Masimo SedLine Operator's Manual
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Masimo SedLine Operator's Manual

Sedation monitor
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  • Page 1 Operator's Manual ® SedLine Sedation Monitor...
  • Page 3 Caution: Federal law restricts this device to sale by or on the order of a physician. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions. This Operator's Manual describes how SedLine information is displayed when used with Root ®...

  • Page 5: Table Of Contents

    Preparation for Use ------------------------------------------------------------------------------------ 17 Connecting the Module to the Patient Cable ----------------------------------------------------- 18 Connecting the Module to Root --------------------------------------------------------------------- 19 Connecting the SedLine Sensor to the Patient --------------------------------------------------- 19 Chapter 4: Operation -------------------------------------------------------------------------------------- 21 The SedLine Window ---------------------------------------------------------------------------------- 21...
  • Page 6 Trends Not Available ---------------------------------------------------------------------------------- 54 Chapter 9: Specifications -------------------------------------------------------------------------------- 57 Measurement Range ---------------------------------------------------------------------------------- 57 Resolution ----------------------------------------------------------------------------------------------- 57 Environmental ------------------------------------------------------------------------------------------ 58 SedLine Module Physical Characteristics ---------------------------------------------------------- 58 Regulatory Symbols ----------------------------------------------------------------------------------- 59 Safety Classifications--------------------------------------------------------------------------------- 60 Safety Compliance ------------------------------------------------------------------------------------- 61 EMC Compliance --------------------------------------------------------------------------------------- 61...

  • Page 7: About This Manual

    About this Manual This manual contains setup and operational instructions for the SedLine® Sedation Monitor. Review it thoroughly before attempting to set up and operate the SedLine® Sedation Monitor. Keep it in a convenient location for easy reference during operation and maintenance.

  • Page 9: Product Description, Indications, And Contraindications

    Cable, and SedLine Sensors. Indications for Use The SedLine® Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.

  • Page 11: Warnings And Cautions

    Warnings and Cautions Warning: A complete reading of this manual by personnel in contact with SedLine prior to use is essential for safety. Improper setup, operation, maintenance, or parts replacement could result in injury to personnel and damage to SedLine components.

  • Page 12: Safety Information

    SedLine Sedation Monitor Warnings and Cautions Safety Information Warning: Do not start or operate the SedLine Module unless the setup was verified to be correct. Warning: Always use the SedLine Module and SedLine Sensor in conjunction with Root. Do not use parts from other systems. Injury to personnel or equipment damage could occur.

  • Page 13: Compliance Information

    Caution: For FCC compliance information, refer to the Operator's Manual for Root. General Information Warning: The SedLine Module 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 15: Chapter 1: Technology Overview

    (3) the inhibition of regions of the frontal cortex. The PSI is computed from continuously monitored changes in the QEEG during surgery, using statistical analysis to estimate the likelihood that the patient is anesthetized. SedLine performs these computations automatically on the continuously recorded EEG after automatic removal of data contaminated with artifact from physiological and environmental signals.

  • Page 17: Chapter 2: System Descriptions

    SedLine Sensor(s) Root SedLine is displayed on Root for the user. This information includes electrode status, EEG waveforms, PSI, DSA, electromyograph (EMG), artifacts (ARTF), suppression ratio (SR), and spectral edge frequency (SEFL for left side and SEFR for right side). The following image illustrates these features being displayed on Root.

  • Page 18: Sedline Module

    Cable and receives its power from Root. SedLine Patient Cable The SedLine Patient Cable transfers analog EEG signals collected from the SedLine Sensor to the SedLine Module for processing. The patient cable is reusable and may be used from patient to patient. SedLine Sensor(s) The SedLine Sensor is comprised of six (6) gelled electrodes, including four (4) active channels (R1, R2, L1, L2), one reference channel (CT), and one ground channel (CB).

  • Page 19: Chapter 3: Setting Up The System

    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 Module To The Patient Cable

    SedLine Sedation Monitor Chapter 3: Setting Up the System Connecting the Module to the Patient Cable The image below shows various SedLine system components connected. To connect the module to the patient cable Identify the module connector end. Align the ridged patient cable connector end with the available module connector end.

  • Page 21: Connecting The Module To Root

    Insert the MOC-9 end of the module securely into a MOC-9 port on Root. Connecting the SedLine Sensor to the Patient For directions on how to connect the SedLine Sensor, see the Directions for Use (DFU) for SedLine Sensors. www.masimo.com...

