Narcotrend Compact M User manual

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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•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.
It is the physician’s responsibility to make the diagnosis or to obtain
expert opinion on the results and to institute correct treatment if
indicated.
•Caution:
Federal law restricts this device to sale by or on the order of a
physician.
Contact:
Narcotrend-Service
Fuhrberger Strasse 4
30625 Hannover
Germany
Phone: [phone] / 201753
Fax: [phone] / 201754
eMail: [email protected]
Web: www.narcotrend.de

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Table of Contents
1 Introduction...........................................................................................................5
2 Equipment description..........................................................................................6
2.1 Operation ............................................................................................................7
2.2 Battery operation.................................................................................................7
2.3 USB port..............................................................................................................8
2.4 Bluetooth (IEEE 802.15.1)...................................................................................8
2.5 IntelliBridge connector (optional) .........................................................................9
2.6 RS232 connector.................................................................................................9
3 Safety instructions.............................................................................................. 10
4 Putting into operation......................................................................................... 12
4.1 Device setup......................................................................................................12
4.2 Device setup (IntelliBridge (optional))................................................................12
4.3 Applying the electrodes..................................................................................... 13
4.4 Start recording / Start screen.............................................................................15
4.5 Options / Start screen........................................................................................ 16
5 Recording screen................................................................................................ 17
5.1 Title line.............................................................................................................17
5.2 EEG ..................................................................................................................17
5.3 Stage / Index..................................................................................................... 18
5.4 Additional parameters........................................................................................19
5.4.1 EMG .............................................................................................................19
5.4.2 BSR.............................................................................................................. 19
5.4.3 STI................................................................................................................19
5.5 Diagrams...........................................................................................................19
5.5.1 Cerebrogram.................................................................................................20
5.5.2 Relative Band Activities / Power....................................................................20
5.5.3 Quantiles.......................................................................................................20
5.5.4 Power Spectrum ...........................................................................................21
5.5.5 DSA.............................................................................................................. 21
5.6 EEG analysis for children in the first year of life................................................. 22
5.7 Button bar..........................................................................................................23
5.8 Review mode.....................................................................................................24
5.9 Electrode settings..............................................................................................25
5.10 Marker............................................................................................................... 26
5.11 Options.............................................................................................................. 27
6 EEG and evaluations (RS232 / IntelliBridge connector)................................... 28
6.1 EEG ..................................................................................................................28
6.2 Narcotrend-Index NI..........................................................................................28
6.3 Additional parameters........................................................................................29
6.4 Electrode check.................................................................................................30
6.5 Error messages................................................................................................. 30
7 Analyse recording............................................................................................... 31
7.1 View..................................................................................................................33
7.2 Save..................................................................................................................35
7.3 Print...................................................................................................................35
7.4 Delete................................................................................................................ 35

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8 Cleaning, maintenance, repair............................................................................36
8.1 Care and cleaning..............................................................................................36
8.2 Recommended checks ......................................................................................37
8.3 Error messages .................................................................................................38
8.4 Battery...............................................................................................................40
8.4.1 Checking the battery......................................................................................40
8.4.2 Changing the battery.....................................................................................40
8.5 Disposal.............................................................................................................40
9 Technical data......................................................................................................41
9.1 Symbols.............................................................................................................41
9.2 Classification and technical data........................................................................42
9.3 Spare parts and article numbers........................................................................43
9.4 EMC-Guidance..................................................................................................44
10 List of figures.......................................................................................................47

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1 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.
Under the influence of narcotics/anesthetics, the EEG reveals very characteristic
changes. The EEG can therefore be used to assess the hypnotic status of the patient.
Based on a large number of parameters derived from the EEG, multivariate statistical
methods are used to carry out an automatic classification of the EEG on a scale ranging
from stage A (conscious) to stage F (very deep hypnosis). This division of stages is
refined by means of an EEG index (100 = conscious, 0 = very deep hypnosis).
Fig. 1: EEG index, EEG stages und typical EEG patterns
The automatic classifications in variation of time constitute the cerebrogram. This
cerebrogram provides the user with important information on the hypnotic status of the
patient in the course of the recording.
An impedance check is available in order to ensure good signal quality. During an on-
going recording, the program carries out automatic electrode tests at regular intervals.
In addition, extensive algorithms for automatic detection of artifacts have been
implemented in the program.
•The automatic assessment is not allowed to be the sole criterion of a
narcosis or sedation controlling function. With respect to the dosing of
narcotics and sedatives, the overall clinical findings must be taken into
account.

