Masimo sedline User manual

Operator's Manual
SedLine®Sedation Monitor

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These operating instructions intend to provide the necessary information for proper
operation of the SedLine® 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.
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®, including display details as well as accessing and changing user-configurable settings.
For additional information related to Root, refer to the Operator's Manual for Root.
For further information contact:
Masimo Corporation
40 Parker
Irvine, CA 92618, USA
Tel.: [phone]
Fax.: [phone]
www.masimo.com
EU authorized representative for Masimo Corporation:
MDSS GmbH
Schiffgraben 41
D-30175 Hannover, Germany
Patents: www.masimo.com/patents.htm
Root, SedLine, Masimo, and are registered trademarks of Masimo Corporation.
MOC-9 is a trademark of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners.
© 2016 Masimo Corporation.

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Contents
About this Manual ------------------------------------------------------------------------------------------ 5
Product Description, Indications, and Contraindications---------------------------------------------7
Product Description--------------------------------------------------------------------------------------7
Indications for Use---------------------------------------------------------------------------------------7
Contraindications ----------------------------------------------------------------------------------------7
Warnings and Cautions ------------------------------------------------------------------------------------ 9
Safety Information-------------------------------------------------------------------------------------10
Compliance Information------------------------------------------------------------------------------ 11
General Information----------------------------------------------------------------------------------- 11
Chapter 1: Technology Overview ------------------------------------------------------------------------13
Theory of Operation------------------------------------------------------------------------------------13
Chapter 2: System Descriptions------------------------------------------------------------------------- 15
Root------------------------------------------------------------------------------------------------------- 15
SedLine Module ----------------------------------------------------------------------------------------16
SedLine Patient Cable---------------------------------------------------------------------------------16
SedLine Sensor(s)-------------------------------------------------------------------------------------- 16
Chapter 3: Setting Up the System---------------------------------------------------------------------- 17
Unpacking and Inspecting the System------------------------------------------------------------- 17
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
EEG Display----------------------------------------------------------------------------------------------22
Parameters Display ------------------------------------------------------------------------------------25
DSA (Density Spectral Array) Display---------------------------------------------------------------31
View Options------------------------------------------------------------------------------------------- 33
Chapter 5: Menu Options--------------------------------------------------------------------------------- 37
Parameter Settings ------------------------------------------------------------------------------------37
Additional Settings ------------------------------------------------------------------------------------45

SedLine Sedation Monitor Contents
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Chapter 6: EEG Download-------------------------------------------------------------------------------- 47
Enable EEG Data Collection -------------------------------------------------------------------------- 47
Download EEG Waveforms----------------------------------------------------------------------------48
Import .edf Files----------------------------------------------------------------------------------------48
Chapter 7: Alarms and Messages -----------------------------------------------------------------------49
Messages and Indications----------------------------------------------------------------------------49
Alarms and Indications-------------------------------------------------------------------------------49
Chapter 8: Troubleshooting ----------------------------------------------------------------------------- 51
Adjusting Electrodes ---------------------------------------------------------------------------------- 52
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
Chapter 10: Service and Maintenance-----------------------------------------------------------------63
Cleaning Procedures-----------------------------------------------------------------------------------63
General Maintenance for Module -------------------------------------------------------------------63
Service Instructions -----------------------------------------------------------------------------------64
Repair Policy-------------------------------------------------------------------------------------------- 64
Return Procedure --------------------------------------------------------------------------------------65
Contacting Masimo------------------------------------------------------------------------------------65
Sales & End-User License Agreement--------------------------------------------------------------66
Warranty-------------------------------------------------------------------------------------------------66
Exclusions ----------------------------------------------------------------------------------------------- 67
End-User License -------------------------------------------------------------------------------------- 67
Restrictions ---------------------------------------------------------------------------------------------68
No Implied License------------------------------------------------------------------------------------68
Index ---------------------------------------------------------------------------------------------------------69

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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.
A warning is given when actions may result in a serious outcome (for example, injury, serious
adverse effect, death) to the patient or user. The following is an example of a warning:
Warning: This is an example of a warning statement.
A caution is given when any special care is to be exercised by the patient or user to avoid
injury to the patient, damage to this instrument or damage to other property. The following is
an example of a caution:
Caution: This is an example of a caution statement.
A note is given when additional general information is applicable. The following is an
example of a note:
Note: This is an example of a note.

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Product Description, Indications, and
Contraindications
Product Description
SedLine® Sedation Monitor is a patient-connected, 4-channel processed
electroencephalograph (EEG) monitor designed specifically for intraoperative or intensive
care use. It displays electrode status, EEG waveforms, Density Spectral Array (DSA), and
Patient State Index (PSI).
The operator controls the unit using menus and dedicated buttons to select various display
options. The system consists of 4 major components: Root, SedLine Module, SedLine Patient
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.
Contraindications
This device is not intended for use in children less than 18 years of age.