Ceribell EEG Recorder User manual

DC-00046, rev B
DCO-000107 Confidential and Proprietary
EEG Recorder
Operator Manual
Ceribell, Inc.
2483 Old Middlefield Way
Suite 120
Mountain View, CA 94043
www.ceribell.com
24 Hour Technical Support: 1-800-436-0826

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© Ceribell, Inc. 2017
This operator manual is copyrighted and may not be repro-
duced in any form without the written permission of Ceribell,
Inc.

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Table of Contents
Table of Contents
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Quick Start Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Step 1: Power On the Ceribell EEG Recorder. . . . . . . . .5
Step 2: Enter the Patient Information . . . . . . . . . . . . . .5
Step 3: Connect the Ceribell EEG Headband . . . . . . . . .8
Step 4: Listen to EEG Waveforms . . . . . . . . . . . . . . . . . .9
Step 5: Stop the EEG Recording . . . . . . . . . . . . . . . . . .10
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . 12
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . .12
System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Powering On and Off the Ceribell EEG Recorder. . . . .15
Ceribell EEG Recorder Software . . . . . . . . . . . . . . 16
Home Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Starting an EEG Recording . . . . . . . . . . . . . . . . . . . . . .16
Checking Electrode Connections . . . . . . . . . . . . . . . . .19
Stopping an EEG Recording . . . . . . . . . . . . . . . . . . . . .20
Adding Tags and Notes . . . . . . . . . . . . . . . . . . . . . . . . .21
Viewing EEG Waveforms . . . . . . . . . . . . . . . . . . . . . . .22
Listening to EEG Waveforms . . . . . . . . . . . . . . . . . . . .22
Transferring EEG Recording Files . . . . . . . . . . . . . . . . .23
Setting Date/Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Device Info . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Ceribell EEG Portal . . . . . . . . . . . . . . . . . . . . . . . . 28
Logging Into the Ceribell EEG Portal. . . . . . . . . . . . . . .28
Viewing EEG Recordings . . . . . . . . . . . . . . . . . . . . . . . .28
Logging Out of the Ceribell EEG Portal. . . . . . . . . . . . .33
System Information . . . . . . . . . . . . . . . . . . . . . . . 34
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . .34
WiFi Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Cybersecurity Precautions and Controls . . . . . . . . . . .35
Electromagnetic Compatibility (EMC) . . . . . . . . . . . . .36
System and Package Labels . . . . . . . . . . . . . . . . . . . . .40
Maintenance and Troubleshooting . . . . . . . . . . . 42
Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . .42
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

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Indications for Use
Indications for Use
The Ceribell EEG Recorder is intended to record and store EEG
signals and to present the EEG signals in visual and audible for-
mats in real time. The visual and audible signals assist trained
medical staff to make neurological diagnoses. The Ceribell EEG
Recorder does not provide any diagnostic conclusion about the
subject's condition and does not provide any automated alerts
of an adverse clinical event. The Ceribell EEG Recorder is
intended to be used in a professional healthcare facility envi-
ronment.
Caution: Federal (US) law restricts this device to sale by or on
the order of a physician.

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Warnings
Warnings
Warning: The Ceribell EEG Recorder is not defibrilla-
tion-proof. Remove the Ceribell EEG Recorder and all accesso-
ries from the patient prior to using a defibrillator.
Warning: The Ceribell EEG Recorder is MR Unsafe.
Remove the Ceribell EEG Recorder and all accessories from the
patient prior to entering an MRI (magnetic resonance imaging)
scanning room.
Warning: Only use the included power adapter and
micro-USB cable to charge the Ceribell EEG Recorder. Use of
other charging devices is not authorized.
Warning: All EEG acquisition functions are automati-
cally disabled when the Ceribell EEG Recorder is plugged into
an external power supply or computer. EEG measurements
and recordings cannot be taken while the Ceribell EEG
Recorder is charging or connected to a computer.
Warning: The Ceribell EEG Recorder does not contain
any user-serviceable parts. Contact Ceribell if your device
requires service. Do not attempt to open or disassemble the
Ceribell EEG Recorder.

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Quick Start Guide
Quick Start Guide
This section outlines how to quickly power on the device and
start and stop an EEG recording. Refer to the Table of Contents
and the rest of the operator manual for additional information.
Step 1: Power On the Ceribell EEG Recorder
Press the power button to turn on the Ceribell EEG Recorder. A
blue LED on the side of the touchscreen will illuminate and the
Home Screen will appear.
Figure 1: Ceribell EEG Recorder
Step 2: Enter the Patient Information
A. Press the RECORD button on the Home Screen to go to the
Patient Info entry pages.
Figure 2: Home Screen
Power LED Power button

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Quick Start Guide
B. Enter the Patient ID and press the ENTER button to con-
tinue to the next entry page.
Figure 3: Patient Info: ID Entry Page
C. Enter the Patient First Name and press the ENTER button to
continue to the next entry page.
Figure 4: Patient Info: First Name Entry Page

