Summary of Contents for Ceribell EEG Recorder
- Page 1 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 DC-00046, rev B DCO-000107 Confidential and Proprietary...
- Page 2 © Ceribell, Inc. 2017 This operator manual is copyrighted and may not be repro- duced in any form without the written permission of Ceribell, Inc. DC-00046, rev B DCO-000107 Confidential and Proprietary...
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Page 3: Table Of Contents
Device Info ........26 Ceribell EEG Portal ......28 Logging Into the Ceribell EEG Portal. -
Page 4: Indications For Use
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. -
Page 5: Warnings
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. -
Page 6: Quick Start Guide
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. - Page 7 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.
- Page 8 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.
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Page 9: Step 3: Connect The Ceribell Eeg Headband
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. DC-00046, rev B... -
Page 10: Step 4: Listen To Eeg Waveforms
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. -
Page 11: Step 5: Stop The Eeg Recording
Quick Start Guide Brain Stethoscope button 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. - Page 12 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. DC-00046, rev B DCO-000107 Confidential and Proprietary...
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Page 13: 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... -
Page 14: System Description
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. - Page 15 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.
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Page 16: Powering On And Off The Ceribell Eeg Recorder
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. -
Page 17: Ceribell Eeg Recorder Software
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. - Page 18 Ceribell EEG Recorder Software Return to previous Patient Info entry page Continue to next Patient Info entry page 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.
- Page 19 Ceribell EEG Recorder Software 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.
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Page 20: Checking Electrode Connections
Ceribell EEG Recorder Software 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. -
Page 21: Stopping An Eeg Recording
Ceribell EEG Recorder Software Figure 27: Check Electrode Connections Warning Page Once an electrode connection has been fixed, press the RESUME RECORDING button to resume the recording. Note: The EEG recording is paused while this page is open. Figure 28: Fix Electrode Connections Page... -
Page 22: Adding Tags And Notes
Ceribell EEG Recorder Software Figure 29: Record Page After stopping the EEG recording, the Recording Complete page displays. Press the DONE button to finish the recording and proceed to the Home screen. Note: It may take a few moments for the recording data to be saved;... -
Page 23: Viewing Eeg Waveforms
Ceribell EEG Recorder Software Figure 31: Tag Event Page Select the appropriate Event Tag, and press the DONE button. If Other: Enter Note was selected, enter the desired note, and press the ENTER button. Viewing EEG Waveforms EEG waveforms can be viewed at any time, both when a recording is in progress and when a recording is not in prog- ress. -
Page 24: Transferring Eeg Recording Files
EEG waveforms per standard procedures. To visually review the EEG waveforms, use the Ceribell EEG Recorder to display the signals in real-time or use the Ceribell EEG Portal to review the signals after a recording has been completed. - Page 25 Ceribell EEG Recorder Software nized as a USB storage device, and the EEG recording files can be copied to the computer. A warning page will appear when less than 2 hours of recording time memory is remaining. Figure 35: Low Memory Warning Page EEG recording files can also be transferred using a wireless (WiFi) connection.
- Page 26 Ceribell EEG Recorder Software Figure 37: WiFi Setup Entry Page Press the Enabled button to go to the Settings: Input Network Name entry page. If WiFi is already enabled and you would like to change the WiFi network, press the Change Network button to go to the Settings: Input Network Name entry page.
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Page 27: Setting Date/Time
Ceribell EEG Recorder Software Figure 39: WiFi Upload Warning Page Setting Date/Time To set the date and time, press the SETTINGS button on the Home Screen to go to the Settings page. Figure 40: Settings Page From the Settings page, press the Date/Time button to go to the Date/Time entry page. - Page 28 Ceribell EEG Recorder Software Figure 41: Device Info Page DC-00046, rev B DCO-000107 Confidential and Proprietary...
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Page 29: Ceribell Eeg Portal
Ceribell EEG Recorder. The Ceribell EEG Portal is only compatible with EEG recordings made with the Ceribell EEG Recorder. The portal cannot be used to view EEG recordings made with other EEG devices. The Ceribell EEG Portal uses a web browser interface. The com-... - Page 30 Ceribell EEG Portal Figure 43: Ceribell EEG Portal - Patient List Page Click the VIEW EEG button to the right of the desired EEG recording to go to the EEG Scan page. The EEG Scan page dis- plays the 8 channels of EEG waveform data recorded from the Ceribell EEG Recorder.
