Masimo LiDCO Operator's Manual
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Masimo LiDCO Operator's Manual

Hemodynamic monitoring
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Operator's Manual
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Masimo LiDCO
Hemodynamic Monitoring

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  • Page 1 Operator's Manual ® Masimo LiDCO Hemodynamic Monitoring...
  • Page 3 General knowledge of blood pressure and hemodynamic measurements and an understanding of the features and functions of Masimo LiDCO are prerequisites for its proper use. Do not operate Masimo LiDCO without completely reading and understanding these instructions. If you encounter any serious incident with this product, please notify the competent authority in your country and the manufacturer.

  • Page 5: Table Of Contents

    Unpacking and Inspecting the System ---------------------------------------------------------------------------------- 17 Preparation for Use----------------------------------------------------------------------------------------------------------- 17 Connecting the LiDCO Module -------------------------------------------------------------------------------------------- 17 Connecting the LiDCO Cable to a Pressure Source ---------------------------------------------------------------- 18 Disconnecting the LiDCO Cable from the LiDCO Module --------------------------------------------------------- 19 Setting Up Masimo LiDCO ------------------------------------------------------------------------------------------------- 20...
  • Page 6 Safety Compliance ----------------------------------------------------------------------------------------------------------- 57 EMC Compliance ------------------------------------------------------------------------------------------------------------- 57 Symbols------------------------------------------------------------------------------------------------------------------------- 57 Chapter 7: Service and Maintenance ------------------------------------------------------------------------------------- 59 Cleaning Procedures -------------------------------------------------------------------------------------------------------- 59 General Maintenance for Module ---------------------------------------------------------------------------------------- 59 Contacting Masimo ---------------------------------------------------------------------------------------------------------- 60 Sales & End-User License Agreement --------------------------------------------------------------------------------- 61 Index --------------------------------------------------------------------------------------------------------------------------------- 63 www.masimo.com Masimo...

  • Page 7: About This Manual

    . Important safety information relating to ® general use of Masimo LiDCO appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes. A warning is given when actions may result in a serious outcome (for example, injury, serious adverse effect, death) to the patient or user.

  • Page 9: Product Description, Indications, And Contraindications

    LiDCO algorithm. ® The LiDCO algorithm calculates a number of derived parameters from the blood pressure waveform, including the following:  Systolic Blood Pressure (Sys)  Mean Arterial Blood Pressure (MAP) ...

  • Page 10: Indications For Use

    Product Description, Indications, and Contraindications Indications for Use Masimo LiDCO is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use for the measurement of blood pressure, cardiac output and associated hemodynamic parameters in adult patients.

  • Page 11: Safety Information, Warnings And Cautions

    WARNING: Do not start or operate Masimo LiDCO unless the setup was verified to be correct. Improper set-up of the device may result in degraded performance and/or patient injury. WARNING: Do not place Masimo LiDCO or accessories in any position that might cause it to fall on the patient.

  • Page 12: Performance Warnings And Cautions

    LiDCO may be inaccurate in such patients. Performance Warnings and Cautions WARNING: Masimo LiDCO is intended only as an adjunct device in patient assessment. It should not be used as the sole basis for diagnosis or therapy decisions. It must be used in conjunction with clinical signs and symptoms.

  • Page 13: Cleaning And Service Warnings And Cautions

    Safety Information, Warnings and Cautions Cleaning and Service Warnings and Cautions WARNING: Do not attempt to remanufacture, recondition, or recycle Masimo LiDCO as these processes may damage the electrical components, potentially leading to patient harm. WARNING: Service of the module should be done by qualified personnel only.

  • Page 15: Chapter 1: Technology Overview

    The beat-to-beat parameters provided by Masimo LiDCO allow clinicians to get immediate feedback on a patient’s fluid and hemodynamic status. The LiDCO algorithm derives stroke volume and heart rate from the patient’s existing arterial pressure waveform.

  • Page 17: Chapter 2: Description

     LiDCO Cable  Additional 3 party components are also required:  Patient Monitor that supports continuous pressure measurements  Pressure Transducer Masimo LiDCO The following image illustrates the parameters being displayed on the monitor when using Masimo LiDCO. www.masimo.com Masimo...

  • Page 18: Lidco Module

    Masimo LiDCO Chapter 2: Description LiDCO Module The LiDCO Module is the component with the LiDCO algorithm. The LiDCO algorithm derives stroke volume and heart rate from the patient’s existing arterial pressure waveform. LiDCO Cable The LiDCO cable connects to a compatible 3 party patient monitor.

  • Page 19: Chapter 3: Setting Up

    Check all materials against the packing list. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. If anything is missing or damaged, contact Masimo Technical Service. Preparation for Use...

