Brain Sentinel SLU01-90001 SeizureLink User Manual
Brain Sentinel SeizureLink Users Manual
Users Manual
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| Date Submitted | 2018-08-29 00:00:00 |
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SeizureLink Alerting System User Manual This user manual is intended for use in the USA only. OVERVIEW For Use During Usability Study only 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.”1 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, overthe-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 OVERVIEW For Use During Usability Study only 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! - 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 SLSupport@brainsentinel.com. Helpful Reminders Charging Dock 2a Box contents SLSupport@BrainSentinel.com CSLBL0006.001 Date: 08/2018 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. Wall and USB Charger Signal is Detected Status Active Box with 32 Electrode Monitoring patches Electrode Patch EZ Battery Tray with Rechargable Batteries Blinks Green If it blinks green every 5 seconds, the Hero is connected correctly and is being monitored for potential GTC seizure events. Blinks Green A small amount of signal is detected. SeizureLink System Condition 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. The free app is available on Google Play and Apple App store 1 SeizureLink biceps monitor 32 Electrodes 2 EZ battery trays 1 Charging dock 1 Wall and USB charger (110-220V) Quick Start Guide LIST OF ITEMS IN THE BOX Troubleshooting Tips BOTTOM OF THE MONITOR EZ BATTERY TRAY SINGLE BUTTON TO: • Power ON/OFF • Set Off Alarm • Stop Alarm TWO LED INDICATOR LIGHTS QUICK START GUIDE TOP OF THE MONITOR Accessories SeizureLink Monitor 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 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 Belly of the Biceps • 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 SLSupport@brainsentinel.com There is no additional charge for alarms and alerts. • 1 Quick start guide 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. • 1 Wall and USB charger (110-220V) • 1 Charging dock • 2 EZ Battery Trays Figure 1 Create Account Figure 2 Connect with Hero Figure 3 Home Screen 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 • 32 Electrodes • 1 SeizureLink biceps monitor 7. Changing the EZ Battery Tray Everything you need to get the SeizureLink System set up quickly (figure 2a): - 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: - 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: - 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. What’s in the Box Page 5 For Use During Usability Study only OVERVIEW OVERVIEW For Use During Usability Study only 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. Belly of the Biceps 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 childfriendly (Figure 2b). 2.2 Electrodes The electrode patch is latex-free and made of white, spunlace, nonwoven 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). 2c sEMG Electrode Patches Triode Configuration 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. OVERVIEW For Use During Usability Study only 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 2d Turn off device • 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 2e Unsnap Electrode Patch from monitor 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). 2f Removing the Electrode Patch 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). 2g Clear adhesive left on the arm 2h Snap a new Electrode Patch into monitor OVERVIEW For Use During Usability Study only 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). 2i Remove the EZ battery tray 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. 2j Remove charged EZ battery trays from charging dock 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). 2k Slide fully charged EZ battery tray into monitor 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). 2l Turn on monitor 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). 2m Slide the discharged EZ Battery tray in to the charging dock OVERVIEW For Use During Usability Study only Page 9 2.4 Charging Dock 2n. 