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Quick Start Guide
D. Enter the Patient Last Name and press the ENTER button to
continue to the next entry page.
Figure 5: Patient Info: Last Name Entry Page
E. Enter the Patient Date of Birth (DOB) and press the ENTER
button to continue to the next entry page.
Figure 6: Patient Info: DOB Entry Page

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Quick Start Guide
F. Enter the Patient Callback Info or Patient Note and press
the ENTER button to continue to the Confirm Patient Info
page. This field is optional.
Figure 7: Patient Info: Note Entry Page
G. Verify that the entered patient information is correct and
press the CONFIRM button to continue.
Figure 8: Confirm Patient Info Page
Note: If any incorrect patient information has been entered,
press the EDIT button to edit the incorrect information.
Step 3: Connect the Ceribell EEG Headband
A. Plug the Ceribell EEG Headband into the connector labeled
“Headband” on the side of the Ceribell EEG Recorder.

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Quick Start Guide
B. Set up the headband, and adjust the electrodes until a
green indication is shown for each electrode on the Check
Electrode Connections page.
C. Press the RECORD button to begin recording.
Figure 9: Check Electrode Connections Page
Note: The Check Electrode Connections page shows the status
of each electrode. A red indication means that the electrode
connection is poor, which will result in noisy EEG signals. A
green indication means that the electrode connection is good.
A yellow indication means that the electrode connection is
acceptable. Try to ensure that all the electrodes are shown as
green prior to starting a recording.
Step 4: Listen to EEG Waveforms
A. Press the SOUND button on the Home Screen or the Brain
Stethoscope button next to the speaker to go to the Sound
page.
Figure 10: Home Screen

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Quick Start Guide
Figure 11: Ceribell EEG Recorder
B. Press the L or R button on the Sound page to switch
between the left and right hemispheres.
Figure 12: Sound Page
Note: When listening to the left hemisphere, electrode channel
3-4 is used. When listening to the right hemisphere, electrode
channel 8-9 is used. To adjust the volume, press the volume up
and down buttons located next to the power button.
Step 5: Stop the EEG Recording
A. Press the RECORD button on the Home Screen to go to the
Record page, and press the STOP RECORDING button to
stop recording.
Brain Stethoscope
button

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Quick Start Guide
Figure 13: Record Page
B. The patient can be disconnected once the Recording Com-
plete page displays.
Figure 14: Recording Complete Page
Note: It may take a few moments for the recording data to be
saved; however, the patient can still be disconnected.

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System Overview
System Overview
The Ceribell EEG Recorder is a portable 8-channel EEG moni-
toring system. 10 patient electrodes (5 left, 5 right) are
required to form the 8 channels. The Ceribell EEG Recorder can
be used with any EEG electrodes. Channels 1-5 should be used
for the patient’s left hemisphere, with channel 1 at the front of
the patient’s head and channel 5 at the back of the patient’s
head. Channels 6-10 should be used for the patient’s right
hemisphere, with channel 6 at the front of the patient’s head
and channel 10 at the back of the patient’s head. Contact Ceri-
bell for technical specifications of the connector used to con-
nect electrodes to the Ceribell EEG Recorder.
When connected to patient electrodes, the Ceribell EEG
Recorder can be used to view or listen to EEG signals in real
time. When viewing EEG signals, the operator can select
between viewing all 8 channels simultaneously or viewing only
one channel at a time. The operator can listen to EEG signals by
using the Brain Stethoscope function. Either the left or the
right hemisphere can be listened to.
The Ceribell EEG Recorder can be used to record EEG sessions.
Recorded sessions can later be reviewed on a computer using
the Ceribell EEG Portal. EEG recording files are transferred
from the Ceribell EEG Recorder to the computer using either a
micro-USB cable or wirelessly using a WiFi connection.
System Components
• Ceribell EEG Recorder (Ceribell part number C100): porta-
ble, battery-powered, 8-channel EEG monitoring system.
• Power adapter (Ceribell part number SA-00003): 100-240 V
ac power adapter used to charge the Ceribell EEG Recorder.
Only use the included power adapter to charge the Ceribell
EEG Recorder.
• Micro-USB cable (Ceribell part number EC-00095): cable
used to connect the Ceribell EEG Recorder to the power
adapter for charging and to a computer for transferring EEG
recording files. Only use the included micro-USB cable to
connect the Ceribell EEG Recorder to the power adapter or
a computer. When the Ceribell EEG Recorder is connected
to the power adapter or a computer, all EEG acquisition
functions are automatically disabled.
• Ceribell EEG Portal (Ceribell part number SW-00001): portal
used to view EEG recordings on a computer. The Ceribell
EEG Portal can only be used to view EEG recordings from
the Ceribell EEG Recorder.

