Brain Sentinel SPC15 Brain Sentinel GTC Seizure Detection and Warning System User Manual

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Document ID	2944347
Application ID	GtXmpNppyzuCUUT1vVv2TA==
Document Description	Users Manual
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Permanent Confidential	No
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Document Type	User Manual
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Filesize	192.01kB (2400066 bits)
Date Submitted	2016-03-29 00:00:00
Date Available	2016-09-24 00:00:00
Creation Date	2016-02-25 17:41:33
Document Lastmod	2016-02-25 17:41:33
Document Title	Users Manual
Document Author:	Jeffrey Jung

Generalized Tonic-Clonic Seizure Detection and
Warning System
User’s Manual
Be Heard
Copyright Brain Sentinel, Inc. 2015. All Rights Reserved.
24-Hour Customer and Technical Support Available 1-855-275-5424
Disclaimer Statements
This User Manual must be read before installing or operating the SPEAC® System, Brain
Sentinel®’s Generalized Tonic-Clonic Seizure Detection and Warning System. The purpose of
this manual is to communicate information required for the operation of the SPEAC® System.
The information presented in this document is recommended for use by the prescribing
physician, patient, patient’s family, and the patient’s caregiver(s).
All patients, caregivers and service personnel should read and thoroughly understand the
contents of this manual and the importance of the warnings, precautions and the operation of
the SPEAC® System by Brain Sentinel® as outlined in this document.
If you do not understand the warnings, precautions, and operational requirements of this
System, do not use the SPEAC® System until you have spoken with your physician and
understand such information. If you do not understand this manual, discuss the medical issues
with your physician, or discuss the technical product issues with Brain Sentinel®. This System is
not a substitute for adequate patient supervision or medication. Please ensure that a trained
caregiver is present to provide assistance when the system alarms
Copyright Brain Sentinel, Inc. 2015. All Rights Reserved.
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Table of Contents
1. SPEAC® System Indications for Use and Warnings ................................................................... 4
2. The SPEAC® System Overview ...................................................................................................... 10
3. Installing the SPEAC® System ....................................................................................................... 17
4.
Using the SPEAC® System .......................................................................................................... 26
5. Discontinuing Monitoring and Returning the SPEAC® System............................................. 51
6. About Brain Sentinel, Inc. ............................................................................................................... 52
7. Glossary of Terms ............................................................................................................................. 53
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1. SPEAC® System Indications for Use and Warnings
1.1 SPEAC® System Indications for Use
The SPEAC® System by Brain Sentinel® is an ambulatory system designed to monitor and analyze
surface electromyography (sEMG) data to detect generalized tonic-clonic (GTC) seizures and to provide a
warning signal to alert caregivers within 30 seconds of onset that a seizure is occurring. The system
records and stores sEMG data for subsequent review by a trained healthcare professional.
The SPEAC® System by Brain Sentinel® is intended for use in patients who have an arm circumference of
at least 16 cm at the biceps. It may be used in the home or healthcare facilities for monitoring during the
day, night, or for continuous monitoring.
1.2 Warnings for the SPEAC® System
Precautions and special care must be taken when using the SPEAC ® System. Here is a list of specific
product warnings that the user must keep in mind for the proper use and functioning of the System.
1.2.1 Ensure Proper Placement of the SPEAC® Detection Device
Proper placement of the SPEAC® Detection Device is directly centered over the bulge of the biceps
muscle. This placements is essential to ensure the user is properly monitored and in order to receive
seizure alarms. Specific instructions for proper placement can be found in Section 4 of this User Manual
and on the Setup Wizard Video on the SPEAC® Laptop Base Station.
1.2.2 Never Attach Unauthorized Connections and/or Equipment to Any Part of the
SPEAC® System
Only authorized equipment sent to you by Brain Sentinel® should be used with the SPEAC® System.
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Connecting the USB connector on the SPEAC® Detection Device to equipment not authorized by
Brain Sentinel® may result in unacceptable hazards to the operator or may damage the Detection
Device, as well as, the unauthorized equipment.
Connecting the SPEAC® Laptop Base Station to an AC Adapter that is not supplied by Brain
Sentinel® may result in unacceptable hazards to the operator, and may damage the SPEAC®
Laptop Base Station and the unauthorized equipment.
Before the SPEAC® Detection Device is connected to the SPEAC® Laptop Base Station for
charging or configuration,
1. Ensure there is no unauthorized equipment connected to the SPEAC® Laptop Base Station.
Review Section 3 for installation requirements.
2. Ensure the AC Adapter is connected to both the SPEAC® Laptop Base Station and the wall
outlet (SUPPLY MAINS).
Connecting unauthorized equipment to the spare IO ports on the SPEAC® Base Station, can
result in unacceptable hazards to the operator, and can damage the SPEAC ® Detection Device
and the unauthorized equipment.
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1.2.3 Never Connect Any Part of the SPEAC® System to Equipment That Is Not Part of the
SPEAC® System
Connecting the USB connector on the SPEAC® Detection Device to equipment not authorized by Brain
Sentinel® may result in unacceptable hazards to the operator, and may damage the SPEAC® Detection
Device and the unauthorized equipment.
Connecting the CradlePoint Wireless Router to an AC Power Adapter that is not authorized by Brain
Sentinel® may result in unacceptable hazards to the operator, and may damage the SPEAC® Laptop
Base Station and the unauthorized equipment. Use only the AC power adapter provided.
The CradlePoint Wireless Router has an ON/OFF switch. It can be turned on/off by this switch. Isolation
of the router from the wall outlet (SUPPLY MAINS) can be safely done by disconnecting the detachable
power inlet cord from the router.
1.2.4 Ensure Uninterrupted System Connections
In order to ensure continuous monitoring, there are three critical connections within the SPEAC® System
that should never be interrupted:
1. Power supply from the wall to the SPEAC® Laptop Base Station
2. Wi-Fi connection between the SPEAC® Detection Devices and the SPEAC® Laptop Base Station
A continuous power supply to the SPEAC® Laptop Base Station helps ensure that the patient is being
continuously monitored for seizure activity.
A continuous Wi-Fi connection between the SPEAC® Detection Device and the SPEAC® Laptop Base
Station helps ensure that the patient is being continuously monitored for GTC seizure activity. If the
patient leaves the Wi-Fi zone, the SPEAC® Laptop Base Station will alarm and the monitoring is
interrupted.
As part of the initial installation of the SPEAC® System in the home, you should test the boundaries of the
Wi-Fi connection between the SPEAC® Detection Device and the SPEAC® Laptop Base Station. See
Section 4.3 of this User Manual for further details about checking the Wi-Fi limits in your home or facility.
3. Connection to the internet via the CradlePoint Access Point/Wireless Router
Internet functionality is represented by the “Web Interface” tile on the SPEAC ® Laptop Base Station
screen. If you are without remote alarms you may need to take additional measures to ensure safety in
case a seizure occurs.
Remote alarms may only be issued when the network is connected to the internet. When not connected
to the internet, the system will alarm those within audible or visual range of the system. The SPEAC®
Detection Device and the SPEAC® Laptop Base Station will still alarm should a seizure occur.
Whether or not the SPEAC® System is connected to the internet, the SPEAC® System is not a substitute
for adequate patient supervision or medication. Please ensure a competent, responsible, trained
caregiver is present to provide assistance to the patient when the SPEAC® System alarms.
1.2.5 Maintain the Charge of the SPEAC® Detection Device batteries
Maintaining the SPEAC® Detection Device batteries charged at all times is critical for their ongoing proper
performance. Like most rechargeable batteries, the SPEAC® Detection Device battery should be charged
at least once every 4-6 weeks or kept at 50% charged when not being used. Fully charged batteries
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discharge when they are left unused and will lose effectiveness if they are left fully discharged for longer
than four (4) weeks. Maintaining their charge will prolong the life of the batteries.
1.2.6 Properly Apply SPEAC® System Parts to the Biceps:
When properly placed, the SPEAC® System monitors the patient for generalized tonic-clonic
seizures. There are three components of the SPEAC® System that are directly or indirectly
applied to the biceps. These parts are the electrode patch, the SPEAC® Detection Device and the
SPEAC® Arm Strap. See Figure 1A, Section 4 of this User Manual and the Wizard Video on the SPEAC®
Laptop Base Station for additional help for proper placement.
Figure 1A. Applied Parts Include: SPEAC® Arm Strap, SPEAC® Detection Device and Electrode Patch
Figure 1B.
Electrode
Sockets
Electrode Patch: A reliable electrical connection between the SPEAC® Detection Device
and the electrode patch is necessary to achieve a good surface EMG (sEMG) signal for
analysis by the SPEAC® Detection Device. The electrode patch snaps into the electrode
sockets on the back of the SPEAC® Detection Device (See Figure 1B). The SPEAC®
Detection Device comes into direct physical contact with the patient’s skin through the
electrode patch on top of the biceps muscle. It is important that the electrodes on the
electrode patch make physical contact with the patient’s skin over this part – AND ONLY
THIS PART – of the biceps.
Be gentle when applying and removing the electrode patch from the biceps. . Gently
remove the electrode patch by slowly pealing it from the outside edge. A small amount of
water may be used to dilute the electrode adhesive. Skin irritation may occur due to prolonged exposure
to the electrode patch, or from frequent electrode patch changes. Never apply the electrode patch to open
or irritated skin.
Grounding: The SPEAC® Detection Device enclosure is marked with the internationally accepted symbol
for a Type BF Applied Part indicating that all of the applied parts are electrically isolated from ground in
order to help avoid electrical shock and harmful leakage currents.
SPEAC® Arm Strap: The SPEAC® Arm Strap should only be placed on the arm, and is designed to
gently support the SPEAC® Detection Device. It should be gently strapped to the arm, allowing space for
two fingers to loosely fit between the SPEAC® Arm Strap and the skin. Should discoloration or swelling of
the hand occur, or other injury, immediately discontinue use and seek medical attention.
Never place the SPEAC® Arm Strap around the neck. Keep the arm strap away from infants and children
when not in use to avoid the risk of strangulation.
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1.2.7 Avoid Liquid, Moisture and Submersion in Water
While the SPEAC® Detection Device exterior plastic casing was designed to be used in the shower, liquid
may damage the electronics inside the SPEAC® Detection Device. Prevent liquids from being spilled into
the SPEAC® Detection Device via the USB port, please contact Brain Sentinel® for a replacement.
The SPEAC® Detection Device is never to be submerged in water, e.g., bath tub, swimming pool, or
kitchen sink, etc. The detection device cannot monitor for Generalized Tonic-Clonic Seizures while
submerged. If you should have any questions regarding whether the SPEAC® Detection Device has been
compromised, contact Brain Sentinel®.
Finally, take care not to spill liquid on the SPEAC® Laptop Base Station. Doing so may damage its
internal electronics rending the entire system unusable.
1.2.8 Avoid Use in a Magnetic Resonance Imaging (MRI) System
The SPEAC® System is not safe for use with an MRI. Do not allow any part of the
SPEAC® System in or near an MRI system.
1.2.9 Use of Radio Frequency (RF) Energy
The SPEAC® System contains a transmitter and receiver of RF energy through an antenna
located on the interior of the Detection Device below the status LEDs.
For more information about the research related to RF energy exposure, see the FCC’s Radio Frequency
Exposure page at www.fcc.gov/oet/safety
1.2.9 Radio Frequency (RF) Energy Interference
Radio frequency emissions from other electronic equipment can negatively affect the operation of the
other electronic equipment and potentially cause them to malfunction. The SPEAC ® System is designed,
tested, and manufactured to comply with regulations governing radio frequency emissions. There is no
known electronic equipment with which the SPEAC® System interferes. However, if the wireless
transmitters and/or other electrical circuits in the SPEAC® System are suspected of causing interference
in other electronic equipment, take the following precautions:
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Relocate the SPEAC® Detection Device that is experiencing the interference.
Increase the distance between the SPEAC® Laptop Base Station and/or Wi-Fi Hotspot and the
equipment experiencing the interference.
Connect the SPEAC® Laptop Base Station and/or Wi-Fi Hotspot to a wall outlet (SUPPLY
MAINS) on a circuit different from that to which the equipment experiencing the interference is
connected.
Always beware of locations that restrict the use of RF devices.
1.2.10 FCC Compliance
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.
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IMPORTANT! Changes or modifications not expressly approved by Brain Sentinel, Inc. could void the
user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or television reception,
which can be determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
—Consult the dealer or an experienced radio/TV technician for help.
1.2.11 IC Compliance
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject
to the following two conditions: (1) this device may not cause interference, and (2) this device
must accept any interference, including interference that may cause undesired operation of the
device.
CAN ICES-3 (B)/NMB-3(B)
This equipment complies with radiation exposure limits set forth for uncontrolled environment.
Français
Cet appareil est conforme avec Industrie Canada, exempts de licence RSS ou
les normes. Opération est soumise aux deux conditions suivantes:
(1) cet appareil ne doit pas causer desinterférences et
(2) cet appareil doit accepter toute interférence reçue, y
compris les interférences pouvantentraîner un fonctionnement non désiré de la
