Masimo sedline User manual

Operator's Manual
SedLine®Sedation Monitor

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For Sale in the USA
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 (USA) law restricts this device to sale by or on the order of a physician. See
instructions for use for full prescribing information, including indications, contraindications,
warnings and precautions.
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
52 Discovery
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
3149433
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH
ANSI/AAMI ES 60601-1:2005/A1, CAN/CSA C22.2 No. 60601-1:2014, and
applicable Particular (EN/ISO 60601-2-26:2012) Standards for which the
product has been found to comply by Intertek.
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.
© 2019 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
Safety Information, Warnings and Cautions ----------------------------------------------------------- 9
Safety Information Warnings and Cautions -------------------------------------------------------- 9
Performance Warnings and Cautions---------------------------------------------------------------- 9
Cleaning and Service Warnings and Cautions ---------------------------------------------------- 11
Compliance Information Warnings and Cautions ------------------------------------------------ 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)-------------------------------------------------------------------------------------- 17
Chapter 3: Setting Up the System---------------------------------------------------------------------- 19
Unpacking and Inspecting the System-------------------------------------------------------------19
Preparation for Use ------------------------------------------------------------------------------------ 19
Connecting the Module to the Patient Cable -----------------------------------------------------19
Connecting the Module to Root -------------------------------------------------------------------- 20
Connecting the SedLine Sensor to the Patient--------------------------------------------------- 21
Chapter 4: Operation--------------------------------------------------------------------------------------23
The SedLine Window ----------------------------------------------------------------------------------23
EEG Display----------------------------------------------------------------------------------------------24
Parameters Display ------------------------------------------------------------------------------------26
View Options-------------------------------------------------------------------------------------------- 31
Chapter 5: Menu Options-------------------------------------------------------------------------------- 35
Parameter Settings ----------------------------------------------------------------------------------- 35
Additional Settings ----------------------------------------------------------------------------------- 40

SedLine Sedation Monitor Contents
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Chapter 6: EEG Download-------------------------------------------------------------------------------- 41
Enable EEG Data Collection -------------------------------------------------------------------------- 41
Download EEG Waveforms---------------------------------------------------------------------------- 42
Import .edf Files---------------------------------------------------------------------------------------- 42
Chapter 7: Alarms and Messages -----------------------------------------------------------------------43
Messages and Indications----------------------------------------------------------------------------43
Alarms and Indications-------------------------------------------------------------------------------43
Chapter 8: Troubleshooting ----------------------------------------------------------------------------- 45
Troubleshooting SedLine----------------------------------------------------------------------------- 45
Adjusting Electrodes ----------------------------------------------------------------------------------46
Trends Not Available---------------------------------------------------------------------------------- 47
Chapter 9: Specifications -------------------------------------------------------------------------------- 49
Display Range ------------------------------------------------------------------------------------------ 49
Resolution-----------------------------------------------------------------------------------------------49
Environmental------------------------------------------------------------------------------------------50
SedLine Module Physical Characteristics----------------------------------------------------------50
Clinical Testing Summary ----------------------------------------------------------------------------50
Safety Classifications---------------------------------------------------------------------------------- 51
Safety Compliance------------------------------------------------------------------------------------- 51
EMC Compliance --------------------------------------------------------------------------------------- 52
Symbols-------------------------------------------------------------------------------------------------- 52
Chapter 10: Service and Maintenance-----------------------------------------------------------------55
Cleaning Procedures-----------------------------------------------------------------------------------55
General Maintenance for Module -------------------------------------------------------------------55
Service Instructions -----------------------------------------------------------------------------------55
Repair Policy--------------------------------------------------------------------------------------------56
Return Procedure --------------------------------------------------------------------------------------56
Contacting Masimo------------------------------------------------------------------------------------ 57
Index --------------------------------------------------------------------------------------------------------- 61

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About This Manual
This manual explains how to set up and use SedLine® 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.
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 device, or damage to other property.
CAUTION: This is an example of a caution statement.
A note is given when additional general information is applicable.
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), EMG Index, Suppression Ratio (SR) and Artifact (ARTF).
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 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.
The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol,
Remifentanil, and Sevoflurane. The SedLine® Sedation Monitor is intended for use with adult
patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and
clinical research laboratory.
Contraindications
This device is not intended for use in children less than 18 years of age.