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SedLine Sedation Monitor

Chapter 2: System Descriptions

www.masimo.com

17

Masimo

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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Содержание sedline

Страница 1: ...Operator s Manual SedLine Sedation Monitor...

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Страница 3: ...rmation 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...

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Страница 5: ...s 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 t...

Страница 6: ...bleshooting 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 T...

Страница 7: ...s 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 stat...

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Страница 9: ...mponents 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...

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Страница 11: ...l 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...

Страница 12: ...ue 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...

Страница 13: ...odium 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 th...

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Страница 15: ...ower 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...

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Страница 17: ...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 sid...

Страница 18: ...ers 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 transf...

Страница 19: ...7 Masimo 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 sin...

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Страница 21: ...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 Confi...

Страница 22: ...ify 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 pat...

Страница 23: ...ystem www masimo com 21 Masimo 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...

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Страница 25: ...rmation 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 graphic...

Страница 26: ...veyed 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 char...

Страница 27: ...omposed of three components 1 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 2 The co...

Страница 28: ...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...

Страница 29: ...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 th...

Страница 30: ...s of no data are displayed as vertical thick black lines Periods of EEG suppression are displayed as vertical thick black lines with a blue tick mark at the 0 Hz position Left and right 95 spectral ed...

Страница 31: ...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 th...

Страница 32: ...y the user The horizontal axis represents time the period of which is configurable by the user SEFL and SEFR Spectral Edge Frequencies Spectral Edge Frequency Left and Right identifies the frequency b...

Страница 33: ...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 betwee...

Страница 34: ...ric 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...

Страница 35: ...SedLine Sedation Monitor Chapter 4 Operation www masimo com 33 Masimo The second image shows the customized view after ARTF SEFL and SEFR are expanded and PSi is minimized...

Страница 36: ...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...

Страница 37: ...configure All changes to configuration settings must be accepted by pressing OK when prompted To decline changes made press Cancel PSi About An informational read only screen with definition of PSi Th...

Страница 38: ...ngs Y Axis Max Highest PSi value that can be displayed 100 5 to 100 in steps of 5 Y Axis Min Lowest PSi value that can be displayed 0 0 to 95 in steps of 5 Threshold Max Upper limit of target PSi rang...

Страница 39: ...30 Hz or 40 Hz DSA Type Type of DSA selectable based on user preference multitaper hanning or multitaper The default setting is multitaper High Contrast Enhance with Root software version v1 8 1 4 or...

Страница 40: ...ard or Maximum Available on SedLine with software V232x or higher SR About An informational read only screen with definition of SR Suppression Ratio SR is a measure of how much the electrical activity...

Страница 41: ...Default Selectable Settings Y Axis Max Highest ARTF value that can be displayed 100 5 to 100 in 5 increments Y Axis Min Lowest ARTF value that can be displayed 0 0 to 95 in 5 increments SEFL and SEFR...

Страница 42: ...ude of the EEG waveforms 5 V mm 1 2 3 5 10 25 50 or 100 V mm EEG Chart Speed Charting speed of the EEG waveforms 30 mm sec 15 or 30 mm sec EEG Display Filter Filters the 50Hz and 60Hz line frequency p...

Страница 43: ...e 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 s...

Страница 44: ...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 sti...

Страница 45: ...mpedance 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 Pati...

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Страница 47: ...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 Incompatible...

Страница 48: ...ay 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 noisy...

Страница 49: ...e 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...

Страница 50: ...ay 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 Line Power and High Frequ...

Страница 51: ...MG 0 to 100 ARTF 0 to 100 SEFL SEFR 0 Hz to 30 Hz DSA Amplitude Left and Right 60 dB to 40 dB DSA Asymmetry 100 to 100 Electrode Impedance 0 Ohms to 65 KOhms Resolution Parameter Resolution PSi 1 SR 2...

Страница 52: ...3 in 3 3 cm Length 4 0 in 10 2 cm Thickness 0 8 in 2 0 cm Clinical Testing Summary Clinical Testing Summary Study Title Retrospective Assessment of PSi by Independent EEG Experts Study Type Retrospec...

Страница 53: ...Protection Class II Degree of Protection of Electrical Shock Defibrillation proof BF Applied Part Protection against harm from liquid ingress IPX1 Protection against vertically falling water drops Mod...

Страница 54: ...ntertek certification See Declarations on Page 1 for certifications Protected against vertically falling water drops Non Sterile Defibrillation proof Type BF applied part Separate collection for elect...

Страница 55: ...o PVC polyvinyl chloride material Manufacturer Not made with natural rubber latex Date of manufacture YYYY MM DD Catalog number model number Storage temperature range Masimo reference number Keep dry...

Страница 56: ...ireless device RS 232 Interface Iris Connection Analog Out Interface Ethernet Greater than USB port Less than China Restriction of Hazardous Substances The names and content of the toxic and hazardous...

Страница 57: ...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 M...

Страница 58: ...al 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...

Страница 59: ...shall be the responsibility of Purchaser 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...

Страница 60: ...d 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...

Страница 61: ...ment 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 wi...

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Страница 63: ...nings and Cautions 11 Cleaning Procedures 55 56 Clinical Testing Summary 50 Compliance Information Warnings and Cautions 11 Connecting the Module to Root 20 Connecting the Module to the Patient Cable...

Страница 64: ...tions 58 Return Procedure 56 Root 15 S Safety Classifications 51 Safety Compliance 51 Safety Information Warnings and Cautions 9 Safety Information Warnings and Cautions 9 55 Sales End User License Ag...

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Страница 66: ...www masimo com 35548 LAB 7373G 0619...

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