers will be directly notified by Edwards via email within 30 days and a patch will be provided as applicable. Additionally, customers can access Edwards’ Product Security website at https://www.edwards.com/healthcare- professionals/products-services/support/product-security to review cybersecurity bulletins.
Page 154 The HemoSphere Alta Swan-Ganz patient cable is compatible with all approved Edwards Swan-Ganz pulmonary artery catheters. The HemoSphere Alta Swan-Ganz patient cable acquires signals to and from a compatible Edwards Swan-Ganz catheter for CO, iCO and EDV/RVEF monitoring. This section provides an overview of the HemoSphere Alta Swan-Ganz patient cable connections.
Page 155: Figure 8-1: Hemosphere Alta Swan-Ganz Patient Cable Connection Overview
IEC 60601-1. Plug the HemoSphere Alta Swan-Ganz patient cable into the HemoSphere Alta advanced monitor. Press the power button to turn on the HemoSphere Alta advanced monitoring platform and follow steps for entering patient data. See Patient Data on page 132.
Page 156: Table 8-1: Available Hemosphere Alta Swan-Ganz Patient Cable Parameters And Required Connections
HemoSphere Alta Swan-Ganz patient cable. 8.2 Continuous Cardiac Output The HemoSphere Alta advanced monitoring platform 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 157: Connecting The Patient Cables
HemoSphere Alta Swan-Ganz Monitoring indicator dilution curves that are obtained by cross-correlation of energy input and blood temperature waveforms. After initialization, the HemoSphere Alta advanced monitoring platform continuously measures and displays the cardiac output in liters per minute without operator calibration or intervention.
Page 158: Initiating Monitoring
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Swan-Ganz Monitoring 8.2.2 Initiating Monitoring 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 159 , SV , SVI These parameters are only available if the 20s flow parameter feature is enabled. Please contact your local Edwards representative for more information on enabling this advanced feature. For more information on PA monitoring, see Pressure Cable Monitoring with an Alta Swan-Ganz patient cable on page 180.
Page 160 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Swan-Ganz Monitoring CAUTION Inaccurate 20-second flow parameter measurements may be caused by: • Incorrect placement or position of the catheter • Improperly zeroed and/or leveled transducer • Over- or under-damped pressure line •...
Page 161: Figure 8-3: Ico Connection Overview
CCO cable illustrated by (3) in Figure 8-3 on page 161. 8.3.2 Configuration Settings The HemoSphere Alta advanced monitoring platform provides the operator with the choice of entering a specific computation constant, or configuring the HemoSphere Alta Swan-Ganz patient cable to allow it to automatically...
Page 162: Figure 8-4: Ico Side Panel - New Set Configuration Menu
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Swan-Ganz Monitoring determine the computation constant by selecting the injectate volume and catheter size. The operator can also select the parameter display type and bolus mode. → iCO Thermodilution button. If another clinical tool is active, use the Touch the Clinical Tools icon drop down menu to select iCO Thermodilution.
Page 163 The HemoSphere Alta Swan-Ganz patient cable factory default setting for bolus measurement is Auto mode. In this mode, the HemoSphere Alta advanced monitoring platform 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 164 When the thermal washout curve is complete the HemoSphere Alta advanced monitoring platform will highlight Wait and then Inject – or Ready during manual mode – when a stable thermal baseline is reached again.
Page 165 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Swan-Ganz Monitoring While the bolus mode Auto toggle is off (manual mode), the operator has a maximum of 30 seconds in which to make a bolus injection after touching the Inject button. If no injection is detected within the time interval, the Inject button is enabled again and the Inject message disappears.
Page 166: Figure 8-5: Thermodilution Summary Screen
ECG heart rate (HR) signal if available. During EDV monitoring, the HemoSphere Alta advanced monitoring platform continuously displays EDV and right ventricular ejection fraction (RVEF) measurements. EDV and RVEF are time-averaged values that can be numerically displayed in parameter tiles, and graphically trended over time in the graphical trend view.
Page 167: Figure 8-6: Edv/Rvef Connection Overview
) measure to the HemoSphere Alta advanced monitoring platform for EDV and RVEF measurements. Pulse rate (PR) from a pressure cable or ClearSight cuff monitored arterial waveform can be used in place of an ECG heart rate (HR) signal if available. For compatible ECG cables, contact your local Edwards representative.
Page 168 This is an optional feature that does not impact the HemoSphere Alta advanced monitoring platform’s primary function of monitoring cardiac output (with the HemoSphere Alta Swan-Ganz patient cable) and venous oxygen saturation (with the HemoSphere oximetry cable).
Page 169 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Swan-Ganz Monitoring 8.4.3 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 170 STAT values. 8.5 SVR While performing CO monitoring, the HemoSphere Alta advanced monitoring platform can also calculate SVR by utilizing MAP and CVP pressure signal inputs from connected pressure cables or CVP entry for CVP values. See CVP...
Page 171 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Swan-Ganz Monitoring 8.6 Global Hypoperfusion Index (GHI) Algorithm Feature The global hypoperfusion index (GHI) algorithm can be activated in Invasive monitoring mode with a connected Swan-Ganz catheter and oximetry cable. The GHI algorithm uses inputs from the CCO or RVCO and oximetry algorithms to determine the GHI value.
Page 172 See Figure 9-1 on page 173. The HemoSphere pressure cable acquires and processes a single pressure signal from a compatible Edwards DPT, such as the TruWave DPT, or a FloTrac sensor. A FloTrac or Acumen IQ sensor connects to an existing arterial catheter to provide minimally invasive hemodynamic parameters. A TruWave transducer can connect to any compatible pressure monitoring catheter to provide location based intravascular pressure.
Page 173: Figure 9-1: Hemosphere Pressure Cable
HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring 1. pressure transducer/sensor connection 4. HemoSphere Alta advanced monitor connection 2. zero button /status LED (HEMPSC100 only) 5. pressure-out connection (HEMAPSC200 only) 3. color insert for pressure type (HEMPSC100 only) Figure 9-1: HemoSphere pressure cable...
Page 174 HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring Available Pressure cable configuration key parame‐ FloTrac/ FloTrac/ FloTrac/ TruWave TruWave TruWave TruWave ters FloTrac Jr/ FloTrac Jr/ Acumen IQ transducer transducer transducer transducer Acumen IQ Acumen IQ sensor with connected to...
Page 175 See Acumen Hypotension Prediction Index (HPI) Software Feature on page 250 for more information on the Acumen IQ sensor and the Acumen Hypotension Prediction Index (HPI) feature. Activation of the Acumen HPI feature is only available in certain areas. Please contact your local Edwards representative for more information on enabling this advanced feature.
Page 176 9.2.1 Connect FloTrac, FloTrac Jr, or Acumen IQ Sensor Connect one end of the pressure cable to the HemoSphere Alta advanced monitoring platform. To de-air and prime I.V. bag and FloTrac, FloTrac Jr, or Acumen IQ sensor: Invert normal saline I.V. bag (anticoagulation per institution policy).
Page 177 HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring Select a radio button under CO/Pressure Averaging Time. The following options are available: • 5 sec • 20 sec (default and recommended time interval) • 5 min For more information on CO/Pressure Averaging Time menu choices, see Delta Intervals / Averaging on page 136.
Page 178 ), right ventricular end diastolic pressure (RV EDP) and right ventricular systolic slope (RV dP/dt). See Table 9-1 on page 173 for a list of available parameters. 9.3.1 Connect TruWave DPT Connect one end of the pressure cable to the HemoSphere Alta advanced monitoring platform.
Page 179 HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring To de-air and prime I.V. flush bag and TruWave transducer: Invert normal saline bag (anticoagulation per institution policy). Spike I.V. bag with fluid administration set, keeping drip chamber upright. While keeping I.V.
Page 180 20-second parameter values. See 20-Second Flow Parameters on page 159. Connect one end of the pressure cable to the HemoSphere Alta advanced monitoring platform. Use a straight in or out motion to connect or disconnect the TruWave DPT. Refer to the TruWave pressure transducer’s instructions for use and to steps 2-6 in section 9.3.1 Connect TruWave DPT on page 178 for...
Page 181 Indications for use. When used in combination with a Swan-Ganz catheter connected to a pressure cable and pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressure measurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring.
Page 182: Figure 9-2: Illustration Of Paop Measurement
HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring 1. pulmonary artery pressure (mmHg) 3. PAOP measurement signal 2. time (s) Figure 9-2: Illustration of PAOP measurement The measured PAOP includes changes in the intrathoracic pressures that occur throughout the respiration cycle.
Page 183: Figure 9-3: Example Of Smart Wedge Paop Measurement With Spontaneous Breathing (A) And Mechanical Ventilated (B) Inputs
HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring 1. pulmonary artery pressure (mmHg) 3. PAOP measurement signal 2. time (s) Figure 9-3: Example of Smart Wedge PAOP measurement with spontaneous breathing (A) and mechanical ventilated (B) inputs Figure 9-3 on page 183 shows examples of PAOP measurements with different respiration types. The most clinically...
Page 184 HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring Precaution. Femoral insertion may lead to a redundancy of the catheter length in the right atrium and difficulties in obtaining a pulmonary artery wedge (occlusion) position. CAUTION Inaccurate PAOP measurements may be caused by: •...
Page 185 HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring WARNING If the pulmonary artery catheter drifts into the wedge position without inflation of the balloon, spontaneous tip wedging may occur, and the pulmonary artery pressure waveform assumes a wedged appearance, which can impact algorithm accuracy.
Page 186: Figure 9-4: Edit Wedge
HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring Once deflation is successfully completed, the PAOP value is provided and a "Wedge Successful" message appears. Successful PAOP measurements can be viewed on the Events & Intervention side panel at any point.
Page 187: Table 9-2: Wedge Index
HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring After Wedge Detected and During Balloon Inflation. After a wedge is detected and while the balloon is inflated, touch the Freeze button. Move the X and Y cursors to the desired occlusion pressure point on the waveform and touch the Save button.
Page 188: Table 9-4: Performance Results Of Paop Measurements
HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring Table 9-4: Performance results of PAOP measurements* Smart Wedge algorithm pa‐ Method used to obtain ref‐ Bias Correlation rameter erence value (mmHg) (mmHg) (mmHg) (consensus) PAOP Measurement Average PAOP measurement 0.98...
Page 189: Table 9-6: Performance Results Of Paop Measurements For Patients With Valvular Disorders, Hcp Confirmed Arrhythmia, Catheter Flinging, And Heart Failure
HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring Table 9-6: Performance results of PAOP measurements for patients with valvular disorders, HCP confirmed arrhythmia, catheter flinging, and heart failure* Smart Wedge al‐ Source under test Method used to Bias Correlation gorithm parame‐...
Page 190: Figure 9-5: Zero Screen - Zero Pressure Cable Channels
HemoSphere Alta Advanced Monitoring Platform HemoSphere Pressure Cable Monitoring 9.5 Zero & Waveform Screen Figure 9-5: Zero screen – Zero pressure cable channels This screen is accessed through the Zero icon located on the navigation bar and provides two primary...
Page 191 WARNING Do not use the HemoSphere Alta advanced monitoring platform as a pulse rate or blood pressure monitor. 9.6 Pressure-Out The HemoSphere Alta pressure cable allows the user to output the pressure waveform to a connected patient monitor.
Page 192 Output Signal to Patient Monitor..................208 10.1 HemoSphere Alta ClearSight System Methodology The HemoSphere Alta ClearSight non-invasive monitoring system is composed of the HemoSphere Alta advanced monitoring platform with connected pressure controller, heart reference sensor, and compatible Edwards finger cuff(s).
Page 193 10.1.6 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 non-invasive system will automatically release the pressure in the cuff at regular user selected intervals (30 minutes, 2 hours, and 4 hours).
Page 194 When using the double cuff configuration, ensure that each finger is sized separately. It is not uncommon for patients to have two different sized fingers requiring two different sized compatible Edwards finger cuffs. Failure to select the correct finger cuff can result in measurement inaccuracy.
Page 195: Figure 10-1: Hemosphere Non-Invasive System Connection Overview
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology Press the power button to turn on the HemoSphere Alta advanced monitor and follow steps for entering patient data. See Patient Data on page 132. Follow instructions below on how to apply the pressure controller, select finger cuff size and apply the finger cuff(s) to the patient.
Page 196 Instructions for Use. The pressure controller is worn on the patient's wrist and connects to the HemoSphere Alta advanced monitor, HRS and finger cuff(s). See Figure 10-2 on page 197.