  • Page 23: Chapter 4: Operation

    Chapter 4: Operation The following sections describe how SedLine information is displayed when used with Root, including display details and accessing and changing user-configurable settings. For additional information, see Operator's Manual for Root. The SedLine Window When SedLine is connected to Root, parameters and measurements display in a window.

  • Page 24: Eeg Display

    EEG Display Electrode Status This feature in the SedLine window is used to monitor electrode impedance. To reveal the Electrode Status Display, swipe down on the tab shown below. The Electrode Status display provides electrode connectivity status of the sensor. There are six (6) icons on the Electrode Status display that correspond to the six sensor electrodes, as shown in the following illustration.
  • Page 25 SedLine Sedation Monitor Chapter 4: Operation Each individual electrode status is composed of three components: L/R/C (Left/Right/Center) represents the corresponding sensor electrodes. Here, the R1 electrode label corresponds to the R1 electrode of the sensor. The color rectangle adjacent to the electrode label represents the electrode impedance status.
  • Page 26 SedLine Sedation Monitor Chapter 4: Operation Each electrode icon can change colors to indicate the impedance status of the corresponding electrode. The following table describes the icon color and its meaning. For troubleshooting details, see Chapter 8: Troubleshooting. Icon Color...

  • Page 27: Parameters Display

    The trend amplitude and speed are configurable by the user. Pressing the chart speed on the bottom left corner or the amplitude in the bottom right corner leads the user to the SedLine Additional Settings menu. Parameters Display Each parameter display consists of a trend line and a numeric value.
  • Page 28 SedLine Sedation Monitor Chapter 4: Operation PSI (Patient State Index) The Patient State Index (PSI) is related to the effect of certain anesthetic agents on a patient. Numeric Value PSI is represented by a numeric value that ranges from 0 to 100. When a PSI numeric value is not available, the value displays dashes (--).
  • Page 29 SedLine Sedation Monitor Chapter 4: Operation EMG (Electromyography) Electromyography (EMG) is a measure of detected muscle activity, such as jaw clenching. Numeric Value EMG is represented by a numeric value that ranges from 0 to 100%. When an EMG numeric value is not available, the value displays dashes (--).
  • Page 30 SedLine Sedation Monitor Chapter 4: Operation SR (Suppression Ratio) Suppression Ratio (SR) is a measure of how much the electrical activity of the frontal and pre-frontal cortex of the brain is suppressed as a percentage of time. Numeric Value SR is represented by a numeric value that ranges from 0 to 100%. When an SR numeric value is not available, the value displays dashes (--).
  • Page 31 SedLine Sedation Monitor Chapter 4: Operation ARTF (Artifact) Artifact (ARTF) is a measure of how much physiological (non-brain related) and environmental noise the system detects. Numeric Value ARTF is represented by a numeric value that ranges from 0 to 100%. When an ARTF numeric value is not available, the value displays dashes (--).
  • Page 32 SedLine Sedation Monitor Chapter 4: Operation SEFL and SEFR (Spectral Edge Frequencies) Spectral Edge Frequency (Left and Right) identifies the frequency below which 95% of the total power of the patient's EEG is located. Numeric Value SEFL and SEFR are represented by numeric values that range from 0 to 30 Hz. When SEFL and SEFR numeric values are not available, the values display dashes (--).

  • Page 33: Dsa (Density Spectral Array) Display

    SedLine Sedation Monitor Chapter 4: Operation DSA (Density Spectral Array) Display The Density Spectral Array (DSA) display contains left and right spectrograms that represents the power of the EEG on both sides of the brain within a specific frequency range.
  • Page 34 SedLine Sedation Monitor Chapter 4: Operation The spectrograms update from the right to left and corresponds to the PSI numeric value every 1.2 seconds. While the DSA displays only 20 minutes of information, it can be scrolled backwards to view up to 2 hours of trend information. The DSA Window Indicator represents the 20-minute time frame of the currently displayed DSA on the general timeline at the bottom of the screen.

  • Page 35: View Options

    View Options When SedLine is the only MOC-9 technology connected to Root, the SedLine window will display in full as shown in the following image. To change the view in the SedLine window, toggle between the Trend and Analog tabs.
  • Page 36 SedLine Sedation Monitor Chapter 4: Operation The Parameters Display can be customized by expanding and minimizing the parameters and measurements in both Trend View and Analog View. Each parameter can be minimized to display only its Numeric Value and Parameter Label. To minimize a parameter's Trend Display, press and hold its Numeric Value until it dims, then drag-and-drop it into the Well.
  • Page 37 SedLine Sedation Monitor Chapter 4: Operation The second image shows the customized view after ARTF, SEFL and SEFR are expanded and PSI is minimized. www.masimo.com Masimo...
  • Page 38 When multiple MOC-9 technologies are connected, the user will have the option to select one of several pre-configured layouts for optimal viewing. Shown in the following illustration is the SedLine window at 37.5% of the display. 1 View Options: Trend, EEG, DSA, Analog...