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 Solid Communication The EZ battery tray is fully charged The EZ battery tray is charging Solid The dock is plugged in and there is no EZ battery tray in the charger. Solid USAGE For Use During Usability Study only Page 10 Monitoring with the SeizureLink System Belly of the Biceps 3a. Correct Positioning of the SeizureLink on the Biceps 3.1 Electrode Placement For proper placement of the SeizureLink monitor, center the monitor directly over the belly of the biceps muscle of the arm. To find the belly of the biceps, bend your arm at the elbow and make a fist. The belly of the biceps is the thickest part of the muscle, about halfway between your shoulder and elbow (Figure 3a). Since the monitor works by continuously sensing and recognizing sEMG signals, this placement is essential to ensure proper alerting in order to receive seizure notifications. The SeizureLink monitor should not be worn on any body location other than the biceps muscle. The monitor can be worn on either the left or right biceps. Prior to placement on the biceps, remove the naturally occurring oils on the surface of the skin. This will ensure that the electrode patch has good skin contact and that it stays properly in place on the arm. You can wash the biceps with soap and water, then completely dry to remove any oils from the skin. Placement Tips: -- Make sure to snap SeizureLink monitor to the electrode patch before attaching to arm. -- Do not attach the SeizureLink system to wet skin. -- Do not use alcohol to prep the skin; the alcohol will react with the electrode gel and may cause skin irritation. -- Never apply an electrode patch to irritated or broken skin. -- Consult your physician if skin irritation or skin discoloration persists for more than 24 hours. USAGE For Use During Usability Study only Page 11 After the skin is properly prepared, follow these instructions: 1. Take one electrode patch from the box. 2. Reseal the packaging to protect the unused electrode patches. 3. Store the unused patches in a cool, dry place out of the sun. 4. Turn the SeizureLink monitor over; on the back of the unit you will see 3 electrode sockets. 5. Take the electrode patch and secure all three snaps into the sockets of the SeizureLink monitor. 6. There is an audible small click when each snap is secured properly. 3.2 Understanding The Buttons and LED Indicators The SeizureLink monitor has one active button and two LED indicator lights. The single button is used to power the unit on and off, and to set off the alarm. Function Turn On Access using the Single Button (figure 3.b) Press once Call for Help / Test Alarm Press once (When already on) Turn Off a Seizure Alarm Press twice quickly Turn Off Hold down 4 seconds Become Discoverable when linking to Bluetooth Press 3 times quickly A. MANUAL SEIZURE ALARM BUTTON When a Hero or Caregiver presses the Manual Seizure Alarm Button on the front of the unit, a Seizure Alarm is triggered. The SeizureLink monitor will sound an alarm and communicate the alarm to the Hero’s alerting device and to all Caregivers. (Figure 3b). TOP Single Button Two Led Indicator lights BOTTOM 3b. sEMG monitor Button and Lights USAGE For Use During Usability Study only Page 12 B. CANCEL BUTTON: STOPPING THE MONITORING SESSION The small button on the face of the SeizureLink monitor can be pressed 2 times quickly to cancel the seizure alarm. C. LED INDICATOR LIGHTS When the unit is in active alerting status, the left LED light will blink green. It will continue to blink green every 5 seconds, indicating the Hero is connected correctly and is being monitored for potential GTC seizure events. The right LED light will shine green when a signal is recognized. When the Hero is approaching the seizure threshold, the right LED light will shine orange to indicate that the sEMG signal is approaching the seizure threshold. An orange light indicates that the seizure alarm may sound soon. When the right LED light is red, this indicates a seizure alarm, meaning the sEMG has gone above the threshold. If the light remains red for 5 seconds, a seizure alarm will activate. Finally, when the unit has a low battery, the left LED light will blink orange to indicate that the battery being used is critically low and should be replaced with a fully charged EZ battery tray from the charging dock. When not in use, keep the extra EZ battery trays in the charging dock for recharging. D. sEMG MONITOR LED INDICATORS SeizureLink System Condition Troubleshooting Tips Active Alerting Status Blinks Green If it blinks green every 5 seconds, the Hero is connected correctly and is the algorithm is checking for potential GTC seizure events. A small amount of signal is recognized. Signal is Recognized Blinks Green sEMG signal is approaching the seizure threshold. Seizure alarm may sound soon. Approaching Threshold Solid Orange The right light goes red when above the threshold- if at red for 5 seconds a seizure will alarm. Seizure Alarm Solid Red The battery being used is critically low and should be replaced with a fully charged battery. Battery Low Blinks Orange USAGE For Use During Usability Study only Page 13 Managing the App This section provides information on how to get the app, create an account, sync it to the SeizureLink monitor, and how to set up the app for Caregiver use. When a generalized tonic-clonic seizure is analyzed, the monitor alarms and sends out a real-time alert to the aleting 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 on the Hero’s phone so that details can be added to later and shared with Caregivers or physicians. 