- Page 31 Ceribell EEG Portal Figure 45: EEG Scan Page - Horizontal Scale Options Select the vertical scale using the “Scale” dropdown menu. Various scale options between 25 V and 500 V can be selected. Figure 46: EEG Scan Page - Vertical Scale Options If desired, select a high pass filter using the “High Pass”...
- Page 32 Ceribell EEG Portal Figure 48: EEG Scan Page - Low Pass Filter Options If desired, enable or disable the 60 Hz notch filter using the “Notch” button. Figure 49: EEG Scan Page - “Notch” Button Navigation Options To navigate the EEG recording, use the recording navigation buttons.
- Page 33 Ceribell EEG Portal Figure 50: EEG Scan Page - ANNOTATIONS Button To indicate that the recording has been reviewed, click the MARK AS REVIEWED button. The button changes to ALREADY REVIEWED, and the status on the Patient List page changes from “Needs Review”...
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Page 34: Logging Out Of The Ceribell Eeg Portal
Figure 54: EEG Scan Page - Sample Report Logging Out of the Ceribell EEG Portal To log out of the Ceribell EEG Portal, click the physician name in the upper right corner of the screen, and then click the Log Out button. -
Page 35: System Information
C to 50 Humidity ° Up to 75% relative humidity at 50 (non-condensing) EEG Electrodes EEG electrodes that are used with the Ceribell EEG Recorder should have cable length less than 2 m. DC-00046, rev B Confidential and Proprietary DCO-000107... -
Page 36: Wifi Connection
IEEE 802.11 b/g compatible, and the network must support WiFi Protected Access (WPA/WPA2) security. The use of the WiFi functionality of the Ceribell EEG Recorder does not present any hazards to the system operator or patient. The WiFi connection only allows data to be transferred from the Ceribell EEG Recorder to a computer;... -
Page 37: Electromagnetic Compatibility (Emc)
Electromagnetic Emissions The Ceribell EEG Recorder is intended for use in the electromagnetic environ- ment specified below. The customer or the user of the Ceribell EEG Recorder should assure that it is used in such an environment. Electromagnetic Environment -... - Page 38 Table 3: Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Ceribell EEG Recorder is intended for use in the electromagnetic environ- ment specified below. The customer or the user of the Ceribell EEG Recorder should assure that it is used in such an environment. Electromagnetic...
- Page 39 Table 4: Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Ceribell EEG Recorder is intended for use in the electromagnetic environ- ment specified below. The customer or the user of the Ceribell EEG Recorder should assure that it is used in such an environment. Immunity...
- Page 40 Portable and Mobile RF Communications Equipment and the Ceribell EEG Recorder The Ceribell EEG Recorder is intended for use in an electromagnetic environ- ment in which radiated RF disturbances are controlled. The customer or the user of the Ceribell EEG Recorder can help prevent electromagnetic interfer-...
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Page 41: System And Package Labels
System Information System and Package Labels Table 6: System Labels System label located on back side of device The 2D barcode, GTIN number, and serial number together comprise the Unique Device Identifier for the device. Symbols: Device emits non-ionizing radio frequency signals Type BF applied part Follow instruction manual... - Page 42 System Information Table 6: System Labels Package label located on outside of device packaging The 2D barcode, GTIN number, and serial number together comprise the Unique Device Identifier for the device. Symbols: Manufacturer Part Number Storage Conditions Follow instruction manual Non-sterile Device Rx only: Federal (US) law restricts this device to sale by or on the order of a...
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Page 43: Maintenance And Troubleshooting
The Ceribell EEG Recorder may be cleaned by wiping with a damp soft cloth. Standard hospital disinfectants and cleaning products, including Sani-Cloths, may be used. Allow the device to dry before using. - Page 44 Maintenance and Troubleshooting The following error and warning messages may be encoun- tered when using the Ceribell EEG Recorder. Table 7: Troubleshooting Guide Error or Warning Message Suggested Action The device should be plugged in and charged Low Battery as soon as possible.
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Page 45: Dc-00046, Rev B Confidential And Proprietary Dco
DC-00046, rev B Confidential and Proprietary DCO-000107...