  • Page 20: Connecting The Lidco Cable To A Pressure Source

    To connect the LiDCO Module to a LiDCO Cable : For additional details, see the Directions for Use (DFU) for the cable. Align the LiDCO Cable connector with the cable connector on the LiDCO Module. Insert the LiDCO Cable connector securely into the LiDCO Module cable connector.

  • Page 21: Disconnecting The Lidco Cable From The Lidco Module

    Select an Analog Cable with a connector that is compatible with your 3 Party Patient Monitor. b. Connect the Analog Cable to the LiDCO Module cable connector. c. Connect the Analog Cable to the 3 Party Patient Monitor. Disconnecting the LiDCO Cable from the LiDCO Module To disconnect the module after monitoring is complete: ...

  • Page 22: Setting Up Masimo Lidco

    Masimo LiDCO Chapter 3: Setting Up Setting Up Masimo LiDCO When the module is connected, the Masimo LiDCO screen will indicate "Start LiDCO". Touch the screen to access LiDCO Setup page. www.masimo.com Masimo...
  • Page 23 Masimo LiDCO Chapter 3: Setting Up LiDCO menu opens. Manually enter patient info in the fields of the LiDCO setup menu (1). The smart keyboard (2) displays when height, age or weight spinner is touched. User has the option to use the keyboard or spinner to select or enter a value. Gender is not required.
  • Page 24 Masimo LiDCO Chapter 3: Setting Up Once patient info is entered, Blue banner is updated. Touch Start button (3) to return to the main display with LiDCO channel in a monitoring state. www.masimo.com Masimo...

  • Page 25: Zeroing

    When using a BP Module Cable, zeroing is required to sync measurements on the 3 party patient monitor and the LiDCO Module. Masimo LiDCO should be "zeroed" at the same time the blood pressure transducer is "zeroed" on the 3 party patient monitor.

  • Page 26: Additional Settings

    Masimo LiDCO Chapter 3: Setting Up Additional Settings Allows user to choose the display as absolute value or the index value for the following parameters: Cardiac Output (CO), Stroke Volume (SV), Systemic Vascular Resistance (SVR), Oxygen Delivery (DO Oxygen Consumption (VO ).

  • Page 27: Chapter 4: Operation

    Masimo LiDCO Window When the LiDCO Module is connected to the monitor, parameters and measurements display in a window. Masimo LiDCO parameters can display as numeric values as either absolute or indices. Only select parameters are available in indices. The image below shows Masimo LiDCO trend screen.

  • Page 28: Masimo Lidco Parameters Display

    See Cardiac Output on page 28. SV Display Stroke Volume is the amount of blood ejected by the heart in a given beat; updated beat-by-beat based on the LiDCO pulse power analysis algorithm. See Stroke Volume on page 29. HR Display The number of beats per minute of the heart.

  • Page 29: About The Action Menu

    About the Action Menu At the top of the Main Screen is the Action Menu with interactive icons. Each icon provides a shortcut to a menu item or an action on Masimo LiDCO. Protocols submenu displays available Guided Protocols. Ref. Feature...

  • Page 30: Parameters Display

    Cardiac Output is calculated on a beat-to-beat basis via the arterial pressure waveform using the LiDCO algorithm. It can be expressed is an index value Cardiac Index (Ci) by dividing CO by the body surface area (BSA).
  • Page 31 Masimo LiDCO Chapter 4: Operation Oxygen Consumption (VO2) Oxygen Consumption (VO ) is a measure of the oxygen consumed by tissues in milliliters/min. Oxygen Consumption is calculated from CO, Hemoglobin (Hb or SpHb) and arterial saturation (SaO or SpO and venous saturation (SVO ).

