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Brain Function Monitor for the Operating Room
and the Intensive Care Unit
(Version ICU)
Operating Instructions
(Software version 3.2)
MT MonitorTechnik GmbH & Co. KG
Maienbass 27
24576 Bad Bramstedt
Germany
Copyright ©, MT MonitorTechnik GmbH & Co. KG. All rights reserved.
This document must not be reproduced, edited or copied without the prior written approval of
MT MonitorTechnik GmbH & Co. KG.
Document: NAT_OperatingInstructions_ICU_US_Rev12, date: 2018-05-25
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Table of Contents
Summary of Contents for Narcotrend Compact M
- Page 1 Brain Function Monitor for the Operating Room and the Intensive Care Unit (Version ICU) Operating Instructions (Software version 3.2) MT MonitorTechnik GmbH & Co. KG Maienbass 27 24576 Bad Bramstedt Germany Copyright ©, MT MonitorTechnik GmbH & Co. KG. All rights reserved. This document must not be reproduced, edited or copied without the prior written approval of MT MonitorTechnik GmbH &...
- Page 2 Page 2 • Warning: The Medical Device Narcotrend is provided for the exclusive use of qualified physicians or personnel under their direct supervision. The numerical and graphical results from a recording must be examined with respect to the patient’s overall clinical condition. The recording preparation quality and the general recorded data quality, which could affect the report data accuracy, must also be taken into account.
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Page 3: Table Of Contents
Marker ....................... 26 5.11 Options ......................27 EEG and evaluations (RS232 / IntelliBridge connector) ........28 EEG ........................28 Narcotrend-Index NI ..................28 Additional parameters ..................29 Electrode check ....................30 Error messages ....................30 Analyse recording ....................31 View ........................33 Save ........................ - Page 4 Page 4 Cleaning, maintenance, repair ................36 Care and cleaning ....................36 Recommended checks ..................37 Error messages ....................38 Battery ....................... 40 8.4.1 Checking the battery..................40 8.4.2 Changing the battery ..................40 Disposal ......................40 Technical data ...................... 41 Symbols ......................
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Page 5: Introduction
Page 5 Introduction The Narcotrend-Compact M serves the purpose of brain function monitoring and was developed specifically for use with hypnotically acting drugs in operating rooms, intensive care units and for clinical research. The Narcotrend-Compact M includes the Narcotrend-Index, a processed EEG parameter, which may be used as an aid in monitoring the effects of certain hypnotically acting anesthetic agents. -
Page 6: Equipment Description
Narcotrend-Compact M - power supply • Patient lead 1-channel (PKM1) • Patient lead 2-channel (PKM4) (optional) • Mounting clamp (optional) • Use only the original Narcotrend-Compact M - power supply. Touchscreen Interface for patient lead On/Off switch Fig. 2: Narcotrend-Compact M, front panel... -
Page 7: Operation
To switch off the device use the button Q on the screen. 2.2 Battery operation The Narcotrend-Compact M is equipped with an integrated battery that allows the device to be used for at least 2 hours without being connected to a power supply system. -
Page 8: Usb Port
The reception of data from the external device is not provided. The point-to-point connection enables just one device to connect with the Narcotrend- Compact M at one time. Thereby the risk of interference is reduced and the integrity of the data is ensured. -
Page 9: Intellibridge Connector (Optional)
2.6 RS232 connector The RS232 interface enables the transmission of EEG signals and evaluated parameters e.g. Narcotrend-Index to store or display the values on an external device (see also chapter 4.5 options -> configurations). The reception of data from the external device is not provided. -
Page 10: Safety Instructions
Only original parts from MT MonitorTechnik GmbH & Co. KG must be used in the system. • The Narcotrend-Compact M - power supply is an essential part of the device Narcotrend-Compact M. No other power supply must be used. •... - Page 11 As a general rule, always avoid that anything external comes into contact with the electrical connector pins. • The patient should not be touched at the same time as the interfaces and the DC connectors of the Narcotrend-Compact M - power supply.
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Page 12: Putting Into Operation
• Use only the components (power supply (incl. power cords, patient lead)) that belong to the device. • For safe use, connect the Narcotrend-Compact M - power supply to a protective earth conductor. • Prior to each application, check the functional safety and proper condition of the device. -
Page 13: Applying The Electrodes
Use the following electrode: Narcotrend Electrode EE-0203 • The Narcotrend Electrodes are disposable and should not be re-used. The electrodes are unsuitable if they are re-used. • Avoid kinking and vigorous pulling of the patient lead because both can result in cable defects. - Page 14 Page 14 Fig. 4: Electrode positions for disposable electrodes, 1-channel (PKM1) * The Reference electrode (R) can be placed anywhere in the forehead area. Fig. 5: Electrode positions for disposable electrodes, 2-channel (PKM4) • Channel 1 (1a 1b) is generally positioned on the healthy side; the evaluation always refers to channel 1.
