SedLine
Operator's Manual
®
Sedation Monitor
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
®
, including display details as well as accessing and changing user-configurable settings.
Root
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.: 949-297-7000
Fax.: 949-297-7001
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
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SedLine Sedation Monitor Contents
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.
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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.
Caution: SedLine is to be operated by, or under the supervision of, qualified personnel only.
The manual, accessories, directions for use, all precautionary information, and specifications
should be read before use.
Caution: Always use SedLine precisely in accordance with the directions in this manual,
including site selection, sensor placement, and subject behavior during testing. Failure to
follow all of the directions in this manual could lead to inaccurate measurements.
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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.
Warning: Do not use the SedLine Module if it appears or is suspected to be damaged.
Warning: Do not adjust, repair, open, disassemble, or modify the SedLine Module. Injury to
personnel or equipment damage could occur. Return the SedLine Module for servicing.
Warning: Do not use SedLine during magnetic resonance imaging (MRI) or in an MRI
environment.
Warning: Explosion hazard: Do not use the SedLine Module in the presence of flammable
anesthetics or other flammable substance in combination with air, oxygen-enriched
environments, or nitrous oxide.
Warning: The SedLine Module may be used during electrocautery, but this may affect the
accuracy or availability of the parameters and measurements.
Warning: The SedLine Module may be used during defibrillation, but this may affect the
accuracy or availability of the parameters and measurements.
Warning: Electrical Shock Hazard: To protect against injury, follow the directions below:
• Avoid placing the device on surfaces with visible liquid spills.
• Do not soak or immerse the device in liquids.
• Use cleaning solutions only as instructed in this operator’s manual.
• Do not attempt to clean the SedLine Module while monitoring patient.
Caution: An operator may only perform maintenance procedures specifically described in the
manual. Otherwise, return the SedLine Module for servicing.
Caution: To ensure that alarm limits are appropriate for the patient being monitored, check
the limits each time SedLine is used.
Caution: As with all medical equipment, carefully route patient cabling to reduce the
possibility of patient entanglement or strangulation.
Caution: To minimize radio interference, other electrical equipment that emits radio
frequency transmissions should not be in close proximity to the SedLine Module.
Caution: Do not place the SedLine Module on electrical equipment that may affect the
instrument, preventing it from working properly.
Caution: Do not submerge the SedLine Module in any cleaning solution or attempt to
sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will
seriously damage the SedLine Module.
Caution: Close proximity to high frequency interference may cause display artifacts. As a
mitigation, consider changing Root location or plug Root into a different outlet if potential
artifacts are displayed.
Caution: Continuous Train of Four stimulation on a patient’s face is not recommended. Doing
so may create EEG artifact, preventing calculation of PSI values.
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SedLine Sedation Monitor Warnings and Cautions
Caution: The PSI value may be elevated in the following situations:
• In patients receiving nitrous oxide or ketamine. These agents may result in
increased EEG activity power at higher frequencies, in the band > 12 Hz, and this
may present an EMG-like pattern.
• On patients with non-typical EEG patterns such as seizure activity.
• When there is significant EMG activity interfering with the EEG waveform.
Caution: Inaccurate PSI values may be caused by:
• Elevated artifact and other sources of electromagnetic interferences.
• Patients with neurological disorders such as stroke, tumor, metabolic disease or
traumatic brain injury.
Compliance Information
Warning: Changes or modifications not expressly approved by Masimo shall void the
warranty for this equipment and could void the user’s authority to operate the equipment.
Caution: Disposal of Product: Comply with local laws in the disposal of the instrument and/or
its accessories.
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.
Warning: Patient State Index (PSI) information shall be used in conjunction with other
indicators of patient state in the delivery of anesthetics.
Warning: SedLine performs continuous impedance measurements (at the sensor) in order to
check that the electrodes are firmly in place. The 83.33 Hz and 125 Hz impedance
measurement signals could interfere with other electronic monitoring equipment connected
to the patient.
Warning: Do not use petroleum-based or acetone solutions, or other harsh solvents, to clean
the SedLine Module. These substances affect the device’s materials and instrument failure
can result.
Caution: Impedance monitoring can interfere with other monitoring devices, in particular
evoked potential monitors.
Caution: Disabling impedance monitoring may lead to decreased signal quality and
decreased PSI reliability due to the user not being notified of inadequate electrode contact.
Note: Use and store the SedLine Module in accordance with specifications. See the
Specifications section in this manual.
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Chapter 1: Technology Overview
Theory of Operation
The Patient State Index (PSI) was constructed based upon multivariate combinations of
quantitative electroencephalogram (QEEG) variables found to be sensitive to changes in the
level of anesthesia but insensitive to the specific substances producing such changes. The
PSI is the result of a complex computation that combines weighted quantitative values
reflecting many dimensions of brain electrical activity, such as: (1) changes in power in
various EEG frequency bands, (2) changes in symmetry and synchronization between critical
brain regions, and (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. The computed PSI is periodically updated, displayed in numeric form, and presented
in a color-coded trend graphic for monitoring the effect of certain anesthetics on the state of
the brain.