appareil.
Cet équipement est conforme aux limites d'exposition
aux radiations établiespour environnement non contrôlé.
1.2.12 Do Not Make Modifications to Any Part of the SPEAC® System
No modification of this System is allowed, unless performed by authorized Brain Sentinel® personnel.
Unauthorized modification of the equipment may result in hazards to the end user. If this equipment is
modified (by authorized personnel), appropriate inspection and testing will be conducted to ensure the
appropriate use of the equipment.
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The SPEAC® Laptop Base Station is optimized for the functions performed by the SPEAC ® System. Do
not install applications, uninstall applications, or alter the configuration or environmental variables of this
laptop computer unless instructed by Brain Sentinel® personnel or the accompanying documents.
1.2.13 Disposal and Return of the SPEAC® System
The SPEAC® System components contain Lithium-Ion Polymer batteries and other
electronics components, and must not be disposed of with other household waste. When
the SPEAC® System has reached the end of its life, please return it to Brain Sentinel® for
proper disposal. See Section 5 of this User Manual for additional details on how to return
the System to Brain Sentinel®.
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24-Hour Customer and Technical Support Available 1-855-275-5424
2. The SPEAC® System Overview
Figure 2A. The Sensing, Portable, EMG, Analysis and Characterization - SPEAC® System
The SPEAC® System by Brain Sentinel® is a surface electromyography (sEMG)-based ambulatory
system that detects and alarms for generalized tonic-clonic seizures at home and in healthcare facilities.
The SPEAC® System detects generalized tonic-clonic seizures in real-time, providing alerts within
seconds. It also provides physicians with a record of the patient’s sEMG history using the system with
accurate seizure counts and seizure history allowing for characterization by the physician.
The SPEAC® System continuously monitors and analyzes surface electromyography data to detect, in
realtime, generalized tonic-clonic (GTC) seizures, both primary and focal onset with secondary
generalization. Once the diagnostic algorithm detects a seizure, the system rapidly alerts and warns
patients and their designated caregivers while continuously and accurately recording the EMG data of the
patient for clinical review by the physician. The GTC Seizure Detection and Warning System helps give
both patients and their caregivers greater security and peace of mind.
Figure 2B. Schematic of the Interfaces Enabling the SPEAC® System
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2.1 How the SPEAC® System Components Work Together As a System
The components of the SPEAC® System by Brain Sentinel® that will arrive to you in the delivery box are
as follows:
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Two (2) SPEAC® Detection Devices. Details in Section 2.2.
One (1) SPEAC® Laptop Base Station. Details in Section 2.3.
One (1) CradlePoint Access Point/Wireless Router. Details in Section 2.4.
Two (2) SPEAC® Bioprene® Arm Straps. Details in Section 2.5.
Twenty (20) Daily Electrode Patches. Details in Section 2.6.
One (1) Pack of Oil-Removing Wipes. Details in Section 2.7.
2.2 SPEAC® Detection Devices
The SPEAC® Detection Device is a battery-operated device
consisting of electrical inputs for surface electromyography (sEMG)
and a signal processing unit. The SPEAC® Detection Device,
designed for daily use, is secured to the biceps. The SPEAC®
Detection Device runs on a diagnostic algorithm that continuously
monitors and analyzes the patient’s EMG signals, and determines
whether the signals from the measured frequency bands are
characteristic of a generalized tonic-clonic seizure. Once a
generalized tonic-clonic seizure is detected, the device provides
Figure 2C. SPEAC® Detection
instant alerts. The SPEAC® Detection Device also provides
Devices
operational alerts – for low battery, critical battery, loose electrodes
and lost connection with the SPEAC® Laptop Base Station – to ensure the system functions properly.
Two SPEAC® Detection Devices are provided. One SPEAC® Detection Device will be connected to the
patient to monitor EMG activity. The other will be connected to the SPEAC® Laptop Base Station for
charging the battery as well as configuration and data transfers. When the monitoring SPEAC®
Detection Device connected to the patient needs charging, it is swapped with the SPEAC® Detection
Device that is charging on the SPEAC® Laptop Base Station. The SPEAC® Detection Device contains
a highly integrated microcontroller that is programmed at the factory. The firmware version of SPEAC®
Detection Device is managed by the SPEAC® Laptop Base Station.
The SPEAC® Detection Devices are powered by an internal, rechargeable battery which has the
capacity for 24 hours of monitoring. The battery requires connecting the SPEAC® Laptop Base Station
to the micro-USB connector on the SPEAC® Detection Device using the USB cable provided.
You should only use the SPEAC® Laptop Base Station to recharge the SPEAC® Detection Devices not
only to minimize the risk of electrical hazards, but also to ensure that the recorded sEMG data are
uploaded to the SPEAC® Laptop Base Station.
2.2.1 SPEAC® Detection Device Component List Overview
The SPEAC® Detection Device is composed of the following:
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Enclosure: Manufactured by Brain Sentinel®
Pickup PCBA: Manufactured by Brain Sentinel®
EMG PCBA: Manufactured by Brain Sentinel®
Processor PCBA: Manufactured by Brain Sentinel®
Wi-Fi Module and Antenna: FCC compliant manufactured by Redpine® Signals
Battery: Rechargeable lithium-ion with PCM manufactured by Varta®
Audible UI: piezo speaker manufactured by PUI Audio, Inc.
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Haptic UI: vibration motor manufactured by PUI Audio, Inc.
Input UI: Membrane Keypad manufactured by Valmark Interface Solutions ®
2.3 The SPEAC® Laptop Base Station
The SPEAC® Laptop Base Station is a computer that serves as the control hub for the entire SPEAC®
System. It displays information received from the SPEAC® Detection Devices worn on the arm. The
SPEAC® Laptop Base Station maintains wireless communication with the SPEAC ® Detection Device that
is applied to the center of the belly of the patient’s biceps. The SPEAC® Laptop Base Station provides
audible and visual alarms to a caregiver when a generalized tonic-clonic seizure is detected by the
SPEAC® Detection Device as well as other system statuses. The SPEAC® Laptop Base Station is also
used to charge and, configure the SPEAC® Detection Device. It also downloads the patient’s sEMG data
from SPEAC® Detection Device while connected via the provided USB cord. The SPEAC® Laptop Base
Station also provides operational alerts to keep the system operating effectively.
Figure 2D. SPEAC® Laptop
Base Station
The SPEAC® System utilizes the computer’s LCD, sound card, USB
and Wi-Fi hardware integrated on the computer. The SPEAC®
Laptop Base Station is installed with the Windows 8.1® Operating
System on an Acer Aspire E3-111-P60S laptop. In addition, Brain
Sentinel® installs proprietary software applications and custom
configurations on SPEAC® Laptop Base Station, including its
“SPEAC® BaseStationApp”. The version of the application software
is managed by a utility integrated within the application. Refer to
section 2.9 for more details on software version control. No other
applications should be loaded to the SPEAC® Base Station without
the approval of Brain Sentinel®.
2.4 Cradlepoint Wireless Router
The CradlePoint Wireless Router performs two key functions. First,
it maintains the communication link between the SPEAC® Detection
Device and the SPEAC® Laptop Base Station. Second, it maintains
constant communication between the SPEAC® Laptop Base Station
and Brain Sentinel’s servers. Both of these communication links are
critical for the proper functioning of the SPEAC® GTC Seizure
Detection and Warning System.
Figure 2E. SPEAC® Laptop
Base Station Alongside the
CradlePoint Wireless Router
2.4.1 CradlePoint Wireless Router Indicator and Control Functions
The SPEAC® System requires a limited subset of the indicator and control functions available on the
router. See Figure 2F for the ports and switches used by the router. The required functions are
summarized in Table 2A.
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Figure 2F. CradlePoint Wireless Router Ports and Switches
Table 2A. CradlePoint Wireless Router LED Status
Indicator
Color
Meaning
Power LED
Power LED
Wi-Fi LED
Wi-Fi LED
Modem LED
Modem LED
Modem LED
Modem LED
Modem LED
Signal Strength LED
Blue (solid)
No Light
Green (solid)
No Light
Green (solid)
Green (blinking)
Amber (solid)
Amber (blinking)
No Light
Green
Power is on
Power is off
Wi-Fi is on
Power is off
DSL is on and operating normally
Connecting
Not Available
Cellular data connection error
Modem is off
More bars mean a stronger signal
2.4.2. CradlePoint Wireless Router Technical Characteristics
2.4.2.1. CradlePoint Wireless Router Mechanical Characteristics
 Height: 3.3-in"
 Width: 4.0-in"
 Depth: 0.9-in"
 Weight: 7.2 oz
2.4.2.2. CradlePoint Wireless Router Electrical Characteristics
 External Modem and Wi-Fi Antennas Two Ethernet Ports
 (LAN/LAN or WAN/LAN)
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Wi-Fi 802.11 with Full Security Fully Integrated Router/Bridge Integrated 3G/4G modem
Ruggedized Metal Housing
Certified for shock and vibration in accordance with MIL STD 810G and SAE J1455 External
3G/4G and Wi-Fi Antennas
Two Ethernet Ports (LAN/LAN or WAN/LAN)
Wi-Fi 802.11 with Full Security Non-Wi-Fi version available Built-in GPS with NMEA Output
Technology: LTE, EVDO Rev A
Downlink Rates: LTE 50 Mbps, EVDO 3.1 Mbps (theoretical)
Uplink Rates: LTE 50 Mbps, EVDO 1.8 Mbps (theoretical)
Frequency Bands: LTE Band 13 (700 MHz); CDMA EVDO Rev A/1xRTT (800/1,900 MHz)
Module Power: LTE 23 dBm +/− 1, EVDO 24 dBm +/− 1 (typical conducted)
Module: Sierra Wireless MC7750
Module Antennas: two SMA male (plug), 1 dBi (LTE), 2 dBi (CDMA) gain; finger tighten only;
support for GPS on aux connection
GPS: standalone GPS support
Power: Idle: typical=350mA@12V(4.2W) worst case=700mA@12V(8.4W)
Tx/Rx: typical=600mA@12V(7.2W)
worst case=1200mA@12V(14.4W)
Industry Standards & Certs: FCC, Wi-Fi Alliance, Verizon, Verizon NEMO/DMNR for Primary
Wireless Access
Certification Part Number: IBR600LE-VZ
See more at: http://CradlePoint.com/products/machine-to-machine-routers/cor-ibr600-3G-4Grouter#sthash.dJq3DV1C.dpuf
2.4.2.3. CradlePoint Wireless Router Software Characteristics
 Managed by CradlePoint, but updates are not mandatory.
2.5 SPEAC® Arm Strap
The SPEAC® Arm Strap is used to secure the SPEAC ® Detection
Device to the patient’s arm. The use of the SPEAC® Arm Strap is
always recommended while the patient is engaged in any activity
that could result in the unintended release of the SPEAC® Detection
Device from the biceps. This is particularly important while
sleeping, showering or vigorous physical activity. Two SPEAC® Arm
Straps are provided for convenience.
Figure 2G. SPEAC® Arm Strap
2.6 Electrode Patches Approved for Use with the SPEAC® System
The surface electrode patch has a triode configuration that
provides physical contact to three equally spaced points on the
skin of the patient’s biceps. A supply of single-use electrode
patches are included with the SPEAC® System. Additional
electrode patches can be ordered from Brain Sentinel®. See
Section 5 for reordering details.
Hydrogel is pre-applied to each electrode to enhance the skin-toelectrode contact. Prolonged exposure to air, heat or sunlight will
Figure 2H. Electrode Patches
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dry the hydrogel prematurely. For this reason the spare electrode patches should be placed in a sealed
container and stored in a cool location out of direct sunlight.
Electrode patches will need to be changed every 24 hours. Patient usage and activities may increase or
decrease the use of the electrode patch.
2.8 Oil-Removing Wipes
Brain Sentinel® provides you with a set of oil removing wipes to be used just before placing the SPEAC®
Detection Device. Never use rubbing alcohol or alcohol wipes to remove the oil from your biceps. Alcohol
interacts with the hydrogel, thereby damaging the electrode patches. This can leave you unmonitored for
generalized tonic-clonic seizures. In addition, the alcohol can irritate the skin.
You can ask for additional wipes from Brain Sentinel’s customer service or you may use non-alcoholic
wipes found at your local pharmacy or grocery store.
2.9 Cables Included with the SPEAC® System
2.9.1 USB Cable
A USB-A to mini USB-B cable is used to communicate data from the SPEAC®
Base Station to the SPEAC® Detection Device as well as charge the SPEAC®
Detection Device when not in use. The USB-A end plugs into SPEAC® Laptop
Base Station and the USB-B end plugs into the detection device. (See Figure 2I
top image).
2.9.2 AC Adapter for the SPEAC® Laptop Base Station
The SPEAC® Laptop Base Station should remain connected to the AC adapter at
all times, but can be powered by the internal battery for convenience for limited
periods of time. In this case or during power outages, the SPEAC® Laptop Base
Station’s internal battery can maintain operation for a minimum of 5 hours when it
is fully charged. Charge time is less than 6 hours. (See Figure 2I middle image).
The SPEAC® Laptop Base Station has the following specifications:
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Figure 2I. From
Top to Bottom:
USB, SPEAC®
Laptop Base
Station, and
Wireless Router
Manufacturer: Emerson
Model #: DP4018N2M
AC Input Voltage: 100-240V
Frequency Input: 50/60 Hz
DC Output Voltage: 18VDC±10%
Output Current: 2.2 A
Class II, 2x MOP
The AC Adapter for the SPEAC® Laptop Base Station does not have an ON/OFF
switch. Isolation of the AC Adapter from the wall outlet (SUPPLY MAINS) can be
safely done by disconnecting the detachable power cord from the AC Adapter.
For this reason, the AC Adapter should be positioned to allow unobstructed
access to the inlet cord. This AC Adapter satisfies the isolation requirements in
the 60601-1-2, 3rd Edition standard for use with medical-electrical equipment.
The SPEAC® Laptop Base Station’s AC Adapter is a Class II electrical equipment and has been approved
by the relevant and required agencies for use in a medical-electrical system. The construction of these
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components provides protection against electric shock. There is no requirement or provision in the
SPEAC® System for protective grounding.
The AC Adapter supplied with the SPEAC® System has been tested and approved by Brain Sentinel® for
use with the SPEAC® System. Only use Brain Sentinel-approved AC adapters with the SPEAC® System.
2.9.3 An AC Adapter for the CradlePoint Wireless Router.
The CradlePoint Wireless Router uses a power adapter for constant mains power and is capable of 240v.
The CradlePoint Router AC Power Adapter has the following specifications:
 Manufacturer: CradlePoint
 Model #:HK-AB120A150US
 Input Voltage: 100-240V
 Input Frequency:50/60Hz
 Input Current: < 0.8 A
 Output Voltage: 12VDC
 Output Current: 1.5A(max)
(See Figure 2I bottom image).
2.10 Software and Firmware Versions
Figure 2J. SPEAC® Laptop Base Station Update Utility Screenshot