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Page 15: Start Recording / Start Screen
Page 15 4.4 Start recording / Start screen After the Narcotrend-Compact M has been switched on, the dialogue for starting a new recording is displayed: Fig. 6: Start screen If the electrodes are already applied and the patient lead is connected, the impedances are displayed in the upper area of the screen. -
Page 16: Options / Start Screen
Page 16 4.5 Options / Start screen On the Start screen, you can use the O button to make global program settings. PTIONS This includes: Electrode Settings Select electrode type: Standard or (Needle (currently not available)) Electrode Check Interval: The time interval between the automatic impedance measurements can be changed. -
Page 17: Recording Screen
Page 17 Recording screen In the recording screen, all information about the recording are displayed. Using the button bar at the bottom margin of the screen, the program is controlled in the recording mode. Fig. 7: Recording screen 5.1 Title line The title line indicates the following information (from left to right): •... -
Page 18: Stage / Index
Page 18 5.3 Stage / Index The current automatically classified EEG stage and the EEG index are indicated in the right top part of the recording screen: Stage: A – B – B – B – C – C – C –... -
Page 19: Additional Parameters
Page 19 5.4 Additional parameters These parameters are displayed on the right side of the recording screen. 5.4.1 EMG EMG = electromyogram The EMG index is a measure for the intensity of the electrical muscle activity. The index is displayed on a scale from 0 (no muscle activity) to 100 (very high amount of muscle activity). -
Page 20: Cerebrogram
Page 20 5.5.1 Cerebrogram The cerebrogram shows the results of the automatic assessments of the EEG in the course of time. In the 2-channel version, only the values from the channel 1 are displayed. Fig. 8: Cerebrogram In the gray gradient bar above the cerebrogram, the STI gradient (top) and the detected artifacts (bottom) are recorded. -
Page 21: Power Spectrum
Page 21 5.5.4 Power Spectrum The power is displayed in the power spectrum depending on the frequency. The individual frequency bands are delimited from one another by vertical lines: δ (delta band) : 0.5 – 3.5 Hz θ (theta band) : 3.5 –... -
Page 22: Eeg Analysis For Children In The First Year Of Life
Page 22 EEG analysis for children in the first year of life The analysability of anesthesia EEGs registered for children in the first months of life, will depend to a large extent on the children's level of development. Appearing from the age of approximately three months until the age of 12 months in an increasing number of children, are typical EEG anesthesia stages, which can be classified visually and automatically. -
Page 23: Button Bar
Page 23 5.7 Button bar The program is controlled in the recording mode via the button bar on the bottom edge of the screen: Button Action Changes the content of the diagram window. Starts the review mode. Starts the manual electrode check and shows the impedance values of each electrode. -
Page 24: Review Mode
Page 24 5.8 Review mode To start the review mode, press the button S . In the review mode it is CROLL REND possible to access previous EEG epochs and diagrams of the current recording. This mode enables the user to scroll back and forward within up to 24 hours of the current recording. -
Page 25: Electrode Settings
Page 25 Button Action Changes the content of the diagram window. Generates from the current screen a PNG image file. Jumps to the start / end of the recording. 1 hour back / ahead. 5 seconds back / ahead. Ends the review mode and returns to the recording screen to display the current values. -
Page 26: Marker
Page 26 5.10 Marker The MARKER button displays a menu for setting and editing markers. Fig. 14: Set and edit markers Button Action Sets markers with predefined text. The text can be changed through the global program requirements (O button on the PTIONS start screen). -
Page 27: Options
Page 27 5.11 Options This dialogue is used to adjust several program options. The preferences for the automatic electrode check and the diagram scales can be changed. Fig. 15: Menu - Options • The settings in this dialogue are valid only for the current recording. -
Page 28: Eeg And Evaluations (Rs232 / Intellibridge Connector)
Page 28 EEG and evaluations (RS232 / IntelliBridge connector) The Narcotrend-Compact M provides the following values and evaluations via the RS232 / IntelliBridge connector. 6.1 EEG Depending on the connected patient lead, the one-channel or two-channel EEG is transmitted (EEG or EEG1/EEG2). -
Page 29: Additional Parameters
Page 29 6.3 Additional parameters There are additional parameters like the EMG index, the BSR and the STI available, see table below. Only for IntelliBridge: To view the additional parameters in the IntelliBridge device data window, either • select the setup key on the EC10-module, or •... -
Page 30: Electrode Check
AC artifacts occur in the signal. NARCOTR INTERFER Errors may occur in the EEG signal, e.g. by high-frequency surgery (cautery). No classification due to high intensity of the electrical muscle activity. • In case of excessive load of artifacts the Narcotrend-Index is not calculated. -
Page 31: Analyse Recording
Page 31 Analyse recording Select the button R in the start screen. The dialogue displays a list of all EVIEW recordings or screenshots that have been stored. A recording or screenshot is selected by direct touch or via the buttons on the right-hand side next to the list. Only for recordings: At the bottom of the screen the Cerebrogram of the selected recording is shown (max. - Page 32 Page 32 The buttons on the right have the following functions: Button Action Switchover from recordings to screenshots. Moves the selection bar up. Marks a selected recording/screenshot and moves the selection bar down. Marks all recordings/screenshots. Moves the selection bar down. Displays the selected recording/screenshot (review).