4.1 Account Setup Both the Caregiver and Hero should download the free SeizureLink app from either the Google Play or the Google App store. Once the app is downloaded, open the app. Press “Create Account” (Figure 4a). A. FOR THE HERO 4a. Account Setup Follow the instructions until the “Device Setup” screen appears. Ensure proper placement of the SeizureLink monitor. See section 3.1 for proper placement instructions. Correct placement is important for the SeizureLink monitor to function properly. 4.2 Syncing The App and The Seizurelink Monitor A. FOR THE HERO After the SeizureLink monitor is properly placed on the Hero’s arm: 1. Turn on the monitor by pressing the button until it beeps. 2. Click “START DISCOVERY” on the app to sync the SeizureLink monitor (Figure 4b). 3. Press the button 3 times quickly on the monitor then follow the instructions on the app. 4. Once the monitor is connected to the app, it should read “Congratulations, your SeizureLink monitor is now linked for monitoring.” 4b. Syncing App to the SeizureLink monitor 5. If you get the screen that says “Whoopsie! That didn’t go as planned”, see the Troubleshooting section in this manual. USAGE For Use During Usability Study only Page 14 6. To test the SeizureLink monitor, press the button once to activate the alarm. 7. To end the alarm, press the button twice quickly. 4.3 For Managing Caregivers When a generalized tonic-clonic seizure is recognized, the monitor alarms and sends out a real-time alert to the monitoring 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 the seizure diary on the Hero’s phone to provide details to later share with Caregivers or physicians. 4c. Manage Caregivers - Add New After the monitor alerts with lights and an audible alarm, the SeizureLink System uses Bluetooth connectivity to send alerts to Caregivers via the smartphone app. The mobile app connects the Hero to Caregivers, manages the seizure diary, creates reports, and includes location-based services. A. FOR THE HERO The app has a special feature for adding and managing Caregivers: 1. Folllow the account creation instructions on the app until you make it to the home screen of the app. 2. Open the SeizureLink App and go to “Settings”. 3. Click “Manage Caregivers”. 4. Click “Add New” to add a new Caregiver to your SeizureLink System (Figure 4c). 5. Complete the form on the “Enroll Caregivers” page and invite them by their email address (Figure 4d). 6. Heroes (wearers) can invite up to 10 Caregivers. NOTE: Caregivers must accept the Caregiver request within the SeizureLink app before they can begin receiving seizure alerts. 4d. Enroll Caregivers form USAGE For Use During Usability Study only Page 15 B. FOR THE CAREGIVER Once the Hero invites a Caregiver using their email that is associated with their SeizureLink profile, the Caregiver should follow these instructions. 1. Log on to the SeizureLink App using your username and password you created upon setup. 2. Go to “Settings,” then click on “manage Caregiver requests” (Figure 4e). 3. If the Hero sent an invitation, you should see their profile picture. Click on their profile then hit the accept button at the bottom of the screen. 4. You are now ready to receive alerts. 4.4 Managing The SeizureLink Phone Call 4e. Settings Screen A. FOR THE CAREGIVER When the SeizureLink Alarm sounds, the Caregiver(s) will also receive a phone call letting them know that the Hero is having a seizure. There are a few things to do to make sure the phone call always comes through. • Save the Phone number: The number that will call you during a seizure alarm is (210) 981-5606 (Figure 4f). Save this number as a contact that you will remember. Ex. Seizure Alert. • Make the Number a favorite: If you ever put your phone on do not disturb, you may still want to receive a call if your loved one is experiencing a seizure. Make the Seizure Alert contact a favorite so that it will come through, even if your phone is in “Do Not Disturb” mode. • Check Your Voicemail: If a phone call is missed, the SeizureLink Alert Call will leave a voicemail on the Caregiver’s and Hero’s phone communicating that the Hero is having a seizure. 4f. Phone Call Alarm USAGE For Use During Usability Study only Page 16 4.5 How To Change Your Profile Photo If you want to change the profile photo in the SeizureLink app follow these steps. 1. Login to the SeizureLink app. 2. Click on “profile” on the left hand side (Figure 4g). 3. Click on the photo to change to a different photo. 4. Next select either “Choose Photo,” to select from the photos on the phone or “Take Selfie” To take a photo to add to the profile now. 4.6 What Happens During A Seizure Alarm? A. FOR THE HERO 4g. Menu - Profile When the Hero is experiencing a seizure, or testing the alarm, there are a few things that will happen. I. During the Seizure Alert: 1. The SeizureLink monitor will audibly sound. 