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2 Equipment description
The Narcotrend consists of the following components:
•Narcotrend-Compact M
•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.
Fig. 2: Narcotrend-Compact M, front panel
On/Off switch
Interface for
patient lead
Touchscreen

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Fig. 3: Narcotrend-Compact M, rear panel
2.1 Operation
The device is switched on by pressing the On/Off switch briefly.
The software is operated completely via the integrated touchscreen, i.e. all input
operations are made by touching the screen briefly.
•The touchscreen reacts very sensitively. Please don’t use sharp or
pointed objects like pens or pencils for operation.
To switch off the device use the button Q UIT 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.
The battery charging time is approx. 2 hours when the device is switched off and
approx. 8 hours when the device is switched on.
Battery box
4 holes to affix
Mounting clamp
(VESA 50)
USB Port
Connection for
Narcotrend-
Compact M –
Power Supply
RS232
connector
IntelliBridge
connector
(optional)
Space for
type plate

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2.3 USB port
The USB 2.0 interface is provided for data backup of EEG measurements and to store
PDF files on USB storage devices. In some cases, USB storage devices are not
detected. To resolve this problem it is recommended to use another USB storage
device.
USB flash drives can be connected.
•The USB port provides 500 mA at 5 V.
•The USB port is used to archive stored recordings on the connected
USB storage media.
2.4 Bluetooth (IEEE 802.15.1)
The integrated Bluetooth interface enables the transmission of EEG signals and
evaluated parameters to store or display the values on a Bluetooth-enabled external
device.
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.
For further information see the document: “NAT_InterfaceSpecification_2017-09-26”.
•This device contains
FCC ID: PVH0946
IC: 5325A-0946
•This device complies with Part 15 of the FCC Rules.
•Operation is subject to the following two conditions;
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including
interference that may cause undesired operation.
Bluetooth is a registered trademark of Bluetooth SIG, Inc.

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2.5 IntelliBridge connector (optional)
The integrated IntelliBridge connector enables the transmission of EEG signals and
evaluated parameters to preconfigured Philips-IntelliVue patient monitors of the series
MP40-90 / MX700 / MX800.
Name and driver version of the Philips EC10 module:
865115/101 IntelliBridge EC10 Module with OpenInterface driver.
The OpenInterface driver must be the revision A.2. The accurate name of the driver
is “ED101-A.2“.
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.
Pin allocation:
Pin Signal
2 RS232 TxD (Narcotrend-Compact M)
3 RS232 RxD (Narcotrend-Compact M)
5 RS232 Ground
For further information see the document: “NAT_InterfaceSpecification_2017-09-26”.
•Integrating the Narcotrend-Compact M into a network can lead to
previously unidentified risks for the patient. These risks should be
identified, analyzed, evaluated and controlled by the responsible
organization.
Changes to the network could introduce new risks that require
additional analysis.
Changes to the network include:
- changes in network configuration
- connection of additional items
- disconnection of items
- update of equipment
- upgrade of equipment
For all Interfaces:
•For evaluation purposes, primarily the data that is displayed by the
Narcotrend-Compact M shall be used.
•As data communication errors cannot be excluded, data on the external
device have to be checked with regard to plausibility.
•USB, RS232 and IntelliBridge are intended to be connected to medical
electrical equipment complying with IEC 60601-1 with SELV.
•The length of the data cable used may not exceed 3 m.

