Operators Manual
64 Pages
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SedLine Sedation Monitor Operator's Manual
These operating instructions intend to provide the necessary information for proper operation of the SedLine Sedation Monitor. General knowledge of electroencephalograph (EEG) monitoring and an understanding of the features and functions of the SedLine Sedation Monitor are prerequisites for proper use. Do not operate the SedLine Sedation Monitor 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. Caution: For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. 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
SedLine and Masimo
are registered trademarks of Masimo Corporation.
All other trademarks and registered trademarks are property of their respective owners. Printed in the USA. © 2014 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 System Related Safety Information ------------------------------------------------------------------ 9 Parameter Related Safety Information ------------------------------------------------------------- 10 Electrical Safety Information, Warning, and Cautions ------------------------------------------- 11 Chapter 1: Technology Overview ------------------------------------------------------------------------ 13 Theory of Operation------------------------------------------------------------------------------------ 13 Chapter 2: System Descriptions ------------------------------------------------------------------------- 15 General SedLine Description ------------------------------------------------------------------------- 15 Chapter 3: Setting Up the System ---------------------------------------------------------------------- 17 Unpacking and Inspecting the System------------------------------------------------------------- 17 Preparation for Use ------------------------------------------------------------------------------------ 17 Connecting the Module to the Patient Cable ----------------------------------------------------- 17 Connecting the Module to an Interface Monitor ------------------------------------------------- 18 Connecting the Sensor to the Patient -------------------------------------------------------------- 19 Chapter 4: Operation -------------------------------------------------------------------------------------- 21 Using SedLine with the Masimo Interface Monitor (Root) ------------------------------------- 21 The SedLine Window ---------------------------------------------------------------------------------- 22 Layout ----------------------------------------------------------------------------------------------------28 Parameter Display and Alarm Configuration Settings ------------------------------------------- 31 Chapter 5: Alarms and Messages ---------------------------------------------------------------------- 35 Messages and Indications --------------------------------------------------------------------------- 35 Alarms and Indications ------------------------------------------------------------------------------ 35 Chapter 6: Troubleshooting ------------------------------------------------------------------------------ 37 Adjusting Electrodes---------------------------------------------------------------------------------- 39 Trends Not Available --------------------------------------------------------------------------------- 39 Chapter 7: Specifications --------------------------------------------------------------------------------- 41 www.masimo.com
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Contents
Measurement Range ---------------------------------------------------------------------------------- 41 Resolution ----------------------------------------------------------------------------------------------- 41 Environmental------------------------------------------------------------------------------------------ 42 Physical Characteristics ------------------------------------------------------------------------------ 42 Regulatory Symbols ----------------------------------------------------------------------------------- 43 Guidance and Manufacturer’s Declaration --------------------------------------------------------- 44 Chapter 8: Service and Maintenance ------------------------------------------------------------------ 51 Cleaning Procedures----------------------------------------------------------------------------------- 51 General Maintenance for Module ------------------------------------------------------------------- 51 Service Instructions ----------------------------------------------------------------------------------- 52 Repair Policy -------------------------------------------------------------------------------------------- 52 Return Procedure -------------------------------------------------------------------------------------- 53 Contacting Masimo ------------------------------------------------------------------------------------ 53 Sales & End-User License Agreement -------------------------------------------------------------- 54 Warranty ------------------------------------------------------------------------------------------------- 54 Exclusions ----------------------------------------------------------------------------------------------- 54 End-User License -------------------------------------------------------------------------------------- 55 Restrictions --------------------------------------------------------------------------------------------- 55 No Implied License ------------------------------------------------------------------------------------ 56 Index --------------------------------------------------------------------------------------------------------- 57
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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 a 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 a 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 a example of a note.
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Product Description, Indications, and Contraindications Product Description SedLine 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 SedLine PSI trend plots. The operator controls the unit using a menu, dedicated buttons, and navigation keys to select various display options. The system consists of 3 major components: the Monitor, Patient Module, and Patient Cable. The system is used in conjunction with the SedLine Sensor.