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Chapter 2: System Descriptions
The SedLine system is comprised of four (4) components:
• Root
• SedLine Module
• SedLine Patient Cable
• 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.
The following image illustrates these features being displayed on Root along with
information from the Radical-7 Pulse CO-Oximeter.
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SedLine Sedation Monitor 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 Root to the SedLine Patient
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). The
sensor is a single-use, non-sterile product that does not contain natural rubber latex.
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Chapter 3: Setting Up the System
Unpacking and Inspecting the System
To unpack and inspect the system
1. Remove the components from the shipping carton and examine them for signs of
shipping damage.
2. 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.
3. If anything is missing or damaged, contact Masimo Technical Service.
Preparation for Use
Prior to using SedLine for monitoring
1. Confirm that you have all system components:
• Root
• SedLine Module
• SedLine Patient Cable
• SedLine Sensor
2. Confirm that Root holds adequate battery power.
3. Confirm that you have alcohol swabs for sensor application.
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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
1. Identify the module connector end.
2. Align the ridged patient cable connector end with the available module connector
end.
3. Push to insert.
4. For additional details, see the Directions for Use (DFU) for the patient cable.
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SedLine Sedation Monitor Chapter 3: Setting Up the System
Connecting the Module to Root
To connect the module to Root
1. Identify the Masimo Open Connect (MOC-9 TM) end of the module.
2. 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.
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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.
SedLine parameters can display as numeric values and graphical representations of the
information acquired through the SedLine Sensor.
1 EEG Display
2 Parameters Display
3 DSA Display
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SedLine Sedation Monitor Chapter 4: Operation
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. For example, the Electrode Status display icon labeled as
R2 corresponds to the R2 electrode of the sensor.
Each icon label corresponds with electrode label on SedLine Sensor
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SedLine Sedation Monitor Chapter 4: Operation
Each individual electrode status is composed of three components:
1. L/R/C (Left/Right/Center) represents the corresponding sensor electrodes. Here,
the R1 electrode label corresponds to the R1 electrode of the sensor.
2. The color rectangle adjacent to the electrode label represents the electrode
impedance status. Refer to the icon color chart in this section for details on
different colors and statuses.
3. The numeric value under the electrode label represents the level of electrode
impedance.
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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 Example Description
Green
Yellow
Red
Blue
Light Gray
Dark Gray with
Cyan X
Dark Gray
Electrode impedance is in good range and acceptable.
Electrode impedance is marginal but acceptable.
Electrode impedance is out of acceptable range.
Unreliable connection or disconnection of sensor electrodes.
Impedance values are unavailable due to sensor, patient
cable, or module not adequately detected.
Gel-bridging detected on the electrode.
Electrode monitoring disabled. All electrodes will be dark
gray.
The range for electrode impedance values is 0.0 to 65.0 kilo-ohms (K). The display of
electrode impedance values can be turned on or off by the user.
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SedLine Sedation Monitor Chapter 4: Operation
EEG Waveforms
The EEG display reflects electrical activity of the frontal and pre-frontal cortex of the brain.
The display is configured to contain four (4) data input sources. These input sources are
acquired from electrodes on the sensor: L1, R1, L2, and R2. After input data is acquired, the
data displays as trends.
1 EEG Chart Speed 2 EEG Amplitude
The vertical axis displays the electrode source. The data values are conveyed by horizontal
gold trend lines which scroll from left to right across the display. The horizontal axis
represents time. 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.
• The gray region on the trend line represents the 20-minute window that is shown
on the DSA display.
• The user can swipe on any trend line to see historical information on all trend
lines.
• The user can pinch in and out on any trend line to expand and contract the time
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frame shown on all trend lines.
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 (--). The PSI value
displays in conjunction with two smaller numeric values, the high alarm limit and
low alarm limit. A brief explanation of PSI is available by pressing the Numeric
Value and then the About icon in the menu that appears.
Trend
PSI trend conveys the PSI numeric values over a period of time. The vertical axis
range is 0 to 100 and is configurable by the user. The horizontal axis represents
time; the period is configurable by the user.
• Green conveys that the PSI reading is within threshold limits.
• Yellow conveys that the PSI reading is above the threshold limits.
• Blue conveys that the PSI reading is below the threshold limits.
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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 (--). A brief explanation of EMG is available
by pressing the Numeric Value and then the About icon in the menu that appears.
Trend
EMG trend conveys the EMG numeric values over a period of time. The vertical axis range is 0
to 100% and it is configurable by the user. The horizontal axis represents time which is
configurable by the user.
