mTrigger 863712000337 User Manual Download Page 24

 

Individual Unit, Clinical Bundle 

User Manual mTrigger

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

Page 24 of 27 

but do not submerge in any solution. Let dry before application to skin or plastic 
backing. Excessive cleaning may lead to decreased hydration/adhesion of gel over 
time. 
 

Table 8.2 Accessory Specifications 

 

Device Classifications 

Item 

Description 

Classification 

Image 

Sensing    
Electrodes 

2” square white cloth, 
sensing gel, self-adhering 
surface electrodes 

Class II special 

controls; 510(k) 

exempt 

 

Sensing 
Cables 

4’ M/F AUX jack pin 
connector pigtail cable 

Non-medical 

 
 

 

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; products on which the original 
identification markings or labels have been intentionally defaced, altered or removed are 
not eligible for warranty. 
 
mTrigger, LLC reserves the rights of determining existence and cause of defect as well 
as  the  option  to  repair  or  replace  products  which  prove  to  be  defective  as  necessary 
during the warranty period. Claims may be submitted for review after the warranty period 
close; however, mTrigger does not guarantee repair or replacement after the close of the 
warranty period. This warranty extends only to the original purchaser of the equipment 
from  mTrigger,  LLC.  The  purchaser  must  notify  mTrigger  Customer  Service  within  15 
days  of  first  detecting  the  defect  and  promptly  return  the  defective  product  before 
expiration of the warranty period if approved for RMA.  
 
Return  shipping  costs  will  be  covered  by  mTrigger,  LLC  within  the  warranty  period. 
mTrigger will return repaired or replaced goods to purchaser within the Continental United 
States at no additional charge. mTrigger does not offer goods internationally at this time.  

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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