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

Brain Sentinel Brain Sentinel GTC Seizure Detection and Warning System Users Manual

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SPC15 User Manual HTML Version

Users Manual

Generalized Tonic-Clonic Seizure Detection and

Warning System

User’s Manual

Be Heard

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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

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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.

 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.

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.

Figure 1B.

Electrode

Sockets

Figure 1A. Applied Parts Include: SPEAC® Arm Strap, SPEAC® Detection Device and Electrode Patch

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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:

 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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2. The SPEAC® System Overview

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 2A. The Sensing, Portable, EMG, Analysis and Characterization - SPEAC® System

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:

 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

instant alerts. The SPEAC® Detection Device also provides

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:

 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.

Figure 2C. SPEAC® Detection

Devices

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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.

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.

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.

Figure 2D. SPEAC® Laptop

Base Station

Figure 2E. SPEAC® Laptop

Base Station Alongside the

CradlePoint Wireless Router

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Indicator

Color

Meaning

Power LED

Blue (solid)

Power is on

Power LED

No Light

Power is off

Wi-Fi LED

Green (solid)

Wi-Fi is on

Wi-Fi LED

No Light

Power is off

Modem LED

Green (solid)

DSL is on and operating normally

Modem LED

Green (blinking)

Connecting

Modem LED

Amber (solid)

Not Available

Modem LED

Amber (blinking)

Cellular data connection error

Modem LED

No Light

Modem is off

Signal Strength LED

Green

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)

Table 2A. CradlePoint Wireless Router LED Status

Figure 2F. CradlePoint Wireless Router Ports and Switches

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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-4G-

router#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.

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-to-

electrode contact. Prolonged exposure to air, heat or sunlight will

Figure 2G. SPEAC® Arm Strap

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:

 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

Figure 2I. From

Top to Bottom:

USB, SPEAC®

Laptop Base

Station, and

Wireless Router

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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

 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.

Figure 2J. SPEAC® Laptop Base Station Update Utility Screenshot

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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.

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.

Figure 3A. The SPEAC® System

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3.2 SPEAC® System Setup Requirements

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.

Figure 3B. The SPEAC® System Connections Diagram

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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.

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.

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.

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

Figure 3E. The SPEAC®

Detection Device Top View

Figure 3C. The SPEAC®

Detection Device Front View

Figure 3D. Head

Icon on back of

SPEAC® Detection

Device

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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

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.

Figure 3F. The SPEAC®

Detection Device Front View

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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.

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.

Figure 3G. The SPEAC®

Detection Device Front View

Figure 3G. The SPEAC®

Detection Device Front View

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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

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

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.

Figure 3I. The SPEAC®

Laptop Base Station

Figure 3H. The SPEAC®

Detection Device Front View

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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.

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)

Table 3A. The SPEAC® Laptop Base Station LED Indicators

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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

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.

Figure 3J. The SPEAC®

Detection Device in the

Shower

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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

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. Turn on the CradlePoint Wireless Router

2. Turn on the SPEAC® Laptop Base Station

3. Review the Setup Wizard on the SPEAC® Laptop Base Station

4. Place the SPEAC® Detection Device on your biceps and turn on

5. Perform the Electrode Setup

6. Be monitored within your home Wi-Fi zone

7. 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.

Figure 4A. The SPEAC® Detection Device on the Biceps of the Arm

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2. Plug the outlet cord into the input on the rear of the CradlePoint Wireless Router.

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.

Figure 4B. CradlePoint Wireless Router Buttons and Lights

Figure 4C. CradlePoint AC Adaptor

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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.

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.

Figure 4D. The Setup and Settings Wizard

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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 4E. The Setup and Settings Wizard

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.

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.

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.

Figure 4G. Moistening

the Electrode Gels

Figure 4H. SPEAC® Detection Device

ON/OFF Button

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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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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

 “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

Figure 4G. SPEAC® System Alert Settings

Figure 4I. Example of Operational Alarm with

Silence Button on 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.

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

Figure 4J. Night Mode Controls

on the SPEAC® Laptop Base

Station

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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. Go to commonly occupied areas of the home.