  • Page 39: Chapter 5: Menu Options

    SEFL, SEFR, EMG, SR, and ARTF. To access a specific parameter's configuration settings • Press the parameter desired directly from the SedLine window. To access all parameter configuration settings Press the Main Menu icon at the bottom right corner of the screen to access menu options.
  • Page 40 SedLine Sedation Monitor Chapter 5: Menu Options About An informational read-only screen with definition of PSI: The Patient State Index (PSI) is related to the effect of certain anesthetic agents on a patient. Alarms Factory Selectable Options Description Default Settings...
  • Page 41 SedLine Sedation Monitor Chapter 5: Menu Options Trends Factory Selectable Options Description Default Settings Y-Axis Max Highest PSI value that can be displayed 5 to 100 Y-Axis Min Lowest PSI value that can be displayed 0 to 95 Threshold Upper limit of target PSI range (green band...
  • Page 42 SedLine Sedation Monitor Chapter 5: Menu Options About DSA An informational read-only screen with definition of DSA: The Density Spectral Array (DSA) is a color representation of the power of the EEG between 0 and 30 Hz showing activity in the right and left areas of the brain using spectral edge frequency as the indices.
  • Page 43 SedLine Sedation Monitor Chapter 5: Menu Options About An informational read-only screen with definition of EMG: EMG (electromyography) is a measure of detected muscle activity, such as jaw clenching. The EMG value varies from 0% to 100%. Trends Factory Selectable...
  • Page 44 SedLine Sedation Monitor Chapter 5: Menu Options About An informational read-only screen with definition of SR: Suppression Ratio (SR) is a measure of how much the electrical activity of the frontal and pre-frontal cortex of the brain is suppressed. Trends...
  • Page 45 SedLine Sedation Monitor Chapter 5: Menu Options ARTF About An informational read-only screen with definition of ARTF: Artifact (ARTF) is a measure of how much physiological (non-brain related) and environmental noise the system detects. Trends Factory Selectable Options Description Default...
  • Page 46 SedLine Sedation Monitor Chapter 5: Menu Options SEFL and SEFR About An informational read-only screen with definition of SEF: The Spectral Edge Frequency (SEF) identifies the frequency below which 95% of the total power of the patient’s EEG is located. SEF is a common EEG power signal processed parameter represented on the DSA display’s 0-30 Hz scale.

  • Page 47: Additional Settings

    SedLine Sedation Monitor Chapter 5: Menu Options Additional Settings SedLine Additional Settings provide the user access to EEG and DSA settings as well as SedLine Sensor information. To access the Additional Settings screen From the Main Menu, press the SedLine icon.

  • Page 49: Chapter 6: Eeg Download

    EEG waveforms displayed into sessions. Terminate the recording session by disabling Data Collection in the Access Control menu. Root will record up to 12 continuous hours of EEG waveforms per session. When recording exceeds 12 sessions, the oldest session will be erased as the newest session starts recording. www.masimo.com Masimo...

  • Page 50: Download Eeg Waveforms

    SedLine Sedation Monitor Chapter 6: EEG Download Download EEG Waveforms To download the EEG waveforms onto the USB stick: Ensure that there is a folder titled, “edf”, in the USB stick that is used to download EEG waveforms from Root. Without this folder, the download cannot activate.

  • Page 51: Chapter 7: Alarms And Messages

    Chapter 7: Alarms and Messages Messages and Indications The table below lists the types of messages that can appear on Root when using SedLine. Error Message Indication SedLine is Indicates that the SedLine module is not connected. Disconnected No Sensor...

  • Page 53: Chapter 8: Troubleshooting

    Chapter 8: Troubleshooting To troubleshoot issues with Root, see the Operator's Manual for Root. To troubleshoot issues with the Masimo sensor, see the Directions for Use (DFU) for the sensor. If a problem persists, contact an Authorized Masimo Representative. Message...

