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