Page 197: Figure 10-2: Pressure Controller Application
Snap the pressure controller into the plastic sleeve of the band, making sure that the cuff connectors are facing towards the fingers. Attach the pressure controller cable to the HemoSphere Alta advanced monitor. (Figure 10-1 on page 195) Remove the plastic connector caps in order to connect the finger cuff (s) and heart reference sensor.
Page 198: Figure 10-3: Cuff Size Selection
Improper finger cuff placement or sizing can lead to inaccurate monitoring. 10.2.3 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 ClearSight, ClearSigh Jr, and Acumen IQ finger cuffs are designed for single patient use.
Page 199: Figure 10-4: Heart Reference Sensor Application
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology Figure 10-4: Heart reference sensor application CAUTION Make sure that the HRS is correctly applied so that it can be leveled to the phlebostatic axis. Connect the HRS to the pressure controller. See (1) in Figure 10-4 on page 199.
Page 200: Table 10-1: 95% Confidence Interval (Ci) Results For Repeated Blood Pressure Measurements From The Same Patient (Bootstrap Re-Sampling)
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology Table 10-1 on page 200 provides a summary of repeated measurements from the same patient to provide accuracy of ClearSight non-invasive technology blood pressure outputs. Table 10-1: 95% Confidence interval (CI) results for repeated blood pressure measurements from the same patient (Bootstrap Re-sampling) Pediatric ≥12 years of age...
Page 201 Always disconnect the finger cuff when it is not wrapped around a finger, to prevent damage by accidental over-inflation. The effectiveness of Edwards compatible finger cuffs has not been established in pre-eclamptic patients. The pulsations from intra-aortic balloon support can be additive to the pulse rate on the instrument pulse rate display.
Page 202: Figure 10-5: Vertical Offset Entry Screen
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology Under the HRS Usage setting, enable the radio button to Optional. Disconnect the HRS and touch the navigation bar Zero icon Under the ClearSight technology tab, a "Please connect the HRS" message is displayed with an instructional image on connecting the HRS to the pressure controller.
Page 203 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology Touch the OK icon Touch the Start ClearSight icon on the navigation bar to start monitoring. Two alerts will cycle through on the information bar with the texts "Alert: ClearSight System – No HRS Connected –...
Page 204: Table 10-2: Arterial Waveform Sqi Levels
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology Table 10-2: Arterial waveform SQI levels Appearance Level Indication Normal Intermediate (moderately compromised) Poor (possible alert status causing limited signal) Unacceptable (possible alert status causing extremely limited or no signal; see Table...
Page 205 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology ClearSight system settings cannot be configured during active non-invasive monitoring or during cuff pressure release mode. Stop ClearSight technology monitoring, and then proceed to the ClearSight system settings screen to make the desired changes.
Page 206 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology 10.7 Calibrate the Heart Reference Sensor The Heart Reference Sensor (HRS) should be calibrated to ensure optimal performance. → HRS Calibration button. Navigate to the HRS Calibration screen by touching the Clinical Tools icon If another clinical tool is active, use the drop down menu to select HRS Calibration.
Page 207: Figure 10-6: Bp Calibration Side Panel
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology Figure 10-6: BP Calibration side panel Touch in the value boxes for SYS and DIA and use the keypad to enter reference blood pressure measurements. Touch Calibrate to complete the calibration process. The abbreviation of calibration (CAL) will appear above the parameter name on the BP tile to indicate that ClearSight technology BP has been calibrated.
Page 208 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology Parameter (units) Calibration reference Bias Precision DIA (mmHg) Radial -0.29 [-0.43, -0.16] 2.91 [2.64, 3.18] Brachial -1.22 [-2.16, -0.28] 5.20 [4.46, 5.94] MAP (mmHg) Radial -0.50 [-0.66, -0.34] 3.54 [3.11, 3.98] Brachial -0.87 [-1.63, -0.12]...
Page 209: Figure 10-7: Pressure Out To External Monitor
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology Figure 10-7: Pressure out to external monitor CAUTION ClearSight system pressure output signal to a patient monitor only intended to be connected to a pressure signal input port of Type BF or CF on the patient monitor that is protected against the effects of a discharge of a cardiac defibrillator.
Page 210 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta ClearSight Technology Zero patient monitor and confirm 0 mmHg is displayed. Toggle the switch from Zero to Waveform on the Patient Monitor panel of the HemoSphere Alta monitor zero screen. A "Sending waveform" message will be displayed when the live waveform is being transmitted to the connected patient monitor.
Page 211 Connect the HemoSphere oximetry cable to the HemoSphere Alta advanced monitor. The following message will appear: Venous Oximetry – Cable Initializing, Please Wait If the HemoSphere Alta advanced monitoring platform is not on, turn on the power switch and follow steps for entering patient data. See Patient Data on page 132.
Page 212: Figure 11-1: Venous Oximetry Connection Overview
Appearance of catheter shown in Figure 11-1 on page 212 is for example only. Actual appearance may vary depending on catheter model. When unplugging the HemoSphere oximetry cable from the HemoSphere Alta advanced monitor or catheters from the oximetry cable, always pull at the connection site. Do not pull from cables or use tools to disconnect.
Page 213: Table 11-1: In Vitro Calibration Options
HemoSphere Alta Advanced Monitoring Platform Venous Oximetry Monitoring Do not wrap the main body of the oximetry cable in fabric or place directly on the patient's skin. The surface does get warm (up to 45 °C) and needs to dissipate heat to maintain its internal temperature level. A software fault will trigger if the internal temperature exceeds its limits.
Page 214 Touch Start Monitoring button. 11.3.1 In Vitro Calibration Error If the HemoSphere Alta advanced monitoring platform 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 215: Table 11-2: In Vivo Calibration Options
HemoSphere Alta Advanced Monitoring Platform Venous Oximetry Monitoring When lab values are received, touch HGB button to enter the patient's hemoglobin and touch g/dL or mmol/L or Hct button to enter the patient's hematocrit. See Table 11-2 on page 215 for acceptable ranges.
Page 216 The SQI signal is sometimes affected by the use of electrosurgical units. Attempt to distance electrocautery equipment and cables from the HemoSphere Alta advanced monitoring platform and plug the power cords into separate AC circuits if possible. If signal quality problems persist, call your local Edwards representative for assistance.
Page 217 Re-enter patient data, if necessary. Note Keep the time and date of all HemoSphere Alta advanced monitoring platform current. If the date and/or time of the HemoSphere Alta advanced monitoring platform being transported "from" differs from the HemoSphere Alta advanced monitoring platform being transported "to"...
Page 218 It should be performed only after attempting other actions to resolve the low SQI as defined in Troubleshooting. Note The HemoSphere Alta advanced monitoring platform will not permit an oximetry cable reset before performing a calibration or recalling calibration from the oximetry cable. Touch the oximetry calibration icon on the ScvO₂/SvO₂...
Page 219 Edwards Algorithm for Measurement of Blood Hemoglobin (tHb Algorithm)....... . .
Page 220: Figure 12-1: Foresight Oximeter Cable Front View
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring ForeSight sensors or ForeSight Jr sensors may also be labeled as FORE-SIGHT ELITE tissue oximetry sensors. 12.2 ForeSight Oximeter Cable Overview The following diagrams provide an overview of the ForeSight oximeter cable’s physical features.
Page 221: Figure 12-3: Mounting Clip Attachment Points
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring Note Images of cable housing rear view in this manual are shown without labeling for clarity. 12.2.1 ForeSight Oximeter Cable Mounting Solutions The ForeSight oximeter cable is packaged with a mounting clip.
Page 222: Figure 12-4: Cable Housing - Mounting Clip Attachment Points
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring Rear View 1. mounting clip retaining recess 2. mounting clip slide 3. mounting clip retaining recess (horizontal) (vertical) Figure 12-4: Cable housing – mounting clip attachment points 12.2.2 Installing the Mounting Clip The mounting clip can be attached to the ForeSight oximeter cable either vertically (typical for a bed rail –...
Page 223: Figure 12-5: Attaching The Mounting Clip Vertically
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring 1. mounting clip retaining recess (vertical) 2. mounting clip retaining tab Figure 12-5: Attaching the mounting clip vertically 12.2.2.2 Attaching the Mounting Clip Horizontally To attach the mounting clip horizontally: Position the mounting clip with the mounting clip retaining tab facing away from the cable housing, from either the left or right.
Page 224: Figure 12-6: Attaching The Mounting Clip Horizontally
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring 1. mounting clip retaining tab 2. mounting clip retaining recess (horizontal) Figure 12-6: Attaching the mounting clip horizontally 12.2.3 Removing the Mounting Clip To remove the mounting clip from the rear of the cable housing (see Figure 12-7 on page 225): Gently lift the mounting clip retaining tab until it disengages from its recess.
Page 225: Figure 12-7: Removing The Mounting Clip
Avoid placing the ForeSight oximeter cable under sheets or blanket that could restrict air flow around the cable that may increase the cable’s case temperature and present an injury. 12.3 Connecting the ForeSight Oximeter Cable The HemoSphere Alta advanced monitoring platform is compatible with a ForeSight oximeter cable and ForeSight/ ForeSight Jr sensors. 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).
Page 226: Figure 12-8: Tissue Oximetry Monitoring Connection Overview
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...
Page 227 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 the left panel of the HemoSphere Alta advanced monitor) or group B (connected to port B on the left panel of the HemoSphere Alta advanced monitor).
Page 228: Figure 12-9: Foresight Oximeter Cable Status Led
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring 1. monitor tissue oximetry connection port A 3. green module group status LED: channels associated with port A on monitor 2. monitor tissue oximetry connection port B 4. blue module group status LED: channels associated...
Page 229 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring Graphic representation Graphic representation Adult (≥40 kg) anatomical lo‐ Pediatric (<40 kg) anatomical (right)* (left)* cation* (sensor size) location* (sensor size) arm (large) flank/abdomen (large) flank/abdomen (medium/small) abdomen (medium/small) leg – quadriceps (large) leg –...
Page 230 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring Select the anatomical location of the sensor. See Table 12-1 on page 228 for a list of available sensor locations. The sensor locations are color coded based on the connection port: Green: Sensor locations for a ForeSight oximeter cable connected to tissue oximetry port A on •...
Page 231: Table 12-2: Sensor Selection Matrix
ForeSight oximeter cable. Connecting a non-Edwards sensor will cause an appropriate alert on that channel and no StO₂ values will be recorded. Sensors are designed for single-patient use, and are not to be reprocessed – re-used sensors present a risk of cross-contamination or infection.
Page 232: Figure 12-10: Removing Protective Liner From Sensor
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring 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. 12.3.1.3 Applying Sensors Select the appropriate sensor (see Table 12-2 on page 231) and remove it from the package.
Page 233: Figure 12-11: Sensor Placement (Cerebral)
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring 1. non-adhesive small sensor Figure 12-11: Sensor placement (cerebral) Non-Cerebral Use (Figure 12-12 on page 234): Select the site that provides the ideal access to the desired skeletal muscle tissue (if muscle cannot be palpated, too much adipose or edema may be present).
Page 234: Figure 12-12: Sensor Placement (Non-Cerebral)
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring 1. adult 3. non-adhesive small sensor 2. pediatric/neonatal Figure 12-12: Sensor placement (non-cerebral)
Page 235 12.3.1.4 Connecting Sensors to Cables Be sure that ForeSight oximeter cable is connected to the HemoSphere Alta advanced monitoring platform and that sensors are placed correctly on the patient’s skin. Use the clips on the sensor cable to secure and prevent the cable from being pulled away from the patient.
Page 236: Figure 12-13: Connecting A Sensor To The Sensor Cable Connector
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring Figure 12-13: Connecting a sensor to the sensor cable connector 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 237 Cable readings may be inaccurate during defibrillator use and up to twenty (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 238: Table 12-3: Sto₂ Validation Methodology
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring consider the faster response and potentially modified StO₂ values when using V3.0.7 software, especially if they are experienced with earlier software versions of the ForeSight oximeter cable. Note For patients experiencing complete bilateral external carotid artery (ECA) occlusion, measurements may be lower than expected.
Page 239: Set Averaging Time
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring Select a time interval between skin check notifications. The options are: 2 Hours, 4 Hours, 6 Hours, 8 Hours or 12 Hours (default). To reset the timer, select Reset button at the bottom of the Skin check window.