The firmware installed on the SPEAC® Detection Device can be found on the startup banner
displayed when the SPEAC® BaseStationApp opens, and on the Wi-Fi Status of the SPEAC®
BaseStationApp
The software version of the SPEAC® BaseStationApp can be found on the startup banner
displayed when the SPEAC® BaseStationApp opens, and on the title bar of the application.
The version of the SPEAC® BaseStationApp Update utility can be found on the startup banner
displayed when the SPEAC® BaseStationApp opens.
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3. Installing the SPEAC® System
When you first start using the SPEAC® System, it is important to ensure that your environment is set up to
support your monitoring. This will help ensure that you identify any issues that could impact the proper
functioning of the SPEAC® System in your home.
Figure 3A. The SPEAC® System
3.1 Setup Checklist for the SPEAC® System
Before proceeding with the placement of the SPEAC® System, review the following checklist to make sure
that you have everything that you need ready.
1. Unpack the box containing the individual parts of the SPEAC® System.
2. Identify each component of the SPEAC® System from Section 2 of the User Guide.
3. Follow the instructions below in Section 3 to find the best location for the CradlePoint Wireless
Router and the SPEAC® Laptop Base Station.
4. Follow the instructions in Section 4 to use and configure the SPEAC® System.
5. Plug in to charge the SPEAC® Detection Device that is not being used currently on the biceps.
6. Test the Wi-Fi connection and boundary limits immediately after placing the device.
7. Set up your daily schedule to change out the SPEAC® Detection Device and electrode patches.
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3.2 SPEAC® System Setup Requirements
Figure 3B. The SPEAC® System Connections Diagram
3.2.1 Finding the Best Place for the CradlePoint Wireless Router
The CradlePoint router should be placed on a stable horizontal surface within 6 feet of a wall outlet. If
possible, the location of the router should be in place central to the patient’s daily activities.
Considerations and Cautions:





Do not place the router in areas exposed to liquids, food or temperature extremes outside normal
room temperatures.
Find a location with minimal or no activities that could damage any component in the system.
Locate the router as far away as possible from electrical equipment or appliances, e.g.,
microwave ovens that can generate Wi-Fi signal interference.
Avoid locations where physical obstructions might weaken the Wi-Fi signals, e.g., metal shielded
wall.
Avoid locations where reflective or metal surfaces, such as mirrors, metal file cabinets, and metal
counter tops that can reduce the network range and performance.
3.2.3 Finding the Best Place for the SPEAC® Laptop Base Station
The SPEAC® Laptop Base Station should be placed on a stable horizontal surface within 6 feet of a wall
outlet (SUPPLY MAINS).
Considerations and Cautions:



The surface should have enough area for the SPEAC® Laptop Base Station, the AC adapter and
a connected SPEAC® Detection Device. The location should allow efficient use of SPEAC®
Laptop Base Station. We recommend a minimum 2ft by 2ft area.
Restrict activities in the vicinity of SPEAC® Laptop Base Station that could distract the operator.
Any activity that could potentially damage the SPEAC® Detection Device should be prohibited in
the vicinity of the SPEAC® Laptop Base Station.
The SPEAC® Laptop Base Station should be located within the audible range of the caregiver.
Ambient noise levels should be minimized so the audible alarms generated by the SPEAC®
Laptop Base Station are heard above all other sounds.
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

The operator will need to view the information displayed on the SPEAC® Laptop Base Station
LCD screen and enter data using the keyboard. The ambient light should be evaluated for
efficient use of the SPEAC® Laptop Base Station keyboard and the LCD screen.
The SPEAC® Laptop Base Station should not be located in areas exposed to liquids, food or
temperature extremes outside normal room temperatures. Potential activities in the vicinity that
could distract the operator or damage any component in the system should also be taken into
consideration when choosing a location.
3.3 SPEAC® Detection Device Buttons and
LEDs
The SPEAC® Detection Device has a simple set of buttons
and LED lights to make it easy to operate and understand.
See Section 4.6.1 in this User Manual for a detailed
description of the LED light settings.
Figure 3C. The SPEAC®
Detection Device Front View
3.3.1 Control Functions
The SPEAC® Detection Device is initially worn on the dominant arm. The Head
Symbol (left) on the back of the SPEAC® Detection Device is always positioned
toward the patient’s head.
Figure 3D. Head
Icon on back of
SPEAC® Detection
Device
3.3.2 Power (ON/OFF) Button
The SPEAC® Detection Device power button is on the top as
seen in Figure 3D. Briefly pressing the ON/OFF button will turn
on the device.
To turn off the device, the ON/OFF button must be pressed and
held for approximately 8 seconds.
Figure 3E. The SPEAC®
Detection Device Top View
When the SPEAC® Detection Device turns on, it will conduct
what is called a ¨Power-On Self-Test” (POST) which will
conclude with both LEDs being white. The speaker will beep
several times and will be followed by a quick vibrations from the
haptic feedback motor. After the POST is completed and after
the Electrode Setup Process has been completed (See Section
4.X), the SPEAC® Detection Device will start monitoring the
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body’s signals present at the EMG connections, join the assigned network, and perform other functions
related to its proper functioning.
The SPEAC® Detection Device is “Monitor Mode” while both LED lights are in solid green
When the SPEAC® Detection Device is not in ¨Monitor¨
mode, it should be connected to the SPEAC® Laptop Base
Station for downloading sEMG data, Detection Device
firmware verification and battery charging and
downloading sEMG data.
3.3.3 Panic Button
Figure 3F. The SPEAC®
Detection Device Front View
The SPEAC® Detection Device has two buttons on the
face of it. See Figure 3E. The large button is the Panic
button, marked with a bell. Use this if you feel that you are
about to have a seizure. You must push and hold the
Panic button for 3-5 seconds for it to alarm. Remember
that if you have a generalized tonic-clonic seizure and do
not push the button, the SPEAC™ System is designed to
visually and audibly alarm automatically on both the
SPEAC® Detection Device and SPEAC® Laptop Base
Station.
Automatic Seizure Alarm Triggered by SPEAC® Detection Device
When a Generalized Tonic-Clonic Seizure is detected by the SPEAC® Detection Device, a Seizure Alarm
is sent to the SPEAC® Laptop Base Station. A seizure alarm and vibration will be generated by the
SPEAC® Detection Device. If the patient believes that the Seizure Alarm is incorrect, the alarm can be
cancelled by pressing the Cancel Button twice on the SPEAC® Detection Device.
Manual Seizure Alarm Triggered by the Panic Button
When a patient presses and holds the “Panic” Button for five (5) seconds, a Seizure Alarm is sent the
SPEAC® Laptop Base Station. The “Seizure has been detected” message will be show on the EMG
Status window in red. The SPEAC® Detection Device will generate an alarm tone and vibration just as if
the Automatic Seizure Alarm had activated. If the patient mistakenly triggers a Seizure Alarm via the
Panic Button, the Seizure Alarm can be cancelled by pressing the Cancel Button twice. See the next
section, 3.3.4 for instructions on cancelling a Seizure Alarm.
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3.3.4 Cancel Button
The face of the SPEAC® Detection Device has 2 lights: a
Wi-Fi Status light on the left and an Electrode Status light
on the right. When Wi-Fi Status light is green it indicates
that it is wirelessly connected to your SPEAC® Laptop
Base Station. When the Electrode Status light is green,
the electrode patch has good contact with your skin. It
does not mean that is necessarily properly placed. See
section 4.6.1 for a description of the LED states.
Figure 3G. The SPEAC®
Detection Device Front View
Figure 3G. The SPEAC®
Detection Device Front View
The LED on the right is called the Patient Connection LED
and indicates the status of the electrode patch’s
connection to the patient’s skin. The Wi-Fi and Patient
Status LEDs should both be green when the SPEAC®
Detection Device and Electrode Patch are properly
connected to the patient and when the SPEAC® Detection
Device is communicating wirelessly to the SPEAC® Laptop
Base Station.
Each LED has three colors to be used to indicate the Wi-Fi Status and Patient Status to the patient and
caregivers. The detailed description of the Patient Status LED states can be found in section 4.6.1.
If the Patient Status LED indicates a condition that is NOT described in section 4.6.1, turn the SPEAC®
Detection Device off and immediately call Brain Sentinel®.
The small button marked with a crossed-out bell is the Cancel button as seen on Figure 3G. Use this if
the SPEAC® System alarms for a seizure incorrectly and you are not having a seizure.
To use the Cancel button you should perform the following sequence:
1. Press the Cancel button for 1 second.
2. Release the Cancel button for about 1 second.
3. Press the Cancel button again for 1 second.
This will cancel the audible and vibration alarms generated by the SPEAC® Detection Device and the
SPEAC® Laptop Base Station.
For operational alarms (Loose Electrode, Critical Battery or Wi-Fi Connection Out-of-Range), the Cancel
button will only shortly delay them like a snooze button on an alarm clock. The alarm will go off again and
can only be stopped once the issue has been resolved.
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3.3.5 LED Indicators
The face of the SPEAC® Detection Device has two lights:
a “Status” LED light on the left and an “Alarm” LED light
on the right.
When the “Status” LED is green, it indicates two
connections are performing correctly.
1. the SPEAC® Detection Device is wirelessly
connected to the SPEAC® Laptop Base Station and
2. the electrode patch has good contact with your skin.
It does not mean that is necessarily properly placed
on the biceps. The Alarm LED is to show alarm
condition when it becomes red and flashing
SPEAC®
Figure 3H. The
Detection Device Front View
The “Status” LED is used to show three statuses. When
this LED is green. All three are operating normally. The
three statuses are
1. Wi-Fi Status
2. Electrode Status
3. Battery Status..
A detailed description of the Status LED and Alarm LED states can be found in section 4.6.1.
If the Status or Alarm LED indicates a condition that is NOT described in section 4.6.1, take note of the
colors and immediately call Brain Sentinel®.
3.3.6 Audio and Haptic Feedback
A speaker and an internal haptic feedback motor are used for additional feedback to the patient and
caregiver when in close proximity to the patient.


