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Individual Unit, Clinical Bundle 

User Manual mTrigger

™ Biofeedback System | V2-d4 | 06-01-21 

Page 7 of 27 

Caution:

 Do not store the battery over a long period of time at temperatures above 

30

  C  (86 

F),  such  as  inside  a  car  on  a  hot  day  or  in  direct  sunlight;  this  may 

damage the battery.  

 
Caution

:  Do  not  disassemble  or  open,  crush,  bend,  deform,  puncture,  shred  or 

burn the battery.  

 

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.

 

 
 

4 | Device Description 

The mTrigger

®

 biofeedback system includes: 

 

mTrigger 

biofeedback device (qty 1 for Individual Unit; qty 3 for Clinical Bundle) 

  Sensing cables (qty 2, IU; qty 6, CB) 

  Sensing electrodes, 4 per pouch (qty 10 pouches, IU; qty 50 pouches, CB) 

  Mobile device stand (qty 1 for Individual Unit; qty 3 for Clinical Bundle) 

  Micro-USB Wall Charger (qty 1 for Individual Unit; qty 3 for Clinical Bundle) 

  User interface software application (free download to any mobile device) 

The 

mTrigger

 user interface consists of a mobile software application. User may pair the 

app with a specific 

mTrigger

 device via Bluetooth and set exercise parameters, complete 

training sessions, track progress, play games, and calculate neuromuscular deficit. Once 
user has selected the desired exercise parameters, complete training session and save 
output to the tracking module. Mobile app usage is detailed in Section 5.   

 
Warning:

 Do not use any accessories, cables, or electrodes not specified or sold 

by mTrigger, LLC as replacement parts. Use of accessories unauthorized for use 
with  this  system  may  result  in  ineffective  signal  transmission  or  damage  to  the 
system.   

 

 
 

Summary of Contents for 863712000337

Page 1: ...e 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...

Page 2: ...Power Malfunction 7 4 Device Description 7 4 1 Indications for Use Purpose of the Device 8 4 2 Contraindications 8 4 3 Biofeedback System Unit 8 4 4 Accessories 9 5 Operation 11 5 1 Safety Precaution...

Page 3: ...dle User Manual mTrigger Biofeedback System V2 d4 06 01 21 Page 3 of 27 9 1 Terms and Conditions 24 9 2 Before You Call Troubleshooting 25 9 3 Return Procedure 25 10 Labeling 26 11 Contact Information...

Page 4: ...stem 2 1 Conventions Used in this Manual Various Warnings Cautions Recommendations and Notes are presented throughout this manual Explanations and the corresponding symbols are Warning Specific or pot...

Page 5: ...em packing list carefully unpack the system and its accessories from the shipping box Step 2 Check for any missing or damaged parts Step 3 If items are missing or damaged call mTrigger Customer Servic...

Page 6: ...during active charging 3 3 Battery Use and Charging Warning Do not modify the battery or attempt to remove it from device Warning Do not immerse the battery in water or get the battery wet Caution mTr...

Page 7: ...Bundle Sensing cables qty 2 IU qty 6 CB Sensing electrodes 4 per pouch qty 10 pouches IU qty 50 pouches CB Mobile device stand qty 1 for Individual Unit qty 3 for Clinical Bundle Micro USB Wall Charge...

Page 8: ...indicated for Biofeedback muscle re education and motor learning Visual feedback to supplement therapeutic exercise performed for the purpose of rehabilitating musculoskeletal injury or improving perf...

Page 9: ...ht Side View Left Side View 4 4 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 Sen...

Page 10: ...Individual Unit Clinical Bundle User Manual mTrigger Biofeedback System V2 d3 03 01 21 Page 10 of 27 Sensing Cables EMG port jack Electrode connector pins Cable connector receptor 2in 2in...

Page 11: ...device in the mTrigger Wearable Wrap or a pocket if available if neither option is available hold the unit during exercise Note For mobile exercises either prop phone or tablet on provided viewing st...

Page 12: ...s and tablets DOWNLOAD iOS APP DOWNLOAD ANDROID APP 2 Turn on device by sliding power switch on the right hand side as indicated A white light will illuminate the logo m when the device is on Note mTr...

Page 13: ...gger 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 A device connected confirmation will pop up 6 At th...

Page 14: ...Page 14 of 27 7 Attach electrode connector cable s to mTrigger EMG ports Note For single channel use set to Single Channel Mode in Settings only data from Channel 1 will be displayed Insert channel 2...

Page 15: ...ut dual channel applications 10 Continue to Settings to define treatment parameters a MVC Setup Launch Use this feature to assist with setting MVC goal level i Tap to launch the automatic maximum volu...

Page 16: ...utomatically b Channel Mode Select Select dual or single channel as desired i If in single channel mode ensure you are plugged into Channel 1 only Channel 2 will not display data in single channel mod...

Page 17: ...ntract and relax times must be set or you will be notified of an error Number of reps is calculated as total time flex time relax time Every training session will begin with the relax period of the re...

Page 18: ...s or by typing b Hit the play button on the bottom bar to begin your session c Pause button pauses the session and will restart at the beginning of the relax segment of the previous rep d Save results...

Page 19: ...ne game apps 14 Neuromuscular Deficit Test Settings Dual Channel Match Goals ON Tap Neuromuscular Deficit Test to start the test NMDT assesses the deficit of the involved side as compared to the healt...

Page 20: ...VC of the healthy side to provide the most accurate percentage deficit Failure of any of these steps will impact test results 15 Tap Track and select a timestamped session to see actual EMG activity c...

Page 21: ...ng so may cause injury and or device damage THERE ARE NO USER SERVICEABLE COMPONENTS inside this device 6 1 Cleaning Warning Always turn off the device before cleaning and remove from charger Keep EMG...

Page 22: ...ed as follows Class II Medical Device per USFDA 21CFR 882 5050 510 k exempt In order to safely perform its intended use the system requires two accessories whose classifications and registrations are...

Page 23: ...pplications if required but this may impact signal quality DO NOT remove electrode by pulling on the lead wire DO NOT use generic electrodes with the mTrigger Biofeedback System DO NOT use electrodes...

Page 24: ...proper handling in use or storage products on which the original identification markings or labels have been intentionally defaced altered or removed are not eligible for warranty mTrigger LLC reserve...

Page 25: ...missions and that you are using only authorized accessories If you experience signal malfunction If hypersensitivity lack of signal inconsistencies within or across channels persists beyond 60 seconds...

Page 26: ...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...

Page 27: ...em 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 The Serial Number SN of th...

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