IMPORTANT IMMWARNINGS & 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
- Do not chew, bend, twist, or jam
- Before every use, inspect the product to ensure no damage to the seal of the circuit board is evident. Discontinue use if damage is seen.
- Ensure that the impact monitor mouthguard is not subject to temperatures higher than 100 °C (212 °F). Ensure that the impact monitor mouthguard is not subject to 60 - 100 °C
(140 - 212 °F) for more than 1 minute.
- Use only the wireless charger provided with the product for
- Avoid cross contamination of impact monitor
- Clean the impact monitor mouthguard by either rinsing in cold water or using a toothbrush to remove debris while rinsing. Do not use toothpaste or detergents, and do not place in dishwasher or under hot water.
- Do not leave the impact monitor mouthguard in a hot vehicle in direct
- Do not place the impact monitor mouthguard in
- Do not operate charger
Protection Provided by the Prevent V1.4 Custom, Prevent V2.0 Custom, Prevent V2.0 Hybrid
The technical specification “prEN ‘Mouthguards for use in sports- Safety requirements and test methods’ (CEN/TC 162WI 00162245); Issue date 12/06” includes requirements for minimum protected area, surface condition free of rough surfaces and sharp edges, a test to ensure the mouthguard remains in place during activity and impacts with three increasing levels of performance: “Level 1”, “Level 2” and “Level 3”(see table 1) and as impact test which identifies the reduction in transmitted force provided by mouthguard materials for each of three increasing levels of performance: “Level 1”, “Level 2” and “Level 3” (see Table 1).
|
TABLE 1 |
Impact performance |
Retention performance |
|
Level 1 |
< 10 kiloNewtons |
>5 Newtons |
|
Level 2 |
< 7.5 kiloNewtons |
>10 Newtons |
|
Level 3 |
<5 kiloNewtons |
>20 Newtons |
Note: The lower the transmitted force, the higher the impact performance impact performance and the higher the retention force, the higher the performance. Mean transmitted force (Impact energy 4 Joules).
The Prevent V1.4 Custom, Prevent V2.0 Custom, Prevent V2.0 Hybridmeet the requirements for Level 3 for impact performance and Level 3 for retention.
MANUFACTURER’S INFORMATION FOR USER TESTING AND APPROVAL OF THIS PRODUCT
This Prevent V1.4 Custom, Prevent V2.0 Custom, Prevent V2.0 Hybrid mouthguard has been tested at SATRA Technology Centre, Kettering, UK, and conforms to the technical specification SATRA M3:2011 Issue 3. It is CE marked as a Category II product in accordance with the Essential Health and Safety requirements of the Personal Protective Equipment Regulation (EU) 2016/425 (including as amended to apply in Great Britain).
CE certification by UK Approved Body, SATRA Technology Centre, Wyndham Way, Kettering, Northamptonshire NN16 8SD, Approved Body 0321.
The Prevent V1.4 Custom, Version 2.0 Custom&Prevent Version 2.0 Hybrid are CE marked to denote compliance with the EU Personal Protective Equipment Directive 2016/425/EU.
Product Patent Protections – Mouthguard and/or Associated Mobile App
- S. Patent 9,149,227 – DETECTION AND CHARACTERIZATION OF HEAD IMPACTS
- S. Patent 9,289,176 – CLASSIFICATION OF IMPACTS FROM SENSOR DATA
- AU Patent 2011278996 – DETECTION AND CHARACTERIZATION OF HEAD IMPACTS
- AU Patent 2011278997 – CLASSIFICATION OF IMPACTS FROM SENSOR DATA
- CA Patent 2,805,252 – DETECTION AND CHARACTERIZATION OF HEAD IMPACTS
- CA Patent 2,805,250 – CLASSIFICATION OF IMPACTS FROM SENSOR DATA
- EP Patent 2,593,010 – DETECTION AND CHARACTERIZATION OF HEAD IMPACTS (Validated in GB, DE, FR, IT, and ES)
- EP Patent 2,593,015 – CLASSIFICATION OF IMPACTS FROM SENSOR DATA (Validated in GB, DE, FR, IT, and ES)
Other Patents Pending.
1.4 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 |
368 Impacts |
|
Mechanical |
|
|
Outer Material |
Food or Medical Grade Polyurethane and EVA |
|
Size (L, W, H) and Weight |
6.5” x 5.0” x 2.0”, 21 g |
|
Environmental |
|
|
Temperature (Operation) |
-20 – 60 °C / -4 – 140 °F (use) 0 – 45 °C / 32 – 113 °F (charging) |
|
Altitude (Max Operation) |
5000 meters (16,404 ft) |
|
Temperature (Shipping & Storage) |
-20 – 45° C |
|
Power |
|
|
Charging Method |
Wireless |
|
Battery Type |
Polymer Lithium-ion |
|
Battery Life (In Use, Standby) |
7 h |
|
Interface |
|
|
Impact event data transmission |
Bluetooth Connection to iOS |
|
Indicators |
Red, Yellow, Green LEDs |
1.4 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 1.0”, 60 g |
|
Environmental |
|
|
Humidity (Operation) |
65 ± 20% RH |
|
Temperature (Operation) |
0 – 45 °C / 32 – 113 °F |
|
Altitude (Operation) |
5000 meters (16,404 ft) |
|
Ultraviolet Sanitization |
|
|
UV wavelength (nm) |
280 |
|
Average UV power (mW) |
4 |
TEAM CHARGER CASE TECHNICAL SPECIFICATIONS
|
Power supply |
|
|
Voltage input (AC Volts) |
100-240 |
|
Maximum current draw (Amps) |
1.52 |
|
Mechanical |
|
|
Material |
Polypropylene |
|
Size (L, W, H) and Weight |
3.5” x 3.75” x 1.0”, 60 g |
|
Environmental |
|
|
Humidity (Operation) |
65 ± 20% RH |
|
Temperature (Operation) |
0 – 45 °C / 32 – 113 °F |
|
Altitude (Operation) |
5000 meters (16,404 ft) |
|
USB port |
|
|
USB voltage (V) |
5 |
|
Maximum USB current output (A) |
2 |