  • Page 32: Parameter Settings

    Cancel. *Masimo LiDCO has the ability to control alarm priority based on the clinical use case. When Audible Alarms are set to Off, the alarm priority is Low. When Audible Alarms are set to On, the alarm priority is Medium.
  • Page 33 Alarms* * Masimo LiDCO has the ability to control alarm priority based on the clinical use case. When Audible Alarms are set to Off, the alarm priority is Low. When Audible Alarms are set to On, the alarm priority is Medium.
  • Page 34 Heart rate from Masimo LiDCO *If the HR from pulse ox is higher than the LiDCO HR, then lower the beat detector threshold until the values are equivalent. If the HR displayed from the pulse ox is less than the LiDCO HR, then raise the beat detector threshold until the values are equivalent.
  • Page 35 Masimo LiDCO Chapter 4: Operation Alarm Factory Selectable Options Description Priority Default Settings Off, or 2-19 in High Limit Upper limit that triggers an alarm Low/Medium* Off steps of 1. Silence Length of time that the audible 30 sec, 1, 2, or 5...
  • Page 36 Masimo LiDCO Chapter 4: Operation Options Factory Selectable Settings Description Default Display how parameter is displayed on the Absolute Absolute, Index or parameter monitor Both CO Calibration Factory Selectable Options Description Default Settings reflects the patient-specific maximum aortic CO(L/min) capacitance and will generally remain constant over short periods of time.
  • Page 37 Masimo LiDCO Chapter 4: Operation Oxygen Consumption (VO2) Alarms Alarm Factory Selectable Options Description Priority Default Settings Off, or 200-900 in High Limit Upper limit that triggers an alarm Low/Medium* Off steps of 25. Off, or 175-800 in Low Limit Lower limit that triggers an alarm Low/Medium* Off steps of 25.
  • Page 38 Masimo LiDCO Chapter 4: Operation Oxygen Consumption Index (VO2i) Oxygen Consumption Index (VO2i) will display only when Index is selected for Oxygen Consumption parameter display. Alarms Alarm Factory Selectable Options Description Priority Default Settings Off, or 180-450 in High Limit Upper limit that triggers an alarm Low/Medium* Off steps of 10.
  • Page 39 Alarms* * Masimo LiDCO has the ability to control alarm priority based on the clinical use case. When Audible Alarms are set to Off, the alarm priority is Low. When Audible Alarms are set to On, the alarm priority is Medium.
  • Page 40 Masimo LiDCO Chapter 4: Operation Oxygen Delivery Index (DO Oxygen Delivery Index (DO i) will display only when Index is selected for Oxygen Delivery parameter display. Alarms Alarm Factory Options Description Selectable Settings Priority Default Upper limit that triggers an...
  • Page 41 Alarms* * Masimo LiDCO has the ability to control alarm priority based on the clinical use case. When Audible Alarms are set to Off, the alarm priority is Low. When Audible Alarms are set to On, the alarm priority is Medium.
  • Page 42 Masimo LiDCO Chapter 4: Operation Stroke Volume Index (SVi) Stroke Volume Index (SVi) will display only when Index is selected for Stroke Volume parameter display. Alarms Alarm Factory Selectable Options Description Priority Default Settings Off, or 10-245 in High Limit...
  • Page 43 Masimo LiDCO Chapter 4: Operation Trends Options Description Factory Default Selectable Settings Y-Axis Max Highest SVV value that can be displayed 50 5 to 100 in steps of 5 Y-Axis Min Lowest SVV value that can be displayed 0 0 to 95 in steps of 5...

  • Page 44: Guided Protocols

    0 to 11000 in steps of 1000 displayed Guided Protocols Masimo LiDCO provides Guided Protocols to assist in performing fluid response assessments. They provide supporting information and guidance to complete each along with a detailed display of the www.masimo.com Masimo...
  • Page 45 Masimo LiDCO Chapter 4: Operation hemodynamic parameters. Touch Guided Protocols for drop-down menu. This menu option is not available when SVi is being displayed. Guided protocols(1) are intended to aid the clinician in giving a fluid challenge and observing the effects on advanced hemodynamic parameters including Stroke Volume (SV), Mean Arterial Pressure (MAP), Heart Rate (HR) and Stroke Volume Variation (SVV) –...
  • Page 46 Select a protocol from the Protocols submenu. The protocol will open behind the action menu. The initializing screen is displayed only while Masimo LiDCO is getting ready to provide data. Until then, data in the table is displayed as"--". The start button is disabled until Masimo LiDCO is ready.Touch/Select Start to begin protocol.
  • Page 47 Masimo LiDCO Chapter 4: Operation the protocol again. Close (2) will remove the protocol from the display. Trends will return to standard positions. A negative result is indicated by red text. www.masimo.com Masimo...
  • Page 48 Select a protocol from the Protocols submenu. The protocol will open behind the action menu. The initializing screen is displayed only while Masimo LiDCO is getting ready to provide data. Until then, data in the table is displayed as"--". The start button is disabled until Masimo LiDCO is ready.
  • Page 49 Masimo LiDCO Chapter 4: Operation A positive result here displays a static graphic along with the results message in green text. Once protocol is complete, a restart button (1) replaces the stop button once the protocol has completed. Results will be displayed in the space to the right of the button. The chart below displays result data.
  • Page 50 Select a protocol from the Protocols submenu. The protocol will open behind the action menu. The initializing screen is displayed only while Masimo LiDCO is getting ready to provide data. Until then, data in the table is displayed as"--". The start button is disabled until Masimo LiDCO is ready.
  • Page 51 Masimo LiDCO Chapter 4: Operation A positive result is indicated by green text. Once protocol is complete, a restart button (1) replaces the stop button once the protocol has completed. Results will be displayed in the space to the right of the button. The chart below displays result data. Touch restart (1) to run the protocol again.