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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 (--). A brief explanation of SR is available by
pressing the Numeric Value and then the About icon in the menu that appears.
Trend
SR trend conveys the SR numeric values over a period of time. The vertical axis range is 100%
to 0 and it is configurable by the user. The horizontal axis represents time which is
configurable by the user.
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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 (--). A brief explanation of ARTF is available
by pressing the Numeric Value and then the About icon in the menu that appears.
Trend
ARTF trend conveys the ARTF numeric values over a period of time. The vertical axis range is
0 to 100% and it is configurable by the user. The horizontal axis represents time, the period
of which is configurable by the user.
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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 (--). A brief explanation
of SEF is available by pressing the Numeric Value of either SEFL or SEFR and then the About
icon in the menu that appears.
Trend
SEFL and SEFR trends convey the SEFL and SEFR numeric values over a period of time. The
vertical axis range is 0 to 30 Hz and it is configurable by the user. The horizontal axis
represents time which is configurable by the user.
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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.
1 Frequency Range (Hz)* 4 DSA Window Indicator
2 Power Spectrum (db)* 5 Left Side Spectrogram**
3 Asymmetry Graph 6 Right Side Spectrogram**
*touch to adjust max and min values
**touch to adjust spectral edge frequency line thickness
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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.
The spectrogram labeled “L” on the right side represents the activity of the EEG from the left
frontal scalp region, and the “L” waveforms in the EEG Display correspond to this bipolar EEG
activity (L1 and L2). Conversely, the spectrogram labeled “R” on the right side represents the
activity of the EEG from the right frontal scalp region, and the “R” waveforms the EEG Display
correspond to this bipolar EEG activity (R1 and R2).
On the spectrogram:
• Artifact is displayed as vertical white lines.
• Periods of EEG suppression is displayed as vertical thick black lines with blue tick
mark at 0 Hz position.
• Periods of no data are displayed in total black.
• Left and right 95% spectral edges are displayed as white trend lines.
The vertical axes for both spectrograms display the frequency range displayed on the
spectrogram, while the vertical color bar on the right represents the power of the EEG as
measured in decibels. The horizontal axis shows the timestamps of the DSA information.
Asymmetry Graph
The Asymmetry Graph visualizes and quantifies the difference in the brain activity between
the left and the right sides with an asymmetry measurement, ASYM, displayed to the right of
the graph. An ASYM value of zero implies that the left and right hemispheres have the same
level of activity. An ASYM value preceded by an “L” implies that the left hemisphere has more
activity relative to the right hemisphere. Conversely, an ASYM value preceded by an “R”
implies more activity on the right hemisphere relative to the left hemisphere. Higher values
indicate greater difference in EEG activity between the two hemispheres.
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SedLine Sedation Monitor Chapter 4: Operation
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.
1 View Options: Trend, Analog
2 Drop-Down Menu
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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.
Each parameter in the Well can also be expanded. To expand a parameter, press and hold its
Numeric Value until it dims, then drag-and-drop it into the Trend Display area.
In the following example, the first image is a default view, and its Parameters Display shows
EMG, PSI and SR with ARTF, SEFL and SEFR in the Well.
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SedLine Sedation Monitor Chapter 4: Operation
The second image shows the customized view after ARTF, SEFL and SEFR are expanded and
PSI is minimized.
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SedLine Sedation Monitor Chapter 4: Operation
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
2 Drop-Down Menu
To select a viewing option, press the drop-down menu icon and press Trend, EEG, DSA, or
Analog icons.
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Chapter 5: Menu Options
Parameter Settings
Parameter configuration settings provide the user access to seven parameters: PSI, DSA,
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
1. Press the Main Menu icon at the bottom right corner of the screen to access menu
options.
2. From the Main Menu, press the SedLine icon.
3. Press the Parameter Settings icon.
4. Press the parameter that you want to configure.
All changes to configuration settings must be accepted by pressing OK when prompted. To
decline changes made, press Cancel.
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SedLine Sedation Monitor Chapter 5: Menu Options
PSI
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
Options Description
Factory
Default
Selectable
Settings
High Limit Upper limit that triggers an alarm 50 Off, 5 to 99
Low Limit Lower limit that triggers an alarm 25 Off, 1 to 95
High Caution
Range
Low Caution
Range
Silence
Duration
Value below High Limit to trigger
caution light
Value above Low Limit to trigger caution
light
Length of time that the audible alarm
remains silenced
Off 0 to 10
Off 0 to 10
2 min
30 sec, 1, 2, or 5
min
Audible Alarms Disables audible alarm On On or Off
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SedLine Sedation Monitor Chapter 5: Menu Options
Trends
Options Description
Factory
Default
Selectable
Settings
Y-Axis Max Highest PSI value that can be displayed 100 5 to 100
Y-Axis Min Lowest PSI value that can be displayed 0 0 to 95
Threshold
Max
Threshold
Min
Upper limit of target PSI range (green band
on PSI Trend display)
Lower limit of target PSI range (green band
on PSI Trend display)
50 5 to 100
25 0 to 95
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SedLine Sedation Monitor Chapter 5: Menu Options
DSA
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. The DSA represents the last 20 minutes of R and L frontal-prefrontal EEG
activity tracked by the 95% Spectral Edge Frequency.