2. Walk the perimeters of each commonly used room.

3. 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 1-

855-275-5424, 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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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.

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.

Figure 4K. SPEAC® BaseStationApp Main Window

Table 4A. SPEAC® BaseStationApp Color Indicators

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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.

24-Hour Customer and Technical Support Available 1-855-275-5424

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 1-855-

275-5424.

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 non-

monitoring 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”

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.

Charge status

Non-monitoring SPEAC® Detection

Device USB Connection Status

Message

SPEAC® Detection Device

Identifier Number

Figure 4L. SPEAC® Laptop Base Station General Access

Tile’s Key Messages

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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. .

Alarm Type

Priority Level

Condition

Tile on

SPEAC®

Laptop Base

Station

Tile Color

Audio?

Seizure

High

Seizure Detected

Seizure

Red

Yes

Seizure

High

Manual Seizure

Activation

Seizure

Red

Yes

Seizure

High

Post Seizure no

acknowledgement

Seizure

Red

Yes

Operational

High

Seizure Detected

but no link to BSN

DD Connection

Red

Yes

Operational

High

Electrode Loose

Connection

Electrode

Red

Yes

Operational

High

DD Battery

Critical

DD Battery

Red

Yes

Operational

High

communication

lost with BSN

DD Connection

Red

Yes

Operational

High

BSN Battery

Critical

BSN Battery

Red

Yes

Operational

Medium

Lost Connection

Initial attempts

DD Connection

Yellow

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.

Table 4B. SPEAC® System Alarm Priority Matrix

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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

Condition

Status (Wi-Fi)

LED

Alarm (Electrode)

LED

Speaker

Haptic

Message

(SPEAC®

System

Detection

Device to

SPEAC® Laptop

Base Station)

Notes

Power On

Self- Test

(POST)

White

Announce

tone

3 bursts

None

Power On Wi-

Fi searching

sequence

Yelllow to

Purple to

Blue to

Green

None

Application

Failure

Red

None

Battery Low

Blue Flash

Purple

Flash

None

Low Battery in

Status

Battery

Critical

Blue Flash

Red Flash

Critical

Battery Alarm

Tone

None

Critical Battery in

Status

Special Notes:

Table 4C. SPEAC® System Alarm Priority Matrix

24-Hour Customer and Technical Support Available 1-855-275-5424

 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.

Condition

Status (Wi-Fi)

LED

Alarm

(Electrode)

LED

Speaker

Haptic

Message

SPEAC®

Detection

Device ->

SPEAC®

Laptop Base

Station

Notes

Patient Status OK

Wi-Fi-Connected

Green

None

Normal

mode

Manual GTC

Seizure Alarm

Activation

Red

Red Flash

GTC

Seizure

Alarm

Tone with

long pulse

GTC

Seizure

Alarm

vibration

with long

pulse

Manual GTC

Seizure Alert

at SPEAC®

Laptop Base

Station

Loose Electrode

Alarm

Yellow

Flash

Red Flash

Electrode

Alarm

Tone

None

Electrode

Message at

SPEAC®

Laptop Base

Station

GTC Seizure

Warning (before

Lag period)

Green

Purple

None

Table 4D. Patient Connection and Wi-Fi Status Summary

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BLIND MODE

GTC Seizure

Warning

(before Lag period)

Green

None

GTC Seizure

Alarm (after Lag

period)

Red

Red Flash

GTC

Seizure

Alarm

Tone with

short pulse

GTC

Seizure

Alarm

vibration

with short

pulse

Alarm at

SPEAC®

Laptop Base

Station

BLIND MODE

Seizure Alarm

Green

None

GTC

Seizure

Alarm

vibration

with short

pulse

Alarm at

SPEAC®

Laptop Base

Station

GTC Seizure

Alarm (Wi-Wi link

is down)

Red

Flash

Red Flash

GTC

Seizure

Alarm

Tone with

short pulse

GTC

Seizure

Alarm

vibration

with short

pulse

None (no

link)