  • Page 52: Oxygen Delivery Tree

    Masimo LiDCO Chapter 4: Operation Oxygen Delivery Tree Toggle to Oxygen Delivery Tree view in the action menu. Oxygen Delivery Tree is only displayed when there is a connected pulse oximetry channel. Touching SpHb parameter would open its manual entry menu. Touching any other parameter would bring up their respective parameter setting.

  • Page 53: Physio Tree

    Masimo LiDCO Chapter 4: Operation Physio Tree Toggle to Physio Tree view in the action menu. The Physio Tree will always be shown and never be hidden, irrespective of the connection to a pulse oximetry channel. Touching SpHb and SpO2 parameters would open their manual entry menu. Touching any other parameter would bring up their respective parameter setting.

  • Page 55: Chapter 5: Troubleshooting

    Chapter 5: Troubleshooting Troubleshooting The following table lists potential causes and corrective action when troubleshooting Masimo LiDCO. Observation Potential Cause Next Steps Cable may be disconnected Check all cable connections Contact Masimo representative No values are displayed for No cable for any channel...

  • Page 57: Chapter 6: Specifications

    Cardiac Output (CO) .1 L/min Stroke Volume (SV) 1 ml Sys/MAP/Dia Pressure 3 mmHg Heart Rate (HR) 1 beat/min Systemic Vascular Resistance (SVR) 50 dyn s/cm5 Stroke Volume Variation (SVV) Pulse Pressure Variation (PPV) Heart Rate Variation (HRV) www.masimo.com Masimo...

  • Page 58: Environmental

    Masimo LiDCO Chapter 6: Specifications Environmental Environmental Conditions +32°F to +104°F Operating Temperature (+0°C to +40°C) Storage Temperature -40°F to +158°F (-40°C to +70°C) Humidity 10% to 95%, non-condensing Atmospheric Pressure 500 to 1060 mBar Module Physical Characteristics Dimension Measurement Overall Length 3.7m (12 ft)

  • Page 59: Safety Compliance

    Masimo LiDCO Chapter 6: Specifications Safety Compliance Safety Compliance EN 60601-1:2006/A12:2014 EN 60601-1-6:2010/A1:2015 IEC 62304:2006/AMD1:2015 EN 60601-2-34:2014 ANSI/AAMI ES60601-1:2005/A1:2012 CAN/CSA C22.2 No. 60601-1:2014 EMC Compliance EMC Compliance EN 60601-1-2:2015 Symbols The following symbols may appear on the product or product labeling:...
  • Page 60 Masimo LiDCO Chapter 6: Specifications Symbol Description Symbol Description Manufacturer Serial number Date of manufacture Catalog number (model number) YYYY-MM-DD Storage temperature Masimo reference number range Keep dry Storage humidity limitation Atmospheric pressure Fragile, handle with care limitation Less than...

  • Page 61: Chapter 7: Service And Maintenance

    Chapter 7: Service and Maintenance Cleaning Procedures The module for Masimo LiDCO is a reusable instrument. The instrument is supplied non-sterile. To clean the module: Disconnect the module from the monitor and ensure the cable is not connected to the module.

  • Page 62: Contacting Masimo

    Please clean contaminated/dirty equipment before returning and make sure it is fully dry before packing the equipment. Call Masimo at 800-326-4890 and ask for Technical Support. Ask for an RMA number. Package the equipment securely – in the original shipping container if possible – and enclose or include the following information and items: ...

  • Page 63: Sales & End-User License Agreement

    Masimo for a full refund. Warranty Masimo warrants to the initial Purchaser for a period of one (1) year from the date of purchase that: each new Product and the Software media as delivered are free from defects in workmanship or materials.
  • Page 64 Ownership of Software: The Software is licensed not sold; all rights and interests in the Software and all copies thereof remain at all times vested in Masimo, and do not pass to Purchaser. Any references in this Agreement to the purchase or sale of the Software shall be deemed the purchase or sale of a Software License as set forth herein.

  • Page 65: Index

    Oxygen Consumption Index (VO2i) • 36 Compliance Information Warnings and Cautions • 11 Oxygen Delivery (DO2) • 26, 29, 36 Connecting the LiDCO Cable to a Pressure Source • Oxygen Delivery Index (DO2i) • 38 Oxygen Delivery Tree • 27, 50 Connecting the LiDCO Module •...
  • Page 66 Safety Warnings and Cautions • 9, 59 Sales & End-User License Agreement • 59, 61 Service Instructions • 59 Setting Up Masimo LiDCO • 20 Stroke Volume (SV) • 26, 29, 39 Stroke Volume Index (SVi) • 40 Stroke Volume Variation % (SVV) • 26, 29 Stroke Volume Variation (SVV) •...
  • Page 68 304241/LAB-11767B 0124...

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