Trends
Options Description Factory Default Selectable Settings
Upper Upper limit of power spectrum -10 db
Lower Lower limit of power spectrum -40 db
-40 to 40 db
(5 db increments)
-60 to -20 db
(5 db increments)
Additional Settings
Options Description
SEF Line
Thickness
Max
Frequency
Thickness of spectral edge trend lines in both
spectrograms
Upper limit of frequency displayed for spectral
edge trend lines on both spectrograms
Factory
Default
2 1, 2, 3
30 Hz 30 or 40 Hz
Selectable
Settings
About ASYM
An informational read-only screen with definition of ASYM:
The asymmetry graph shows the degree of asymmetry in between the left and right
hemispheres of the brain over time. The asymmetry parameter (ASYM) to the right of the graph
indicates the percentage of EEG power present in the left or right hemisphere with respect to
total EEG power present.
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SedLine Sedation Monitor Chapter 5: Menu Options
EMG
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
Options Description
Factory
Default
Y-Axis Max Highest EMG value that can be displayed 100%
Y-Axis Min Lowest EMG value that can be displayed 0
Selectable
Settings
5% to 100%
(5% increments)
0 to 95%
(5 db increments)
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SedLine Sedation Monitor Chapter 5: Menu Options
SR
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
Options Description Factory Default Selectable Settings
Y-Axis Max Highest SR value that can be displayed 100%
Y-Axis Min Lowest SR value that can be displayed 0
5% to 100%
(5% increments)
0 to 95%
(5 db increments)
www.masimo.com 42 Masimo
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
Options Description
Y-Axis Max
Highest ARTF value that can be
displayed
Y-Axis Min Lowest ARTF value that can be displayed 0
Factory
Default
100%
Selectable
Settings
5% to 100%
(5% increments)
0 to 95%
(5 db increments)
www.masimo.com 43 Masimo
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. 95% SEF power is displayed as a white
horizontal line and as a value for both left and right frontal-prefrontal hemispheres of the
brain. EF values display the predominant EEG frequency and corresponding changes.
Trends
Options Description Factory Default Selectable Settings
Y-Axis Max Highest SEF value that can be displayed 30 Hz
Y-Axis Min Lowest SEF value that can be displayed 0
5 Hz to 30 Hz
(5% increments)
0 to 25 Hz
(5 db increments)
www.masimo.com 44 Masimo
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
1. From the Main Menu, press the SedLine icon.
2. Press the Additional Settings icon.
All changes to configuration settings must be accepted by pressing OK when prompted. To
decline changes made, press Cancel.
Options Description
EEG Amplitude Amplitude of the EEG waveforms
EEG Chart
Speed
DSA
Placement
Monitor
Impedance
Display
Impedance
Charting speed of the EEG
waveforms
Location of DSA display (DSA
above or below PSI)
Deactivate the Electrode Status
display
Hide impedance values on the
Electrode Status display
Factory
Default
5 µV/mm
Selectable Settings
1, 2, 3, 4, 5, 10, 25, 50, or
100 µV/mm
30 mm/sec 15 or 30 mm/sec
EEG/PSI/DSA
EEG/PSI/DSA or
EEG/DSA/PSI
On On or Off
On On or Off
www.masimo.com 45 Masimo
Chapter 6: EEG Download
The four (4) channels of EEG data can be downloaded as .edf files (European Data Format)
onto a USB stick.
Enable EEG Data Collection
Activate EEG waveform storage session by enabling Data Collection in the Access Control
menu (see image below), and then press the OK button on the screen. (See Operator’s Manual
for Root for further instructions on accessing the Access Control menu). Root will then record
any 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 47 Masimo
SedLine Sedation Monitor Chapter 6: EEG Download
Download EEG Waveforms
To download the EEG waveforms onto the USB stick:
1. 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.
2. Remove all sensors from the patient’s application sites and silence any alarms.
3. Plug in the USB stick into one of two USB ports (located on the back of Root), and
the EEG information will automatically begin to download.
4. A confirmation message will briefly display at the top of the Root screen when the
information transfer is complete.
5. Unplug the USB stick from Root.
Note: The USB stick should have a minimum of 450MB of free storage space in order to
download the EEG waveforms from Root.
Note: Ensure that all information has been transferred before unplugging the USB stick as
this may cause corruption of the .edf files.