Audio Feedback: A low-power speaker is used to generate audible alarms for the patient and
caregivers in close proximity.
Haptic Feedback: A low-power vibratory motor is used to generate haptic feedback (vibration) to
the patient.
3.4 SPEAC® Laptop Base Station’s Indicator and Control Functions
Power Button
The Power button is located in the upper left corner of the
keyboard (see Figure 3H). Pressing this button will turn on
the SPEAC® Laptop Base Station when it is off. When the
SPEAC® Laptop Base Station is on, pressing this button
will turn it off.
Touchpad
Figure 3I. The SPEAC®
Laptop Base Station
The touchpad is a touch sensitive pointing device which
functions like a computer mouse. Use the touchpad to
navigate within the SPEAC® BaseStationApp application
as well as the required Windows 8.1® control functions.
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Display
The SPEAC® BaseStationApp displays visual information, alarms and messages will appear on the
SPEAC® Laptop Base Station’s LCD display. See Section 9.9 for details on the SPEAC® BaseStationApp
application indicators and control functions.
Status Indicators
The SPEAC® Laptop Base Station has three status indicators located at the lower left corner of the
keyboard surface. Each Status is described in Table 3A.
Table 3A. The SPEAC® Laptop Base Station LED Indicators
Indicator
Description
Computer Power Indicator. LED will be blue when the Laptop is operational
Computer Battery Indicator. It indicates the Laptop’s battery status. The LED will be yellow
when the Laptop is charging and blue when the battery is fully charged. The LED will be off
when the Laptop is running on battery (AC Adapter is disconnected from Laptop or AC input
to the adapter is disconnected.)
Wi-Fi Status Indicator. Indicates the status of the Wi-Fi hardware. If the LED is off the Wi-Fi
hardware is disabled or is not working properly. If the LED is orange, the Wi-Fi is on
3.5 Safe Operating Conditions for the SPEAC® System
All patients, operators, caregivers, and service personnel must read and thoroughly understand the
contents of this Instruction for Use of the SPEAC® System to assure safe installation, operation and
transport of the SPEAC® System. Immediately contact Brain Sentinel® if there is any question regarding
the operation, service, return, or disposal of this equipment (See Section 5 for contact information). If you
do not understand this manual, discuss the medical issues with your physician, or discuss the technical
product issues with Brain Sentinel®. Regardless, do not use the system until you have a clear
understanding of how the product works and the contents of this manual. This SPEAC ® System and its
alarms are not a substitutes for adequate patient supervision or medication. Please ensure that a trained
caregiver is present to provide assistance when the system alarms
The safety characteristics of the SPEAC® System’s modes of operation are described in the following
sections.
3.5.1 Optimal Environmental Conditions for Operating the SPEAC® System
3.5.1.1 SPEAC® System Detection Device Operating Limits
 Temperature: 0° C to 35° C (32°F to 95°F)
 Humidity: 15% to 93% RH (non-condensing)
 Pressure: 106 – 70 [kPa] (1.05Atmosphere – 0.69Atmosphere)
 Altitude: -15 m to 3048 m (-49 ft to 10,000 ft) [Note: not under water, but below sea level in land]
The SPEAC® Detection Device can rise to the temperature at an uncomfortable level while using the
SPEAC® Detection Device in an >35°C ambient environment.
3.5.1.2 SPEAC® System Laptop Base Station Operating Limits
 Temperature: 0° C to 50° C (32°F to 122°F)
 Humidity: 15 to 93% RH (non-condensing)
 Pressure: 106 – 70 [kPa] (1.05 Atmosphere – 0.69 Atmosphere)
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
Altitude: -15 m to 3048 m (-49 ft to 10,000 ft) [Note: not under water, but below sea level on land]
3.5.1.3 CradlePoint Wireless Router Operating Limits
 Temperature Range: -20 C to 50° C (14° F to 122° F)
 Humidity: 10% to 85% RH (non-condensing)
 Pressure: 106 – 70 [kPa] (1.05Atmosphere – 0.69Atmosphere)
 Altitude: -10 m to 3000 m [Note: not under water, but below sea level in land]
3.5.2 Safe Storage and Transport of the SPEAC® System
3.5.2.1 Environmental Condition for Safe Transport and Storage
 Temperature: 0° C to 35° C (32° F to 95° F)
 Humidity: 15% to 65% RH
 Pressure: 70 [kPa] to 106 [kPa] (0.69 Atmosphere to 1 Atmosphere)
 Altitude: -15 m to 10000 m (-49 ft to 32808 ft)
3.5.2.2 Battery Precautions for Safe Transport and Storage
 This product contains a rechargeable Lithium battery. DO NOT EXPOSE TO TEMPERATURES
GREATER THAN 95°F (35°C) and humidity in excess of 65% RH. If the batteries have sustained
prolonged exposure to high heat, contact Brain Sentinel’s technical support.
 The SPEAC® Laptop Base Station has limited minimum storage temperature of 0°C.
 During extended periods of storage, charging the batteries is required to achieve the specified
performance.
3.5.3 Safe Usage of the SPEAC® System While Monitoring
Figure 3J. The SPEAC®
Detection Device in the
Shower
3.5.3.1 Electro-Static Discharge Shock
The SPEAC® Detection Device is an internally powered device when it is ON
and operating in the ¨Monitor Mode” (both LEDs are solid green). The
SPEAC® Detection Device enclosure is marked with the internationally
accepted symbol for a Type BF Applied Part indicating all of the applied
parts are electrically isolated from ground. The patient and operator are safe
from electrostatic discharge shock.
3.5.3.2 Ingress Protection
When a SPEAC® Detection Device is attached to the patient as instructed and its USB door is
closed and locked, the SPEAC® Detection Device meets the IP47 classification. The SPEAC®
Detection Device in ¨Monitor Mode” (both LEDs are solid green) will limit the intrusion of solid materials as
small as dust-sized particles and will withstand exposure to splashing water from any direction.
Having said this, you must never expose the SPEAC® Detection Device to high-pressure water jets. Also,
never allow the SPEAC® Detection Device to be submerged in any liquid while powered on. Contact Brain
Sentinel® if the SPEAC® Detection Device or SPEAC® Laptop Base Station has been submerged. Do not
attempt to use or service a SPEAC® Detection Device or SPEAC® Laptop Base Station that has been
submerged.
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3.5.3.3 Temperature of the Applied Parts
The temperature of the SPEAC® System’s applied parts (those applied to the patient’s biceps and arm)
should never exceed 35°C or 95° F. In normal conditions, the temperature of the applied parts will
approach the skin temperature of the patient. If the surface temperature of any applied part is hot when
touched, immediately detach the SPEAC® Detection Device and turn it off and contact Brain Sentinel®.
3.5.4 Safe Usage of the SPEAC® System While Charging or During Configuration
3.5.4.1 Electro-Static Discharge Shock
When the SPEAC® Detection Device is detached from the Electrode patch, or the USB connector and the
three electrode connections are accessible to the patient and/or operator, the basic safety of the SPEAC®
Detection Device is the same as when it is attached to the Electrode.
Typically, the SPEAC® Detection Device will be connected to the SPEAC® Laptop Base Station for
charging when it is not in the ¨Monitor Mode” (both LEDs are solid green). Charging can only be done by
connecting the SPEAC® Detection Device to the SPEAC® Laptop Base Station with the USB cable
provided. When the SPEAC® Detection Device is connected to the SPEAC® Laptop Base Station for
charging, the required isolation for safety is maintained because the AC Adapter and SPEAC® Laptop
Base Station meet the requirements of Class II Medical Electrical Equipment.
3.5.4.2 Ingress Protection
The SPEAC® System meets the IP22 classification when the SPEAC® Detection Device is in the
Charge Mode (when the USB door of the SPEAC® Detection Device is open and connected to
the USB cable). Solid material as small dust sized particles will have limited intrusion to the interior of the
SPEAC® Detection Device enclosure through the USB door. The USB connector and the electrode
connections are accessible and the SPEAC® Detection Device enclosure will only limit the intrusion of
water to falling drops and light sprays. When the SPEAC® Detection Device is in the
Charge/Configuration mode, position the SPEAC® Detection Device with the front surface facing up. This
will restrict any liquid from accumulating on the rear surface near the USB connector and the electrode
connections.
The SPEAC® Detection Device meets the IP47 classification when the SPEAC® Detection Device is in
¨Monitor Mode¨ (USB Door closed). However, if the SPEAC® Detection Device is submerged, it will be at
risk of taking in water, permanently damaging the SPEAC® Detection Device and preventing it from being
able to monitor for GTC seizures. Further, while the SPEAC® Detection Device is submerged, it cannot
monitor or alarm for GTC seizures.
3.5.4.3 Temperature of the SPEAC® Detection Device, Laptop Base Station and AC Adapter
The parts of the SPEAC® Detection Device in the Charge/Configuration Mode are not Applied Parts. In
normal room temperature and conditions, the temperature of the SPEAC® Detection Device, SPEAC®
Laptop Base Station, and AC adapter should never exceed 35°C.
If the surface temperature of any SPEAC® Detection Device is hot to the touch, immediately detach the
SPEAC® Detection Device from the SPEAC® Laptop Base Station, turn it off and contact Brain Sentinel®.
If the surface temperature of the AC Adapter or the SPEAC® Laptop Base Station is hot to the touch,
immediately disconnect the power inlet cord to the AC Adapter, disconnect it from the SPEAC® Laptop
Base Station, and shut it down.
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4. Using the SPEAC® System
Figure 4A. The SPEAC® Detection Device on the Biceps of the Arm
Before using the SPEAC® System for the first time, please read through all of Section 4 so you can better
understand how to use the SPEAC® System. The order in which you complete the tasks is important.
Here is the summary of the steps you will complete. The rest of this section contains the details for
completing each step.
1.
2.
3.
4.
5.
6.
7.
Turn on the CradlePoint Wireless Router
Turn on the SPEAC® Laptop Base Station
Review the Setup Wizard on the SPEAC® Laptop Base Station
Place the SPEAC® Detection Device on your biceps and turn on
Perform the Electrode Setup
Be monitored within your home Wi-Fi zone
Change out the SPEAC® Detection Device and Electrode Patch every 24 hours
4.1 Placing the SPEAC® System to Begin Being Monitored
For proper functioning of the SPEAC® System, complete the setup process in the order listed below.
4.1.1 Turn On the CradlePoint Router
1. Attach the WiFi and modem antennas.
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Figure 4B. CradlePoint Wireless Router Buttons and Lights
2. Plug the outlet cord into the input on the rear of the CradlePoint Wireless Router.
Figure 4C. CradlePoint AC Adaptor
3. Plug the cord of the CradlePoint Wireless Router into the wall outlet.
4. Press the Power ON/OFF switch located next to the power input connector on the back of the
CradlePoint Wireless Router.
5. Before powering ON the SPEAC® Laptop Base Station (step 3 in the next section), wait until the Wi-Fi
LED indicator is blue – this is your signal that the router has successfully connected to the internet.
6. If you cannot see that the CradlePoint router has connected successfully to the internet, contact Brain
Sentinel’s Customer Service for assistance.
4.1.2 Turn On the SPEAC® Laptop Base Station
1. Plug the outlet cord of the AC adapter into the input on the left side of the SPEAC® Laptop Base
Station.
2. Plug the inlet cord into the AC adapter and then into the wall outlet.
3. Turn on the SPEAC® Laptop Base Station by pressing the power button on the upper left corner
of the keyboard.
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4. Check the bottom Windows bar to see if the SPEAC® Laptop Base Station is connected to the
Wi-FI. You should see a series of bars like in this screenshot.
5. The SPEAC® BaseStationApp, will start automatically after Windows boots up.
6. If the “POST Error” appears, select OK. Close the SPEAC® BaseStationApp and reopen it. If the
“POST Error” appears again, contact Brain Sentinel to help troubleshoot this issue. Leaving a
POST Error unresolved means that the wireless connections are not functioning properly and
may leave you unmonitored for generalized tonic-clonic seizures.
4.1.3 Launch the “Setup and Settings Setup Wizard”
In the SPEAC® BaseStationApp, there is a
button on the bottom right called “Setup
and Settings Setup Wizard”. Click this
button to begin playing the Configuration
Wizard videos. These Wizard videos
provide instructions on the proper
configuration, calibration and use of the
SPEAC® System.
Figure 4D. The Setup and Settings Wizard
The videos included in the Wizard are as follows:









Welcome to your SPEAC® System
Your Biceps, a Critical Communicator to Help You “SPEAC®”
Preparing Your Biceps for Placement
Attaching the Electrode to the Detection Device
Placing the Device
Turning on the Detection Device
Electrode Setup
The Arm Strap
Changing the Device
If you forget something you can always go back to the Wizard later to see the videos again.
Sections 4.1.4 – 4.1.6 of this User Manual are included for you to use along with the Wizard videos.
4.1.4 The Importance of Your Biceps
Before using one of the pre-charged Detection Devices, you need to prepare your biceps. Your SPEAC®
Detection Device works by continuously sensing and monitoring your surface electromyography (sEMG)
signals. The Detection Device reads and records 1,000 sEMG samples every second. Then our
SparkSenseTM diagnostic algorithm analyzes those samples looking for tonic-clonic muscle activity that is
indicative of generalized tonic-clinic seizures. The continuous analysis and storage of your real-time EMG
activity is why we say that the SPEAC® System is ready to speak for you during a seizure, and again
when you visit your doctor.
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Figure 4E. The Setup and Settings Wizard
The only place for the SPEAC® Detection Device is on your biceps, specifically what is known as ¨the
belly of the biceps¨ as seen in Figure 4.C. To find it, flex your elbow. The belly of the biceps is the thickest
part of the muscle, about halfway between your shoulder and elbow. When properly placed, the
electrodes on the Detection Device are recording your biceps’ activity 1,000 times a second. This helps
the SPEAC® System stay on top of changes from your normal EMG patterns that might be indicative of a
generalized tonic-clonic seizure.
The electrode patch should never be applied to irritated or broken skin. Please consult your physician if
skin irritation should occur with use of this product.
4.1.5 Attaching the Detection Device to Your Biceps
Before using one of the pre-charged SPEAC® Detection Devices, you need to prepare your biceps. Your
doctor may recommend whether you should place the Detection Device on your right or left biceps, or if
either is acceptable.
You must first prepare your skin over your biceps before placing the SPEAC® Detection Device on it. To
do so, you need to remove the naturally occurring oils on the surface of your skin to ensure that the
electrode patch stays properly attached to your arm.
Find the wipes that came with your SPEAC® System and gently wipe the skin on top of your biceps. Do
not use alcohol to clean your skin. Alcohol will react with the electrode gel and cause severe skin
irritation.
Once your skin is prepared, take an electrode patch
from the supply you were sent. Turn the Detection
Device over and secure all three snaps in the sockets.
You’ll hear a small click when you put them in. Don’t
turn on the Detection Device just yet or else the alarm
will sound.
Figure 4F. Electrode Patch placement in the
SPEAC® Detection Device sockets
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Once the electrode patch is snapped in correctly, remove the plastic
covering. This will expose the adhesive. Take a cotton swab, dip it in water,
and moisten the gel on each of the three grey electrode contacts, twice.
Figure 4G. Moistening
the Electrode Gels
Now take the SPEAC® Detection Device and place it on your biceps, holding
it firmly against your biceps for five (5) seconds. As mentioned before you
must place it on the belly of the biceps – not on the side, and not above or
below the belly of the biceps. Remember, the electrode patch should never
be applied to irritated or broken skin.
The adhesive on the electrode patch will generally last up to 24 hours. If the contact with your skin
becomes poor, the Loose Electrode alarm will sound. Remember that you are still not being monitored,
but you soon will be soon after you calibrate the electrode.
Now, check the time and take note. The electrode gel needs 5 minutes to absorb the water you just
applied to it so the Detection Device can properly monitor you. So, start a five minute countdown as soon
as you have the SPEAC® Detection Device properly placed on your biceps.
4.1.6 The Electrode Setup Process
In order for the surface electrodes to work properly, you must calibrate every new electrode patch you
place on the SPEAC® Detection Device. Not doing so could result in you not being monitored properly.
Before proceeding, make sure that
1. The SPEAC® Detection Device is OFF
2. The CradlePoint Wireless Router is turned ON
3. The SPEAC® Detection Device is adhered properly to your biceps
Now the equipment is ready for you to move ahead to set up the electrodes.
Turn on the SPEAC® Detection Device by pressing the small
button located on the top, as seen in Figure 4H.
When you press it, you’ll hear a sound. A series of lights will
flash and after a moment, both lights will turn green to
indicate that it is connected wirelessly to the SPEAC® Laptop
Base Station. If the lights don’t turn green, double-check that
the SPEAC® Laptop Base Station is connected to the
CradlePoint Wireless Router.
Figure 4H. SPEAC® Detection Device
ON/OFF Button
Do not proceed past this step until both lights on your
Detection Device are green. If you need immediate
assistance, please call Brain Sentinel® at 1-855-275-5424.
The final step in getting your SPEAC® Detection Device
ready for use is setting up the electrode. This is part of helping the SPEAC® System know the difference
between a generalized tonic-clonic seizure and your normal activity. It also helps calibrate the SPEAC®
Detection Device to background electrical noise.
Once five (5) minutes have passed (as indicated in Section 4.1.4) for the gel to absorb the water, relax
the arm that has the SPEAC® Detection Device on it. During this setup, don’t flex your biceps muscles. It’s
best to have your arm simply hanging at your side. On the SPEAC® Laptop Base Station screen you will
see a button for the Electrode Setup. Press it, then click “Begin Electrode Setup” and for the next 10
seconds, the SPEAC® System will be taking your EMG measurements. You can see the status on the
screen while the three electrodes are automatically setup for you.
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Correct EMG analysis relies on the characteristics of the electrode/skin interface. When a new electrode
patch is applied to the patient, these characteristics must be measured to make certain the proper
compensations are provided. These measurements are required at each electrode change. During this
procedure, the patient’s EMG levels at rest will be measured.
When you see the "Electrode Setup is Complete" message, click the “Dismiss” button. You are now being
monitored for generalized tonic-clonic seizure activity. Remember the electrode setup process must be
completed whenever you apply a new electrode.
4.1.7 Electrode Patch Adhesive and Your Skin
Ongoing use of the electrode patch may irritate your skin. To minimize this, it is important to take care
when applying and removing the electrode patch. Here are a few tips.
Tips for applying the adhesive electrode patch


Apply an alcohol-free skin protectant to protect skin prior to applying the Adhesive Patch. (Please
contact Brain Sentinel, Inc. for a list of skin protectants)
Allow all skin protectants to dry thoroughly before applying the Adhesive Patch
Recommended procedures for removing Adhesive Patch






Loosen the edges of the Adhesive Patch
With the fingers of the opposite hand, push the skin down and away from the adhesive electrode
patch, then…
Peel the adhesive electrode patch low and slow back over itself, keeping it horizontal and close to
the skin surface
As the adhesive electrode patch is removed, continue moving fingers of the opposite hand as
necessary to support newly exposed skin
You may want to loosen the adhesive bond by slow and careful removal of the adhesive
electrode patch using water-soaked cotton balls to continuously wet the adhesive-skin interface
Use proper removal technique to avoid skin injury. Injury can be caused by quick removal of the
Adhesive Patch at a high angle (perpendicular to the skin). Injury can also be caused by not
holding the skin at the peel line when removing the Adhesive Patch.
4.2 Configure the SPEAC® System Alarm Settings
The SPEAC® System has both Seizure Alarms and System Operational Alarms. Through the SPEAC®
BaseStationApp, you can configure




Alarm tones
Alarm tone volumes
Silence times for Operational Alarms (similar to a Snooze button on an alarm clock)
Alarm grace time periods (how long before a seizure alarm goes off once detected)
The Alarm Settings are accessed from the Configuration window. Select the “Setup and Settings Setup
Wizard” button in the bottom right of the application window and then select the Alert Settings tab to
configure the tones generated for the alarms, and the silence and grace time periods.
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Figure 4G. SPEAC® System Alert Settings
The default settings for the alarm settings are shown above. These will be configured by the physician’s
office and should not be changed.
4.2.1. Alarm Tones and Volume Levels
There are five alarm tones available in the SPEAC® System. The default selections will result in unique
tones for each of the alarm conditions and should not be changed. The default volume levels are set to
“High” for all alarm conditions. But “Medium” and “Low” options are available. If you mute the alarm tones,
the SPEAC® System will automatically turn them back on to medium level.
4.2.2. Silence Time
There are three (3) Operational Alarms that will go off if something is preventing the SPEAC® System
from working properly. These alarms are the



“Electrode” which sounds when the electrode patch is not adhered properly to the skin
“Battery” which sounds when the rechargeable battery is critically low and needs to be recharged
“Out of Range” which sounds when the SPEAC® Detection Device is outside of the Wi-Fi
coverage zone and cannot connect to the rest of the SPEAC® System
You have the option to “Silence” these alarms
temporarily when they go off. However, the only
way to permanently turn these alarms off is to
resolve the underlying cause that set them off. For
these alarms, the resolution for each is
Figure 4I. Example of Operational Alarm with
Silence Button on the SPEAC® Laptop Base
Station

