mTrigger Biofeedback User Manual
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mTrigger Biofeedback User Manual

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mTrigger
Please read the entire User Manual before attempting to operate this device.
If you have any questions or problems with this device, please contact:
®
mTrigger
Customer Service:
101 Lukens Drive
Suite A
New Castle, DE 19720
Phone: 302-502-7262 ext 1
Email: customerservice@mtrigger.com
Manual Part Numbers:
863712000337 | SKU BI2612 - Individual Unit + Accessories
863712000382 | SKU BK2613 - Clinical Bundle
Effective Date: 1 November 2017
Individual Unit, Clinical Bundle
®
Biofeedback System User Manual
User Manual mTrigger™ Biofeedback System | V2-d4 | 06-01-21
Page 1 of 27

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Summary of Contents for mTrigger Biofeedback

  • Page 1 Manual Part Numbers: 863712000337 | SKU BI2612 - Individual Unit + Accessories 863712000382 | SKU BK2613 - Clinical Bundle Effective Date: 1 November 2017 Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d4 | 06-01-21 Page 1 of 27...

  • Page 2: Table Of Contents

    Table 8.1 System Specifications ................22 8.2: Accessory Details .................... 23 Table 8.2 Accessory Specifications ................ 24 9 | Warranty Information ....................24 Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d3 | 03-01-21 Page 2 of 27...
  • Page 3 9.2: Before You Call—Troubleshooting ..............25 9.3: Return Procedure ....................25 10 | Labeling ........................26 11 Contact Information ....................27 11.1 Customer Service ....................27 Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d4 | 06-01-21 Page 3 of 27...

  • Page 4: Glossary And Abbreviations

    2 | Safety This section provides safety guidelines and safety-related statements to operate this biofeedback system safely and effectively. Additional guidelines, statements, and protocols appear throughout this manual. Follow all printed guidelines, warnings, cautionary statements, and protocols when using this biofeedback system.

  • Page 5: System Set-Up

    3 | System Set-Up 3.1: Location of Use ® The mTrigger Biofeedback System can be used in virtually any location, so long as there is sufficient space to perform therapy exercises. 3.2: Unpacking and Initial Set-up ® Step 1. Using the mTrigger Biofeedback System packing list, carefully unpack the system and its accessories from the shipping box.

  • Page 6: Battery Use And Charging

    Warning: Do not immerse the battery in water or get the battery wet. Caution: mTrigger hardware cannot establish a Bluetooth connection while in a charging state. Do not attempt to use the mTrigger device/system while charging. Caution: DO NOT leave device charging overnight; charging time in excess of 6 hours can cause over-charging and impact battery life and device performance.

  • Page 7: Battery Or Power Malfunction

    3.4: Battery or Power Malfunction ® If the battery is not charging or device is not powering on as expected, contact mTrigger Customer Service to determine if a replacement accessory or repair is required. The battery cannot be removed from the unit or replaced except by the manufacturer.

  • Page 8: Indications For Use (Purpose Of The Device)

    Biofeedback System simultaneously with an electrical muscle stimulation system may impact signal quality. 4.3: Biofeedback System Unit Top View: Bottom View: Serial Number Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d3 | 03-01-21 Page 8 of 27...

  • Page 9: Accessories

    Warning: Use of accessories unauthorized for use with this system may result in ineffective signal transmission or damage to the system. Micro USB Charger: Sensing Electrodes: Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d4 | 06-01-21 Page 9 of 27...
  • Page 10 2in. Cable connector receptor Sensing Cables: Electrode connector pins EMG port jack Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d3 | 03-01-21 Page 10 of 27...

