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Individual Unit, Clinical Bundle 

User Manual mTrigger

™ Biofeedback System | V2-d3 | 03-01-21 

Page 4 of 27 

1 | Glossary and Abbreviations 

Table 1.1: Abbreviations 

 

Abbreviation 

Term 

EMC 

Electromagnetic Compatibility 

FDA 

Food and Drug Administration 

US or USA 

United States 

 
 

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. 

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  potential  danger.  If  ignored  or  compromised,  the  situation 

could result in harm. Warning statements are preceded with a yellow symbol.  
 

Caution: 

Possible  problem  with  the  device  associated  with  its  use  or  misuse.

 

Problems  include,  but  are  not  limited  to,  device  malfunction,  device  failure,  or 
damage  to  the  device.  Caution  statements  are  preceded  by  a  black-and-white 
symbol. 
 

Recommendation: 

Offers guidance for the optimal application and usage of the device. 

Recommendation statements are in a shaded box. 

 
Note:

  Describes  the  conditions  or  exceptions  that  may  apply  to  the  subject  matter 

presented.

 

 

 

 

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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