 “Electrode”: Adhere the electrode patch properly
to the patient’s skin, which should be on the belly of
the biceps. This may involve changing the electrode
patch for a new one and/or putting on the SPEAC® Arm Strap.
“Battery”: Change out the battery for the charged one attached to the SPEAC® Laptop Base
Station
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
“Out of Range”: Return to the covered Wi-Fi zone. It is important to know where these boundaries
are in your home.
Three Silence Lag Time options (1, 5 and 15 minutes), are available for these Operational Alarms. In
addition, the SPEAC® Laptop Base Station will also visually display and sound for these alarms. When
this happens, a “Silence” button will appear, allowing you to silence the alarm until you can resolve the
issue and continue being monitored. Note: The SPEAC® Detection Device Critical Battery Alarm cannot
be silenced or snoozed, and the alarm sound will start as soon as the alarm condition is received by the
Base Station.
4.2.3. Seizure Alarm Grace Time
The “Seizure Grace Time” is the delay between when a Seizure Alarm is received by the SPEAC® Laptop
Base Station and when the Seizure Alarm sound is generated. Select one of four Seizure Grace Time
settings: 0, 10, 15, or 20 seconds.
4.2.4. Operational Alert Grace Time
When a Loose Electrode or Wi-Fi connection Alarm is received by the SPEAC® Laptop Base Station, the
alarm sound will be delayed by the time selected in the “Alarm Grace Time” column. Select one of four
Alarm Grace Time settings: 0, 1, 2 or 5 minutes.
4.2.5. Night Mode
In order to help you sleep soundly, you have the option to dim the LED lights on the SPEAC ® Detection
Device at night. Dimming the lights puts the SPEAC® Detection Device in “Night Mode”. This option is
located at the bottom of SPEAC® BaseStationApp as shown below in Figure 4J.
Clicking the “Enable Night Mode” button will activate “Night
Mode”, making the SPEAC® Detection Device LED light softer.
This button will only appear when the “Night Mode” is disabled.
Clicking the “Disable Night Mode” button will bring back
daylight mode, making the SPEAC® Detection Device LED
operate at regular brightness. This button will only appear
when the “Night Mode” is enabled.
Figure 4J. Night Mode Controls
on the SPEAC® Laptop Base
Station
4.3 Test the Wi-Fi Range of the SPEAC® Detection Device
In an open field environment the CradlePoint IBR600 series router can communicate with the SPEAC®
Detection Device up to approximately 300ft. However, the range within a building or dwelling will vary
based on their size, shape and type of building material. These differences in home construction can
affect the safe and effective monitoring range for Generalized Tonic-Clonic Seizures. Upon first setup in a
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new location, you should take the following steps to ensure your awareness of the monitoring range in
each new environment.
Slowly walk away from the router, monitoring the Wi-Fi status LED, and perform the following
1.
2.
3.
Go to commonly occupied areas of the home.
Walk the perimeters of each commonly used room.
Next, walk the perimeter of each floor.
Note: Not all routers will achieve the same range of communication, the previous steps should also be
performed when using a different router or when changing to a new router.
4.3.1. Troubleshooting Lost Wi-Fi Connections with the Detection Device
If the SPEAC® Detection Device has lost communication with the SPEAC® Laptop Base Station the Wi-Fi
status LED will cease to illuminate green, and will begin to flash. If this happens, during any of the
previous steps, you can do one of two things; note where the loss of connection takes place and avoid
this area while being monitored for Generalized Tonic-Clonic Seizures, or contact Brain Sentinel® at 1855-275-5424, to discuss your options regarding a Wi-Fi repeater installation to improve the
communication distance.
Note: A Wi-Fi repeater may not solve communication issues due to obstacles in your home.
4.4 Understanding the SPEAC® Laptop Base Station Application, Indicators and
Controls
The SPEAC® Laptop Base Station Application screen is composed of multiple tiles. Each one
corresponds to a specific monitor to ensure that the SPEAC® System is working properly, that you are
being monitored, and that the SPEAC® Detection Device is communicating with the SPEAC® Laptop Base
Station whether or not a seizure is currently being detected.
This section defines and describes the stages each tile you will see and need to become familiar with
when using the SPEAC® System:










EMG Tile, See Section 4.4.1
Status Tile, See Section 4.4.2
Electrode Tile, See Section 4.4.3
Connection Tile, See Section 4.4.4
DD Battery Tile, See Section 4.4.5
Base Station Battery Tile, See Section 4.4.6
Web Interface Tile, See Section 4.4.7
General Access Tile, See Section 4.4.8
Seizure Diary, See Section 4.4.9
Daily Log, See Section 4.4.10
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Figure 4K. SPEAC® BaseStationApp Main Window
The indicators (visual and audible), and controls are arranged on the SPEAC® BaseStationApp main
window in an array of tiles. The following sections describe the function of each tile. Software and
firmware version are displayed in the banner and in the Detection Device Communication tile.
NOTE: Indicators and controls are not always visible. The following sections describe the detailed
functions of each tile.
Table 4A. SPEAC® BaseStationApp Color Indicators
Tile Background
Color
Event
Type
Description
Indicators and
controls
Green
Normal
Monitored activity within normal operating parameters
Visible when needed
Blue
Notice
Monitoring activities have fallen out of normal operating
parameters and status is unknown. Unless action is
taken, a warning will be issued.
Visible when needed
Yellow
Warning or
Advisory
Warn the local and remote users that action needs to
be taken.
Visible when needed
Red
Warning or
Advisory
Warn the local and remote users that action needs to
be taken immediately.
Visible when needed
4.4.1 EMG Tile
The EMG tile is on the top left of the SPEAC® BaseStationApp main window and contains both indication
and control functions. The tile can be green, red or blue and contains a progress bar showing the time
until the alarm is live. It is called the “Time to Live Alarm”. It is also an indication of the relative EMG
signal.
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GREEN State: When the EMG Tile is green, the
patient’s EMG is normal. In the GREEN state, the
“Time to Live Alarm” indicator is inactive (i.e.
progress bar is all grey).
RED State: The EMG Tile will turn red when a GTC
seizure alarm condition is received from the
SPEAC® Detection Device. If a seizure alarm
condition has been received, the “Seizure Detected
Acknowledge/Silence” control button will appear in
the tile, and the Time to Live Alarm indicator (Grace
Time) will show the time remaining until the alarm
sounds.
If the Acknowledge/Silence control button is not selected before the Time to Live Alarm expires, an
audible alarm will be generated and tile will flash red.
•
•
•
Selecting the Acknowledge/Silence button will silence the audio alarm for 5 minutes or until the
GTC Seizure condition has ended.
If the GTC seizure condition persists, the tile will continue to flash red, and the alarm will sound
again after 5 minutes.
The EMG tile will return the GREEN State when the Acknowledge/Silence button is selected and
the GTC seizure condition has ended.
BLUE State: If the state of the EMG signal is unknown,
the EMG tile will turn blue and a status message will be
displayed. The LED will be blinking yellow and the Seizure
Alarm sound will be heard. Typically this is an indication of
a loose electrode. See Electrode Tile (4.4.3) for details.
The same message will appear if the communication link
between the SPEAC® Detection Device and the SPEAC® Laptop Base Station is lost or if the
communication link between the SPEAC® Laptop Base Station and the web is lost.
4.4.2 Status Tile
The Status Tile is on the top right of the SPEAC® BaseStationApp main window and contains both
indication and control functions.
BLUE State: Indicates all functions of the
system are normal and the patient is being
monitored.
The status tile will display the message, “YOU
ARE BEING MONITORED” if the system is
functioning.
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If any part of the system is not functioning
properly or as expected to maintain monitoring,
the Status tile will display the corresponding
message.
While a GTC Seizure is being detected, this message will be shown on the Status tile.
Web Connection Lost Status message. If you
see this message, your internet connection is not
working properly. Correct the issue immediately.
Call Brain Sentinel for assistance if needed.
Decision Input Popup: If user input is
required, a question will be displayed in the
status tile. The answers are used to direct
the user to the appropriate help wizard.
The example at left will be displayed when
the EMG signal is not within the expected
limits indicating the electrode patch has
been disconnected from the skin.
Wizard Display State: Wizards will be
displayed in the status tile based on the
outcome of the decision icon and when Help
buttons are selected in Electrode Tile or
Detection Device Battery Tile.
4.4.3 Electrode Tile
The “Electrode Tile” is located on the left center of the main SPEAC® BaseStationApp window and
contains both indication and control functions. The Electrode tile contains a Help button. When the Help
button is selected, a pop-up window will be displayed in the Status tile.
GREEN State: The Electrode Tile will be green
when the quality of the contact of the electrode to
patient’s skin is within the expected parameters
to monitor the EMG signal.
The progress bar is inactive in this state. If the
quality of the electrode to patient contact does not meet the expected limits, the tile will turn blue.
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BLUE State: When the SPEAC® Laptop Base
Station cannot determine the state of the contact
between the patient and the electrodes, the
Electrode Tile will be blue. A message indicating
the status will be displayed as shown at left.
Typically this indicates that the communication link between the SPEAC® Detection Device and the
SPEAC® Laptop Base Station has been lost and the SPEAC® Detection Device’s status has not been
received by the SPEAC® Laptop Base Station. The message: “Electrode is unknown” will be displayed
when the connection between the SPEAC® Detection Device and the SPEAC® Laptop Base Station is
lost.
RED State: When the quality of the
contact between the patient and the
electrodes is substandard, the
Electrode Tile will turn red and the
progress bar will start advancing. The
“Silence” button will be shown and start
to count down for 300 seconds/5
minutes.
Selecting the “Silence” button will mute the audible
alarm. If the electrode/patient contact does not return to
normal before the Silence timer (300 sec) expires, the
Electrode tile will blink RED and audible alarm will
restart.
4.4.4 Connection Tile (Connection Between the SPEAC® Detection Device and the
SPEAC® Laptop Base Station)
The Connection Between Detection Device and Base Station Tile is located on the right center of the
main SPEAC® BaseStationApp window. It contains both indication and control functions. Depending on
the state of the Wi-Fi link between the SPEAC® Laptop Base Station and Detection Device, the Wi-Fi tile
can contain both indication and control functions.
GREEN State: A satisfactory Wi-Fi link exists
between the SPEAC® Detection Device and
SPEAC® Laptop Base Station. The SPEAC®
Detection Device serial number and FW version
are displayed in the upper right corner of the tile.
The relative signal strength of the Wi-Fi network
as seen by SPEAC® Detection Device is displayed in the lower right corner. The progress bar at the
bottom of the tile will be blank as long as the tile is green.
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RED State: If the link between the SPEAC®
Detection Device and the SPEAC® Laptop Base
Station is lost, the Wi-Fi tile will turn red and the
progress bar will begin counting down. The Silence
button with timer will be shown. Selecting the
Silence button will silence the audible alarm for the
out-of-range-silence time.
The out-of-range-silence delay expires according to
the delay settings set during the setup of the
SPEAC® System. Then the Wi-Fi tile will transition
to the blinking RED state and an audible alarm will
be generated.
The Wi-Fi tile will remain in the RED state until the
connection between the SPEAC® Detection
Device and SPEAC® Laptop Base Station is
restored.
4.4.5 Detection Device Battery Tile
The “Detection Device Battery” tile is located on the bottom left the main SPEAC® BaseStationApp
window. It contains the SPEAC® Detection Device battery status indications.
GREEN State: The SPEAC® Detection Device is
communicating with the SPEAC® Laptop Base
Station and has sufficient battery life.
YELLOW State: The SPEAC® Detection Device
is communicating with the SPEAC® Laptop
Base Station and the battery is nearing critical
status while the battery has less than 2 hours
left.
RED State: When the Detection Device battery
is at a critical level, the tile will flash red and an
audible alarm will be generated. In addition, a
wizard will start in the Status tile providing
instructions on how to charge the SPEAC®
Detection Device.
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Follow the instructions provided in the Status
tile.
BLUE State: When the SPEAC® Laptop Base
Station cannot determine the state of the battery
in the SPEAC® Detection Device that is
monitoring the patient, the SPEAC® Detection
Device’s Battery tile will be blue. A message
indicating the status will be displayed.
Typically when this occurs the communication link between the SPEAC® Detection Device and the
SPEAC® Laptop Base Station has been lost and the SPEAC® Laptop Base Station cannot receive the
SPEAC® Detection Device’s status.
4.4.6 SPEAC® Laptop Base Station Battery Tile
The Base Station Battery tile is located on the center right of the main SPEAC® BaseStationApp
window. It indicates the status of the SPEAC® Laptop Base Station battery.
GREEN State: The SPEAC® Laptop Base Station is plugged in and the
battery is charged.
GREEN State: Unplugging the SPEAC® Laptop Base Station’s AC
Adaptor from the wall will not automatically generate a red tile. As long
as there is sufficient charge left in the SPEAC® Laptop Base Station
battery, the status tile will remain green.
YELLOW State: The SPEAC® Laptop Base Station is not plugged in
and is powered by the internal battery. The battery gauge will indicate
the relative capacity remaining in the battery.
Reconnect the AC Adapter as soon as possible.
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RED State: The SPEAC® Laptop Base Station is not plugged in and
the battery capacity is at a critical level. Only a few minutes remain
before the SPEAC® Laptop Base Station will shut down and remote
monitoring will be unavailable. Reconnect the AC Adapter as soon as
possible.
In addition, the SPEAC®
Laptop Base Station (BSN)
operating system, Windows
8.1, will show a message
“Your battery is running low”
while the BSN battery is
running low.
4.4.7 Web Interface Tile
This tile shows the status of the link with the external Brain Sentinel® web server.
GREEN State: Remote alarm and monitoring functionality is fully
operational.
YELLOW State: Multiple messages will appear in the Web Interface tile
when it is in the Yellow state.
NOTE: While in a yellow state, Seizure and Operational alarms may not be
received by the Brain Sentinel® server.
Note: This IP address window is only for troubleshooting while the SPEAC®
Detection Device and/or SPEAC® Laptop Base Station are not on the
correct Wi-Fi network.
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RED State: No external communication can take place with the Brain
Sentinel® web server. Either the internet connection is down or the Brain
Sentinel® server is down. For assistance, contact Brain Sentinel® at 1-855275-5424.
4.4.8 General Access Tile
The General Access Tile is located at the bottom of the SPEAC® BaseStationApp window. This tile
contains both indication and control functions. The time of day is always displayed as well as the Tech
Support phone number. The charging status of the SPEAC® Detection Device connected to the SPEAC®
Laptop Base Station’s USB port is displayed in the lower right corner of this tile. The state of the spare
SPEAC® Detection Device is displayed in the lower right corner of the General Access tile. If the nonmonitoring SPEAC® Detection Device is connected to the USB port on the SPEAC® Laptop Base Station,
the identification number of the SPEAC® Detection Device is displayed above the ¨Charge Status
Indicator¨ and a message indicating if the non-monitoring SPEAC® Detection Device is connected or
disconnected. The ¨Charge Status Indicator¨ will be yellow when the Detection Device is connected and
charging the battery. The ¨Charge Status Indicator¨ will be green when the battery is fully charged. If the
SPEAC® Detection Device is not connected, the ¨Charge Status Indicator¨ will be grey, the identification
number will be blank, and the message will be “Unplugged”
Figure 4L. SPEAC® Laptop Base Station General Access
Tile’s Key Messages
SPEAC® Detection Device
Identifier Number
Charge status
Non-monitoring SPEAC® Detection
Device USB Connection Status
Message
4.4.9 Seizure Diary
Selecting the Seizure Diary button activates an electronic form. The operator/patient can enter details
related to his or her seizures. Complete the form as instructed in the window
4.4.10 Daily Log
Selecting the Diary Log button activates a dialog so the operator/patient can enter details related to the
patient’s daily routine. Complete the form as instructed in the window.
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4.5 Understanding the SPEAC® System Alarms, Alerts and Messages
4.5.1 SPEAC® System Alarms and Alerts
The audio sounds generated by the SPEAC® System fall into two categories: Seizure Alarms and System
Operational Alarms. Familiarize yourself with the different types of alarms that exist in the SPEAC®
System using the alarm priority matrix in Table 4B. .
Table 4B. SPEAC® System Alarm Priority Matrix
Alarm Type
Priority Level
Seizure
High
Seizure
High
Seizure
High
Operational
High
Operational
High
Operational
High
Operational
High
Operational
High
Operational
Medium
Condition
Seizure Detected
Manual Seizure
Activation
Post Seizure no
acknowledgement
Seizure Detected
but no link to BSN
Electrode Loose
Connection
DD Battery
Critical
DD
communication
lost with BSN
BSN Battery
Critical
Lost Connection
Initial attempts
Tile on
SPEAC®
Laptop Base
Station
Tile Color
Audio?
Seizure
Red
Yes
Seizure
Red
Yes
Seizure
Red
Yes
DD Connection
Red
Yes
Electrode
Red
Yes
DD Battery
Red
Yes
DD Connection
Red
Yes
BSN Battery
Red
Yes
DD Connection
Yellow
No
4.5.2 Laptop BaseStationApp System Messages
“POST Error”: The POST Error will be
displayed when SPEAC® BaseStationApp has
been configured to join a network different than
the network to which the SPEAC® Laptop Base
Station has joined. If you see this error, close
the BaseStationApp and reopen it. This should
resolve it. If the problem persists, call Brain
Sentinel’s Customer and Technical Support to
resolve the issue. Leaving this problem
®
unresolved will result in your SPEAC System not monitoring you.
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“Base Station is running”: This message may be
shown while the user starts to run another
“SPEAC® BaseStionApp” program while the
existing program is not completely closed. Click
OK to close window and the application will open
automatically.
4.6 Understanding the SPEAC® System LED Lights and Indicators
4.6.1 Patient Connection and Wi-Fi Status at Startup
Table 4C. SPEAC® System Alarm Priority Matrix
Speaker
Haptic
Message
(SPEAC®
System
Detection
Device to
SPEAC® Laptop
Base Station)
Announce
tone
3 bursts
None
None
None
None
None
None
None
Purple
None
None
Low Battery in
Status
None
Critical Battery in
Status
Red Flash
Critical
Battery Alarm
Tone
Status (Wi-Fi)
Alarm (Electrode)
LED
LED
Condition
Power On
Self- Test
(POST)
White
White
Notes
Yelllow to
Power On WiFi searching
sequence
Purple to
Blue to
Green
DD
Application
Failure
Red
Red
Battery Low
Blue Flash
Battery
Critical
Blue Flash
Flash
Special Notes:
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