2. The mobile app will audibly sound if the phone’s sound is turned on. 3. The Hero’s phone will display the alarm screen along with the amount of time since the seizure was recognized (Figure 4h). 4h. Hero Screen During Seizure Alarm The screen gives the Hero the option to choose one of the three options: -- SILENCE – Quiets the alarm on the phone, but the seizure alarm screen will still show until either “False Alarm” or “Seizure Ended” is selected -- FALSE ALARM – Stops the alarm on the phone and takes the Hero back to the home screen. Alarm ends and seizure ended notification is sent to the Caregiver -- SEIZURE ENDED – Stops the alarm on the phone and takes the Hero to the post-ictal survey; Caregiver alarm ends and goes to the post-ictal survey as well (Figure 4j) NOTE: The SeizureLink monitor will continue to sound until the button on the device is pressed two times. USAGE For Use During Usability Study only Page 17 II. After the Seizure Alert: 1. The post-ictal survey will appear, and it will ask a few questions to assess the Hero after the seizure. 2. Once the information is recorded, it is stored into the seizure diary on the Hero’s app. B. FOR THE CAREGIVER The Caregiver has a few things that happen on their phone when the seizure alert is sounding (Figure 4i). I. During the Seizure Alert: 1. The Caregiver will receive a notification saying “(Hero’s Name) seizure alarm has gone off. Time since monitor alert: X Phone’s location is: X”. 4i. Hero Screen During Seizure Alarm 2. The Caregiver will receive a phone call from (210) 981-5606 that tells them the Hero is having a seizure. 3. If they do not answer the call, the Caregiver will receive a voicemail. 4. If the SeizureLink App is open, the Caregiver will get the Caregiver Alarm Screen with four options: -- I Cannot Respond -Goes back to home screen – no postictal survey -- Silence – Quiets alarm, but stays on the alarm screen until the seizure ends -- False Alarm – Goes back to home screen – no post-ictal survey -- Confirm Seizure – Stops the alarm, and goes to post-ictal survey (Figure 4j) II. After the Seizure Alert: 1. The Caregiver will receive a notification letting them know that the seizure ended. 4j. Post-Ictal 2. If the Caregiver clicks the “Confirm Seizure” button, they are taken to the post-ictal screen where they answer questions regarding the Hero’s condition after the seizure. This is later saved in the Hero’s seizure diary. USAGE For Use During Usability Study only Page 18 4.7 Seizure Diary The seizure diary is a log of recognized seizure events (Figure 4k). The Hero can see all diary events and can edit events to add important information about the seizure event. The app even creates a diary report. Simply select a start and end date to generate a report of all events during that date range. The report can be emailed to the email address associated with the Hero’s app account (Figure 4l). 4.8 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 4k. Seizure Diary • 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, feel free to email us at SLSupport@brainsentinel.com Ordering/Reordering Information You can request additional components by contacting Brain Sentinel’s Hero Support Team at SLSupport@brainsentinel.com 4l. Seizure Diary Report ADDITIONAL INFORMATION For Use During Usability Study only Page 19 Technical Specifications 5a Technology: surface electromyography (sEMG) 5.1 Monitor • Cover is made of acrylonitrile butadiene • Weight: 1 ounce (29 grams) • Dimensions: Width=1.7 in / 44mm Height=2.5 in / 64mm Depth = 0.6 in / 15mm 5.2 Electrode • Each electrode is single-use and designed for 24-hour use • Skin contact material is a skin-friendly hydrogel that is latex free ADDITIONAL INFORMATION For Use During Usability Study only Page 20 5.3 EZ Battery Tray • 200mAh rechargeable battery • Lithium-ion polymer construction • Lasts for approximately 24 hours before needing to be recharged 5.4 Connectivity • Bluetooth: 4.1 • Mobile app compatibility & availability: Android, iOS • Location-based services via the phone application included • Connected to multiple Caregivers Customer Support For customer support contact us at SLSupport@brainsentinel.com. Changes or modifications not expressly approved by Brain Sentinel could void the user’s authority to operate the equipment. FOR USE DURING USABILITY STUDY ONLY FCC ID: 2AG2I-SLU01-90001 This device complies with Part 15 of 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. 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. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. www.SeizureLink.com CSLBL0007
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