Page 240: Figure 12-15: Tissue Oximetry Physiology Screens
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring Toggle "Show ΔctHb Trend Graph" on. The trend will be plotted in pink with a corresponding y-axis on the right side of the graph. 12.3.7.3 Reset ΔctHb To reset the baseline value of ΔctHb to zero for all channels: Touch anywhere in the StO₂...
Page 241 12.4 Edwards Algorithm for Measurement of Blood Hemoglobin (tHb Algorithm) The Edwards algorithm for measurement of blood hemoglobin gives clinicians continuous and non-invasive access to the concentration of total hemoglobin in the blood/circulatory system of patients and can offer many advantages in the assessment of both acute and chronic anemic status in a variety of clinical settings.
Page 242: Indications For Use
HemoSphere ForeSight oximeter cable and non-invasive ForeSight IQ sensors in cerebral locations. 12.4.2 Intended Use The Edwards algorithm for measurement of blood hemoglobin is intended for use as an adjunct monitor of relative and total hemoglobin concentration of blood in individuals at risk for reduced-flow or no-flow ischemic states in surgical and ICU settings.
Page 243: Figure 12-16: Block Diagram Of The Edwards Algorithm For Measurement Of Blood Hemoglobin (Thb Algorithm)
(ΔctHb, ForeSight oximeter cable) tHb algorithm (laboratory blood gas analyzer) Figure 12-16: Block Diagram of the Edwards algorithm for measurement of blood hemoglobin (tHb Algorithm) 12.4.3.1 Inputs of Edwards tHb Algorithm The Edwards algorithm for measurement of blood hemoglobin utilizes two inputs: ΔctHb parameter obtained from the ForeSight oximeter cable sampled every 2 seconds.
Page 244: Figure 12-17: Thb Parameter Display
HemoSphere Alta Tissue Oximetry Monitoring 12.4.4 Total Blood Hemoglobin (tHb) Parameter Display Total blood hemoglobin (tHb) is selectable as a key parameter for display on the HemoSphere Alta advanced monitoring platform. Connect one or two large ForeSight IQ sensors to the left and/or right cerebral locations. See Attaching Sensors to the Patient on page 230.
Page 245: Figure 12-19: Thb Parameter Recalibration Warning
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring Touch the Calibrate icon on the tHb parameter display. The tHb Calibration screen is displayed. Touch the Calibrate tHb button. Note tHb monitoring and calibration can only occur when ΔctHb values are being monitored using one or two large ForeSight IQ sensors configured for left (L) and/or right (R) cerebral locations.
Page 246: Table 12-5: Patient Demographics Used For Verification Testing
(when not forbidden to collect by local law of the study sites) and the surgery types from all five sites. Full subgroup analyses across other demographic factors, including Race and Ethnicity, are on File at Edwards Lifesciences.
Page 247 HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring Site Number Gender Height Weight Surgery Race/ Reference of Pa‐ Type ethnicity (years) (cm) (kg) Device Used* tients Heart valve repair (1) Greenville Black or Af‐ Coronary Memorial rican artery dis‐...
Page 248: Figure 12-20: Bland-Altman Plots For Thb Vs Blood Gas Analyzer For Thb
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring Table 12-6: RMSE and Bland-Altman analysis results comparing tHb with reference blood gas analyzer measurements Number of pa‐ RMSE, g/dL Bias, g/dL Precision, g/dL BA plot tients 0.77 0.07 0.73 Edwards algorithm for tHb vs.
Page 249: Table 12-8: Thb Calibration And Recalibration Troubleshooting Messages
HemoSphere Alta Advanced Monitoring Platform HemoSphere Alta Tissue Oximetry Monitoring • calibration should not be performed • a new calibration is recommended • the input signal (ΔctHb) is unstable The troubleshooting causes and solutions listed in this section are associated with these output flags to inform of common error conditions which are displayed on a compatible monitor’s help screens.
Page 250: Advanced Features
Advanced Features Contents Acumen Hypotension Prediction Index (HPI) Software Feature............250 Global Hypoperfusion Index (GHI) Algorithm Feature.
Page 251 13.1.2 Introduction to Acumen Hypotension Prediction Index (HPI) Software in Non-Invasive Mode The Edwards Acumen Hypotension Prediction Index (HPI) feature provides the clinician with physiological insight into a patient’s likelihood of future hypotensive events (predefined as mean arterial pressure < 55, 60, 65, 70, 75, 80, or <...
Page 252 HemoSphere Alta Advanced Monitoring Platform Advanced Features Note Cuff sizing may not be applicable to all cuffs. Precaution. If in the clinician’s judgment, a mean arterial pressure (MAP) value of < 55, 60, 65, 70, 75, 80, or < 85 mmHg would not be meaningful for an individual patient, the clinician may choose to disable the HPI feature completely from the HPI settings menu, or if the information available on the secondary screen is useful, may choose to silence the HPI alarm from the Parameter Settings screen.
Page 253: Table 13-1: Hpi Display Configurations
HemoSphere Alta Advanced Monitoring Platform Advanced Features 13.1.3 Acumen Hypotension Prediction Index Parameters Overview The Acumen Hypotension Prediction Index parameter, HPI, which can be configured as a key parameter on all monitoring screens, displays as an integer value ranging from 0 to 100, with higher values indicating a higher likelihood of a hypotensive event.
Page 254: Table 13-2: Hpi Value Graphical And Audible Display Elements
HemoSphere Alta Advanced Monitoring Platform Advanced Features 13.1.4 Acumen Hypotension Prediction Index (HPI) Parameter Display The HPI value will update every 20 seconds and displays as a value equating to the likelihood that a hypotensive event may occur on a scale from 0 to 100. The higher the value, the higher the likelihood that a hypotensive event (predefined as mean arterial pressure <...
Page 255 HemoSphere Alta Advanced Monitoring Platform Advanced Features HPI value Graphical display Audible General interpretation Recommended user action elements HPI = 100 Red (flashing) High priori‐ Patient is hypotensive Acknowledge popup by chosen Popup ty alarm method tone Check patient hemodynamics using the secondary screen and other pri‐...
Page 256: Figure 13-1: Hpi Key Parameter Tile
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-3: HPI versus other key parameters: similarities and differences Similarities Differences • Values update every 20 seconds • HPI key parameter tile does not have green target color in colored font, depending on clinical/alarm indicator status •...
Page 257: Figure 13-2: Hpi Key Parameter On Cockpit Screen
0 to 100 and the associated parameter color (white/red). As with other available alarms on the HemoSphere Alta advanced monitoring platform, the volume of the HPI available alarm is adjustable. See Alarms/Targets on page 139 for information about silencing the alarm and configuring the alarm volume.
Page 258: Figure 13-3: Information Bar With Hpi
HemoSphere Alta Advanced Monitoring Platform Advanced Features 13.1.7 HPI on Information Bar When HPI is not configured as a key parameter, the parameter value is still computed and displayed on the information bar as shown in Figure 13-3 on page 258.
Page 259: Figure 13-4: Hpi High Alert Notification
HemoSphere Alta Advanced Monitoring Platform Advanced Features Figure 13-4: HPI high alert notification Upon acknowledgment, the following will occur: • The notification will disappear. • The HPI alarm tone will be silenced for as long as the alert is active.
Page 260: Figure 13-5: Hpi Parameter Hypotension Threshold Settings Screen
HemoSphere Alta Advanced Monitoring Platform Advanced Features Figure 13-5: HPI parameter hypotension threshold settings screen Select one of the following Hypotension Threshold menu options: 55, 60, 65, 70, 75, 80, or 85 mmHg. The default value is 65 mmHg. Touch Save to commit a new hypotension threshold. The selected value will be displayed on the parameter tile (see Figure 13-1 on page 256) and on the high alert notification (see Figure 13-4 on page 259).
Page 261 HemoSphere Alta Advanced Monitoring Platform Advanced Features 13.1.11.1 Navigate to HPI Algorithm Side Panel To access the HPI algorithm side panel, touch one of the following: → Hypotension Prediction Index button. If another clinical tool is active, use the Clinical Tools icon •...
Page 262: Figure 13-6: Hpi Algorithm Side Panel - Relationship View
HemoSphere Alta Advanced Monitoring Platform Advanced Features Figure 13-6: HPI algorithm side panel – relationship view For parameter derivations, see Table C-1 on page 411 in Equations for Calculated Patient Parameters on page 411. 13.1.11.3 HPI Smart Alerts and Smart Trends...
Page 263: Figure 13-7: Hpi Smart Alert Notification
For each parameter, there are specific thresholds that are relevant to the HPI smart alerts decisions. See Table 13-5 on page 263. Pre-selected parameter target values are set on the parameter Alarms/Targets screen. See Alarms/Targets on page 139. The hard threshold target values listed below are the Edwards default thresholds for parameter warning (yellow) ranges.
Page 264: Figure 13-8: Hpi Algorithm Settings Menu
HemoSphere Alta Advanced Monitoring Platform Advanced Features Parameter Default threshold MAP (mmHg)* ≤72 *Note: Hypotension Threshold + 10% (Not configurable) ≤72 A smart alert condition is displayed as a shaded region on the trend graph for that parameter. Smart alert settings (% change value and time interval) are configured by the user.
Page 265: Additional Parameters
HemoSphere Alta Advanced Monitoring Platform Advanced Features When HPI is displayed in the Information Bar: • After a second consecutive HPI value exceeds 85, High Alert popup appears. • Check patient hemodynamics using the HPI secondary screen and other primary screen parameters in order to investigate the potential cause of the high likelihood of hypotension in order to inform a potential course of action.
Page 266 HemoSphere Alta Advanced Monitoring Platform Advanced Features Most interventions to treat SV (or SVI) and MAP, impact primarily SV and its determinants preload, contractility, afterload. Decision support for treatment decisions should integrally provide information on all three aspects, since they often inter-relate.
Page 267: Table 13-7: 95% Confidence Interval (Ci) Results For Bias And Limits Of Agreement (Loa)
HemoSphere Alta Advanced Monitoring Platform Advanced Features has been shown to provide an indication of potential afterload responsiveness to increase MAP by giving volume in preload volume responsive mechanically ventilated patients [4] and spontaneously breathing patients [5]. Afterload responsiveness to increase MAP is greater potentially at values of Ea >...
Page 268: Figure 13-9: Bland-Altman Plots For Svv, Ppv, And Eadyn
HemoSphere Alta Advanced Monitoring Platform Advanced Features 1. ClearSight SVV - FloTrac SVV, % 3. ClearSight PPV - FloTrac PPV, % 5. ClearSight Ea - FloTrac Ea 2. FloTrac SVV, % 4. FloTrac PPV, % 6. FloTrac Ea Figure 13-9: Bland-Altman plots for SVV, PPV, and Ea 13.1.14 Clinical Validation with Hypotension Threshold in Minimally-Invasive...
Page 269: Table 13-8: Patient Demographics (Minimally-Invasive Monitored Surgical Patients, N=1141)
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-8: Patient demographics (minimally-invasive monitored surgical patients, N=1141) Description Value # of Patients 1141 Gender (Male/Female) 631/510 58.0 ± 17.0 BSA (m 1.9 ± 0.3 Height (cm) 169.1 ± 10.8 Weight (kg) 80.3 ±...
Page 270: Table 13-11: Patient Demographics (Minimally-Invasive Monitored Non-Surgical Patients, N=672)
HemoSphere Alta Advanced Monitoring Platform Advanced Features segments included for each MAP target and a summary of patient data lengths (in minutes) are provided below in Table 13-12 on page 270. The 672 non-surgical patients can be further stratified as described in Table 13-13 on page 270 below.
Page 271: Table 13-14: Clinical Validation Study Results* (Minimally-Invasive Monitored Surgical Patients)
HemoSphere Alta Advanced Monitoring Platform Advanced Features Diagnosis # patients (% of total) TOTAL 672 (100%) 13.1.14.3 Hypotension Threshold Clinical Validation Study Results – Minimally-Invasive Monitoring The results of the receiver operating characteristic (ROC) analyses for surgical and non-surgical patients are summarized below in Table 13-14 on page 271 and Table 13-15 on page 272.