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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Safety Information, Warnings, and Cautions System Related Safety Information Warning: Explosion hazard: Do not use the SedLine in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. Warning: A complete reading of this manual by personnel in contact with the SedLine prior to use is essential for safety. Improper setup, operation, maintenance, or parts replacement could result in injury to personnel and damage to the SedLine components. Warning: Do not use the SedLine during magnetic resonance imaging (MRI). Warning: Do not use a Sensor or Patient Cable that is damaged or has with exposed optical or electrical components. Warning: Do not start or operate the SedLine unless the setup was verified to be correct and all safety and control functions were checked. Warning: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. Warning: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) for noninvasive patient monitoring and may not be used for any processes, procedures, experiments or any other use for which the device is not intended or cleared by the FDA, or in any manner inconsistent with the instructions for use or labeling. Warning: The device and related accessories are not intended for use in combination with other medical devices or in high-risk applications. Caution: Do not submerge the SedLine 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. Caution: Impedance monitoring can interfere with other monitoring devices, in particular evoked potential monitors. Caution: When positioned on a flat surface, the system should be secured with a mounting system recommended by Masimo. Caution: The 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: The SedLine is designed to minimize the possibility of hazards from errors in the software program by following sound Engineering Design Processes, Risk Analysis and Software Validation. Caution: Do not place containers with liquids on or near the SedLine. Liquids spilled on the SedLine may cause it to perform inaccurately or fail. Note: Use the SedLine in accordance with Environmental Specifications section in of this manual. Note: A functional tester cannot be used to assess the accuracy of the SedLine. www.masimo.com
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Safety Information, Warnings, and Cautions
Parameter Related Safety Information 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:The PSI value may be unreliable in the following situations: •
On patients with neurological disorders such as stroke, tumor, metabolic disease or traumatic brain injury.
•
Be careful when working around equipment to prevent breakage due to spilling of fluids on the SedLine, dropping the SedLine, or other unwanted events.
•
The conductive parts of electrodes, sensors, or connectors should not contact other conductive parts including earth ground.
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: The SedLine may be used during defibrillation, but this may affect the accuracy or availability of the parameters and measurements.
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Safety Information, Warnings, and Cautions
Electrical Safety Information, Warning, and Cautions Warning: Do not connect powered devices to the SedLine USB port while the patient is connected, as this may compromise patient safety. Warning: Electrical shock hazard, do not remove the monitor cover. This could cause injury to personnel or equipment damage. Warning: The system devices should be used together. Do not attempt to use parts from other systems. Do not use with other commercial amplifiers, electrodes, or cables, as this presents an electrical shock hazard. Injury to personnel or equipment damage could occur. Warning: Electrical shock hazard: Injury to personnel could occur. Do not plug in or remove the power cord with wet hands. Ensure that your hands are clean and dry before touching the power cord. Warning: Do not place electrodes between the surgical site and the electro-surgical return electrode. Doing so increases the risk of burns in case of a defect in the electro-surgical return electrode. Warning: Use a grounded outlet for proper equipment grounding. A hospital-grade outlet is required. Warning: Patient State Index (PSI) information shall be used in conjunction with other indicators of patient state in the delivery of anesthetic. Warning: SedLine performs continuous impedance measurements (to 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: Electrical shock hazard: Carry out periodic tests to verify that leakage currents of patient-applied circuits and the system are within acceptable limits as specified by the applicable safety standards. The summation of leakage currents must be checked and in compliance with IEC 60601-1 and UL60601-1. The system leakage current must be checked when connecting external equipment to the system. When an event such as a component drop of approximately 1 meter or greater or a spillage of blood or other liquids occurs, retest before further use. Injury to personnel could occur. Caution: Continuous Train of Four stimulation on a patient’s face is not recommended. Doing so may create EEG artifact, thereby preventing the PSA from entering the Trend page or calculating PSI values.
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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 General SedLine Description Interface Monitor SedLine information is displayed on the Interface Monitor for the user. SedLine information includes the Patient State Index (PSI), electrode status, EEG waveforms, Electromyograph (EMG) trend, Artifacts (ARTF), Suppression Ratio (SR), and Density Spectral Array (DSA) displayed with the Masimo Interface Monitor (RootTM).