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3 Safety instructions
•Read this entire manual of operating instructions carefully before putting the
device into operation. Pay special attention to the marked instructions.
•This equipment is intended for use by healthcare professionals only.
•The automatic assessment is not allowed to be the sole criterion of a narcosis
or sedation controlling function. With respect to the dosing of narcotics and
sedatives, the overall clinical findings must be taken into account.
•Prior to each application, check the functional safety and proper condition of
the device. A damaged device must not be put into operation.
•For safe use, connect the Narcotrend-Compact M - power supply to a
protective earth conductor.
•Use only the power cords supplied by MT MonitorTechnik GmbH & Co. KG.
•For putting into operation use only the components that belong to the device.
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.
•All the consumables that are used (e.g. electrodes, preparation paste, etc.)
must comply with the equivalent safety requirements and/or harmonized
national standards.
•The use of a defibrillator is restricted. The electrodes must not be placed
between the defibrillator pads.
•Before putting the device into operation, check the connection cables for any
signs of damage. Damaged cables and plug-and-socket devices must be
replaced.
•Operating the device beyond the operation temperature range is not
permissible (see technical documentation). Do not cover the air vents.
•No liquids must be penetrating into the device. Whenever any liquid does
penetrate into the device, the device must not be put into operation again until
it has been properly checked by an expert.
•The device is not intended to be used in the presence of oxygen enriched
environments or flammable anesthetic mixtures.
•Whenever the device has been subjected to increased mechanical stress
(dropping, strong vibrations or severe impact), the device must not be put into
operation again until it has been properly checked by an expert.
•This device may cause radio interference or may disrupt the operation of
nearby equipment. It may be necessary to take mitigation measures such as
reorienting or relocating the equipment or shielding the location.
•The equipment needs special precautions regarding electromagnetic
compatibility and needs to be installed and put into service according to
information provided in accompanying documents.

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•Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
•Using accessories other than those specified may result in increased
electromagnetic emissions or decreased electromagnetic immunity of the
Narcotrend-Compact M.
•Portable and mobile radio frequency communication devices (incl. antennas)
can affect the equipment. There should be a distance of at least 30 cm (12
inches) to the Narcotrend-Compact M and its accessories.
•The equipment is not designed for use in MRI environment.
•In case of simultaneous use of the device together with other systems or
devices, the sum of all leakage currents is not allowed to exceed the
permissible values:
(in accordance with IEC 60601-1: 100 µA (AC) and 10µA (DC)).
•When using a high-frequency surgical device, care must be taken to ensure
that the EEG electrodes are correctly placed (refer to the section "Applying
the electrodes"). In order to reduce the risk of burns and irritation to the skin
during use, EEG electrodes may not be situated between the operation area
and the neutral electrode. It is also absolutely necessary to follow the use and
safety instructions included with the high-frequency surgical device. It is
forbidden to continue to operate the system if the neutral electrode is
defective.
•During the use of diathermy/high-frequency surgical devices, disturbances
may occur in the EEG signal or in automatic classification.
•Whenever the failure of the device or the limitation of the proper function of
the device becomes detectable, this is always a clear indication of a defect. In
such cases, further operation of the device is then no longer permissible. The
device must then be subjected to proper inspection by an expert.
•No assembly tasks must be carried out on the components of the device,
since trouble-free operation can no longer be guaranteed in such cases. It is
not allowed to open the device and to make any changes to the cables or
electrodes.
•The electrodes and the push button adapters may only be placed on the
patient’s head, because otherwise other patient’s applications could be
disturbed.
•The electrodes and the push buttons adapters must not come into contact
with electrically conductive parts and earth.
•At any time, it must be possible to separate the device from the mains supply
by disconnecting the mains plug. Consider this when placing the device.
•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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4 Putting into operation
4.1 Device setup
When setting up the device, please proceed as described below:
•Connect the Narcotrend-Compact M via its external power supply to a power
socket.
•Switch on the Narcotrend-Compact M.
•Place the electrodes on the patient's head (see below).
•Connect the patient lead to the input on the front side of the
Narcotrend-Compact M.
•(Optional) Connect the RS232 interface connector to the parent host device.
•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. A damaged device must not be put into operation.
•Do not block the ventilation inlet holes on the equipment’s rear panel.
•The touchscreen reacts very sensitively. Please don’t use sharp or pointed
objects like pens or pencils for operation.
4.2 Device setup (IntelliBridge (optional))
When setting up the device, please proceed as described below:
•Plug the Philips-IntelliBridge EC10 module in a free slot space of the Philips-
IntelliVue patient monitor.
•Connect the Narcotrend-Compact M to the connecting cable (CAT-5 cable) and the
Philips IntelliBridge EC10 module.
•Place the electrodes on the patient's head.
•Connect the patient lead to the Narcotrend-Compact M.
Once the Narcotrend-Compact M is connected to the Philips-IntelliVue patient monitor,
the data transfer begins including the EEG and the results of the automatic
classification.