Page 272: Table 13-15: Clinical Validation Study Results* (Minimally-Invasive Monitored Non-Surgical Patients)
HemoSphere Alta Advanced Monitoring Platform Advanced Features HPI Thresh‐ Variable PPV [confidence NPV [confidence Specificity (%) Sensitivity (%) MAP Value interval] interval] [95% confidence [95% confidence (mmHg) interval] interval] 99.3 78.0 99.6 69.3 0.88 =(2590/2607) =(4071/5221) =(4071/4088) =(2590/3740) [0.86, 0.89] [98.8, 99.8]...
Page 273: Table 13-16: Event Rate Analysis (Surgical Minimally-Invasive, N=1141)
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-17 on page 274 provides the hypotensive event occurrence percentage and time-to-event data for a given HPI range for non-surgical 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 non-surgical patients.
Page 274: Table 13-17: Event Rate Analysis (Non-Surgical Minimally-Invasive, N=672)
HemoSphere Alta Advanced Monitoring Platform Advanced Features HPI Range 55 mmHg 60 mmHg 65 mmHg 70 mmHg 75 mmHg 80 mmHg 85 mmHg MAP target MAP target MAP target MAP target MAP target MAP target MAP target Event rate Event rate Event rate Event rate Event rate...
Page 275 HemoSphere Alta Advanced Monitoring Platform Advanced Features HPI Range 55 mmHg 60 mmHg 65 mmHg 70 mmHg 75 mmHg 80 mmHg 85 mmHg MAP target MAP target MAP target MAP target MAP target MAP target MAP target Event rate Event rate Event rate Event rate Event rate...
Page 276: Table 13-18: Patient Demographics (Non-Invasive Monitored Surgical Patients, N=927)
HemoSphere Alta Advanced Monitoring Platform Advanced Features HPI Range 55 mmHg 60 mmHg 65 mmHg 70 mmHg 75 mmHg 80 mmHg 85 mmHg MAP target MAP target MAP target MAP target MAP target MAP target MAP target Event rate Event rate Event rate Event rate Event rate...
Page 277: Table 13-20: Surgical Patient Characteristics (Non-Invasive, N=927)
HemoSphere Alta Advanced Monitoring Platform Advanced Features Proposed MAP targets Number of hypotensive Median total data length Mean total data length events (minutes) (± Std Dev, minutes) 75 mmHg 2894 80 mmHg 2440 85 mmHg 3381 Table 13-20: Surgical patient characteristics (non-invasive, N=927)
Page 278: Table 13-21: Patient Demographics (Non-Invasive Monitored Non-Surgical Patients, N=424)
HemoSphere Alta Advanced Monitoring Platform Advanced Features segments included for each MAP target and a summary of patient data lengths (in minutes) are provided below in Table 13-22 on page 278. The 424 non-surgical patients can be further stratified as described in Table 13-23 on page 278 below.
Page 279: Table 13-24: Clinical Validation Study Results* (Non-Invasive Monitored Surgical Patients)
HemoSphere Alta Advanced Monitoring Platform Advanced Features Diagnosis # patients (% of total) pulmonary 7 (1.7%) renal 2 (0.5%) respiratory 40 (9.4%) sepsis 18 (4.2%) shock 4 (0.9%) trauma 8 (1.9%) vascular 32 (7.5%) TOTAL* 424 (100%) 13.1.15.3 Hypotension Threshold Clinical Validation Study Results – Non-Invasive...
Page 280: Table 13-25: Clinical Validation Study Results* (Non-Invasive Monitored Non-Surgical Patients)
HemoSphere Alta Advanced Monitoring Platform Advanced Features HPI Thresh‐ Variable PPV [confidence NPV [confidence Specificity (%) Sensitivity (%) MAP Value interval] interval] [95% confidence [95% confidence (mmHg) interval] interval] 98.3 89.2 99.2 78.5 0.90 =(2011/2046) =(4533/5083) =(4533/4568) =(2011/2561) [0.89, 0.92] [97.1, 99.2]...
Page 281: Table 13-26: Event Rate Analysis (Surgical Non-Invasive, N=927)
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-26 on page 281 provides the hypotensive event occurrence percentage and time-to-event data for a given HPI range for surgical 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 surgical patients.
Page 282 HemoSphere Alta Advanced Monitoring Platform Advanced Features HPI Range 55 mmHg 60 mmHg 65 mmHg 70 mmHg 75 mmHg 80 mmHg 85 mmHg MAP target MAP target MAP target MAP target MAP target MAP target MAP target Event rate Event rate Event rate Event rate Event rate...
Page 283: Table 13-27: Event Rate Analysis (Non-Surgical Non-Invasive, N=424)
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-27: Event rate analysis (non-surgical non-invasive, N=424) HPI Range 55 mmHg 60 mmHg 65 mmHg 70 mmHg 75 mmHg 80 mmHg 85 mmHg MAP target MAP target MAP target MAP target MAP target MAP target MAP target Event rate...
Page 284: Study Design
HemoSphere Alta Advanced Monitoring Platform Advanced Features HPI Range 55 mmHg 60 mmHg 65 mmHg 70 mmHg 75 mmHg 80 mmHg 85 mmHg MAP target MAP target MAP target MAP target MAP target MAP target MAP target Event rate Event rate Event rate Event rate Event rate...
Page 285: Table 13-28: Hpi Prospective Subject Selection Criteria
HemoSphere Alta Advanced Monitoring Platform Advanced Features who are confirmed to be pregnant/nursing, known clinically important intra-cardiac shunts, and known moderate to severe aortic and mitral valve disease. Table 13-28: HPI prospective subject selection criteria Inclusion criteria Exclusion criteria Written informed consent Participating in another (interventional) study Age ≥18 years...
Page 286: Table 13-29: Mpog Historical Control Patient Selection Criteria
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-29: MPOG historical control patient selection criteria Inclusion criteria Exclusion criteria Receiving care at an Institution planning on partic‐ Baseline mean arterial pressure <65 mmHg (A ipating in the prospective study of Hypotension blood pressure measurement obtained in the im‐...
Page 287: Table 13-31: Procedure Type (Hpi)
HemoSphere Alta Advanced Monitoring Platform Advanced Features Description MPOG (Intent-to-treat) (Full analysis set) (Full analysis set) Age (year) Mean ± SD 63.0 ± 12.97 62.8 ± 13.0 65.3 ± 13.8 Median (min-max) 65 (19 - 94) 65 (19 - 89)
Page 288: Table 13-32: Surgery Type By Cpt Grouping
HemoSphere Alta Advanced Monitoring Platform Advanced Features Procedure type % (n/N) Other gastrointestinal surgery 2.0 (9/460) Hip revision 1.7 (8/460) Prostatectomy 1.7 (8/460) HIPEC 1.3 (6/460) Hysterectomy with debulking 1.3 (6/460) Cholecystectomy 0.9 (4/460) Reoperative orthopedic surgery 0.9 (4/460) Splenectomy 0.9 (4/460)
Page 289: Table 13-33: Receiver Operating Characteristics (Roc) For Hpi Subjects (N=482)
HemoSphere Alta Advanced Monitoring Platform Advanced Features specificity are defined and calculated in Table 13-33 on page 289, see Hypotension Threshold Clinical Validation Study Results – Minimally-Invasive Monitoring on page 271. Table 13-33: Receiver operating characteristics (ROC) for HPI subjects (N=482)*...
Page 290: Table 13-36: Effectiveness Stratified By Map Level, Hpi Study Versus Mpog Historical Control
HemoSphere Alta Advanced Monitoring Platform Advanced Features Study category Subject AUC mean AUC SD AUC median AUC range AUC Q3-Q1 (min*mmHg) (min*mmHg) (min*mmHg) (min*mmHg) (min*mmHg) All pivotal subjects with 47.07 85.30 16.83 833.00 51.00 ≥3 hours surgery duration All pivotal subjects with 65.23...
Page 291: Table 13-37: Frequency Pattern Of Subjects And Intervention Instances By Hpi Threshold
HemoSphere Alta Advanced Monitoring Platform Advanced Features MAP value Statistic HPI (subject=406) MPOG (sub‐ p value ject=22,109) Total IOH minutes 10,241 1,185,983 IOH mean (minutes) 27.31 56.50 <0.0001 IOH STD 28.79 70.40 Note: Standard Method - IOH episode defined as at least three consecutive observations with MAP < MAP value defining IOH. FAS pivotal subjects with surgery duration at least 3 hours are included.
Page 292: Table 13-38: Hpi Study - 30 Days Postoperative Composite Endpoint Components - Cc Analysis Population (Pivotal Subjects, N=400)
HemoSphere Alta Advanced Monitoring Platform Advanced Features individual composite elements). The safety data collected for the MPOG arm included mortality (375, 1.83%); AKI Stage 1 (2068, 9.35%); AKI Stage 2 (381, 1.72%); AKI Stage 3 (152, 0.69%); and, Myocardial Injury [MINS] (178, 0.81%).
Page 293 HemoSphere Alta Advanced Monitoring Platform Advanced Features In this unblinded prospective-to-historical comparison study design, IOH was demonstrated to be reduced with the use of the HPI software feature. This study has limitations secondary to potential bias associated with clinician awareness in the prospective arm and the comparison to a historical cohort.
Page 294 HemoSphere Alta Advanced Monitoring Platform Advanced Features algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient’s predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration.
Page 295: Table 13-40: Ghi Display Configurations
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-40: GHI display configurations Display option Audible and visual alarm Information bar alarm mes‐ saging Key Parameter Key Parameter (audible alarm silenced) Not displayed Unlike other monitored parameters, the GHI alarm limits are not adjustable, as GHI is not a physiologic parameter with a selectable target range (as with cardiac output, for example), but rather a likelihood of physiological state.
Page 296: Figure 13-10: Ghi Key Parameter Tile
HemoSphere Alta Advanced Monitoring Platform Advanced Features GHI value Graphical dis‐ Audible General interpretation Recommended user action play elements GHI ≥ 75 and Red (flashing) Medium priority Surgical patient has a high likeli‐ Check patient hemodynamics us‐ persists for alarm tone hood of experiencing a future hy‐...
Page 297: Table 13-42: Parameter Status Colors For Ghi
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-42: Parameter status colors for GHI Parameter status color Lower limit Upper limit Gray Fault condition White Red/Gray Flashing 13.2.4 GHI Alarm When GHI is configured as a key parameter and exceeds or equals the upper threshold of 75 for three consecutive readings, a medium priority alarm will activate which indicates to the user that the patient may be trending towards hemodynamic instability and a hypoperfusive event.
Page 298: Table 13-43: Patient Numbers In Ghi Algorithm Clinical Validation Datasets
HemoSphere Alta Advanced Monitoring Platform Advanced Features • When GHI exceeds 75, check patient hemodynamics using other primary screen parameters in order to investigate the potential cause of the high likelihood of hypoperfusion in order to inform a potential course of action.
Page 299: Table 13-45: Patient Demographics And Surgery Types (Surgical Patients, N=189)
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-45: Patient demographics and surgery types (surgical patients, N=189) Description ICU patients, all datasets # of Patients Age (years) 60.4 ± 13.2 BSA (m 2.02 ± 0.31 Gender (% male) 123 [65.1%] Pulmonary Hypertensive (# of patients [% of total patients]) 54 [28.6%]...
Page 300: Table 13-46: Clinical Validation Study Results - All Patients
HemoSphere Alta Advanced Monitoring Platform Advanced Features Performance of the GHI algorithm can be seen in Table 13-46 on page 300 for all patients in the clinical validation datasets. Table 13-46: Clinical validation study results - all patients* GHI Threshold...
Page 301: Figure 13-12: Cai Key Parameter Trend Display And Parameter Tile
HemoSphere Alta Advanced Monitoring Platform Advanced Features of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO₂) in patient's cerebral tissue. MAP is acquired by the HemoSphere pressure cable and StO₂ is acquired by the ForeSight oximeter cable.
Page 302: Table 13-48: Patient Demographics
HemoSphere Alta Advanced Monitoring Platform Advanced Features CAI value General interpretation Recommended user action CAI ≥ 45 MAP and StO₂ are strongly associated. Review individual MAP and StO₂ trends. Potential changes in MAP are likely as‐ Be aware that potential changes in MAP...
Page 303: Table 13-49: Roc Analysis Results For Clinical Data (N=50)
HemoSphere Alta Advanced Monitoring Platform Advanced Features • ROC AUC: the area under the ROC curve (AUC) summarizes the performance as a single number (0.5 to 1) with a higher AUC associated with a better performing algorithm. The performance goals for CAI algorithm are defined as follows: Sensitivity and Specificity ≥...
