Brain Sentinel Seizurelink Manual de usuario

SeizureLink Alerting System

User Manual

This user manual is intended for use in the USA only.

OVERVIEW

Page 1

Content

OVERVIEW........................................................................................................................... 2

1. Welcome to the SeizureLinkTM Community ....................................................................... 2

1.1 Product Description...............................................................................................................................2

1.2 Disclaimers...........................................................................................................................................2

1.3 How to Properly Use the SeizureLink System.........................................................................................3

2. What’s in the Box ............................................................................................................ 5

2.1 sEMG Monitor .......................................................................................................................................6

1.2 Electrodes.............................................................................................................................................6

1.3 Rechargable Battery..............................................................................................................................8

1.4 Charging Dock ......................................................................................................................................9

3. Monitoring with the SeizureLink System ....................................................................... 10

3.1 Electrode Placement ...........................................................................................................................10

3.2 Understanding The Buttons and LED Indicators.................................................................................... 11

4. Managing the App ........................................................................................................ 13

4.1 Account Setup.....................................................................................................................................13

4.2 Synching The App and The Seizurelink Monitor.................................................................................... 13

4.3 For Managing Caregivers ....................................................................................................................14

4.4 Managing The Seizurelink Phone Call .................................................................................................15

4.5 How To Change Your Proﬁle Photo .......................................................................................................15

4.6 What Happens During A Seizure Alarm?............................................................................................... 16

4.4 Seizure Diary ......................................................................................................................................18

4.5 Troubleshooting ..................................................................................................................................18

5. Technical Speciﬁcations ................................................................................................ 29

5.1 Monitor...............................................................................................................................................29

5.2 Electrode ............................................................................................................................................29

5.3 Battery................................................................................................................................................20

5.4 Connectivity........................................................................................................................................ 20

6. Customer Support ......................................................................................................... 20

For Use During Usability Study only

OVERVIEW

Page 2

Welcome to the

SeizureLinkTM Community

Welcome to the Hero community! At Brain Sentinel, we refer to the wearers of the SeizureLink System device

as Heroes. Christopher Reeve1, described a Hero in the following way:

“A Hero is an ordinary individual who ﬁnds the strength to persevere and endure in spite of overwhelming

obstacles.”

We think his deﬁnition of a Hero truly deﬁnes those living with epilepsy and perfectly describes why you are

our Heroes.

Thank you for making the SeizureLink Alerting System part of your daily routine. Our goal is to provide you

with the shortest link between a seizure happening and help arriving. We love helping Heroes just like you.

This instruction manual describes how to properly use your SeizureLink System.

1.1 Product Description

The SeizureLink System is designed to do one job: Alarm and notify Caregivers to help shorten the time

needed to get help to a Hero (wearer) during a seizure. The SeizureLink System is the only consumer, over-

the-counter (OTC) seizure alerting system that recognizes surface electromyography (sEMG) – the new

standard in seizure monitoring.

The sEMG signal is analyzed by SeizureLink’s algorithm to sense for muscle contractions that may be

indicative of a generalized tonic-clonic seizure even when there is no shaking so the system knows when

to alert. In fact, the SeizureLink System offers the fastest signal on the market; a clinical study showed that

SeizureLink’s algorithm alerts on average between 9-12 seconds*. The SeizureLink algorithm also recognized

94 percent of generalized tonic-clonic seizures, with a false alarm rate of only 0.67 per day and only 1 per

every 82 nights in the evening.

The easy-to-use free SeizureLink app helps you send alerts to your connected Caregivers, manage your

seizure diary and create reports.

1.2 Disclaimers

The SeizureLink System is not a medical device and is not cleared by the FDA for medical device application

or to monitor, treat, diagnose or prevent a medical condition. Use of SeizureLink System is not a substitute

for professional medical advice concerning your condition, medical treatment for you, or for proper

supervision concerning your condition. Please consult your physician or your healthcare provider to ask

questions, discuss your condition and the options for you.

*Beniczky, Sándor, et al.

“Automated Real-Time Detection of Tonic-Clonic Seizures Using a Wearable EMG Device.”

Advances in Pediatrics., U.S. National Library of Medicine,

30 Jan. 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC5791791/.

1. http://www.chrisreevehomepage.com/stillme.html

For Use During Usability Study only

OVERVIEW

Page 3

1.3 How to Properly Use the SeizureLink System

Special care must be taken when using the SeizureLink System.