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Page 33: View
Page 33 7.1 View The selected recording or screenshot is read and displayed. Only for recordings: If recordings which are longer than 24 hours shall be displayed, at first the recording period (“day”) has to be selected. This day will then be shown completely. Apart from the button bar, the screen is identical with the review mode screen of an ongoing recording. - Page 34 Page 34 Button Action Changes the content of the diagram window. Shows the button bar to navigate through the recording. Shows the list of all markers (only available in the extended version). Generates from the current screen a PNG image file. Opens a dialogue to change the diagram scales.
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Page 35: Save
Page 35 7.2 Save The selected or all marked recordings or screenshots are saved on a USB flash drive. • This is possible when the USB storage medium has been recognized and accepted by the device. • The connected USB storage medium has to be FAT32. •... -
Page 36: Cleaning, Maintenance, Repair
Cleaning, maintenance, repair 8.1 Care and cleaning To clean the Narcotrend-Compact M and the display surface use a lint-free cloth moistened with warm water (max. 40 °C / 104 °F) and soap, a thinned non-corrosive cleaner, or an ammonia/alcohol-based cleaner. -
Page 37: Recommended Checks
12 months. Visual inspection • Presence of all system components • Signs of damage on the Narcotrend-Compact M (cracks, missing housing parts) • Condition of the plug-in connections on the Narcotrend-Compact M (firmly seated in the housing, pins not bent) •... -
Page 38: Error Messages
Battery is low. Connect power The monitor is operated on battery power and the battery supply! is nearly empty. Connect the Narcotrend-Compact M - power supply to continue working. Battery is empty. Connect The monitor is operated on battery power and the battery power supply! is empty. - Page 39 Page 39 Error messages Description Not enough free disk space. The current measurement was stopped because there is Recording terminated! not enough space available to store the data. Push the button R to save or delete some of the past EVIEW measurements and get free space on the hard disk.
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Page 40: Battery
8.4.1 Checking the battery Connect the Narcotrend-Compact M to the mains for at least 2 hours. Interrupt the power supply and switch the equipment on. If the Narcotrend-Compact M can no longer be operated for 2 hours in battery mode the battery may be replaced. -
Page 41: Technical Data
Page 41 Technical data 9.1 Symbols Follow instructions for use Manufacturer Consult the instructions for Date of manufacture Attention Order number Type BF applied part Serial number Indicates ON / OFF for a Lot number part of equipment IP-Code (Protection IPX1 against dripping water Expiration date... -
Page 42: Classification And Technical Data
70 kPa Power Supply Identifier E2DFMW3_E 30 Input 100–240 V~ / 50–60 Hz / 620-380 mA Power Supply Narcotrend-Compact M - power supply Exchangeable mains plug system IEC (CEE 7/7), USA NEMA 5-15P (hospital grade)) Battery Type Lithium-Ion Battery operating time Approx. -
Page 43: Spare Parts And Article Numbers
(10 pouches à 25 pcs.) NC-0110 Narcotrend-Compact M - power supply Mains Cord for Narcotrend-Compact M - power supply (US, 1,8 m) plug: NEMA 5-15P (hospital-grade), 125 V, 10 A NC-0113 mains cord: SJT 3/C 18, AWG, 300 V, VW-1/FT2, 105 °C... -
Page 44: Emc-Guidance
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Narcotrend-Compact M is intended for use in the electromagnetic environment specified below. The customer or the user of the Narcotrend-Compact M should ensure that it is used in such an environment. Emissions test... - Page 45 Guidance and manufacturer’s declaration - electromagnetic immunity The Narcotrend-Compact M is intended for use in the electromagnetic environment specified below. The customer or the user of the Narcotrend-Compact M should assure that it is used in such an environment. Immunity test...
- Page 46 Guidance and manufacturer’s declaration - electromagnetic immunity The Narcotrend-Compact M is intended for use in the electromagnetic environment specified below. The customer or the user of the Narcotrend-Compact M should assure that it is used in such an environment. Immunity test...
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Page 47: List Of Figures
10 List of figures Fig. 1: EEG index, EEG stages und typical EEG patterns ........5 Fig. 2: Narcotrend-Compact M, front panel .............. 6 Fig. 3: Narcotrend-Compact M, rear panel ............... 7 Fig. 4: Electrode positions for disposable electrodes, 1-channel (PKM1) ....14 Fig.