Page 304: Table 13-53: Roc Analysis Results For Northwestern University Clinical Data (N=18)
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-53: ROC analysis results for Northwestern University clinical data (N=18) CAI Threshold Sensitivity (%) [95% Specificity (%) [95% ROC AUC [95% confidence in‐ confidence interval] confidence interval] terval] 0.87 [61, 87] [89, 98] [0.79, 0.95]...
Page 305: Table 13-55: Afm Algorithm States
HemoSphere Alta Advanced Monitoring Platform Advanced Features The assisted fluid management (AFM) feature cycles through various states during a session. Table 13-55 on page 305 describes each of these states. Table 13-55: AFM algorithm states State AFM dashboard notification Definition...
Page 306 HemoSphere Alta Advanced Monitoring Platform Advanced Features • The final prediction is compared to the chosen fluid strategy to determine if a fluid suggestion should be generated. If the predicted delta stroke volume is greater that the selected fluid strategy, then the output of the algorithm is a fluid suggestion prompt on the hemodynamic monitor.
Page 307 The AFM algorithm help screens include content about getting started, using the AFM feature, and common questions about how the system works. On each AFM algorithm help screen, touch the question that interests you to see a brief answer. For additional information, contact your Edwards representative. 13.4.4 Starting or Restarting the AFM Software Feature The Acumen IQ sensor must be zeroed to atmospheric pressure to ensure accurate monitoring.
Page 308 HemoSphere Alta Advanced Monitoring Platform Advanced Features The Maximum case volume provides the user with the anticipated fluid volume for the entire case based upon available information at the start of the case. A patient’s fluid needs may change over the course of the case and therefore this value should be considered as a guide and not the absolute threshold between optimal and excessive fluid delivery.
Page 309: Figure 13-13: Afm Algorithm Dashboard - Session Initialization
HemoSphere Alta Advanced Monitoring Platform Advanced Features Figure 13-13: AFM algorithm dashboard - Session initialization 13.4.5 AFM Dashboard Display The AFM dashboard (shown in Figure 13-13 on page 309) can be displayed on the side panel while an AFM session is active.
Page 310 Note By default, the AFM feature requires a fluid meter connection to initialize. Using the AFM feature in Manual mode is optional. For more information on changing this advanced setting, contact your Edwards representative. 13.4.6.2 Fluid Strategy It is important to correctly identify the Fluid Strategy. The selected fluid strategy influences AFM fluid suggestions.
Page 311: Table 13-56: Afm Algorithm Fluid Status Icons
HemoSphere Alta Advanced Monitoring Platform Advanced Features 13.4.6.4 Maximum Case Volume The Maximum case volume provides the user with the anticipated target fluid volume for the entire case and is set by the clinician at the start of the case based upon available clinical data at that point. A patient’s fluid needs may change over the course of the case and therefore this value should be considered as a guide and not the absolute threshold between optimal and excessive fluid delivery.
Page 312 HemoSphere Alta Advanced Monitoring Platform Advanced Features AFM fluid status icon AFM fluid status icon Meaning on information bar in AFM dashboard display Fluid is not recommended The AFM software feature will not suggest fluid (neither AFM recommen‐ dation nor test bolus) when specific physiology indicates that fluid is not recommended.
Page 313: Figure 13-14: Acumen Iq Fluid Meter And Hemosphere Alta Afm Cable Connection Overview
By default, the AFM feature requires a fluid meter connection to initialize. Using the AFM feature in Manual mode is optional. For more information on changing this advanced setting, contact your Edwards representative. 13.4.7.1 Fluid Administration Workflow – Acumen IQ Fluid Meter Use the following AFM software workflow when an Acumen IQ fluid meter is connected.
Page 314 HemoSphere Alta Advanced Monitoring Platform Advanced Features Ensure proper orientation, then plug the HemoSphere Alta AFM cable into one of the five common cable ports on the right panel of the HemoSphere Alta monitor. Connect the Acumen IQ fluid meter to the end of the Acumen AFM cable indicated by (2) in Figure 13-14 on page 313.
Page 315 HemoSphere Alta Advanced Monitoring Platform Advanced Features Note With a fluid meter connected, the Fluid Type must be specified. Note It may be appropriate to decline an AFM algorithm suggestion if review of patient hemodynamics does not suggest administration of fluid or in surgical situations where is it inappropriate to administer fluid. Note that constantly declining bolus suggestions may limit the usefulness of AFM algorithm to determine future fluid responsiveness.
Page 316 HemoSphere Alta Advanced Monitoring Platform Advanced Features The color around the volume meter will turn green when the target volume has been reached. Close the fluid line when the desired bolus volume has been delivered. Note The bolus delivery rate is dependent upon stopping the bolus when fluid administration is complete. Incorrect bolus delivery rate can impact the accuracy of the hemodynamic response assessment to a fluid bolus and the reliability of the future AFM algorithm suggestions.
Page 317 HemoSphere Alta Advanced Monitoring Platform Advanced Features • Surgical manipulation • Arterial line interference * External compression (i.e., leaning on A-line) * ABG draw, fast flush * Overdamping of line • Vascular clamping • Additional line of fluid simultaneously opened during bolus administration •...
Page 318 HemoSphere Alta Advanced Monitoring Platform Advanced Features Note If an additional AFM algorithm session for the same patient is desired after the previous session has ended, refer to Starting or Restarting the AFM Software Feature on page 307. All initial AFM settings, with the exception of the Maximum case volume, will be maintained.
Page 319 HemoSphere Alta Advanced Monitoring Platform Advanced Features Note If 40 seconds have elapsed when the AFM algorithm does not recommend fluid for the patient, the "Bolus Suggested" message will be removed from the dashboard. The fluid delivery message prompts the user to review patient hemodynamics and begin a fluid bolus if they agree with the suggestion.
Page 320 HemoSphere Alta Advanced Monitoring Platform Advanced Features Note The bolus delivery rate is dependent upon stopping the bolus when fluid administration is complete. Incorrect bolus delivery rate can impact the accuracy of the hemodynamic response assessment to a fluid bolus and the reliability of the future AFM suggestions.
Page 321 HemoSphere Alta Advanced Monitoring Platform Advanced Features Enter the fluid bolus volume on the Bolus Volume keypad. Touch enter key when complete. Precaution. When estimating the amount of fluid delivered and entering the information into the system for analysis, it is important to ensure that the fluid bolus volume entered into the system is as accurate as possible.
Page 322 HemoSphere Alta Advanced Monitoring Platform Advanced Features Note The prompt to analyze the hemodynamic response after a fluid bolus times out after 90 seconds. If analysis is available (Analyze is selectable), this will automatically be chosen. Upon fluid bolus completion, if the total volume delivered through the AFM is approaching (within 500 mL)
Page 323 HemoSphere Alta Advanced Monitoring Platform Advanced Features While the bolus is being analyzed by the algorithm, the User Bolus button will be unavailable and the user will not receive any fluid suggestions from the algorithm. The AFM algorithm will only analyze fluid boluses within the following ranges: •...
Page 324 HemoSphere Alta Advanced Monitoring Platform Advanced Features Change to enter a new value through the keypad if patient fluid needs have changed. A notification will • appear again if the total volume delivered through AFM is approaching (within 500 mL) the Maximum case volume;...
Page 325 To resume AFM session after being paused, touch the AFM start button. Each AFM session can be ended by the user. The HemoSphere Alta advanced monitoring platform will end the AFM session if a new patient is selected or the user switches to a different monitoring technology. AFM is only available...
Page 326 AFM on previous user interfaces and the user interface presented here for the HemoSphere Alta advanced monitoring platform. Relevant differences have been noted where necessary. Subjects included in the study were ≥18 years of age, with planned non-cardiac/non-thoracic surgery (e.g., abdominal surgery, combined abdominal/pelvic surgery, major peripheral vascular surgery) expected to last >2 hours post-anesthesia induction and had an American Society of Anesthesiologists (ASA) Score of 3 or 4.
Page 327: Table 13-57: Subject Demographics
60.5% [57.8, 63.2] *Note: An AFM recommendation in this study is equivalent to a fluid bolus suggestion on the HemoSphere Alta advanced monitoring platform. An AFM test is equivalent to a test bolus suggestion on the HemoSphere Alta advanced monitoring platform.
Page 328: Table 13-59: Afm Performance By Bolus Volume (Ml)
HemoSphere Alta Advanced Monitoring Platform Advanced Features stroke volume 40.9% [37.4, 44.1] of the time. The user boluses were not given exclusively as part of a manually administered fluid management protocol. A secondary analysis provided the AFM algorithm performance stratified by delivered bolus volume (see Table 13-59 on page 328).
Page 329: Table 13-61: Frequency Of Afm Algorithm Recommendations Per Hour
HemoSphere Alta Advanced Monitoring Platform Advanced Features the majority of the time (see Table 13-61 on page 329). It is also possible for an AFM suggestion to immediately follow the completion of a non-responsive fluid bolus if current hemodynamic state has changed since the prior non-responsive bolus.
Page 330: Table 13-63: Reasons Boluses Were Discarded (Analysis Declined) In The Per Protocol Pivotal Subjects
HemoSphere Alta Advanced Monitoring Platform Advanced Features Table 13-63: Reasons boluses were discarded (analysis declined) in the per protocol pivotal subjects Fluid demographics % (n/N) Reasons bolus discarded (analysis declined) Administered vasoactive agent with fluids 35.0% (89/254) Other 18.1% (46/254) ABG draw / fast flush 11.8% (30/254)
Page 331 HemoSphere Alta Advanced Monitoring Platform Advanced Features Fluid demographics % (n/N) Reasons AFM algorithm prompt not accepted Waiting for RBC administration 2.1% (29/1399) There was a change in subject position and clinician would like to wait and see 1.9% (26/1399) Fluid recently administered, now observing 1.9% (26/1399)
Page 332 HemoSphere Alta Advanced Monitoring Platform Advanced Features Note Active AFM algorithm sessions will end when Fluid Meter Only Mode is entered. Total accumulated fluid volume delivered during all previous AFM algorithm sessions from the current patient session will continue to be tracked.
Page 333 HemoSphere Alta Advanced Monitoring Platform Advanced Features iCO measurement is made and accepted, RVCO parameters will display "CAL" on the parameter tile to indicate they have been calibrated. CAUTION Inaccurate RVCO values may be caused by: • Inaccurate or noisy right ventricular pressure •...
Page 334: Figure 13-15: Swan-Ganz Iq Catheter Connection Overview
HemoSphere Alta Advanced Monitoring Platform Advanced Features 1. Swan-Ganz IQ catheter 5. injectate temperature probe connection* 2. thermistor connection* 6. HemoSphere Alta Swan-Ganz patient cable 3. EEPROM connection to HemoSphere Alta Swan-Ganz 7. pressure cable patient cable 4. catheter RV port to TruWave transducer / pressure cable 8.
Page 335: Figure 13-16: Rvco Calibrated Key Parameter Tile
HemoSphere Alta Advanced Monitoring Platform Advanced Features Figure 13-16: RVCO calibrated key parameter tile 13.5.4 RVCO Clinical Validation A total of 9 retrospective datasets were performed to validate the algorithm and assess the performance of RVCO. The data collected over these sites included both surgical and non-surgical data including cardiac surgery, liver transplant surgery, chronic thromboembolic pulmonary hypertensive (CTEPH), and patients undergoing invasive cardiopulmonary exercise testing in the cardiac catheterization laboratory (Cath Lab).
Page 336: Table 13-67: Clinical Validation Study Results - (Non-Calibrated State)
*Data on file at Edwards Lifesciences 13.6 Transpulmonary Thermodilution Algorithm The HemoSphere Alta advanced monitoring platform, in conjunction with an Acumen IQ sensor connected to an Edwards Lifesciences femoral arterial catheter and a pressure transducer connected to a central venous catheter, will continuously display a calibrated cardiac output (CO), stroke volume (SV), cardiac index (CI), and stroke volume index (SVI) once intermittent transpulmonary thermodilution (TPTD) has been conducted.
Page 337 * Centrally administered cooled or warmed solutions of blood products * Clot formation on the thermistor * External heat sources (cooling or heating blankets) placed on the Edwards Lifesciences femoral arterial catheters thermistor connection * Electrocautery or electrosurgical unit interference * Rapid changes in cardiac output ...