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4.3 Applying the electrodes
As a standard procedure, the registration of the EEG is carried out with self-adhesive
disposable electrodes, which are placed on the forehead. They are known for their
simplified handling and long-lasting, firm fit. 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.
•Always follow the instructions of the electrode manufacturer as well.
•Electrodes made of different materials must not be used together.
•Avoid placing the electrodes over bone gaps, scars or skin lesions.
•Whenever electrodes are placed on oedematous skin areas, it is
important to note that the amplitudes can be lower here than over non-
oedematous areas.
•Make sure that there are no moisture bridges between the electrodes.
•Lay the patient lead so that it moves as little as possible during the
recording. Furthermore, the patient should not be lying on the
electrodes or on the patient lead since this can result in malfunctions
during the recording.
The electrodes should be placed on the hairless skin area of the scalp. They should be
positioned close to the hairline. In the region close to the eyes artifacts may occur,
especially in stages of light hypnosis.

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Fig. 4: Electrode positions for disposable electrodes, 1-channel (PKM1)
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.
Channel 2 (2a2b) is positioned on the side to be operated, or sick side.
1. Wipe the skin at the electrode positions with alcohol or an alcohol pad.
2. Apply a drop of preparation cream (0.5 – 1 ml) to a gauze swab. Use the swab
to treat the skin at the electrode positions carefully and thoroughly.
3. Rub the skin dry with a dry gauze swab.
4. Pull off the protective material from the electrode and then stick the electrode on
the skin. Avoid exerting pressure on the center of the electrode since this could
cause the electrode gel to be pressed under the adhesive ring, thus reduces the
electrode adhesion.
5. Connect the pushbutton adapters of the patient lead to the electrodes.
6. Seal the pouch with unused electrodes as airtight as possible.
•Spacing: at least 8 cm (3 in) between
1a and 1b (1-channel recording)
1a/2a and 1b, 1a/2a and 2b (2-channel recording)
•Electrode impedances: < 2 kΩ(max. 8 kΩ)
Ensure uniform impedance values to the extent possible.
* The
Ref
erence electrode
(R)
can be placed anywhere in the
forehead area.

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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.
The date of birth is entered by using the numeric keypad, as in the figure above.
You can also assign a name for the recording (e.g. patient name). Press the keyboard
symbol on the right-hand side next to the input line for Name. The input operation is
carried out via the displayed screen keyboard.
The button LAST RECORD accepts the date of birth and the name of the last record in the
corresponding input lines.
To start a recording the following requirements must be fulfilled
•patient lead is connected
•a valid date of birth has been entered
•the input line “Name” is not empty
•the internal battery is not empty
•there is enough free space on the memory card
Not fulfilled conditions are displayed below the input fields.
If all conditions are fulfilled, start the recording via the button S TART R ECORDING . The
“Recording screen” appears and from now on the data will be stored.
It is not possible to make a 1-channel-recording with a 2-channel-lead.
The button R EVIEW is used to show stored recordings (chapter 7).
The button Q UIT is used to switch off the device.
•The touchscreen reacts very sensitively. Please don’t use sharp or
pointed objects like pens or pencils for operation.

