Operators Manual
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Operator's Manual
SedLine® Sedation Monitor
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.: 949-297-7000 Fax.: 949-297-7001 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 www.masimo.com
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Contents
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.
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Safety Information, Warnings and Cautions CAUTION: SedLine is to be operated by, or under the supervision of, qualified personnel only. Read the manual, accessories, directions for use, all precautionary information, and specifications before use. Refer to the Operator’s Manual for Root for additional safety information, warnings and cautions.
Safety Information Warnings and Cautions WARNING: Do not start or operate the SedLine Module unless the setup was verified to be correct. Improper set-up of the device may result in degraded performance and/or patient injury. 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: All sensors and cables are designed for use with specific devices. Verify the compatibility of the device, cable and sensor before use; otherwise degraded performance and/or patient injury can result. 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. WARNING: Do not adjust, repair, open, disassemble, or modify the SedLine Module. Damage to the module may result in degraded performance and/or patient injury. WARNING: Do not use the SedLine Module in the presence of flammable anesthetics or other flammable substance in combination with air or oxygen-enriched environments. WARNING: Do not use SedLine during magnetic resonance imaging (MRI) or in an MRI environment. WARNING: To protect against Electrical Shock Hazard, 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.
WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation.
Performance Warnings and Cautions 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: Use Patient State Index (PSi) information in conjunction with other indicators of patient state in the delivery of anesthetics. www.masimo.com
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Safety Information, Warnings and Cautions
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: 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. 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: 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 Root, or plugging Root into a different outlet if potential artifacts are displayed. CAUTION: Train-of-Four stimulation on a patient’s face is not recommended. Doing so may create EEG artifact, preventing calculation of PSi values. 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.
CAUTION: To ensure that alarm limits are appropriate for the patient being monitored, check the limits each time SedLine is used. 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. CAUTION: Replace the cable or sensor when a replace sensor or low SIQ message is consistently displayed while monitoring consecutive patients after completing the low SIQ troubleshooting steps listed in the troubleshooting section. Note: The SedLine electrodes detect electrical activity primarily EEG. Similar to other EEG devices, electrical signals artifacts, such as ECG, EOG etc., may also be displayed when present. Note: Use and store the SedLine Module in accordance with specifications. See the Specifications section in this manual. Note: The anesthetic agents listed below were used in the comparison study* to evaluate the improved performance of the current PSi on the SedLine Sedation Monitor: www.masimo.com
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SedLine Sedation Monitor •
Alfentanil
•
Desflurane
•
Fentanyl
•
Isoflurane
•
Nitrous Oxide
•
Propofol
•
Remifentanil
•
Sevoflurane
Safety Information, Warnings and Cautions
*All data is based on the retrospective analysis of clinical data in Masimo Corporation’s files.
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. WARNING: Service of the SedLine Module should be done by qualified personnel only. CAUTION: Only perform maintenance procedures specifically described in the manual. Otherwise, return the SedLine Module for servicing. CAUTION: To avoid permanent damage to the SedLine Module, do not use undiluted bleach (5% - 5.25% sodium hypochlorite) or any other cleaning solution not recommended. CAUTION: 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: 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 device. CAUTION: To prevent damage, do not soak or immerse the SedLine Module in any liquid solution.
Compliance Information Warnings and Cautions WARNING: Any 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. NOTE: Use SedLine in accordance with the Environmental Specifications section in the Operator’s Manual for Root. NOTE: For FCC compliance information, refer to the Operator's Manual for Root. NOTE: For EMC compliance information, refer to the Operator’s Manual for Root. www.masimo.com
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Chapter 1: Technology Overview Theory of Operation The Patient State Index (PSi) formula 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. The 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.
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Chapter 2: System Descriptions
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. 2. 3.
Remove the components from the shipping carton and examine them for signs of shipping damage. Check all materials against the packing list. Save all packing materials, invoice and bill of lading. These may be required to process a claim with the carrier. If anything is missing or damaged, contact Masimo Technical Service.
Preparation for Use Prior to using SedLine for monitoring 1.
2. 3.
Confirm that you have all system components: •
Root
•
SedLine Module
•
SedLine Patient Cable
• SedLine Sensor Confirm that Root holds adequate battery power. Confirm that you have alcohol swabs for sensor application.
Connecting the Module to the Patient Cable The image below shows various SedLine system components connected.
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Chapter 3: Setting Up the System
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. 4.
Push to insert. For additional details, see the Directions for Use (DFU) for the patient cable.
Connecting the Module to Root To connect the module to Root 1.
Identify the Masimo Open Connect (MOC-9 TM) end of the module.
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SedLine Sedation Monitor 2.
Chapter 3: Setting Up the System
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. See EEG Display on page 24. 2 Parameters Display. See Parameters Display on page 26. 3 DSA Display. See DSA (Density Spectral Array) Display on page 27.
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SedLine Sedation Monitor
Chapter 4: Operation
EEG Display 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* * Touch to adjust the max and min values. 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 adjust the max and min values directly. Note: When Synchronized Waveforms on Root are Enabled (On) under Access Control, the EEG Chart Speed cannot be changed. Refer to the Operator's Manual for Root.
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.
Note: The feature can be enabled or disabled though Additional Settings on page 40. www.masimo.com
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Chapter 4: Operation
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
Each individual electrode status is composed of three components:
1. 2. 3.
L/R/CB (Left/Right/Center) represents the corresponding sensor electrodes. In the example above, the R1 electrode label corresponds to the R1 electrode of the sensor. The color rectangle adjacent to the electrode label represents the electrode impedance status. Refer to the icon color chart in this section for details on different colors and statuses. The numeric value under the electrode label represents the level of electrode impedance.
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 on page 45. www.masimo.com
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Icon Color
Example
Chapter 4: Operation
Description
Green
Electrode impedance is in good range and acceptable.
Yellow
Electrode impedance is marginal but acceptable.
Red
Electrode impedance is out of acceptable range.
Blue
Electrode impedance is extremely high or disconnection of sensor electrodes.
Dark Gray with Cyan X
Gel-bridging detected on the affected electrodes.
The range for electrode impedance values is 0.0 to 65.0K ohms. The display of electrode impedance values can be turned on or off by the user.
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 frame shown on all trend lines.
PSi (Patient State Index) The Patient State Index (PSi) is related to the effect of certain anesthetic agents on a patient.
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