Page 338: Figure 13-17: Transpulmonary Thermodilution Algorithm (Tptd) Patient Cable Connection Overview
HemoSphere Alta Advanced Monitoring Platform Advanced Features 13.6.1 Connection Overview Refer to Pressure Cable Overview on page 172 and Connecting the HemoSphere Alta Swan-Ganz Patient Cable on page 154 for details on connecting the pressure cables (HEMPSC100 or HEMAPSC200) and HemoSphere Alta Swan-Ganz patient cable.
Page 339: Table 13-69: Recommended Injectate Volumes
Attach the thermistor end of the HemoSphere Alta Swan-Ganz patient cable to the thermistor connector on the Edwards Lifesciences femoral arterial catheter as shown by (2) in Figure 13-17 on page 338. Connect the pressure cables as previously described in Pressure Cable Overview on page 172.
Page 340: Figure 13-18: Tptd Procedure
HemoSphere Alta Advanced Monitoring Platform Advanced Features Touch the Start Set button. See (1) in Figure 13-18 on page 340. Note The Start Set button is disabled if: • The femoral artery sensor is not an Acumen IQ sensor. •...
Page 341: Figure 13-19: Review Tptd Set And View Results
HemoSphere Alta Advanced Monitoring Platform Advanced Features 11. When the thermal washout curve is complete and a stable thermal baseline is reached, the Inject screen will appear. Repeat steps 6 through 10 up to six times. Figure 13-19: Review TPTD set and view results 12.
Page 342: Table 13-70: Transpulmonary Thermodilution Intermittent Parameters
13.7 Enhanced Parameter Tracking The HemoSphere alta 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 343: Figure 13-20: Gdt Menu Screen - Parameter Selection
HemoSphere Alta Advanced Monitoring Platform Advanced Features 13.7.1.1 Key Parameter and Target Selection → Goal Directed Therapy button. If another clinical tool is active, use the Touch the Clinical Tools icon drop down menu to select Goal Directed Therapy. Figure 13-20: GDT menu screen - parameter selection The parameters shown match the key parameters selected on the trend monitoring screen.
Page 344: Figure 13-22: Gdt - Start Active Tracking
HemoSphere Alta Advanced Monitoring Platform Advanced Features Touch on the boxes next to parameters to select and designate those parameters for tracking. Touch the play icon to begin GDT tracking. Figure 13-22: GDT - start active tracking 13.7.1.2 Active GDT Tracking During active GDT tracking, the plot area of the parameter trend graph within targeted range appears shaded in blue.
Page 345: Table 13-71: Gdt Target Status Indicator Colors
HemoSphere Alta Advanced Monitoring Platform Advanced Features → Assisted Fluid Management button to access GDT Tracking Side Panel. Touch the Clinical Tools icon the GDT side panel at any time. Touch the stop icon to stop tracking or the pause icon to pause tracking.
Page 346 HemoSphere Alta Advanced Monitoring Platform Advanced Features Observe the SV trend while administering necessary fluid management to a achieve an optimal value. The trend line appears blue. In place of the time-in-target value, a light gray "n/a" icon appears on the SV/SVI parameter tile and GDT side panel.
Page 347: Figure 13-24: Fluid Responsiveness Test Side Panel - Main Menu Screen
HemoSphere Alta Advanced Monitoring Platform Advanced Features Figure 13-24: Fluid Responsiveness Test side panel – main menu screen Select the Fluid Challenge type as: Passive Leg Raise or Fluid Bolus. For more continued instructions for the selected Fluid Challenge type, follow the steps below.
Page 348 HemoSphere Alta Advanced Monitoring Platform Advanced Features SV, SVI, CO, or CI (FloTrac and ClearSight technology types) • • , SVI , CO , or CI (Swan-Ganz technology type with PAP signal; see 20-Second Flow Parameters on page 159). Select the Duration: 1 min, 1 min 30sec, or 2 min (FloTrac and ClearSight technology types) or 3 min (Swan-Ganz technology type).
Page 349 HemoSphere Alta Advanced Monitoring Platform Advanced Features 10. A new countdown timer will appear starting at the selected challenge duration time. Ensure that the patient remains still during the measurement period. Note Before sufficient measurements have been taken, the Cancel button can be touched to abort the test. A confirmation popup window will appear.
Page 350: Figure 13-25: Fluid Responsiveness Test - Results Screen
HemoSphere Alta Advanced Monitoring Platform Advanced Features Figure 13-25: Fluid Responsiveness Test – results screen 13.8.2 Fluid Bolus Test The Fluid Bolus test is a sensitive method for assessing a patient's fluid responsiveness. During this test, a fluid bolus is administered to the patient and preload responsiveness may be assessed by tracking the value of SV, SVI, CO, or CI.
Page 351 HemoSphere Alta Advanced Monitoring Platform Advanced Features Note The baseline value is averaged from multiple readings. Ensure that the patient remains still and stays in the same position during this measurement period. The baseline measurement duration is 1 minute. Once measurement of the baseline has commenced, the side panel is locked until the fluid bolus challenge is completed or the process is canceled and you have returned to the FRT menu screen.
Page 352 HemoSphere Alta Advanced Monitoring Platform Advanced Features After sufficient measurements have been taken, the Cancel button is no longer available. To stop the test and analyze measured data before the full time of the test has been reached touch End Now. Touch Back to Main to return to the FRT menu side panel.
Page 353: Troubleshooting
These issues are continually updated and compiled as a result of ongoing product improvements. The main help screen allows the user to navigate to specific help for HemoSphere Alta advanced monitoring platform issues. Faults, alerts and warnings notify the user of error conditions affecting parameter measurements.
Page 354: Figure 14-1: Hemosphere Alta Advanced Monitoring Platform Led Indicators
HemoSphere Alta Advanced Monitoring Platform Troubleshooting 1. visual alarm indicator 2. monitor power status Figure 14-1: HemoSphere Alta advanced monitoring platform LED indicators Table 14-1: HemoSphere Alta advanced monitoring platform visual alarm indicator Alarm status Color Light pattern Suggested action...
Page 355: Figure 14-2: Pressure Cable Led Indicator (Hempsc100 Only)
Yellow Solid ON This alarm condition requires non-urgent atten‐ tion Refer to the status bar for specific alarm condi‐ tion Table 14-2: HemoSphere Alta advanced monitoring platform power light Monitor status Color Light pattern Suggested action Monitor power ON Green...
Page 356: Figure 14-3: Foresight Oximeter Cable Led Indicators
HemoSphere Alta Advanced Monitoring Platform Troubleshooting Table 14-3: Pressure cable communication light (HEMPSC100 only) Condition Color Light Pattern Suggested Action No pressure sensor/trans‐ No light Solid OFF None ducer connected Pressure sensor/transducer Green Flashing ON/OFF Zero the pressure sensor to begin monitoring connected but not yet ze‐...
Page 357: Figure 14-4: Pressure Controller Led Indicators
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 358: Table 14-6: Monitoring Faults/Alerts
If the problem persists, contact Edwards Techni‐ cal Support. *Finger cuff error may also be indicated by software. See Table 14-26 on page 381. 14.6 HemoSphere Alta Advanced Monitoring Platform Error Messages 14.6.1 System/Monitoring Faults/Alerts Table 14-6: Monitoring faults/alerts Message...
Page 359 If problem persists, contact Edwards Technical Support Alert: Low Battery The battery has less than 20% Connect the HemoSphere Alta advanced monitor charge remaining or will be deple‐ to an alternate source of power to avoid loss of ted within 8 minutes...
Page 360 Alert: Battery Needs Conditioning Gas gauge is not synched to actual To ensure uninterrupted measurement, make battery capacity status certain the HemoSphere Alta advanced monitor is connected to an electrical outlet Condition the battery (ensure a measurement is not active)
Page 361: Table 14-7: Numeric Keypad Errors
HemoSphere Alta Advanced Monitoring Platform Troubleshooting 14.6.2 Monitoring Troubleshooting – Numeric Keypad Errors Table 14-7: Numeric keypad errors Message Possible causes Suggested actions Value out of range (xx-yy) The entered value is either higher or Displayed when the user enters a value that is out lower than the allowed range of range.
Page 362: Table 14-9: Hemosphere Alta Swan-Ganz Patient Cable Co Faults/Alerts
Expires < 4 Weeks expires in less than 4 weeks ity settings from the Advanced Setup menu and upload a valid certificate If the problem persists, contact Edwards Techni‐ cal Support Alert: HemoSphere Remote App Cer‐ HemoSphere Remote App certificate Navigate to HemoSphere Remote App Connectiv‐...
Page 363 Poor catheter thermal filament con‐ Change patient CCO cable Error* nection Use Bolus CO mode Catheter CO error Verify catheter is an Edwards CCO catheter Patient CCO cable malfunction Cath‐ eter CO error Auto QA failure Catheter connected is not an Edwards CCO catheter Fault: Swan-Ganz System –...
Page 364 Catheter connected is not an Change patient CCO cable Edwards CCO catheter Use Bolus CO mode Verify catheter is an Edwards CCO catheter Alert: Swan-Ganz System – Thermal Catheter thermal filament connec‐ Verify that the catheter thermal filament is Filament or Thermistor Connection...
Page 365: Table 14-10: Hemosphere Alta Swan-Ganz Patient Cable Edv And Sv Faults/Alerts
HemoSphere Alta Advanced Monitoring Platform Troubleshooting 14.7.2 EDV and SV Faults/Alerts Table 14-10: HemoSphere Alta Swan-Ganz patient cable EDV and SV faults/alerts Message Possible causes Suggested actions Alert: Swan-Ganz System – EDV – Re‐ Patient’s respiratory pattern may Allow more time for monitor to measure and dis‐...
Page 366 Verify that catheter thermistor is connected se‐ detected curely to patient CCO cable Monitored blood temperature is <15 Verify catheter is an Edwards CCO catheter °C or >45 °C Use Bolus CO mode Verify that blood temperature is between 15 - 45 °C...
Page 367: Table 14-12: Hemosphere Alta Swan-Ganz Patient Cable 20S Parameters Faults/Alerts
Catheter connected is not an check for bent/missing pins Edwards CCO catheter Change patient CCO cable Catheter thermistor connection not Verify catheter is an Edwards CCO catheter detected Use Bolus CO mode Monitored blood temperature is <15 Verify that the catheter thermistor is connected °C or >45 °C...
Page 368: Table 14-13: Hemosphere Alta Swan-Ganz Patient Cable General Troubleshooting
Patient CCO cable malfunction check for bent/missing pins Catheter connected is not an Change patient CCO cable Edwards CCO catheter Verify catheter is an Edwards CCO catheter Swan-Ganz System – Connect pul‐ , CI , SV or SVI is config‐...
Page 369 External monitor not optimally con‐ Stop CO monitoring and verify heart rate is the HRavg ≠ External Monitor HR figured for ECG signal output same for HemoSphere Alta advanced monitor External monitor malfunction and external monitor ECG interface cable malfunction Select appropriate lead configuration to maxi‐...
Page 370: Table 14-14: Smart Wedge Faults/Alerts
HemoSphere Alta Advanced Monitoring Platform Troubleshooting 14.7.6 Smart Wedge Algorithm Faults/Alerts Table 14-14: Smart Wedge faults/alerts Message Possible causes Suggested actions Alert: Smart Wedge – Artifact Detec‐ Abnormally high systolic PAP pres‐ Assess pressure monitoring system starting from ted – Check Lines sure (systolic PAP pressure >...
Page 371: Table 14-15: Rvco Faults/Alerts
HemoSphere Alta Advanced Monitoring Platform Troubleshooting 14.7.7 Right Ventricular Cardiac Output (RVCO) Algorithm Faults/Alerts Table 14-15: RVCO faults/alerts Message Possible causes Suggested actions Fault: RVCO – Failed to Run – Poor Right Ventricle Pressure waveform is Verify proper catheter position in the right ventri‐...
Page 372: Table 14-16: Rvco Warnings
HemoSphere Alta Advanced Monitoring Platform Troubleshooting Message Possible causes Suggested actions Alert: RVCO – Failed to Calibrate Poor iCO bolus Re-perform iCO Time between last iCO and first valid RVCO is too long Alert: RVCO – PA Systolic Higher Systolic peak of Pulmonary Artery Verify proper catheter position for both Pulmona‐...
Page 373 Change Edwards CO/pressure sensor If problem persists, contact Edwards Technical Support Fault: Pressure – Port {0} – Pressure A non-Edwards sensor has been de‐ Verify that an Edwards pressure sensor has been Sensor Error* tected used Cable or sensor malfunction Dam‐...
