Use Instructions

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IMPACT MONITOR MOUTHGUARD

| Gen 1.3 Instructions for Use |

Revision 1.3.1

Table of Contents

PRODUCT DESCRIPTION ........................................................................2

SETUP AND USE OPERATIONS ...................................................................2

WARNINGS & CAUTIONS ........................................................................3

IMM TECHNICAL SPECIFICATIONS ...............................................................4

INDIVIDUAL CHARGER CASE TECHNICAL SPECIFICATIONS ...........................................5

TEAM CHARGER CASE TECHNICAL SPECIFICATIONS .................................................5

PORTAL SETUP ...............................................................................6

LOGGING IN ..............................................................................6

ORGANIZATION SETUP ......................................................................7

ROSTERING ATHLETES ......................................................................7

TEAM APP INITIAL SETUP .....................................................................8

LOGGING IN ..............................................................................8

ASSIGNING IMPACT MONITOR MOUTHGUARDS .......................................................9

IMPACT MONITOR MOUTHGUARD INITIAL FIT ......................................................9

IMPACT MONITOR – CHARGING .................................................................12

CHARGING WITH TEAM CASE ................................................................13

TEAM CASE AUXILIARY CHARGING PORT ......................................................13

IMM OPERATION .............................................................................14

SYNCING BEFORE AND AFTER USE ...........................................................14

FUNCTIONALITY CHECK ....................................................................14

CONDITIONS FOR IMPACT DETECTION ........................................................14

TEAM APP OPERATIONS .......................................................................15

IMM FIRMWARE UPDATE ....................................................................15

TEAM ROSTER PAGE .......................................................................15

ATHLETE DETAIL .........................................................................19

TASKS PAGE .............................................................................21

PORTAL OPERATIONS .........................................................................22

REPORTING SCREEN .......................................................................22

SYSTEM TROUBLESHOOTING ....................................................................23

Summary of content (23 pages)