  • Page 11: Operation

    Secure device inside mTrigger Wearable Wrap if available. • If exercise is mobile, secure the device in the mTrigger Wearable Wrap or a pocket if available; if neither option is available, hold the unit during exercise.
  • Page 12 1) Search “mTrigger biofeedback” on the Apple Store or Google Play Store and download the mTrigger Biofeedback App to your mobile device. Native app and separate game apps are available across Android and iPhone phones and tablets. DOWNLOAD iOS APP DOWNLOAD ANDROID APP 2) Turn on device by sliding power switch on the right hand side as indicated.
  • Page 13 4) Select "CONNECT" in the upper right corner of the Home screen. 5) Locate the serial number on the sticker on the underside of the mTrigger device. Match the serial number to the devices that appear in the scanned device list. Tap to select your device number and connect via Bluetooth.
  • Page 14 Note: For single channel use, set to Single Channel Mode in Settings; only data from Channel 1 will be displayed. Insert channel 2 cable ONLY for dual channel use. 8) Attach sensing electrodes to sensing cables Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d3 | 03-01-21 Page 14 of 27...
  • Page 15 Select recovery phase relative to duration of entire rehabilitation program, not within the current treatment session. This appropriately adjusts the visual display on the next screen. Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d4 | 06-01-21 Page 15 of 27...
  • Page 16 Toggle Match Goals OFF to adjust Ch 1 and Ch 2 goals independently. Use for comparison of muscles with different MVC levels. Ch 1 goal is default when Match Goals is ON. Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d3 | 03-01-21 Page 16 of 27...
  • Page 17 “BACK” in upper left or m in lower left. If settings have not already been saved, accept “save settings” prompt upon exiting. 12) From the Home screen, tap to enter Train. Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d4 | 06-01-21 Page 17 of 27...
  • Page 18 Real-time feedback will always be displayed in Train mode. To save session data, complete the session (12b) per the time parameters in Settings (10e). Individual Unit, Clinical Bundle User Manual mTrigger™ Biofeedback System | V2-d3 | 03-01-21 Page 18 of 27...
  • Page 19 Select the PLAY [GAME NAME] button to take you to the individual app for that game. There you will reconnect your mTrigger device and customize settings for that session of play; native app settings will not carry over, nor be affected by changes made to Settings in the standalone game apps.
  • Page 20 You can also delete individual sessions using your mobile device’s standard delete gesture. Note: mTrigger data is stored locally and only identified by timestamp on the mobile device on which the session was recorded. It is not remotely accessible or backed up to any additional location.

  • Page 21: Maintenance And Calibration

    If cleaning is necessary, use a dry dusting cloth. Warning: DO NOT use water or a damp cloth to clean any part of the mTrigger Biofeedback System; no component of the system is waterproof. Individual Unit, Clinical Bundle User Manual mTrigger™...

  • Page 22: Quality And Regulatory

    United States Food and Drug Administration’s general manufacturing practices concerning medical devices. 7.2: Regulatory Compliance According to the applicable standards, the mTrigger™ Biofeedback System is classified as follows: • Class II Medical Device per USFDA 21CFR 882.5050 • 510(k) exempt...

  • Page 23: Accessory Details

    DO NOT remove electrode by pulling on the lead wire. DO NOT use generic electrodes with the mTrigger Biofeedback System. DO NOT use electrodes that have been incorrectly applied or damaged. Follow placement instructions carefully – electrodes should be separated on the skin and positioned as indicated for your treatment and target muscle(s).

  • Page 24: Warranty Information

    9 | Warranty Information 9.1: Terms and Conditions The mTrigger biofeedback system is warranted to be free from manufacturer defects in materials and workmanship for a period of 1 year, starting from the date of initial shipment. This warranty does not extend to incidental or consequential damages nor to damage caused by negligent or improper handling in use or storage;...

  • Page 25: Before You Call-Troubleshooting

    9.2: Before You Call—Troubleshooting If you are having a problem with your biofeedback system, please check the list below of common conditions that can occur that you may be able to resolve without having to contact mTrigger Customer Service. If the device will not turn on: Attempt to charge.

  • Page 26: Labeling

    Step 3. Complete our online contact form, or call or email Customer Service to obtain a Return Material Authorization (RMA) number and detailed return instructions. Step 4. Complete and sign the RMA form and return to mTrigger Customer Service. Adhere to mTrigger’s complete return instructions for transportation and packaging to ship the product (freight and insurance prepaid) with completed and signed RMA form to mTrigger.

  • Page 27: Contact Information

    For immediate assistance, contact mTrigger Customer Service directly. If this biofeedback system does not function as expected and/or if the biofeedback system malfunctions, contact mTrigger Customer Service immediately. Please have the device serial number so that Customer Service can provide you with the highest level of service.

This manual is also suitable for:

863712000337863712000382Bi2612Bk2613

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