Page 374: Table 14-18: Hemosphere Pressure Cable Art And Rvp Faults/Alerts
Fault: Pressure – Port {0} – Arterial Arterial pressure low and non- Verify arterial catheter connection Pressure Disconnected pulsatile Verify Edwards pressure cable and pressure sen‐ Arterial catheter disconnected sor and check for missing pins Cable connections not detected Change Edwards pressure cable...
Page 375 Make sure the pressure bag is inflated and the The fluid line is being flushed flush bag is at least ¼ full Perform Square Wave Test to assess the Edwards pressure monitoring system frequency response Change Edwards pressure cable Change Edwards CO/pressure sensor...
Page 376: Table 14-19: Hemosphere Pressure Cable Tptd Faults/Alerts
HemoSphere Alta Advanced Monitoring Platform Troubleshooting 14.8.3 Transpulmonary Thermodilution Algorithm (TPTD) Faults/Alerts and Warnings Table 14-19: HemoSphere pressure cable TPTD faults/alerts Message Possible causes Suggested actions Fault: TPTD – Check Injectate Tem‐ Injectate temperature probe not de‐ Verify the catheter thermistor connection is perature Probe Connection tected.
Page 377: Table 14-20: Hemosphere Pressure Cable Tptd Warnings
System is restarting due to an error Allow the system to automatically resolve the is‐ Error – Recovery in Process – Please Wait If the problem persists, contact Edwards Techni‐ cal Support Fault: Acumen AFM Cable Malfunc‐ Internal system malfunction Disconnect and reconnect Acumen AFM cable tion –...
Page 378 / missing contacts Non-Edwards fluid meter in use Replace Acumen IQ Fluid Meter Verify that an Edwards fluid meter is being used Disconnect and reconnect Acumen IQ Fluid Me‐ Replace the fluid meter with an Edwards Acumen IQ Fluid Meter...
Page 379: Table 14-22: Hemosphere Pressure Cable Afm Warnings
HemoSphere Alta Advanced Monitoring Platform Troubleshooting Table 14-22: HemoSphere pressure cable AFM warnings Message Possible causes Suggested actions Port {0} - Acumen AFM Cable Discon‐ Acumen AFM Cable has become dis‐ Connect Acumen AFM Cable to HemoSphere Alta nected connected...
Page 380: Table 14-24: Hemosphere Pressure Cable Cai Warnings
HemoSphere Alta Advanced Monitoring Platform Troubleshooting Message Possible causes Suggested actions Alert: CAI – Cannot Be Initialized – CAI is monitoring and multiple StO₂ Verify only one ForeSight sensor is attached to Multiple Sensors Configured to Left sensors are configured to the left each cerebral location.
Page 381: Table 14-26: Clearsight Monitoring Faults/Alerts
HemoSphere Alta Advanced Monitoring Platform Troubleshooting Message Possible causes Suggested actions Pressure - Connect Acumen IQ Sen‐ An Acumen IQ dependent key pa‐ Verify the connection between the pressure cable rameter is configured and catheter The connection between the pres‐...
Page 382 HRS Connector Error HRS connector on pressure control‐ Replace HRS ler is damaged Replace pressure controller Non-Edwards HRS detected Restart measurement Verify that an Edwards HRS is being used Replace HRS with an Edwards HRS If problem persists, contact Edwards Technical Support...
Page 383 Disconnect and reconnect Edwards Pressure Con‐ Controller Error Poor connection between Pressure troller Controller and HemoSphere Alta Replace pressure controller monitor Verify that an Edwards pressure controller is be‐ Pressure Controller authentication ing used failure If problem persists, contact Edwards Technical Defective Pressure Controller Support...
Page 384 SVV accurately artifact Frequent Physiocals within wave‐ Make sure the heart end of Edwards HRS is form aligned with the patient’s phlebostatic axis Systolic pressure too high or diastol‐ Confirm electrical connections of cables...
Page 385: Table 14-27: Clearsight Monitoring Warnings
HemoSphere Alta Advanced Monitoring Platform Troubleshooting Message Possible causes Suggested actions Alert: ClearSight System – Cuff Pres‐ Finger cuff pressure has been re‐ Monitoring will automatically resume when the sure Release Mode – Monitoring Sus‐ leased countdown clock on the status bar reaches 00:00...
Page 386 HemoSphere Alta Advanced Monitoring Platform Troubleshooting Message Possible causes Suggested actions HRS Calibration Unsuccessful! Prior to calibration, no HRS move‐ Move heart end of HRS up and down. Next, keep ment detected both ends at same level, wait 1-2 seconds, and HRS is defective then re-calibrate while keeping both ends steady.
Page 387: Table 14-28: Clearsight Monitoring General Troubleshooting
HemoSphere Alta Advanced Monitoring Platform Troubleshooting Table 14-28: ClearSight monitoring general troubleshooting Message Possible causes Suggested actions Pressure Difference: ClearSight BP vs. HRS detached from finger cuff or Verify HRS placement -The finger end should be Other BP phlebostatic axis...
Page 388 HemoSphere Alta Advanced Monitoring Platform Troubleshooting Message Possible causes Suggested actions Fault: Venous Oximetry – Value Out Incorrectly entered ScvO₂/SvO₂, HGB Verify correctly entered ScvO₂/SvO₂, HGB, and Hct of Range or Hct values values Incorrect HGB units of measure Verify correct HGB units of measure Calculated ScvO₂/SvO₂...
Page 389 HemoSphere Alta Advanced Monitoring Platform Troubleshooting Message Possible causes Suggested actions Alert: Venous Oximetry – Poor Signal Low blood flow at catheter tip or If the cable is wrapped in fabric or sitting on an Quality catheter tip against vessel wall insulating surface such as a pillow, place it on a Significant change in HGB/Hct val‐...
Page 390: Table 14-30: Venous Oximetry General Troubleshooting
Last oximetry cable calibration > 24 Perform in vivo calibration oximetry cable more than 24 hours hours old Synchronize date and time on all Edwards’ moni‐ old — Recalibrate Date and time on Edwards’ monitors tors at facility at facility differ Venous Oximetry –...
Page 391 Check for bent or broken pins ted ForeSight oximeter cable Try switching the ForeSight oximeter cable to an‐ other tissue oximetry port on the monitor If the problem persists, contact Edwards Techni‐ cal Support Fault: Tissue Oximetry – Incompati‐ Unsuccessful software upgrade or Contact Edwards Technical Support ble Software –...
Page 392 HemoSphere Alta Advanced Monitoring Platform Troubleshooting Message Possible causes Suggested actions Fault: Tissue Oximetry – {0} Algo‐ A processing error has occurred in Disconnect and reconnect the indicated sensor rithm Fault* the calculation of StO₂ for the indica‐ channel ted channel...
Page 393: Table 14-32: Tissue Oximetry General Troubleshooting
HemoSphere Alta Advanced Monitoring Platform Troubleshooting 14.11.2 Tissue Oximetry General Troubleshooting Table 14-32: Tissue oximetry general troubleshooting Message Possible causes Suggested actions Tissue Oximetry – Connect ForeSight Connection between the Connect a FSOC to the indicated port of the Oximeter Cable <A or B> for StO₂...
Page 394 HemoSphere Alta Advanced Monitoring Platform Troubleshooting Message Possible causes Suggested actions Alert: tHb – Recalibration Recom‐ Calibrated tHb value is unsteady Navigate to the recalibration tab to enter Hgb or mended from changes in hemodynamic state Extended period of time has passed...
Page 395: Essential Performance Characteristics
HemoSphere Alta Advanced Monitoring Platform Characteristics and Specifications........
Page 396 HemoSphere Alta Advanced Monitoring Platform Specifications and Device Characteristics Cable Parameter Essential Performance HemoSphere Alta Continuous Cardiac Output (CO), Monitors the filament surface temperature and time at temperature. Swan-Ganz pa‐ and associated parameters, both If a time and temperature threshold is exceeded (above 45 °C),...
Page 397: Table A-2: Hemosphere Alta Advanced Monitor Physical And Mechanical Characteristics
30 seconds after the noise event. A.2 HemoSphere Alta Advanced Monitoring Platform Characteristics and Specifications Table A-2: HemoSphere Alta advanced monitor physical and mechanical characteristics HemoSphere Alta advanced monitor Weight 21.57 lb (9.78 kg)
Page 398: Table A-4: Hemosphere Alta Advanced Monitoring Platform Transportation Environmental Specifications
Table A-3 on page 397 and Table A-4 on page 398. MRI Information. Do not use the HemoSphere Alta advanced monitoring platform or platform modules and cables in an MR environment. The HemoSphere Alta advanced monitoring platform, including all compatible connecting cables, is MR unsafe since the device contains metallic components, which can experience RF-induced heating in the MRI environment.
Page 399: Table A-6: Hemosphere Alta Monitor Battery Technical Characteristics
HemoSphere Alta Advanced Monitoring Platform Specifications and Device Characteristics Input/Output ECG monitor input ECG sync line conversion from ECG signal: 1V/mV; Input voltage range ±10V full scale; Resolution = ±1 BPM; Accuracy = ±10% or 5 BPM of the input, whichever is greater; Range = 30 to 200 BPM; 1/4 in.
Page 400: Table A-7: Hemosphere Alta Swan-Ganz Patient Cable Physical Characteristics
HemoSphere Alta Advanced Monitoring Platform Specifications and Device Characteristics A.4 HemoSphere Alta Swan-Ganz Patient Cable Characteristics and Specifications Table A-7: HemoSphere Alta Swan-Ganz patient cable physical characteristics HemoSphere Alta Swan-Ganz patient cable Weight approximately 0.81 lb (0.37 kg) Length 120 ± 6 in (305 ± 15 cm) Ingress protection at monitor connection IPX1 Ingress protection at catheter connec‐...
Page 401: Table A-9: Hemosphere Alta Swan-Ganz Patient Cable 20-Second Flow Parameter Measurement Specifications
If your equipment experiences a malfunction, please contact Technical Support or your local Edwards representative for further assistance. Table A-9: HemoSphere Alta Swan-Ganz patient cable 20-second flow parameter measurement specifica‐...
Page 402: Table A-13: Hemosphere And Hemosphere Alta Pressure Cable Parameter Measurement Specifications
It is recommended that after 3 years from the date of purchase, a replacement HemoSphere Alta pressure cable may be considered depending on its condition and functionality at that time. If your equipment experiences a malfunction, please contact Technical Support or your local Edwards representative for further assistance.
Page 403: Table A-14: Hemosphere Oximetry Cable Physical Characteristics
It is recommended that after 3 years from the date of purchase, a replacement oximetry cable may be considered depending on its condition and functionality at that time. If your equipment experiences a malfunction, please contact Technical Support or your local Edwards representative for further assistance. A.7 HemoSphere Tissue Oximetry Characteristics and Specifications Note For ForeSight oximeter cable environmental specifications, see Table A-3 on page 397.
Page 404: Table A-17: Foresight Oximeter Cable Parameter Measurement Characteristics
HemoSphere Alta Advanced Monitoring Platform Specifications and Device Characteristics ForeSight oximeter cable Ingress protection IPX4 Applied part classification Type BF defibrillation proof The length of the monitor and sensor cables are nominal lengths. Table A-17: ForeSight oximeter cable parameter measurement characteristics...
Page 405: Table A-18: Hemosphere Alta Clearsight Technology Parameter Measurement Specifications
It is recommended that after 5 years from the date of purchase, a replacement ForeSight oximeter cable may be considered depending on its condition and functionality at that time. If your equipment experiences a malfunction, please contact Technical Support or your local Edwards representative for further assistance. A.8 HemoSphere Alta ClearSight Technology Characteristics and...
Page 406: Figure A-1: Spectral Irradiance And Location Of Light Emission Aperture
HemoSphere Alta Advanced Monitoring Platform Specifications and Device Characteristics Table A-19: Edwards finger cuff characteristics Finger cuff Maximum weight 11 g (0.02 lb) LED spectral irradiance See Figure A-1 on page 406 Max optical output 0.013 mWatts Max variation of output over treatment area 1.
Page 407: Table A-22: Hemosphere Alta Afm Cable Transportation Environmental Specifications
It is recommended that after 3 years from the date of purchase, a replacement HemoSphere Alta AFM cable may be considered depending on its condition and functionality at that time. If your equipment experiences a malfunction, please contact Technical Support or your local Edwards representative for further assistance. Table A-23: HemoSphere Alta AFM cable parameter measurement specifications...