POST should take less than 5 seconds to complete. Both LEDs should be white unless battery is
in a low condition during this time. If the LEDs display any other color at the end of the POST
time, turn off the SPEAC® Detection Device and contact Brain Sentinel®.
NOTE 2: The SPEAC® Detection Device goes through a sequence to find the Wi-Fi network
generated by the CradlePoint Router and SPEAC® Laptop Base Station connection.
NOTE 3: SPEAC® Detection Device cannot boot up and fails. Please call Brain Sentinel®. (Refer
to contact information in Section 5)
NOTE 4: The SPEAC® Detection Device Laptop Base Station continues monitoring the SPEAC®
Detection Device battery status.
NOTE 5: The SPEAC® Detection Device battery requires immediate re-charging. Within 5
minutes, you must swap the SPEAC® Detection Device with the spare (fully charged) SPEAC®
Detection Device. If this condition is not remedied, the SPEAC® Detection Device will power off
and monitoring will be discontinued.
4.6.2 SPEAC® Detection Device LED’s Patient Connection and Wi-Fi Statuses during
Normal Operation
Note: Red row shows LED indication during Blind Mode.
Table 4D. Patient Connection and Wi-Fi Status Summary
Message
Condition
Status (Wi-Fi)
LED
Alarm
(Electrode)
SPEAC®
Detection
Device ->
SPEAC®
Laptop Base
Station
Speaker
Haptic
None
None
None
GTC
Seizure
Alarm
Tone with
long pulse
GTC
Seizure
Alarm
vibration
with long
pulse
Manual GTC
Seizure Alert
at SPEAC®
Laptop Base
Station
Electrode
Alarm
Tone
None
Electrode
Message at
SPEAC®
Laptop Base
Station
None
None
None
LED
Patient Status OK
Wi-Fi-Connected
Green
Manual GTC
Seizure Alarm
Activation
Red
Loose Electrode
Alarm
GTC Seizure
Warning (before
Lag period)
Red Flash
Red Flash
Green
Normal
mode
Green
Yellow
Flash
Notes
Purple
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BLIND MODE
GTC Seizure
Warning
Green
None
None
None
GTC
Seizure
Alarm
Tone with
short pulse
GTC
Seizure
Alarm
vibration
with short
pulse
Alarm at
SPEAC®
Laptop Base
Station
None
GTC
Seizure
Alarm
vibration
with short
pulse
Alarm at
SPEAC®
Laptop Base
Station
GTC
Seizure
Alarm
Tone with
short pulse
GTC
Seizure
Alarm
vibration
with short
pulse
None (no
link)
None
GTC
Seizure
Alert
vibration
with very
short pulse
GTC
Seizure
Alarm
Tone with
long pulse
GTC
Seizure
Alarm
vibration
with long
pulse
Alarm at
SPEAC®
Laptop Base
Station
None
None
Alarm at
SPEAC®
Laptop Base
Station
none
None
Low Battery
in Status
Green
(before Lag period)
GTC Seizure
Alarm (after Lag
period)
Red
Red Flash
BLIND MODE
Green
Seizure Alarm
GTC Seizure
Alarm (Wi-Wi link
is down)
Green
Red
Flash
Red Flash
BLIND MODE
Seizure Alarm
(Wi-Fi link is down)
Green
Post-GTC Seizure
and no
acknowledgement
Red
Green
Red
Flash
BLIND MODE
Post-GTC Seizure
and no
acknowledgement
Green
Battery Low
Blue
Flash
Green
Purple
Flash
None (no
link)
Send seizure
when link is
reestablished
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Battery Critical
Flash
Flash
Lost Wi-Fi
Connection
Purple
Blip
Wi-Fi lost SPEAC®
Laptop Base
Station
connection
•
•
•
Red
Blue
Red
Critical
Battery
Alarm
Tone
Wi-Fi Link
Alarm
None
Critical
Battery in
Status
None
Web
Interface
Message at
SPEAC®
Laptop Base
Station
None
Web
Interface
Message at
SPEAC®
Laptop Base
Station
Flash
Blue Blip
Red
Wi-Fi Link
Alarm
Flash
NOTE 1: Alarm moves to lowest internal priority allowing all other alerts to be active.
NOTE 2: If the Wi-Fi Status LED remains off for more than 10 seconds, power off the Detection
Device and contact Brain Sentinel®.
NOTE 3: The seizure has ended, but no acknowledgment has been received from the SPEAC ®
Laptop Base Station. The SPEAC® Detection Device will stay in a post-GTC seizure state until this
GTC Seizure Alarm is acknowledged by an operator at the SPEAC® Laptop Base Station, or
cancelled by the patient, or a new GTC seizure is detected
4.7 The SPEAC® Arm Strap
Once the SPEAC® Detection Device is secured to the patient using an
Electrode Patch, the SPEAC® Arm Strap can be used.
1. See Figure 4M. Make sure the Velcro tab is on the outside.
2. Fit the SPEAC® Arm Strap over the front of the SPEAC® Detection
Device.
3. Tighten the SPEAC® Detection Strap by pulling the long end through
the loop, until the slack in the strap is removed. Secure in place with the
Velcro tab.
4. Take care not to over tighten the strap, you should be able to gently
insert one finger between your skin and the strap
If discoloration or swelling occurs, immediately remove the SPEAC® Arm
Strap and seek medical attention with your prescribing physician if the
condition persists.
Figure 4M. SPEAC® Arm
Strap
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4.8 Daily SPEAC® Detection Device Changes
4.8.1 Remove the SPEAC® Detection Device From Your Biceps
Now that the application is closed, carefully and gently remove the SPEAC® Detection Device from your
biceps.
1. Loosen the Velcro on the SPEAC® Arm Strap, then slide it toward the elbow freeing it from the
SPEAC® Detection Device.
2. Gently peel the electrode patch from the skin from the edge of the patch. A small amount of water
may help dissolve the adhesive making it easier to remove.
3. Gently pull the Electrode Patch from the SPEAC® Detection Device and discard the patch as
normal household waste.
4. End a monitoring session at the SPEAC® Laptop Base Station by clicking on the red “X” in the
upper right corner of the application window. (Standard method to close a Windows application.)
The Status tile will turn white while this condition is reported to the Brain Sentinel ® website.
5. Ensure at least one SPEAC® Detection Device is connected to the SPEAC® Laptop Base Station
using the USB cable so a fully charged SPEAC® Detection Device will be available when
monitoring is again necessary.
4.8.2 Connect the SPEAC® Detection Device to the SPEAC® Laptop Base Station for
Charging and Uploading
The SPEAC® Detection Device that is not being used in the ¨Monitor¨ mode should always be connected
to the SPEAC® Laptop Base Station. When the SPEAC® Detection Device is connected to the SPEAC®
Laptop Base Station, the SPEAC® Detection Device’s battery is charging, EMG data is being transferred
and configuration data is being updated.
Before the SPEAC® Detection Device is connected to the SPEAC® Laptop Base Station, make sure the
SPEAC® Detection Device is on. Then connect the USB cable that came with your System to the USB
connector on the bottom of the SPEAC® Detection Device behind the USB protective door. Once
connected to the SPEAC® Detection Device, connect the other end to a USB port on the SPEAC® Laptop
Base Station.
Figure 4N. Detection Device USB Door and USB connector
1. Before connecting, always make sure that the “SPEAC® BaseStationApp” on the SPEAC® Laptop
Base Station is running.
2. Slide the USB Door lock away from the front face of the SPEAC® Detection Device. See Figure 4N
above.
3. Once the connection is made, the “SPEAC® BaseStationApp” will verify the configuration of the
SPEAC® Detection Device and transfer the collected EMG data to the Brain Sentinel® secure cloud
storage.
4. Even though the LEDs on the connected SPEAC® Detection Device will be off, charging will continue.
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5. The additional SPEAC® Detection Device should always be connected to SPEAC® Laptop Base
Station’s USB for charging and transferring the collected EMG data. After the SPEAC ® Detection
Device is connected to the SPEAC® Laptop Base Station’s USB port, both status LEDs will turn off.
4.9 Maintaining the SPEAC® System for Optimal Performance
The patient and other users are expected to perform the routine maintenance of the SPEAC® System
described in the following sections.
The rechargeable internal battery of the SPEAC® Detection Device and the electrode sockets integrated
into the SPEAC® Detection Device require scheduled service after 500 days of use. All other components
of the SPEAC® Detection Device will be evaluated at this time.
Contact Brain Sentinel® to arrange for service of your SPEAC® System. See Section 5 for contact
information.
4.9.1 Cleaning
All maintenance described below should only be performed while the Detection Device is NOT in use.
The exterior surfaces of the SPEAC® System can be cleaned with a soft clean cloth, a paper towel
dampened with 70% Isopropyl alcohol or disinfecting wipes. Lightly rub the exterior surfaces of the
SPEAC® components: SPEAC® Detection Device, SPEAC® Laptop Base Station, AC Adapter, and USB
cable and power cord. Remove any standing alcohol with a dry cloth or paper towel.
Do apply any liquid to the USB connector of the SPEAC® Detection Device.
4.9.2 Battery Maintenance
Maintaining the SPEAC® Detection Device batteries charged at all times is critical for their ongoing proper
performance. Like most rechargeable batteries, the SPEAC® Detection Device battery should be charged
at least once every 4-6 weeks or kept at 50% charged when not being used. Fully charged batteries
discharge when they are left unused and will lose effectiveness if they are left fully discharged for longer
than four (4) weeks. Maintaining their charge will prolong the life of the batteries.
Charge the battery after each monitoring session. When the battery is fully charged, the battery can
supply power for a 24-hour monitoring session. The time to charge a fully discharged battery is less than
6 hours.
The internal rechargeable battery used in the SPEAC® Detection Device has a minimum of 500 chargedischarge cycles.
Temperature is a key factor in the battery’s performance over its life. Never charge the SPEAC ® Detection
Device if the ambient temperature is below 32° F (0° C) or above 113° F (45° C). Operating (or
discharge) temperature should be not be below 0° F (-18° C) or above 113° F (45° C).
The rechargeable battery used in the SPEAC® Detection Device can only be replaced by authorized
personnel from Brain Sentinel®.
If properly used and maintained, the expected service life of the battery will meet the three-year expected
service life of the SPEAC® System.
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4.9.3 Electrode Socket Maintenance
Prior to insertion of a new electrode patch into the Electrode Sockets, inspect each
socket for discoloring spots. Clear any debris or foreign materials.
The force applied by the electrode retaining snap will eventually reduce during
normal use. Tests have shown the snap is capable of effectively retaining the
electrode beyond 500 cycles.
Figure 4O. SPEAC®
Detection Device Electrode
Sockets
4.9.4 SPEAC® Detection Device Enclosure/Case Maintenance
Inspect the exterior for cracks and the interface between the front
and rear enclosure halves. See Figure 4.9.4.
If defects are found, do not use the SPEAC® Detection Device and
immediately contact Brain Sentinel® for a replacement.
Figure 4P. SPEAC® Detection
Device Enclosure
4.9.5 Electrode Patch Maintenance
Replacement of the electrode patch is required when the skin-to-electrode contact does not provide
adequate EMG signal quality to the SPEAC® Detection Device’s electrical connections. The SPEAC®
Detection Device continually monitors whether the electrode-to-skin contact is adequate to detect
generalized tonic-clonic seizure conditions. When it is inadequate, the SPEAC® Detection Device issues
an alarm to the patient and operator.
The skin-to-electrode contact is maintained by the hydrogel applied to the electrodes and the adhesive
that bonds the electrode patch to the patient’s skin. Over time, the adhesive will degrade and the hydrogel
will dry causing intermittent connection of the electrodes to the patient’s skin causing an inadequate
electrode-to-skin condition.
Dispose of the used electrode patch as regular household waste.
4.9.6 Expected Service Life
Expected service life of the SPEAC® System is three years.
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5. Discontinuing Monitoring and Returning the SPEAC® System
When your prescribed time for monitoring ends, you must return the entire SPEAC ® System to Brain
Sentinel®. You have two options for returning
1. Call Brain Sentinel® Customer Service toll free at 1-855-275-5424 and tell the Customer
Service Representative that you need to return your System. Brain Sentinel® will send you a
package and a shipping label.
2. Email Brain Sentinel® at info@BrainSentinel.com – wordsmith this
Within three (3) business days of receiving the shipping materials, pack up and ship the SPEAC ® System
back to Brain Sentinel®.
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24-Hour Customer and Technical Support Available 1-855-275-5424
6. About Brain Sentinel, Inc.
Brain Sentinel, Inc. is the manufacturer of the SPEAC® System. For technical or customer support, please
contact the company toll free at 1-855-275-5424, or send an email to info@brainsentinel.com.
Physical Address:
Brain Sentinel, Inc.
8023 Vantage Dr.
Suite 216
San Antonio, Texas, 78230
Telephone: +1-855-275-5424