Import .edf Files
To import the data from the USB stick onto a computer
• Access the USB drive’s base directory from the computer
• Open the “edf” folder
• Select the desired session folder
• Open the .edf files with an EDF viewing program, such as EDF Viewer or Polyman.
www.masimo.com 48 Masimo
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
Disconnected
No Sensor
Connected
Incompatible
Sensor
Sensor Off Patient
Indicates that the SedLine module is not connected.
Indicates the sensor is not properly connected to the patient cable or the
electrodes of the sensor are not connected to the patient's forehead.
Indicates the sensor type cannot be used in conjunction with SedLine.
Indicates the electrodes of the sensor are not connected to the patient's
forehead.
High Impedance Indicates the impedance values of the sensor electrodes are too high.
Gel Bridging
Detected
Indicates that the active (L1, R1) and ground (CB) electrodes may have
gel between them.
Alarms and Indications
SedLine has a Patient State Index audible and visual alarm.
Alarm Text Indication
PSI High >
##
Indicates the PSI is greater than the high alarm limit value configuration
setting.
PSI Low < ## Indicates the PSI is less than the low alarm limit value configuration setting.
www.masimo.com 49 Masimo
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 Action
SedLine is
Disconnected
No Sensor
Connected
Replace Sensor
Incompatible
Sensor
Sensor Off Patient
Reconnect the module.
1. Confirm the sensor is properly inserted into the patient
cable connector.
2. The sensor may be defective and may need to be replaced.
3. The patient cable may be defective and may need to be
replaced.
4. The module may be defective and may need to be replaced.
1. Confirm the sensor is properly inserted into the patient
cable connector.
2. Replace the sensor if it has been used for more than 24
hours of patient monitoring.
3. Confirm the expiration date of the sensor has not passed.
1. Confirm the sensor is properly inserted into the patient
cable connector.
2. Confirm the expiration date of the sensor has not passed.
3. The sensor may need to be replaced.
1. Confirm the CB and CT are properly connected.
2. Confirm the sensor is properly inserted into the patient
cable connector.
3. The sensor may be defective and may need to be replaced.
4. The patient cable may be defective and may need to be
replaced.
5. The module may be defective and may need to be replaced.
www.masimo.com 51 Masimo
SedLine Sedation Monitor Chapter 8: Troubleshooting
Message Action
Incompatible
Sensor
High Impedance
Gel Bridging
Detected
Alarm Text Action
If you wish to delay the audible alarm: press the red alarm bell on the top left
PSI High >
##
of the window.
Note: If you adjust the alarm limit, the selected value will remain until it is
adjusted by the user.
If you wish to delay the audible alarm: press the red alarm bell on the top left
PSI Low <
##
of the window.
Note: If you adjust the alarm limit, the selected value will remain until it is
adjusted by the user.
Replace the sensor.
1. Confirm the all electrodes of the sensor are properly
connected.
2. The sensor may need to be replaced.
1. Clean any gel that has leaked outside of the electrodes on
the patient's forehead.
2. Confirm that all electrodes of the sensor are properly
connected.
3. The sensor may need to be replaced.
Adjusting Electrodes
The following scenarios may indicate an issue with electrodes or cabling and may be resolved
by improving patient-electrode contact:
• If Root displays an electrode status icon in any color other than green.
• 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:
Icon Color Action
Green No electrode adjustment necessary.
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SedLine Sedation Monitor Chapter 8: Troubleshooting
Icon Color Action
Yellow
Minor electrode adjustment may be required.
Red
Blue
Light Gray
Dark Gray with
Cyan X
Dark Gray
1. Gently push/wiggle electrodes until all are yellow and/or
green.
2. Re-prepping of the application site may be necessary.
Confirm that all electrodes, particularly electrodes CT and CB, of the
sensor are properly connected.
1. Replace the patient cable.
2. The module may need to be replaced.
1. Clean any gel that has leaked outside of the electrodes on the
patient's forehead.
2. Confirm that all sensor electrodes are properly connected.
3. The sensor may need to be replaced.
Electrode monitoring is disabled. Turn on electrode monitoring from the
additional settings menu.
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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.
Issue Action
1. To improve electrode-patient contact, push
and wiggle the white lining around the
electrodes. Do not press directly on the
If the EEG display does not
display waveforms for electrodes,
the electrode failed to pass the
initial impedance check.
Note: For details on applying the sensor, see the
Directions for Use (DFU) for the sensor.
electrode, otherwise the gel may leak out.
2. Remove the sensor from the patient.
3. Wipe the patient's forehead with alcohol and
dry.
4. Apply a new sensor.
Artifacts Issues
The following information may help resolve artifacts issues.
Issue Action
1. Determine if artifact is the problem by
referring to the ARTF display.