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4.5 Options / Start screen
On the Start screen, you can use the O PTIONS button to make global program settings.
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.
Max. Impedance: Shows the set warning / limit value of the permissible
impedance of an electrode.
Max. Impedance Difference: Shows the set warning / limit value of the permissible
impedance difference of the electrodes.
See also chapter 5.9, Electrode Check.
Date / Time
To change the time or date, change the corresponding values and confirm with the
A PPLY button.
Language
The language used for the device can be set by selecting the corresponding button.
Marker
Up to 20 different marker texts can be defined in order to access markers with the
predefined texts during the measurement.
Configuration
•User Preferences:
oIf the option "Show query for channel 1" is activated, the position of the
electrodes of channel 1 (left side of the head / right side of the head /
alternative position) is requested before the start of the measurement.
A corresponding marker is set at the beginning of the measurement.
•Service: Setup and maintenance menu for service technicians.
•Device Information: Displays device and version information.

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5 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):
•Name
•Date of birth and age in years/months
•Date and time
•Bluetooth / RS232-symbol (when function is switched on)
•Power supply symbol or battery symbol
In the title bar also system messages, such as information about the battery capacity
are displayed.
5.2 EEG
The EEG data currently coming from the patient are indicated in the raw EEG window.
In the case of a 2-channel recording, the top curve indicates Channel 1, and the bottom
curve indicates Channel 2.
Within the EEG window, information about artifacts and status messages are also
displayed.

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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
0
– B
1
– B
2
– C
0
– C
1
– C
2
– D
0
– D
1
– D
2
– E
0
– E
1
– E
2
– F
0
– F
1
Index: 100 0
Conscious Deepest hypnosis
Every stage from A to F
1
refers explicitly to a range of indices.
Stage Index
A 95 - 100
B
0
90 - 94
B
1
85 - 89
B
2
80 - 84
C0 75 - 79
C1 70 - 74
C2 65 - 69
D0 57 - 64
D1 47 - 56
D2 37 - 46
E0 27 - 36
E1 20 - 26
E2 13 - 19
F0 5 - 12
F1 0 - 4
•A/B classification: In the ICU version not provided
•The current assessment always refers to Channel 1.
•If the raw EEG is not classified, additional information, e.g. recognized
artifacts or atypical signal patterns were displayed. The information is
recorded in the course of time over the cerebrogram
(See the following overview).
Information Description
Start Recording was started successfully, evaluation is running
Impedance At least one impedance limit has been exceeded
Artifact The EEG signal is loaded with artifact interference
Atypical Atypical signal patterns
Sharp waves Occurrence of epilepsy-typical potentials
EMG EMG superposition of the EEG signal

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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).
5.4.2 BSR
BSR = burst suppression ratio
The burst suppression ratio quantifies the suppression percentage of a 60 s EEG
epoch. It is displayed on a scale from 0 (no suppression detected) to 100 (isoelectric
EEG).
5.4.3 STI
STI = sharp transient intensity
The STI detection shows in three stages the frequency and the intensity of sharply
contoured potentials within the last minute.
Artifacts may be involved in rare cases with the sharply contoured
potentials detected (e.g. cautery).
5.5 Diagrams
The diagrams being offered are displayed in this window. The diagram changing
operation is carried out via the button N EXT D IAGRAM .

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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.
The left axis shows the stages A - F with the corresponding sub-stages and the right
axis shows the index range 0 to 100.
In an ongoing recording, a white triangle at the upper margin of the cerebrogram
indicates the current time.
5.5.2 Relative Band Activities / Power
The percent activity proportions for the individual frequency bands and the absolute
power are displayed.
Fig. 9: Relative Band Activities / Power, 1-channel and 2-channel
5.5.3 Quantiles
This diagram shows the median (50% quantile) and the spectral edge frequency (95%
quantile).
Fig. 10: Quantiles, 1-channel and 2-channel