  • Page 54: Adjusting Electrodes

    If a signal is high in amplitude and appears different from the other channels. To improve electrode contact Note: After making any electrode adjustments, wait two (2) to three (3) seconds for SedLine to update. It is important to check the electrodes in the order listed below:...
  • Page 55 SedLine Sedation Monitor Chapter 8: Troubleshooting Icon Color Action Yellow Minor electrode adjustment may be required. Gently push/wiggle electrodes until all are yellow and/or green. Re-prepping of the application site may be necessary. Blue Confirm that all electrodes, particularly electrodes CT and CB, of the sensor are properly connected.

  • Page 56: Trends Not Available

    SedLine Sedation Monitor Chapter 8: Troubleshooting Trends Not Available If trends do not appear, this may be due to the one of the following issues: • Electrode impedance issues • Artifact issues • Line power and high frequency artifacts Electrode Impedance Issues The EEG window displays waveforms for electrodes only after the module conducts an internal check for impedance issues.
  • Page 57 SedLine Sedation Monitor Chapter 8: Troubleshooting Line Power and High Frequency Artifacts The following information may help resolve line power and high frequency artifact issues. Issue Action Confirm that all displayed parameters are within normal limits. Proximity of the module to other devices can cause high frequency interference.

  • Page 59: Chapter 9: Specifications

    SEFL, SEFR 0 to 30 Hz Electrode Impedance 0.0 to 65.0 K Resolution This section contains information about resolution. Parameter Resolution ARTF 0.1% DSA (left and right) 1 Hz SEFL 1 Hz SEFR 1 Hz Electrode Impedance 0.1 K www.masimo.com Masimo...

  • Page 60: Environmental

    SedLine Module Operating Conditions Item Description Temperature at ambient humidity 5°C to 40°C Operational Humidity 15% to 95%, non-condensing SedLine Module Storage and Shipping Conditions Item Description Temperature at ambient humidity -40°C to 70°C Storage humidity 15% to 95%, non-condensing Exposure to pressure 500 to 1060 mbar.

  • Page 61: Regulatory Symbols

    SedLine Sedation Monitor Chapter 9: Specifications Regulatory Symbols The following symbols are on the product hardware or packaging. Symbols Definition Symbols Definition Caution UL, LLC, certification Federal Communications Consult Instructions for Use Commission (FCC) licensing Follow Instructions for Use Storage Altitude Limitation...

  • Page 62: Safety Classifications

    Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, or with oxygen or nitrous oxide. Mode of Operation of SedLine Continuous: The SedLine may be operated under normal load for a normal period without exceeding the specified limits of temperature. Classification: Medical electrical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1/CAN/CSA C22.2 No.

  • Page 63: Safety Compliance

    SedLine Sedation Monitor Chapter 9: Specifications Safety Compliance Safety Compliance UL 60601-1, 1 CAN/CSA C22.2 No. 601.1 IEC 60601-1, 2 EN 60601-1, 2 IEC 60601-2-26 EMC Compliance EMC Compliance See Operator's Manual for Root. www.masimo.com Masimo...

  • Page 65: Chapter 10: Service And Maintenance

    Chapter 10: Service and Maintenance Cleaning Procedures Cleaning of SedLine should be performed at regular intervals in accordance with hospital, as well as local and governmental regulations. See the Warnings and Cautions section in this manual. SedLine is a reusable instrument. The instrument is supplied non-sterile.

  • Page 66: Service Instructions

    Please clean contaminated and/or dirty equipment before returning, following the cleaning procedure described in the Cleaning Procedures section. Make sure the equipment is fully dry before packing. To return SedLine for service, please follow the Return Procedure in the next section. www.masimo.com Masimo...

  • Page 67: Return Procedure

    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 –...

  • Page 68: 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 69: Exclusions

    Products or Software. In no event shall Masimo’s liability arising from any Product and Software (under contract, warranty, tort, strict liability or other claim) exceed the amount paid by purchaser for the Products giving rise to such claim.

  • Page 70: Restrictions

    Product or the Software on a temporary basis. Purchaser shall not assign or transfer this License, in whole or in part, by operation of law or otherwise without Masimo’s prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included.

  • Page 71: Index

    Connecting the SedLine Sensor to the Index Patient • 19 Contacting Masimo • 65 Contraindications • 7 About this Manual • 5 Additional Settings • 45 Download EEG Waveforms • 48 Adjusting Electrodes • 52 DSA • 40 Alarms and Indications • 49 DSA (Density Spectral Array) Display •...
  • Page 72 SedLine Sedation Monitor Index No Implied License • 68 The SedLine Window • 21 Theory of Operation • 13 Trends Not Available • 54 Parameter Settings • 37 Parameters Display • 25 Preparation for Use • 17 Unpacking and Inspecting the System •...
  • Page 74 35548/7373D-0416...

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