PAGE 1
IMPACT MONITOR MOUTHGUARD | Gen 1.3 Instructions for Use | Revision 1.3.1 Table of Contents PRODUCT DESCRIPTION ........................................................................2 SETUP AND USE OPERATIONS ...................................................................2 WARNINGS & CAUTIONS ........................................................................3 IMM TECHNICAL SPECIFICATIONS ...............................................................
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PRODUCT DESCRIPTION The Prevent Biometrics head impact monitor system comprises an impact monitor mouthguard (IMM), a tablet or smartphone with installed app that communicates with the IMM(s) to monitor head impacts in real time, and individual and team charging cases that wirelessly charge the IMM. The impact monitor measures impact force and location and reports them via the app interface for use by team personnel.
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WARNINGS & CAUTIONS            The head impact monitor is not a replacement, substitute or adjunct of any existing methods for identifying athletes for evaluation due to head impacts. The head impact monitor does not indicate, diagnose or assist in diagnosis of a concussion. Impact data is used to indicate to staff that an impact event has occurred and reliably measure it. The head impact monitor does not provide any protection against head impacts.
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IMM TECHNICAL SPECIFICATIONS Performance Impact Detection Accuracy ± 5% False Positive Filtering 99% Range of Impact Detection ± 200 g Sample Rate 3200 Hz BLE Range 60 ft (18.28 m) Impact Data Storage 450 Impacts Mechanical Outer Material Food or Medical Grade Polyurethane and EVA Size (L, W, H) and Weight 6.5” x 5.0” x 2.
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INDIVIDUAL CHARGER CASE TECHNICAL SPECIFICATIONS Power supply Voltage input (DC Volts) 4.5-5.5 Maximum current draw (Amps) 0.5 Mechanical Material Polypropylene Size (L, W, H) and Weight 3.5” x 3.75” x 1.
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PORTAL SETUP The first step in the process of setting up your impact monitor system is to gain access to the portal. The portal is where most administrative functions are performed, including populating your team roster so that impact monitors can be assigned to players. At the time of purchase, Prevent staff will invite you to create an account to access the portal. LOGGING IN Once Prevent staff have set up your organization in the portal, you will receive an email inviting you to create an account.
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ORGANIZATION SETUP On first entry to the portal, a setup wizard will guide you through your initial setup of your organization, first teams, and team staff.
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TEAM APP INITIAL SETUP The team app is the “Dashboard” for the impact monitor system. Most operations with the impact monitor are done with the team app, including viewing data and alerts, updating firmware, and checking the health of the impact monitors. This section will walk you through initial setup of the team app. LOGGING IN During organization setup in the portal, you will see a link to download the app. The can also be downloaded from the Apple App Store by searching for “Prevent”.
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ASSIGNING IMPACT MONITOR MOUTHGUARDS First, select the team you would like to view from the drop-down menu at the top of the app. Each monitor has a unique serial number that identifies data sent to the team app. Before beginning use, each monitor must be assigned to a player. Begin by selecting the team of interest within the team app. Click the Assign Monitor button attached to the player you would like to assign a monitor to.
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Boil water - Boil enough water to a boil to completely cover the IMM. Ensure the water is at a rolling boil. Heat IMM – Using a slotted spoon or tongs, suspend in the water for exactly 50 seconds. Have a timer ready and do not exceed 50 seconds. Remove IMM - Remove the IMM from the water. Shake any remaining water off, and immediately proceed to the next step. Any delay will negatively affect fit. Center & Fit – Carefully center the IMM in your mouth and firmly press the IMM onto the upper teeth.
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Bite – Bring the lower jaw up to a comfortable position and bite down firmly, ensuring that you bite all the way through the soft dentition encasement material (blue), up to the harder dental tray (grey). Press & Suck – While biting down, suck in continually and press (with 2-4 fingers) on the front of the IMM for 30 seconds, pushing the front teeth up to the front of the IMM. Wait – While continuing to bite down, leave the IMM in your mouth for an additional 30 seconds.
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IMPACT MONITOR – CHARGING Charging Case If the blue IMM tooth-molding material is sticking out past the end of the IMM and is interfering with the ability to push the IMM all the way back in the alignment slot, it can be trimmed with scissors. Caution: Only trim the blue IMM tooth-molding material. Do not trim the clear or gray material. Place the IMM in the charging case and securely close the lid. Ensure the IMM is pushed all the way down in the charging case, as shown in the photo.
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CHARGING WITH TEAM CASE Plug the charging case into any slot in the team case. Ensure the team case is plugged into mains power. TEAM CASE AUXILIARY CHARGING PORT The team case includes an auxiliary USB charging port at the bottom of the case. The port is rated for 1A charging and can be used to charge a smartphone or tablet.
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IMM OPERATION The impact monitor is always on and active whenever it is charged. There is no preparation required after removing it from the charger. Simply wear it in your mouth like a normal mouthguard, and monitor measurements with the Prevent Team App. SYNCING BEFORE AND AFTER USE For best data results, the IMMs should be synced often with an iOS device. This is done by simply ensuring that the app is open on an iOS in proximity to the IMMs.
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TEAM APP OPERATIONS This section will lead you through the general operations of the team app once the IMMs are set up and ready to use. IMM FIRMWARE UPDATE Initially and periodically, your IMM(s) will need updated firmware. This will be evident be the appearance of an “Update” button on the player’s pane in the team app when connected to the IMM. Firmware updates are best done when on the charging system.
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To add an athlete, tap the “+” button in the top right. You will be presented with the add athlete page.
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If the barcode cannot be scanned, click the “Having Trouble?” button at the bottom of the screen to type the serial number. Once athletes are assigned, the team data view can be adjusted in the following ways: Filter by Position The team list can be filtered by position, if athletes have been input with a position assigned. Click a position in the position bar above the player list. Tap “ALL” to remove the filter.
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View Impact Quantity or Impact Load The quantity indicator next to each player can list the total quantity of impacts for the day, or the Impact Load for the day. This can be changed in the “VIEW BY” drop down. Impact Load is a composite of the quantity and magnitude of impacts for the day.
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ATHLETE DETAIL Tap on an athlete’s bar to open the Athlete Detail page.
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Impacts can be viewed within the context of Today, this Week, and this Season. To view impacts in the past, select the Season view and select a date in the past. If an IMM must be replaced, click the 3 dots in the player page and select “Unassign Monitor”: Once unassigned, the player will drop to the bottom of the team list and will now have the option to assign a new IMM.
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TASKS PAGE The Tasks page is the main interface for ensuring the IMMs are working correctly and are communicating with the iOS app. Any issues will be reported as tiles attributed to the athlete’s monitor that exhibiting an issue: Tasks are presented in the following categories:     No Connection to IMM: The IMM has not communicated with iOS for more than 15 minutes. Low Battery: The IMM is in a low battery state and should be charged as soon as possible.
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PORTAL OPERATIONS This section will lead you through general operations in the team portal, once initial setup is complete.
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SYSTEM TROUBLESHOOTING Symptom Cause Solution Red light on charger case Poor IMM alignment in case or missing IMM. Check IMM alignment in case “No Connection to IMM” Task IMM not charging or broken. Ensure proper charging. If not remedied in 20 minutes, please contact Prevent for additional troubleshooting steps or a replacement at support@preventbiometrics.com “Low Battery” Task IMM is running low on battery Return to the charger case as soon as possible.