Electrode icons on the display are
either green or yellow and the ARTF
display shows artifacts.
www.masimo.com 54 Masimo
2. If the problem is artifact, instruct the
patient to relax and close his or her eyes.
3. If the problem persists, refer to the Line
Power and High Frequency Artifacts
section.
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
1. Confirm that all displayed parameters
Proximity of the module to other devices
can cause high frequency interference.
are within normal limits.
2. Change the location of Root and plug
it into another outlet.
www.masimo.com 55 Masimo
Chapter 9: Specifications
Measurement Range
This section contains information about measurement ranges.
Parameter Range
PSI 0 to 100
EMG 0 to 100%
SR 0 to 100%
ARTF 0 to 100%
DSA (Left and Right) -60 to 40 dB over frequency range of 0 to 30 Hz
SEFL, SEFR 0 to 30 Hz
Electrode Impedance 0.0 to 65.0 K
Resolution
This section contains information about resolution.
Parameter Resolution
PSI 1
EMG 1%
SR 1%
ARTF 0.1%
DSA (left and right) 1 Hz
SEFL 1 Hz
SEFR 1 Hz
Electrode Impedance 0.1 K
www.masimo.com 57 Masimo
SedLine Sedation Monitor Chapter 9: Specifications
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.
SedLine Module Physical Characteristics
Dimension Measurement
1.3 in
Width
Length
3.3 cm
4 in
10.2 cm
0.8 in
Thickness
2.0 cm
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SedLine Sedation Monitor Chapter 9: Specifications
Regulatory Symbols
The following symbols are on the product hardware or packaging.
Symbols Definition Symbols Definition
Caution
Consult Instructions for Use
Follow Instructions for Use
Manufacturer
Date of Manufacture
Non sterile
Defibrillation-Proof. Type BF
Applied Part
IPX1 Protection against liquid
IPX1
drops falling vertically
Serial Number R
Only
X
UL, LLC, certification
Federal Communications
Commission (FCC) licensing
Storage Altitude Limitation
Storage Temperature Range
Storage/transport relative
humidity range
Keep Dry
Fragile/Breakable, Handle with
Care
Do not cut
Federal Law (USA) restricts this
device to sale by or on the order of
a physician
Mark of Conformity to European
Medical Device Directive
93/42/EEC
Separate collection for electrical
and electronic equipment
(WEEE)
Catalog number (model number)
Authorized Representative in the
European Community
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SedLine Sedation Monitor Chapter 9: Specifications
Symbols Definition Symbols Definition
Instructions/Directions for Use/Manuals are available in electronic format
@http://www.Masimo.com/TechDocs
Note: eIFU is not available for CE mark countries.
Safety Classifications
1. Type of Protection against Electric Shock of the Module
Class II: Electrical equipment in which protection against electric shock does not
rely on BASIC INSULATION only, but in which additional safety precautions such
as DOUBLE INSULATION or REINFORCED INSULATION are provided, there being
no provision for protective earthing or reliance upon installation conditions.
2. Degree of Protection against Electric Shock of the Module
An F-type applied part is isolated from all other parts of the equipment to such a
degree that the patient leakage current allowable in single fault condition is not
exceeded when a voltage equal to 1.1 times the highest rated AC supply voltage is
applied between the applied part and earth. Root incorporates circuitry, creepage,
and clearance distances that provide isolation from the mains in accordance with
EN 60601-1. The module also provides patient isolation.
3. Degree of Protection against effects of Defibrillation
SedLine provides protection for the patient and operator during defibrillation
when using the SedLine Sensor. The isolation barrier within the module provides
this protection.
4. Degree of Protection against the Ingress of Water
Both Root and the module have an ingress of water rating of IPX1 (drip proof).
5. Degree of safety of application in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide
Equipment is not suitable for use in the presence of a flammable anesthetic
mixture with air, or with oxygen or nitrous oxide.
6. 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.
7. 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. 601.1 and IEC
60601-2-26
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SedLine Sedation Monitor Chapter 9: Specifications
Safety Compliance
Safety Compliance
UL 60601-1, 1st
CAN/CSA C22.2 No. 601.1
IEC 60601-1, 2
nd
EN 60601-1, 2nd
IEC 60601-2-26
EMC Compliance
EMC Compliance
See Operator's Manual for Root.
www.masimo.com 61 Masimo
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.
To clean the module
• The outer surface of the module can be cleaned with a soft cloth dampened with a
mild detergent and warm water solution.
• Do not allow liquids to enter the interior of the module.
• The outer surface of the module can also be wiped down using any of the following
solvents:
• Cidex Plus (3.4% glutaraldehyde)
• 10% bleach solution
• 70% isopropyl alcohol solution
To clean the patient cable
• Moisten a lint-free towel with a mild soapy solution or mild disinfectant. Do not
use abrasive cleaners
• Wipe down surfaces of the patient cable with the lint-free towel
• Dry completely after cleaning
General Maintenance for Module
Safety tests and internal adjustments should be done by qualified personnel only. Safety
checks should be performed at regular intervals or in accordance with hospital, as well as
local and governmental regulations.