Technical Support, Extension 1
Clinical Study Support, Extension 2
Customer Service, Extension 3
Website: BrainSentinel.com
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24-Hour Customer and Technical Support Available 1-855-275-5424
7. Glossary of Terms
7.1 Acronyms, Abbreviation and Definitions
Acronyms or
Abbreviations
Definitions
AC
Alternating Current
BSN
Refers to the SPEAC® Laptop Base Station, and, in some contexts, the
combination of the SPEAC® Laptop Base Station and AC power adapter.
CLASS II
Refers to electrical equipment in which protection against electric shock does
not rely on BASIC INSULATION only, but in which additional safety
precautions such as DOUBLE INSULATION or REINFORCED INSULATION
are provided, there being no provision for protective grounding or reliance
upon installation conditions.
Contraindication
Condition or factor that serves as a reason to withhold a certain medical
treatment.
DD
Refers to the SPEAC® Detection Device, in some contexts, the combination of
the Detection Device and electrode.
EMG
Electromyography
GTC Seizure
Generalized Tonic-Clonic Seizure
IP Code/ IP
Classification
The Ingress Protection Code classifies and rates the degree of protection
provided against the intrusion (including body parts such as hands and
fingers), dust, accidental contact, and water by mechanical casings and
electrical enclosures.
Applied Part(s)
Part of ME EQUIPMENT that in NORMAL USE necessarily comes into
physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to
perform its function
Operator
Refers to the person handling the equipment. The patient is also considered
an Operator for the functions related to the use of the SPEAC® Detection
Device including the daily maintenance described in section 18.
Patient
Refers to the person to whom a physician has prescribed the SPEAC®
System. The patient is also considered an Operator for the functions related to
the use of the Detection Device including the daily maintenance described in
Section 18.
PCBA
Printed Circuit Board Assembly
RF
Radio Frequency
RH
Relative Humidity
sEMG
Surface Electromyography (non-invasive)
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SPEAC® System
The product brand name for the Brain Sentinel® Generalized Tonic-Clonic
Seizure Detection and Warning System. SPEAC® System = Sensing,
Portable, EMG, Analysis, Characterization System
Type BF
Type BF is a classification used generally for devices that have been
electrically connected to a Patient but not directly to the heart.
UI
User Interface
USB
Universal Serial Bus
7.2 Internationally Recognized Symbols and Markings
Symbol
Meaning
Reference
SPEAC®
This symbol is used on the
Detection Device and the
ISO 7010-M002
SPEAC® Laptop Base Station indicating the patient and operator
Refer to instruction
must consult the accompanying documents prior to using this
manual/booklet
medical device.
This symbol is used in the United States to show that federal law
restricts this device to sale, distribution, and use by or on order of
a licensed physician.
This symbol is used on the electrode package indicating that the ISO 7000-1051
electrodes are a single use item.
Do not reuse
This symbol is used on the SPEAC® Detection Device indicating IEC 60417-5333
that the applied part complies with the IEC 60601-1 standard
Type BF applied part
regarding electrical shock and leakage currents.
This symbol is used on the SPEAC® Detection Device indicating IEC 60417-5140
the SPEAC® Detection Device includes an RF transmitter.
Non-ionizing radiation
This symbol indicates the SPEAC® Detection Device is powered IEC 60601-1
by direct current. 5v and 500mA.
This symbol is used on the SPEAC® Detection Device indicating WEEE Directive
General Safety
the SPEAC® Detection Device should not be placed in the regular (2012/19/EU)
®
waste stream. To dispose of the device contact Brain Sentinel .
See section 5 for contact information.
This symbol appears on the Panic control button on the SPEAC® IEC 60417-5013
Detection Device.
This symbol appears on the Cancel control button on the
SPEAC® Detection Device.
IEC 60417-5576
This symbol is used on the SPEAC® Laptop Base Station label
and is followed by the manufacturer name and address.
ISO 7000-3082
Manufacturer
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This symbol is used on the SPEAC® Laptop Base Station label
and describes the date the device was manufactured
SPEAC®
ISO 7000
Manufacturer
This symbol is used on the
Laptop Base Station label
and is followed by the model/type number, name and version.
ISO 7000-2493
This symbol is used on the SPEAC® Laptop Base Station label
and is followed by the serial number
ISO 7000-2498
Catalog Number
This symbol indicates the manufacturer’s declaration that the
CE
marking
certification
Serial
Number
product complies with the essential health and safety
requirements of the relevant European health, safety and
environmental protection legislation. This product conforms with
the Medical Device Directive, Council Directive 93/42/EEC: June
14, 1993, as amended by 2007/47/07 (as applicable) following
the provisions of Annex II, when it bears the following CE Mark of
Conformity.
7.3 Other Markings
7.3.1 Brain Sentinel, Inc. Markings
Brain Sentinel® labels are added to the laptop identifying the following:





Manufacturer: Brain Sentinel®
Model: SPEAC® System
Serial #: 
Refer to instruction manual
SW Version: see SPEAC® Laptop Base Station.
7.3.2 SPEAC® Detection Device Identification and Markings











Manufacturer: Brain Sentinel®
Model: SPEAC® System by Brain Sentinel®
Serial #: Located on back of SPEAC® Detection Device enclosure
VA Rating: 500mA at 5VDC;
SW Version: located on SPEAC® BaseStationApp.
IP Classification: IP67, located in accompanying documents
Consult Accompanying Documents (ISO 7010-M002)
Non-ionizing Radiation (ISO 60417-5140)
Type BF Applied Part
FCC ID: located on back of device.
The “Head Direction” icon seen here and located at back of Detection Device indicates that the
symbol should be oriented toward the patient’s head to help ensure proper
placement.
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7.3.3 SPEAC® Laptop Base Station Markings







Manufacturer: Acer America Corporation
Model Number: E3-111-P60S
Marketing Name: Aspire E11
DC Rating: 2.5A at 19VDC
S/N: 
SNID: 
Numerous regulatory markings
7.3.4 Access Point/Wireless Router Identifications and Markings







Manufacturer: CradlePoint
Model Name: CradlePoint router
Model Number: COR IBR600LE
DC Rating: 1.5A at 12VDC
S/N: 
SNID: 
Numerous regulatory markings
7.3.5 Other Hardware Markings



Manufacturer: Emerson
Model #: DP4018N2M
Required regulatory and standard markings.
7.3.6 Software Markings

Windows® 8.1 Starter label
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24-Hour Customer and Technical Support Available 1-855-275-5424
The SPEAC® System, a Generalized Tonic-Clonic Seizure Detection and Warning System, is
manufactured by:
Brain Sentinel, Inc.
8023 Vantage Dr.
Suite 216
San Antonio, TX 78212
Brain Sentinel’s 24-Hour Customer Service line is: 1-855-275-5424, Extension 3.
Web Site: www.BrainSentinel.com
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