A. DO NOT USE IN WATER

1. The SeizureLink monitor is not waterproof.

2. Liquids will damage the electronics inside the SeizureLink monitor.

The SeizureLink monitor is never to be submerged in water or any other liquid, including but not

limited to:

- bathtub

- swimming pool

- ﬁlled kitchen sink

3. The SeizureLink monitor should not be worn in the shower.

4. The SeizureLink monitor cannot recognize seizures or send remote alarms while submerged.

5. Do not use the sEMG monitor if there is any liquid inside.

6. Do NOT spill liquid on the sEMG monitor; doing so may damage its internal electronics and make

the entire system unusable.

7. If you feel any part of the SeizureLink System has been compromised, please contact Brain Sentinel

to determine whether a replacement is needed.

B. DO NOT USE IN A MAGNETIC RESONANCE IMAGING (MRI) SYSTEM

The SeizureLink System is not safe for use during or near an MRI scan. Do not allow any part of the

SeizureLink System in or near an MRI system.

C. RADIO FREQUENCY (RF) ENERGY

The SeizureLink System contains a transmitter and receiver of RF energy through an antenna located on

the inside of the sEMG monitor below the status LEDs.

The SeizureLink System is designed, tested, and manufactured to comply with regulations governing

radio frequency emissions. There is no known electronic equipment with which the SeizureLink System

interferes. However, if the wireless transmitters and/or other electrical circuits in the system are

suspected of causing interference in other electronic equipment, take the following precautions:

- Increase the physical distance between the SeizureLink System and the equipment you suspect

may be experiencing RF energy interference

- Always beware of locations that restrict the use of RF devices

For Use During Usability Study only

OVERVIEW

Page 4

D. UNINTERRUPTED BLUETOOTH CONNECTIONS

In order to ensure continuous monitoring, a Bluetooth connection must be maintained between the

monitor and the Bluetooth device on which the app has been loaded (i.e phone, tablet, etc...). This will

help ensure uninterrupted, active alerting of potential GTC seizure activity when the sEMG monitor is in

use and properly placed on the belly of the biceps.

If the SeizureLink System is out of Bluetooth range, an alarm will sound on the mobile device for the

Hero and the Caregiver, and real-time alerting will be interrupted. Remote seizure alerts will only be sent

when the SeizureLink System is connected to the internet for both Caregivers and Heroes. Caregivers

should take additional measures to ensure Hero safety when a GTC seizure occurs. Whether or not the

SeizureLink System is connected to Bluetooth, the SeizureLink System is not a substitute for adequate

supervision or medication. A competent, responsible, trained Caregiver needs to be present to provide

assistance to the Hero when the SeizureLink System alarms.

E. SYSTEM SECURITY

Brain Sentinel uses commercially available best practices to secure the data that is transmitted to our

servers.

F. ADDITIONAL NOTES ABOUT THE PROPER USE OF SEIZURELINK

1. The System is not to be used for recognizing partial onset seizures that do not secondarily

generalize.

2. The System does not predict sEMG signals that may be associated with GTC seizures.

3. The safety and effectiveness of the SeizureLink System has not been established in recognizing

sEMG signals that may be associated with seizures other than a GTC seizure.

4. Connecting the USB connector on the SeizureLink charger to equipment not authorized by Brain

Sentinel can result in unacceptable hazards to the operator, and can damage the SeizureLink

System as well as the unauthorized equipment.

NOTE OF ADHESIVE ALLERGY:

DO NOT USE IF THE HERO IS ALLERGIC TO ADHESIVES!

For Use During Usability Study only

OVERVIEW

Page 5

What’s

in the Box

Everything you need to get the SeizureLink System set up quickly

(ﬁgure 2a)

• 1 SeizureLink biceps monitor

• 32 Electrodes

• 2 EZ Battery Trays

• 1 Charging dock

• 1 Wall and USB charger (110-220V)

• 1 Quick start guide

There is no additional charge for alarms and alerts.

QUICK START GUIDE

LIST OF ITEMS IN THE BOX

1 SeizureLink biceps monitor

32 Electrodes

2 EZ battery trays

1 Charging dock

1 Wall and USB charger (110-220V)

Quick Start Guide

The free app is available on

Google Play and Apple App store

SeizureLink™ monitors for muscle activation and it is not a medical device nor is it cleared by

the FDA for medical device application. It is not cleared to monitor, treat, diagnose or prevent a

medical condition. Use of SeizureLink is not a substitute for professional medical advice concerning

your condition or medical treatment for you. Please consult your physician or your healthcare

provider to ask questions, discuss your condition and the options for you.