BLIND MODE

Seizure Alarm

(Wi-Fi link is down)

Green

None

GTC

Seizure

Alert

vibration

with very

short pulse

None (no

link)

Send seizure

when link is

reestablished

Post-GTC Seizure

and no

acknowledgement

Red

Flash

GTC

Seizure

Alarm

Tone with

long pulse

GTC

Seizure

Alarm

vibration

with long

pulse

Alarm at

SPEAC®

Laptop Base

Station

BLIND MODE

Post-GTC Seizure

and no

acknowledgement

Green

None

Alarm at

SPEAC®

Laptop Base

Station

Battery Low

Blue

Flash

Purple

Flash

none

None

Low Battery

in Status

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Battery Critical

Blue

Flash

Red

Flash

Critical

Battery

Alarm

Tone

None

Critical

Battery in

Status

Lost Wi-Fi

Connection

Purple

Blip

Red

Flash

Wi-Fi Link

Alarm

None

Web

Interface

Message at

SPEAC®

Laptop Base

Station

Wi-Fi lost SPEAC®

Laptop Base

Station

connection

Blue Blip

Red

Flash

Wi-Fi Link

Alarm

None

Web

Interface

Message at

SPEAC®

Laptop Base

Station

•

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

24-Hour Customer and Technical Support Available 1-855-275-5424

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.

24-Hour Customer and Technical Support Available 1-855-275-5424

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 charge-

discharge 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.

24-Hour Customer and Technical Support Available 1-855-275-5424

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.

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.

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.

Figure 4O. SPEAC®

Detection Device Electrode

Sockets

Figure 4P. SPEAC® Detection

Device Enclosure

24-Hour Customer and Technical Support Available 1-855-275-5424

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®.

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

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

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.

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

Radio Frequency

Relative Humidity

sEMG

Surface Electromyography (non-invasive)

24-Hour Customer and Technical Support Available 1-855-275-5424

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.

User Interface

USB

Universal Serial Bus

7.2 Internationally Recognized Symbols and Markings

Symbol

Meaning

Reference

This symbol is used on the SPEAC® Detection Device and the

SPEAC® Laptop Base Station indicating the patient and operator

must consult the accompanying documents prior to using this

medical device.

ISO 7010-M002

Refer to instruction

manual/booklet

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

electrodes are a single use item.

ISO 7000-1051

Do not reuse

This symbol is used on the SPEAC® Detection Device indicating

that the applied part complies with the IEC 60601-1 standard

regarding electrical shock and leakage currents.

IEC 60417-5333

Type BF applied part

This symbol is used on the SPEAC® Detection Device indicating

the SPEAC® Detection Device includes an RF transmitter.

IEC 60417-5140

Non-ionizing radiation

This symbol indicates the SPEAC® Detection Device is powered

by direct current. 5v and 500mA.

IEC 60601-1

General Safety

This symbol is used on the SPEAC® Detection Device indicating

the SPEAC® Detection Device should not be placed in the regular

waste stream. To dispose of the device contact Brain Sentinel®.

See section 5 for contact information.

WEEE Directive

(2012/19/EU)

This symbol appears on the Panic control button on the SPEAC®

Detection Device.

IEC 60417-5013

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

24-Hour Customer and Technical Support Available 1-855-275-5424

This symbol is used on the SPEAC® Laptop Base Station label

and describes the date the device was manufactured

ISO 7000

Manufacturer

This symbol is used on the SPEAC® Laptop Base Station label

and is followed by the model/type number, name and version.

ISO 7000-2493

Catalog Number

This symbol is used on the SPEAC® Laptop Base Station label

and is followed by the serial number

ISO 7000-2498

Serial Number

This symbol indicates the manufacturer’s declaration that the

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.

CE marking certification

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 #: <unique>

 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.

24-Hour Customer and Technical Support Available 1-855-275-5424

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: <unique>

 SNID: <unique>

 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: <unique>

 SNID: <unique>

 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

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

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

Brain Sentinel Brain Sentinel GTC Seizure Detection and Warning System Users Manual

Users Manual

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