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

Masimo SedLine Operator's Manual

Sedation monitor
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SedLine
Sedation Monitor

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Summary of Contents for Masimo SedLine

  • Page 1 Operator's Manual ® SedLine Sedation Monitor...
  • Page 3 Sedation Monitor (SedLine). General knowledge of electroencephalograph (EEG) monitoring ® and an understanding of the features and functions of SedLine are prerequisites for proper use. Do not operate SedLine without completely reading and understanding these instructions. Notice: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents.

  • Page 5: Table Of Contents

    Troubleshooting in the Presence of Artifact --------------------------------------------------------------------------- 23 Chapter 6: Specifications ----------------------------------------------------------------------------------------------------- 25 Display Range ----------------------------------------------------------------------------------------------------------------- 25 Resolution----------------------------------------------------------------------------------------------------------------------- 25 Environmental ----------------------------------------------------------------------------------------------------------------- 25 SedLine Module Physical Characteristics ------------------------------------------------------------------------------ 26 Clinical Testing Summary -------------------------------------------------------------------------------------------------- 26 Safety Classifications -------------------------------------------------------------------------------------------------------- 26 Safety Compliance ----------------------------------------------------------------------------------------------------------- 27 EMC Compliance ------------------------------------------------------------------------------------------------------------- 27...
  • Page 6 SedLine Sedation Monitor Contents General Maintenance for Module ---------------------------------------------------------------------------------------- 29 Service Instructions ---------------------------------------------------------------------------------------------------------- 29 Repair Policy ------------------------------------------------------------------------------------------------------------------ 30 Return Procedure ------------------------------------------------------------------------------------------------------------ 30 Contacting Masimo ---------------------------------------------------------------------------------------------------------- 30 Index --------------------------------------------------------------------------------------------------------------------------------- 35 www.masimo.com Masimo...

  • Page 7: About This Manual

    Sedation Monitor. Important safety information ® relating to general use of SedLine 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

    The operator controls the unit via the host device. See the host device's operator's manual or user's guide for information and instructions. The system consists of 4 major components: a host device, SedLine Module, SedLine Patient Cable, and SedLine Sensors.

  • Page 11: Safety Information, Warnings And Cautions

    WARNING: Do not use the SedLine Module if it appears or is suspected to be damaged. Damage to the module enclosure can result in exposed electrical circuits that may cause patient harm.
  • Page 12 CAUTION: Close proximity to high frequency interference may cause display artifacts. As a mitigation, consider moving the SedLine Module away from the source of radiation, changing the location of the host device, or plugging the host device into a different outlet if potential artifacts are displayed.

  • Page 13: Cleaning And Service Warnings And Cautions

    WARNING: Do not attempt to remanufacture, recondition or recycle the SedLine Module as these processes may damage the electrical components, potentially leading to patient harm. WARNING: To avoid electric shock, always turn off SedLine and physically disconnect the AC power and all patient connections before cleaning.

  • Page 15: Chapter 1: Technology Overview

    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. The 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 Module The SedLine Module computes and calculates PSi and additional parameters using the EEG signals acquired from the SedLine Sensor. The module connects the host device to the SedLine Patient Cable and receives its power from the host device.

  • Page 18: Sedline Patient Cable

    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

     SedLine Patient Cable  SedLine Sensor Host device operator's manual or user's guide. SedLine Sensor DFU for sensor application. Connecting the Module and Patient Cable The image below shows the SedLine system components connected as one unit for patient monitoring. www.masimo.com Masimo...

  • Page 20: Connecting To The Host Device

    Identify the host device connector on the end of the SedLine Module cable. Identify the appropriate port on the host device. Connect the SedLine Module cable to the host device. For directions on how to connect the SedLine Sensor, See the Directions for Use (DFU) for SedLine Sensors. www.masimo.com...

  • Page 21: Chapter 4: Operation

    Chapter 4: Operation The information in this chapter assumes that SedLine is set up and ready for use. This chapter describes how SedLine information is provided to the host monitor. For additional information, See the host monitor Operator’s Manual to identify supported features. Do not operate SedLine without completely reading and understanding these instructions.
  • Page 22 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. SEFL and SEFR are represented by numeric values that range from 0- 30Hz.