1. Account Setup

- Download the SeizureLink App on the Google Play store or the

Apple Store.

- WEARER: Open the app. Press “Create Account”

(Figure 1)

. Follow the

instructions until you get to the “Device Setup” screen.

- CAREGIVER: Open the app. Press “Create Account”

(Figure 1)

. Follow

the instructions until you get to the “Device Setup” screen.

2. Proper Placement of the

SeizureLink Monitor

- EZ battery tray should be fully charged before use.

- Get an electrode patch. Snap it to the back of your SeizureLink monitor.

- Clean the skin on the biceps before adding your electrode patch.

Skin should not have lotion and should NOT be cleaned with

alcohol, as these can interfere with the connection between the

skin and the electrode.

- Find the belly of the biceps by ﬁnding your highest peak when ﬂexing

your biceps muscle. Remove the plastic backing of the electrode

patch and place it on the top of the belly of the biceps muscle.

- Turn on the monitor by pressing the button until you hear it beep.

- Turn on Bluetooth on your mobile device.

- Push the button 3 quickly times on the monitor then follow the

instructions on the app.

- Click “START DISCOVERY” on the app to sync your SeizureLink.

- Once the monitor is connected to the app, it should read

Congratulations, your SeizureLink monitor is now linked for monitoring.”

- If you get the screen that says “Whoopsie! That didn’t go as planned.”

See Section 5. Troubleshooting:

3. Managing Caregivers

- Open up the SeizureLink App and go to “Settings”.

- Click “Manage Caregivers”.

- Click “Add New” to add a new Caregiver to your SeizureLink System.

- Complete the form on the “Enroll Caregivers” and invite up to 10

Caregivers by their email address.

- If the Hero does not have a phone, the Primary Caregiver should

create a wearer account instead of a Caregiver one. The Hero should

stay within Bluetooth range of the phone they were set up on in order

to continue monitoring.

4. Testing Your

SeizureLink Monitor

- For your Caregiver to receive seizure alerts, they must accept the

Caregiver request sent by the Hero. To do this, the Caregiver must

log into the app, go to settings, then click “Manage Caregiver

Requests”. Next, click the image of the Hero and hit “Connect”

(Figure 2).

- To test your, press the button once until you hear it beep. The

Caregiver should receive a phone call as well as notiﬁcations. You can

turn it off by pressing the button twice quickly.

- To stop the alert, press the button twice quickly.

5.Troubleshooting

- If you are having issues connecting your app to your monitor or if your

Caregiver is not receiving alerts, make sure the following items have

been done:

• Bluetooth is turned on

• The monitor is powered on

• The Caregiver accepted your request in their app

- If you still have issues, try restarting the app and your monitor.

- If that does not work, try logging out, then log back into the account.

- If all of those items do not work, email us at

[email protected]

6. About the Electrode Patches

- Electrode patches should be changed every 24 hours: Any time the

SeizureLink monitor is removed from the Hero’s arm, or whenever a

loose electrode alarm occurs.

- Electrode patches need to be stored in a cool, dry place. Electrode

patches are not waterproof. Exposure to water or excessive sweat may

cause the patch to come off the biceps. When replacing an electrode

patch it is a good idea to alternate on which arm you are wearing the

monitor to limit skin integrity issues. To change an electrode patch:

- Step 1: Turn OFF the SeizureLink monitor by pressing the button for

4 seconds.

- Step 2: Unsnap the monitor from the used electrode patch.

- Step 3: Gently remove the patch by rolling the adhesive away from

the skin. Discard the used patch as regular household waste.

- Step 4: Clear any adhesive residue left on your arm.

- Step 5: Snap a new electrode patch into the SeizureLink monitor.

- Repeat Section 2: “Proper Placement of the SeizureLink Monitor” to

place a new electrode on your biceps.

7. Changing the EZ Battery Tray

- The EZ battery trays are designed to last a maximum of 24 hours, and

changing them can be done while still wearing the monitor. To change

the EZ battery tray, follow the steps below:

- Turn OFF the SeizureLink monitor by pressing the button on the

device for 4 seconds.

- Remove the EZ battery tray on the side of the SeizureLink monitor.

- Remove a fully charged battery tray from the SeizureLink charging dock.

- Slide the fully charged EZ battery tray into the SeizureLink monitor

until it snaps into place.