The following is a checklist for the general maintenance of SedLine:
• Visually inspect equipment for functional or structural damage, including poor
seals, cracks, damaged springs, etc.
• Visually inspect cables, connectors, and connector pins for signs of damage or
wear.
• Visually inspect product identification labels to ensure they are clear and legible.
www.masimo.com 63 Masimo
SedLine Sedation Monitor Chapter 10: Service and Maintenance
Service Instructions
SedLine has no customer serviceable parts. Attempting to service SedLine will void the
warranty.
Safety tests and internal adjustments should be done by qualified personnel only.
See the Sales & End-User License Agreement section.
See the Contacting Masimo section.
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 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 64 Masimo
SedLine Sedation Monitor Chapter 10: Service and Maintenance
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 – and enclose or include the following information and items:
• A letter describing in detail any difficulties experienced with the equipment.
Please include the RMA number in the letter.
• Warranty information – a copy of the invoice or other applicable documentation
must be included.
• Purchase order number to cover repair if the instrument is not under warranty, or
for tracking purposes if it is.
• Ship-to and bill-to information.
• Person (name, telephone/Telex/fax number, and country) to contact for any
questions about the repairs.
• A certificate stating that SedLine has been decontaminated for bloodborne
pathogens.
Return the equipment to the following shipping address:
USA, Canada, and Asia
Europe: All Other Locations:
Pacific:
Masimo Corporation
40 Parker
Irvine, California 92618
(949) 297-7000
Fax: (949) 297-7001
Masimo International
Sàrl
Puits-Godet 10
2000 NeuchatelSwitzerland
Contact your local Masimo
Representative
Tel:+41 32 720 1111
Fax: +41 32 724 1448
Contacting Masimo
Masimo Corporation
40 Parker
Irvine, California 92618
Tel:+1 949 297 7000
Fax:+1 949 297 7001
www.masimo.com 65 Masimo
SedLine Sedation Monitor Chapter 10: Service and Maintenance
Sales & End-User License Agreement
This document is a legal agreement between you (“purchaser”) and Masimo Corporation
(“Masimo”) for the purchase of this Product (“Product”) and a license in the included or
embedded Software (“Software”) except as otherwise expressly agreed in a separate contract
for the acquisition of this Product, the following terms are the entire agreement between the
parties regarding your purchase of this Product. If you do not agree to the terms of this
agreement, promptly return the entire Product, including all accessories, in their original
packages, with your sales receipt to 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. Masimo’s sole obligation under this warranty is to replace any
product that it deems to be covered under warranty with a replacement SedLine.
To request a replacement under warranty, Purchaser must contact Masimo for a returned
goods authorization. If Masimo determines that a Product must be replaced under warranty,
it will be replaced and the cost of shipment covered. All other shipping costs shall be the
responsibility of Purchaser.
www.masimo.com 66 Masimo
SedLine Sedation Monitor Chapter 10: Service and Maintenance
Exclusions
The warranty does not extend to, and Masimo is not responsible for, repair, replacement, or
maintenance needed because of: a) modification of the Product or Software without Masimo’s
written authorization; b) supplies, instruments or electrical work external to the Product or
not manufactured by Masimo; c) disassembly or reassembly of the Product by anyone other
than an authorized Masimo agent; d) use of the Product with Sensors or other accessories
other than those manufactured and distributed by Masimo; e) use of the Product and
Software in ways or in environments for which they are not labeled; and f) neglect, misuse,
improper operation, accident, fire, water, vandalism, weather, war, or any act of God. This
warranty does not extend to any product that has been used in violation of the operating
instructions supplied with the product. This warranty does not extend to any Product that has
been reprocessed, reconditioned or recycled.
This warranty also does not apply to any Products provided to Purchaser for testing or
demonstration purposes, any temporary Products Modules or any Products for which Seller
does not otherwise receive a usage or purchase fee; all such Products are provided AS-IS
without warranty.
This warranty, together with any other express written warranty that may be issued by
Masimo is the sole and exclusive warranty as to the Product and Software. This warranty is
expressly in lieu of any oral or implied warranties, including without limitation any implied
warranty of merchantability or fitness for a particular purpose. Masimo shall not be liable for
any incidental, special or consequential loss, damage or expense directly or indirectly arising
from the use or loss of use of any 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. The
limitations in this section shall not be deemed to preclude any liability that cannot legally be
disclaimed by contract.
End-User License
1. Grant of License: In consideration of payment of the Software license fee, which is
part of the price paid for the Product, Masimo grants to Purchaser a nonexclusive,
nontransferable (except as set forth below) license (“License”), without right to
sublicense, to use the copy of the Software in connection with Purchaser’s use of
the Product for its labeled purpose as set forth in these directions for use. Masimo
reserves all rights not expressly granted to Purchaser.