Page 408: Accessories List
WARNING Only use approved HemoSphere Alta advanced monitoring platform 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. Table B-1: HemoSphere Alta advanced monitoring platform components...
Page 409: Roll Stand
*Please contact your Edwards representative for model and ordering information. **Edwards Lifesciences Edwards Lifesciences analog input cables are bedside monitor specific; they are available for a family of bedside monitor companies such as Philips (Agilent), GE (Marquette) and Spacelabs (OSI Systems). Please contact your Edwards representative for specific model and ordering information.
Page 410: Figure B-1: Applying Pressure Controller Cover
B.2.2 Oximetry Cradle The HemoSphere oximetry cradle is a reusable accessory intended to properly secure the HemoSphere oximetry cable while monitoring with the HemoSphere Alta advanced monitoring platform. Follow included instructions for proper cradle mounting directions. B.2.3 Pressure Controller Cover The pressure controller cover secures the heart reference sensor into the pressure controller.
Page 411: Table C-1: Cardiac And Oxygenation Profile Equations
Parameters This section describes the equations used to calculate continuous and intermittent patient parameters displayed on the HemoSphere Alta advanced monitoring platform. 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.
Page 412 HemoSphere Alta Advanced Monitoring Platform Equations for Calculated Patient Parameters Parameter Description and formula Units Venous Oxygen Content mL/dL = (0.0138 x HGB x SvO₂) + (0.0031 x PvO₂) (mL/dL) = [0.0138 x (HGB x 1.611) x SvO₂] + [0.0031 x (PvO x 7.5)] (mL/dL)
Page 413 HemoSphere Alta Advanced Monitoring Platform Equations for Calculated Patient Parameters Parameter Description and formula Units DO₂I Oxygen Delivery Index mL O /min/m DO₂I = CaO x CI x 10 where: CaO – Arterial Oxygen Content, mL/dL CI – Cardiac Index, L/min/m...
Page 414 HemoSphere Alta Advanced Monitoring Platform Equations for Calculated Patient Parameters Parameter Description and formula Units LVSWI Left Ventricular Stroke Work Index g-m/m /beat LVSWI = SVI x (MAP – PAWP) x 0.0136 LVSWI = SVI x (MAP – PAWP ) x 0.0136 x 7.5 where: SVI –...
Page 415 HemoSphere Alta Advanced Monitoring Platform Equations for Calculated Patient Parameters Parameter Description and formula Units PVRI Pulmonary Vascular Resistance Index dyne-s-m PVRI = {(MPAP – PAWP) x 80} /CI (kPa-s-m PVRI = {(MPAP – PAWP ) x 60} /CI where: MPAP –...
Page 416 HemoSphere Alta Advanced Monitoring Platform Equations for Calculated Patient Parameters Parameter Description and formula Units Systemic Vascular Resistance dyne-s/cm SVR = {(MAP - CVP) x 80} /CO (dyne-sec/cm (kPa-s/L) SVR = {(MAP – CVP ) x 60} /CO where: MAP – Mean Arterial Pressure, mmHg MAP...
Page 417 HemoSphere Alta Advanced Monitoring Platform Equations for Calculated Patient Parameters Parameter Description and formula Units Ventilation Perfusion Index where: HGB – Total Hemoglobin, g/dL HGB – Total Hemoglobin, mmol/L SaO₂ – Arterial O Saturation, % SvO₂ – Mixed Venous O Saturation, % PAO...
Page 418: Patient Data Input Range
Appendix Monitor Settings and Defaults Contents Patient Data Input Range................... . 418 Trend Scale Default Limits.
Page 419 Note The HemoSphere Alta advanced monitoring platform 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 420: Parameter Display And Configurable Alarm/Target Ranges
HemoSphere Alta Advanced Monitoring Platform Monitor Settings and Defaults D.3 Parameter Display and Configurable Alarm/Target Ranges Table D-3: Configurable parameter alarm and display ranges Parameter Units Display Range Configurable Alarm/Target Range CO/CO L/min 1.0 to 20.0 1.0 to 20.0 L/min 0.0 to 20.0...
Page 421: Alarm And Target Defaults
HemoSphere Alta Advanced Monitoring Platform Monitor Settings and Defaults Parameter Units Display Range Configurable Alarm/Target Range MPAP mmHg 0 to 99 0 to 99 † MRVP mmHg 0 to 99 mmHg 0 to 300 10 to 300 mmHg 0 to 99 0 to 99 †...
Page 422: Alarm Priorities
HemoSphere Alta Advanced Monitoring Platform Monitor Settings and Defaults Parameter Units EW default lower EW default lower EW default upper EW default upper alarm (red zone) target setting target setting alarm (red zone) setting setting mmHg mmHg mmHg mmHg mmHg...
Page 423 HemoSphere Alta Advanced Monitoring Platform Monitor Settings and Defaults Physiologic parameter Lower physiological alarm Upper physiological alarm Message type priority (alarms)/ message type (red zone) priority (red zone) priority High High MPAP Medium Medium MRVP High High Medium Medium Medium...
Page 424: Table E-1: Computation Constants For Bath Temperature Probe
Appendix Computation Constants Contents Computation Constant Values..................424 E.1 Computation Constant Values In iCO mode, the HemoSphere Alta Swan-Ganz patient cable computes cardiac output employing either a bath probe setup or an in-line temperature probe using the computation constants listed in the following tables.
Page 425: F.1 General Maintenance
Follow all cleaning instructions carefully to ensure that the monitor and platform cables are thoroughly cleaned. After cleaning, inspect the HemoSphere Alta advanced monitor and all accessories for any residue or foreign material. If residue is still visible after cleaning, please repeat the cleaning instructions. Follow any additional cleaning instructions provided by the manufacture of listed approved cleaning agents.
Page 426: F.2 Cleaning The Monitor And Cables
Do not use any other cleaning agents. Unless otherwise stated, these cleaning agents are approved for all HemoSphere Alta advanced monitoring platform accessories, and cables. CAUTION Do not pour or spray liquid on any portion of the HemoSphere Alta advanced monitoring platform, accessories, or cables. Do not use any disinfecting solution other than the types specified.
Page 427 HemoSphere Alta Advanced Monitoring Platform System Care, Service and Support Use an approved disposable cleaning wipe or moisten a lint-free cloth with disinfectant and wipe the surfaces. Follow the disinfectant wipe with rinsing wipes using cotton gauze moistened with sterile water. Use sufficient rinsing wipes to remove all residual disinfectant.
Page 428 Do not immerse any cable connectors in detergent, isopropyl alcohol or glutaraldehyde. Do not use a hot air gun to dry cable connectors. Please contact Technical Support or your local Edwards representative for further assistance. F.3.3 Cleaning the HemoSphere Pressure Cable...
Page 429 Do not, under any circumstances, perform any cleaning or maintenance of the ForeSight oximeter cable, while the cable is being used to monitor a patient. The monitor must be turned off and the HemoSphere Alta advanced monitoring platform power cord disconnected, or the cable must be disconnected from the monitor and the sensors removed from the patient.
Page 430: Figure F-1: Removing Pressure Controller From Band
E-mail operational support questions to tech_support@edwards.com. Have the following information before you call: • The HemoSphere Alta advanced monitoring platform’s serial number, located on the rear panel; • The text of any error message and detailed information as to the nature of the problem.
Page 431: F.6 Monitor Disposal
Routinely inspect cords and cables for fraying and cracks, and make sure there are no exposed conductors. In addition, check that the enclosure door at catheter connection point of the oximetry cable moves freely and latches properly. Do not pull on any platform cables when unplugging them from the HemoSphere Alta advanced monitoring platform.
Page 432: Battery Maintenance
F.7.1.1 Battery Storage The battery pack can remain stored in the HemoSphere Alta advanced monitoring platform. Refer to HemoSphere Alta Advanced Monitoring Platform Characteristics and Specifications on page 397 for environmental specifications for storage.
Page 433: F.8 Testing Of Alarm Signals
F.8 Testing of Alarm Signals Each time the HemoSphere Alta advanced monitoring platform 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 434: Electromagnetic Compatibility
The HemoSphere Alta advanced monitoring platform is intended for use in the electromagnetic environment specified in this appendix. The customer or the user of the HemoSphere Alta advanced monitoring platform should assure that it is used in such an environment. When connected to the HemoSphere Alta advanced monitoring platform, all accessory cables listed in Table B-1 on page 408 comply with the EMC standards listed above.
Page 435: Table G-1: Electromagnetic Emissions
Guidance and Manufacturer's Declaration - Electromagnetic Emissions The HemoSphere Alta advanced monitoring platform is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere Alta advanced monitoring platform should assure that it is used in such an environment.
Page 436 (V/m) The HemoSphere Alta advanced monitoring platform is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere Alta advanced monitoring platform should ensure that it is used in such an environment. 704 - 787...
Page 437: Table G-3: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Hemosphere Alta Advanced Monitoring Platform
HemoSphere Alta advanced monitoring platform The HemoSphere Alta advanced monitoring platform is intended for use in an electromagnetic environment in which radi‐ ated RF disturbances are controlled. To help prevent electromagnetic interference, maintain a minimum distance between portable and mobile RF communications equipment (transmitters) and the HemoSphere Alta advanced monitoring platform as recommended below, according to the maximum output power of the communications equipment.
Page 438: Table G-5: Wireless Coexistence Radiated Anechoic Chamber (Rac) Results - Normal Mode (2.4, 5 And 6 Ghz Wifi) For Companion Device (Router) With Unintended Signal Present
Guidance The HemoSphere Alta advanced monitoring platform is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere Alta advanced monitoring platform should assure that it is used in such an environment. Electrostatic discharge ±8 kV contact...
Page 439: Table G-7: Electromagnetic Immunity (Rf Radiated And Conducted)
Guidance The HemoSphere Alta advanced monitoring platform is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere Alta advanced monitoring platform should assure that it is used in such an environment. Power frequency...
Page 440: Wireless Technology Information
Electromagnetic Environment - Guidance The HemoSphere Alta advanced monitoring platform is intended for use in the electromagnetic environment specified below. The customer or user of the HemoSphere Alta advanced monitoring platform should assure that it is used in such an environment.
Page 441 HemoSphere Alta Advanced Monitoring Platform Guidance and Manufacturer's Declaration Feature Description Bluetooth Operation De‐ Bluetooth Basic Rate +EDR tails Transmit frequency 2402 MHz to 2480 MHz Receive frequency 2402 MHz to 2480 MHz Modulation GFSK, Π/4 DQPSK, 8DPSK Transmit power 13.2 dBm, e.i.r.p.
Page 442 HemoSphere Alta Advanced Monitoring Platform Guidance and Manufacturer's Declaration Feature Description Wi-Fi Operation Details IEEE 802.11b/g/n/ax WLAN Transmit frequency 2412 MHz to 2472 MHz (20 MHz) 2422 MHz to 2462 MHz (40 MHz) Receive frequency 2412 MHz to 2472 MHz (20 MHz)
Page 443 HemoSphere Alta Advanced Monitoring Platform Guidance and Manufacturer's Declaration Feature Description Receive frequency 5745 MHz to 5825 MHz (20 MHz) 5755 MHz to 5795 MHz (40 MHz) 5775 MHz (80 MHz) Modulation OFDM/OFDMA (BPSK, QPSK, 16QAM, 64QAM, 256QAM, 1024QAM) Transmit power 13.95 dBm, e.i.r.p.
Page 444 HemoSphere Alta Advanced Monitoring Platform Guidance and Manufacturer's Declaration Feature Description Compliance ETSI Regulatory Domain EN 300 328 EN 60950-1 EN 300 328 v1.8.1 (BT 2.1) EN 55022:2006 Class B EN 301 489-1 EN 55024:1998 +A1:2001, A2:2003 EN 301 489-17...
Page 445: Wireless Security Measures
Edwards recommends securing wireless data transmission by enabling IEEE 802.11i (WPA2) security and FIPS mode. Edwards also recommends implementing network security measures like virtual LANs with firewalls to further secure HemoSphere Alta monitor data in transit to the HIS.
Page 446: Industry Canada Statements
HemoSphere Alta Advanced Monitoring Platform Guidance and Manufacturer's Declaration Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Page 447 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 2014/53/EU (RED).
Page 448 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, Edwards Lifesciences, and the stylized E logo are trademarks of Edwards Lifesciences Corporation. Acumen, Acumen AFM, Acumen HPI, Acumen IQ, AFM, CCOmbo, CCOmbo V, ClearSight, ClearSight Jr,...