  • Page 23: Chapter 5: Troubleshooting

    Chapter 5: Troubleshooting Troubleshooting SedLine To troubleshoot issues with the SedLine Sensor, See the Directions for Use (DFU) for the sensor. If a problem persists, contact an Authorized Masimo Representative.  Verify that the SedLine Module is connected to the host device.

  • Page 24: Troubleshooting Unexpected Changes In Psi

    Troubleshooting Unexpected Changes in PSi The following table lists potential causes and corrective action for unexpected changes in PSi values. Observation Potential Cause Next Steps Proximity of the SedLine EEG appears module to other devices Position the source of interference away from the corrupted can cause high frequency SedLine module.

  • Page 25: Troubleshooting In The Presence Of Artifact

    Potential Cause Next Steps Check that the electrosurgical generator and cables are physically separated from the Host monitor and the SedLine module and sensors. Verify that the patient is not in contact with potentially grounded metal objects, such as bed rails, patient positioning devices, etc.
  • Page 26 SedLine Sedation Monitor Chapter 5: Troubleshooting Symptom Potential Cause Next Steps Take action to reduce surgical stress, which could decrease  Confirm that the EMG interference. elevation in the EMG Check for patient movement and parameter corresponds wait until patient movement has...

  • Page 27: Chapter 6: Specifications

    Electrode Impedance ≤ 1 KOhm Environmental Environmental Conditions +41°F to +104°F Operating Temperature (+5°C to +40°C) Storage Temperature -40°F to +158°F (-40°C to +70°C) Operating and Storage Humidity 10% to 95%, non-condensing Operating Pressure 500 to 1060 mbar www.masimo.com Masimo...

  • Page 28: Sedline Module Physical Characteristics

    Retrospective Assessment of PSi by Independent EEG Experts Study Type Retrospective Study The study compared the performance of two SedLine Patient State Index (PSi) Study Design algorithms (proposed vs. predicate) through a review by three independent EEG experts, Board Certified Anesthesiologists.

  • Page 29: Safety Compliance

    SedLine Sedation Monitor Chapter 6: Specifications Safety Compliance Safety Compliance IEC 60601-1:2005/AMD1:2012 IEC 60601-1-6:2010/AMD1:2013 IEC 62304:2006/AMD1:2015 IEC 60601-2-26:2012 EN 60601-1:2006/AMD1:2013 ANSI/AAMI ES60601-1:2005/A1:2012 CAN/CSA C22.2 No. 60601-1:2014 EMC Compliance EMC Compliance See the host device operator's manual or user's guide. Symbols...
  • Page 30 SedLine Sedation Monitor Chapter 6: Specifications Symbol Description Symbol Description Non-ionizing electromagnetic Identifies unit has been radiation registered as a radio device Warning, electricity Industry Canada Identification Electrostatic Biohazardous Waste Not for continuous monitoring No parameter alarms (No alarm for SpO...

  • Page 31: Chapter 7: Service And Maintenance

    Chapter 7: 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 Safety Information, Warnings and Cautions on page 9. SedLine is a reusable instrument. The instrument is supplied non-sterile.

  • Page 32: Repair Policy

    Chapter 7: Service and Maintenance Repair Policy Masimo or an authorized Service Department must perform warranty repair and service. Do not use malfunctioning equipment. Have the instrument repaired. Please clean contaminated and/or dirty equipment before returning, following the cleaning procedure.

  • Page 33: Warranty

    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 34 Masimo reusable sensors are licensed under Masimo patents for use on more than a single patient, but are not sold. Possession of any Masimo device does not convey any express or implied license to use the device with unauthorized sensors or cables that would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.

  • Page 35: No Implied License

    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 37: Index

    Sales & End-User License Agreement • 29, 30 Specifications • 25 SedLine Module • 15 Chapter 7 SedLine Module Physical Characteristics • 26 Service and Maintenance • 29 SedLine Operation • 19 Cleaning and Service Warnings and Cautions • 11 SedLine Patient Cable •...
  • Page 40 39980/LAB-10106C-1022...

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