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System Overview
System Description
The Ceribell EEG Recorder has a 4-inch touchscreen display as
its primary interface. The Ceribell EEG Recorder also has a
power button, a Brain Stethoscope button, and volume up and
down buttons. The power button turns the device on and off.
When the device is on, the power button also toggles the dis-
play on and off. The Brain Stethoscope button turns the Brain
Stethoscope function on and off, and the volume up and down
buttons control the volume of the EEG waveform sound.
Figure 15: Ceribell EEG Recorder
On the left side of the device is a blue LED that illuminates
whenever the device is powered on. On the right side of the
device are headband and micro-USB connectors. The EEG elec-
trode headband plugs into the headband connector. The
micro-USB cable plugs into the micro-USB connector for
charging the device and transferring EEG recording files.
Charging the Battery
To charge the battery, connect the Ceribell EEG Recorder to an
external power supply using the micro-USB cable and power
adapter. When the Ceribell EEG Recorder is plugged into a
power source and powered on, the device will indicate that it
is charging and EEG acquisition features have been disabled.
Power LED
Volume up/down buttons
Power button
Headband and micro-USB
connectors
Touchscreen Speaker Brain Stethoscope
button

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System Overview
Figure 16: Device Charging Page
You can check the battery status by unplugging the Ceribell
EEG Recorder, turning it on, and looking at the battery status
icon in the status bar. When 20% of the battery is remaining, a
Low Battery Warning page will appear.
Figure 17: Low Battery Warning Page
Warning: Only use the included power adapter or
micro-USB cable to charge the Ceribell EEG Recorder. Use of
other charging devices is not authorized.
Warning: All EEG acquisition functions are automati-
cally disabled when the Ceribell EEG Recorder is plugged into
an external power supply or computer. EEG measurements
and recordings cannot be taken while the Ceribell EEG
Recorder is charging or connected to a computer.

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System Overview
Powering On and Off the Ceribell EEG Recorder
To turn on the Ceribell EEG Recorder, press the power button.
To turn off the Ceribell EEG Recorder, press the power button
and hold for 3 seconds. A message will appear on the touch-
screen display to confirm that you would like to power off the
device. Press the Power Off button on the display, and the sys-
tem will power off.
Figure 18: Power Off Confirmation Page
Note: When the device is on, pressing the power button toggles
the touchscreen display on and off.
When no battery is remaining, the Ceribell EEG Recorder will
automatically save an in-progress recording before powering
off.
Figure 19: Powering Off Page

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Ceribell EEG Recorder Software
Ceribell EEG Recorder Software
Home Screen
The Home Screen provides access to entering patient informa-
tion; starting a recording; listening to and displaying EEG sig-
nals; monitoring electrode connection status, WiFi status, and
battery level; and adjusting system settings. The blue “Home”
button provides easy access to the Home Screen from any sys-
tem page. Similarly, the orange “Tag Event” button provides
quick access to tag an event during recording from any system
page.
Figure 20: Home Screen
Starting an EEG Recording
Before starting an EEG recording using the Ceribell EEG
Recorder, you must first enter the patient information. Press
the RECORD button on the Home Screen to go to the Patient
Info entry pages.
On each Patient Info entry page, enter the requested patient
information (Patient ID, Patient First Name, Patient Last Name,
etc.), and press the ENTER button to continue to the next entry
page.
Home
button
Tag Event
button

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Figure 21: Sample Patient Info Entry Page
After entering all the requested patient information, press the
ENTER button on the final Patient Info entry page to continue
to the Confirm Patient Info page.
Figure 22: Confirm Patient Info Page
Verify that the entered patient information is correct. If any
incorrect patient information has been entered, press the EDIT
button to edit the incorrect information.
After verifying the patient information, press the CONFIRM
button to continue to the Check Electrode Connections
page.The Check Electrode Connections page shows the status
of each electrode. A red indication means that the electrode
connection is poor, which will result in noisy EEG signals. A
green indication means that the electrode connection is good.
A yellow indication means that the electrode connection is
Return to previous
Patient Info entry page
Continue to next
Patient Info entry page

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acceptable. Try to ensure that all the electrodes are shown as
green prior to starting a recording.
Ensure that all the electrodes are shown as green prior to
starting a recording.
Figure 23: Check Electrode Connections Page
Note: If an electrode headband is not connected, a message
will appear prompting you to connect a headband.
Figure 24: Electrode Headband Disconnected Page
Individual electrodes can be skipped and left red, if desired.
However, a warning page will appear to confirm that some
electrodes are to be skipped and left red during recording.
Press the CONTINUE WITHOUT FIXING button to continue
begin recording or press the CHECK ELECTRODES button to go
back to the Check Electrode Connections page and adjust the
electrodes that are shown in red.

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Figure 25: Check Electrode Connections Warning Page
Note: When listening to the left hemisphere, electrode channel
3-4 is used. When listening to the right hemisphere, electrode
channel 8-9 is used. Continuing without fixing these electrode
channels will affect the Brain Stethoscope function sound qual-
ity.
Checking Electrode Connections
To check the quality of the electrode connections during,
before, or after a recording, press the ELECTRODES button on
the Home Screen to go to the Electrodes page.
Note: During EEG recordings, electrode connection quality is
checked and updated once every minute.
Figure 26: Electrodes Page
If a poor electrode connection is detected, a warning page will
appear on the screen. Press the PAUSE RECORDING AND
CHECK ELECTRODES button to go to the Check Electrodes page
and adjust the electrodes that are shown in red, or press the
BACK button to continue without adjusting any electrodes.
Note: If the display screen is powered off, the display screen
will power on to display this page.