2. 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
www.masimo.com 67 Masimo
forth herein.
SedLine Sedation Monitor Chapter 10: Service and Maintenance
Restrictions
1. Copyright Restrictions: The Software and the accompanying written materials are
copyrighted. Unauthorized copying of the Software, including Software that has
been modified, merged, or included with other software, or the written materials is
expressly forbidden. Purchaser may be held legally responsible for any copyright
infringement that is caused or incurred by Purchaser’s failure to abide by the terms
of this Agreement. Nothing in this License provides any rights beyond those
provided by 17 U.S.C. §117.
2. Use Restrictions: Purchaser may physically transfer the Product from one location
to another provided that the Software is not copied. Purchaser may not
electronically transfer the Software from the Product to any other device.
Purchaser may not disclose, publish, translate, release, distribute copies of, modify,
adapt, translate, reverse engineer, decompile, disassemble, or create derivative
works based on the Software or the written materials.
3. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell,
or otherwise dispose of the 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.
Any attempt to assign any rights, duties or obligations arising hereunder other
than as set forth in this paragraph shall be void.
4. U.S. Government Rights: If Purchaser is acquiring Software (including the
related documentation) on behalf of any part of the United States Government,
the following provisions apply: the Software and documentation are deemed to be
"commercial software" and "commercial computer software documentation,"
respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any
use, modification, reproduction, release, performance, display or disclosure of the
Software (including the related documentation) by the U.S. Government or any
of its agencies shall be governed solely by the terms of this Agreement and shall
be prohibited except to the extent expressly permitted by the terms of this
Agreement.
No Implied License
Possession or purchase of this 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 the
device, fall within the scope of one or more of the patents relating thereto. BY ACCEPTANCE
OR USE OF THIS DEVICE, YOU ACKNOWLEDGE YOUR ACCEPTANCE OF THESE TERMS.
www.masimo.com 68 Masimo
Index
A
About this Manual • 5
Additional Settings • 45
Adjusting Electrodes • 52
Alarms and Indications • 49
ARTF • 43
ARTF (Artifact) • 29
Artifacts Issues • 54
Asymmetry Graph • 32
C
Chapter 1
Technology Overview • 13
Chapter 10
Service and Maintenance • 63
Chapter 2
System Descriptions • 15
Chapter 3
Setting Up the System • 17
Chapter 4
Operation • 21
Chapter 5
Menu Options • 37
Chapter 6
EEG Download • 47
Chapter 7
Alarms and Messages • 49
Chapter 8
Troubleshooting • 51
Chapter 9
Specifications • 57
Cleaning Procedures • 63
Compliance Information • 11
Connecting the Module to Root • 19
Connecting the Module to the Patient
Cable • 18
Connecting the SedLine Sensor to the
Patient • 19
Contacting Masimo • 65
Contraindications • 7
D
Download EEG Waveforms • 48
DSA • 40
DSA (Density Spectral Array) Display • 31
E
EEG Display • 22
EEG Waveforms • 25
Electrode Impedance Issues • 54
Electrode Status • 22
EMC Compliance • 61
EMG • 41
EMG (Electromyography) • 27
Enable EEG Data Collection • 47
End-User License • 67
Environmental • 58
Exclusions • 67
G
General Information • 11
General Maintenance for Module • 63
I
Import .edf Files • 48
Indications for Use • 7
L
Line Power and High Frequency Artifacts
• 55
M
Measurement Range • 57
Messages and Indications • 49
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SedLine Sedation Monitor Index
N
No Implied License • 68
P
Parameter Settings • 37
Parameters Display • 25
Preparation for Use • 17
Product Description • 7
Product Description, Indications, and
Contraindications • 7
PSI • 38
PSI (Patient State Index) • 26
T
The SedLine Window • 21
Theory of Operation • 13
Trends Not Available • 54
U
Unpacking and Inspecting the System •
17
V
View Options • 33
W
R
Regulatory Symbols • 59
Repair Policy • 64
Resolution • 57
Restrictions • 68
Return Procedure • 65
Root • 15
Warnings and Cautions • 9
Warranty • 66
S
Safety Classifications • 60
Safety Compliance • 61
Safety Information • 10
Sales & End-User License Agreement •
66
SedLine Module • 16
SedLine Module Physical Characteristics
• 58
SedLine Patient Cable • 16
SedLine Sensor(s) • 16
SEFL and SEFR • 44
SEFL and SEFR (Spectral Edge
Frequencies) • 30
Service Instructions • 64
SR • 42
SR (Suppression Ratio) • 28
www.masimo.com 70 Masimo
www.masimo.com
35548/7373D-0416
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