- Turn ON the SeizureLink monitor by pressing the button on the

monitor. Make sure it is synced with your app.

- Slide the Discharged EZ battery tray in to the charging Dock to

recharge.

Figure 1

Create Account

Figure 2

Connect with Hero

Figure 3

Home Screen

SeizureLink

System

Condition

Troubleshooting Tips

Active

Monitoring

Status

Blinks

Green -

If it blinks green every

5 seconds, the Hero is

connected correctly and

is being monitored for

potential GTC seizure

events.

Signal is

Detected -Blinks

Green

A small amount of signal

is detected.

Approaching

Threshold - Orange

sEMG signal is

approaching the seizure

threshold. Seizure alarm

may sound soon.

Seizure

Alarm - Red

The right light goes

red when above the

threshold- if at red for

5 seconds a seizure will

alarm.

Battery Low Blinks

Orange -

The battery being used

is critically low and

should be replaced with

a fully charged battery.

SeizureLink Monitor

SINGLE BUTTON TO:

• Power ON/OFF

• Set Off Alarm

• Stop Alarm

EZ BATTERY

TRAY

TWO LED

INDICATOR

LIGHTS

TOP OF THE

MONITOR

BOTTOM OF

THE MONITOR

- When not in use, keep the extra EZ battery trays in the charging

dock for recharging.

- Do NOT submerge the SeizureLink monitor in water, including

in a bathtub

- Do NOT shower while wearing the SeizureLink monitor.

- Make sure the SeizureLink is placed on the belly of the biceps

muscle.

- Order additional electrodes at SeizureLink.com

- For additional questions or system troubleshooting, contact us at

[email protected].

Helpful Reminders

Accessories

Electrode Patch

Charging Dock

EZ Battery Tray with

Rechargable Batteries

Wall and USB Charger

CSLBL0006.001 Date: 08/2018

[email protected]

Belly

of the

Biceps

2a Box contents

Box with 32 Electrode patches

For Use During Usability Study only

OVERVIEW

Page 6

2.1 sEMG Monitor

The SeizureLink monitor runs on an internal, rechargeable EZ battery

tray, if fully charged, the battery can provide up to 24 hours of alerting

before needing to be recharged.

When a generalized tonic-clonic seizure is analyzed, the monitor alarms

and sends out a real-time alert to the SeizureLink app on a mobile

device. This alert goes out to Caregivers so that help can arrive as

soon as possible. The recognized event gets logged into a seizure diary

so that details can be added to it later and shared with Caregivers or

physicians.

The SeizureLink algorithm is muscle activated. It recognizes an electrical

(electromyography) signal that comes on from the motor cortices of the

brain. Since we recognize it on the skin surface over the biceps, it is

more properly known as surface electromyography, or sEMG.

The SeizureLink algorithm can sense when the muscles clench and

tighten during the tonic phase of seizure, which is the part when there

is little or no movement. Active recognizing for seizure activity occurs at

a rate of 1024 Hz, meaning 1,024 times per second.

The SeizureLink monitor is discreet. It weighs only one ounce and is

roughly the size of a sugar packet. The monitor is durable and child-

friendly

(Figure 2b)

2.2 Electrodes

The electrode patch is latex-free and made of white, spunlace, non-

woven polyester fabric. The electrode patch has a triode conﬁguration

that provides physical contact to three equally spaced points on the

skin of the Hero’s biceps. Each electrode is designed to be used for

24 hours. Usage and activities of the Hero may require more frequent

replacement. When removing the electrode patch, take care to pull it

away gently to avoid skin irritation. Make sure to alternate the arm

used for alerting. If the electrode patch is removed and the skin shows

redness or irritation that does not improve after 24 hours, contact

your physician. If the Hero has a known allergy to adhesives and/

or conductive hydrogels, shows signs of an allergic reaction to the

electrode patch, consult the physician’s ofﬁce immediately

(Figure 2c)

Prolonged exposure to air, heat, or sunlight will prematurely dry out the

hydrogel. For this reason, the unused electrode patches should be kept

in the resealable bag and stored in a cool location out of direct sunlight.

Note: Store Electrode patches in a cool, dry place out of direct sunlight.