1. Module The Module computes and calculates the PSI and additional parameters, given the EEG signals acquired from the Sensor. The Module connects the Interface Monitor to the Patient Cable and receives its power from the Interface Monitor. 2. Patient Cable The Patient Cable transfers analog EEG signals collected from the Sensor to the Module for processing. The Patient Cable is a reusable cable and may be used from patient to patient. 3. Sensor The SedLine Sensor is comprised of 6 gelled electrodes, 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 the Masimo Technical Service Department.
Preparation for Use Prior to using the SedLine system for monitoring 1.
2. 3.
Confirm that you have all system components: •
Interface Monitor
•
Module
•
Patient Cable
• Sensor Confirm adequate battery power of the Interface Monitor. Confirm that you have alcohol swabs for Sensor application.
Connecting the Module to the Patient Cable The illustration 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 the ridged Patient Cable connector end with the available Module connector end.
3. 4.
Push to insert. For additional details, see Instructions for Use of the Patient Cable.
Connecting the Module to an Interface Monitor To connect the Module to an Interface Monitor 1.
Identify the Flash Connector TM end of the Module.
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Chapter 3: Setting Up the System
Insert the Flash Connector end of the Module securely into a compatible port of an Interface Monitor. As an example, see the connection with a Masimo Interface Monitor (Root) below.
Connecting the Sensor to the Patient For directions on how to connect the Sensor, see the Sensor Instructions for Use.
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Chapter 4: Operation Using SedLine with the Masimo Interface Monitor (Root) The following sections describe how SedLine information is displayed when used with the Masimo Interface Monitor (Root), including display details and accessing and changing configuration settings. For additional information, see Root Operator's Manual.
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Chapter 4: Operation
The SedLine Window When SedLine is connected to Root; parameters and measurements may display in a window. SedLine parameters can display as a numeric value and graphical representation of the information acquired through the Sensor. 1. Electrode Status Display 2. EEG Display 3. EMG Display 4. PSI Display 5. SR Display 6. ARTF Display 7. DSA Display 8. Main Menu
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Chapter 4: Operation
The Electrode Status Display 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.
1. 2. 3.
L/R/C represent the corresponding Sensor electrodes. The color rectangle adjacent to the electrode label represents the electrode impedance status. The numeric value under the electrode label represents the level of electrode impedance.
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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 6: Troubleshooting on page 37. Icon Color
Example
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
Unreliable connection or disconnection of Sensor electrodes .
Gray
Impedance values are unavailable due to Sensor, Patient Cable, or Module not adequately detected.
Gray with X
Gel-bridging detected on the electrode.
Black
Electrode monitoring disabled. All electrodes will be black.
The range for electrode impedance values is 0.0 kilo-ohms (K-Ohms) to 65.0 kilo-ohms (K-Ohms). The display of electrode impedance values can be turned on or off by the user.
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Chapter 4: Operation
The EEG Display The EEG display reflects electrical activity of the frontal and pre-frontal cortex of the brain. The display is configured to contain 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. The trend amplitude and speed are configurable by the user.
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 PSI Display The PSI display is related to the effect of certain anesthetic agents on a patient.
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Chapter 4: Operation
The PSI display consists of two areas: 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.
Trend PSI trend conveys the PSI numeric values over a period of time. The vertical axis range is 0 to 100. The horizontal axis represents time, the period is configurable by the user.
•
Green conveys that the PSI reading is between the high alarm and the low alarm limit.
•
Yellow conveys that the PSI reading is above the high alarm limit.
•
Blue conveys that the PSI reading is below the low alarm limit.
Expanding and Contracting Trend The user is able to expand and contract the trend horizontal axis in the ARTF, EMG, PSI, and SR parameters by using a pinch gesture with two fingers. This expand and contract option is available only from the PSI trend.
The DSA Display The DSA is a color representation of the power of the EEG between 0 and 30 Hz on an epoch-by-epoch basis. The “L” horizontal color graph represents the activity of the EEG from the left frontal scalp region, and the “L” upper EEG waveform corresponds to this bipolar EEG activity (L1–L2). The “R” horizontal color graph represents the activity of the EEG from the right frontal scalp region, and the “R” upper EEG waveform corresponds to this bipolar EEG activity (R1–R2). The DSA vertical axis displays the frequency range 0 to 30 Hz, while the horizontal axis displays the time and allows the user to view the previous 20 minutes . The vertical color www.masimo.com
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