2c sEMG Electrode Patches

Triode Conﬁguration

Belly

of the

Biceps

For Use During Usability Study only

OVERVIEW

Page 7

• The electrode patch should never be applied to wet, irritated or

broken skin

• The electrode patch may damage the skin if removed carelessly

• Discontinue use and consult your physician if any of the following

occur:

- Redness, itching or discomfort that persists for more than

24 hours after removal

- Skin discoloration

- Blisters forming near the patch

- Bruising at the electrode site

- Tearing of the skin

A. CHANGING THE ELECTRODES

Electrode patches should be changed every 24 hours, any time the

SeizureLink monitor is removed from the Hero’s arm, or whenever a

loose electrode alarm occurs. Electrode patches are not waterproof;

exposure to water or excessive sweat may cause the patch to come

off. When replacing an electrode patch, it is a good idea to alternate the

wearing arm to give your skin a break.

To change an electrode patch:

1. Turn OFF the SeizureLink monitor by pressing the button and

holding for 4 seconds

(Figure 2d)

2. Unsnap the monitor from the used electrode patch

(Figure 2e)

3. Gently remove the patch by rolling the adhesive away from the skin

(Figure 2f).

Discard the used patch as regular household waste.

4. Clear any adhesive residue left on your arm

(Figure 2g)

5. Snap a new electrode patch into the SeizureLink monitor.

(Figure 2h)

2f Removing the Electrode Patch

2d Turn off device

2g Clear adhesive left on the arm

2e Unsnap Electrode Patch from monitor

2h Snap a new Electrode Patch into monitor

For Use During Usability Study only

OVERVIEW

Page 8

2.3 Rechargeable EZ Battery Tray

The lithium-ion polymer EZ battery trays are rechargeable and designed

to last a maximum of 24 hours

(Figure 2i)

If the EZ battery tray is low, the Left LED light on the monitor will blink

orange to indicate that the EZ battery tray is critically low and should be

replaced with a fully charged EZ battery tray. When not in use, keep the

extra EZ battery trays in the charging dock for recharging.

Keep batteries away from children. If the EZ battery tray compartment

does not close securely, stop using the product and keep it away from

children.

NOTE: DO NOT INGEST EZ BATTERY TRAY. IF YOU THINK EZ BATTERY

TRAYS MIGHT HAVE BEEN SWALLOWED, SEEK IMMEDIATE

MEDICAL ATTENTION.

CHANGING THE EZ BATTERY TRAYS

The EZ battery trays are designed to last approximately 24 hours.

Changing them is simple and can be done while still wearing the

monitor. To change the EZ battery trays, follow the steps below:

1. Turn OFF the SeizureLink monitor by pressing the button on

the system and holding for 4 seconds

(Figure 2d)

2. Remove the EZ battery tray on the side of the SeizureLink

monitor

(Figure 2i)

3. Remove a fully charged EZ battery tray from the SeizureLink

charging dock

(Figure 2j)

4. Slide the fully charged EZ battery tray into the SeizureLink

monitor until it snaps into place

(Figure 2k)

5. Turn ON the SeizureLink monitor by pressing the button on

the monitor. Make sure it is synced with your app

(Figure 2l)

6. Slide the Discharged EZ battery tray in to the charging dock

to recharge the battery

(Figure 2m)

2k Slide fully charged EZ battery tray into monitor

2i Remove the EZ battery tray

2l Turn on monitor

2m Slide the discharged EZ Battery tray

in to the charging dock

2j Remove charged EZ battery trays from

charging dock

For Use During Usability Study only

OVERVIEW

Page 9

2.4 Charging Dock

The charging dock is designed to recharge the two SeizureLink EZ

battery trays at the same time

(ﬁgure 2n)

. The unit contains charging slots

on either side, one for each EZ battery tray. While the device itself is not

charged on the dock, it can ﬁt on top of the charging dock as a storage

system when the device is not being worn by the Hero. The EZ battery

trays click into the dock the same way they click into the unit, so there

is no concern about proper EZ battery tray placement. See the section

above,

Changing the EZ battery trays

, for more information.

Battery status is communicated from the SeizureLink device to the app

only, not from the charging dock. The charging dock has LED indication

lights to indicate effective battery recharging. The lights glow bright

enough to be seen in the daytime and just bright enough at night to be

seen but to not be a distraction during sleep.

The lights are the only form of communication between the dock and the

user. Here are the three things these two lights communicate:

LED Light Communication

Solid

The EZ battery tray is fully charged

Solid

The EZ battery tray is charging

Solid

The dock is plugged in and there is no EZ battery tray in the charger.

2n. Charging Dock

For Use During Usability Study only

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