mTrigger Biofeedback User manual

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d4 | 06-01-21 Page 1 of 27
mTrigger®Biofeedback System User Manual
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: [phone] ext 1
Email: [email protected]
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-d3 | 03-01-21 Page 2 of 27
Table of Contents
1 | Glossary and Abbreviations........................................................................................4
Table 1.1: Glossary...................................................... Error! Bookmark not defined.
Table 1.2: Abbreviations..............................................................................................4
2 | Safety.........................................................................................................................4
2.1: Conventions Used in this Manual .........................................................................4
3 | System Set-Up...........................................................................................................5
3.1: Location................................................................................................................5
3.2: Unpacking and Initial Set-up.................................................................................5
3.3: Battery Use and Charging ....................................................................................6
3.4: Battery or 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 Precautions..............................................................................................11
5.2: Patient Preparation.............................................................................................11
5.3: Device Operation................................................................................................11
6| Maintenance and Calibration.....................................................................................21
6.1: Cleaning .............................................................................................................21
7 | Quality and Regulatory.............................................................................................22
7.1: Quality Environment ...........................................................................................22
7.2: Regulatory Compliance ......................................................................................22
8 | Specifications and Environmental Conditions...........................................................22
8.1: Specifications......................................................................................................22
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-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..................................................................................................27
11.1 Customer Service..............................................................................................27

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.

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d4 | 06-01-21 Page 5 of 27
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.
Step 2. Check for any missing or damaged parts.
Step 3. If items are missing or damaged, call mTrigger®Customer Service. Notify
the carrier if the damage occurred during shipping and retain shipping
packaging for evidence.
Step 4. Fully charge the battery via the USB port and provided charger before using
the device(s). See figure 3.1
Fig. 3.1: Micro USB charging port setup
Fig 3.3: Charging state LEDs
green = fully charged, red = actively charging, white = not charging/in use

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d3 | 03-01-21 Page 6 of 27
Recommendation: Charge the device before use. The system ships with the device
battery only partially charged.
Recommendation: Turn device off before charging. If device is on during active
charging, LEDs cannot indicate a full charge and full charge will take longer.
Note: Device cannot be used for feedback while charging as Bluetooth capabilities are
disabled 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: 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.
Caution: The temperature range for charging this battery is -10° C to 45C (14
F to 113F). Do not charge, store, or attempt to use the battery outside of this
range.

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.

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d3 | 03-01-21 Page 8 of 27
Warning: DO NOT attempt to gain access to any internal component. Doing so
may cause injury and/or device damage. THERE ARE NO USER-SERVICEABLE
COMPONENTS inside this device.
4.1: Indications for Use (Purpose of the Device)
This biofeedback system is 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 performance
•Assessment & treatment of atrophy, weakness, inhibition, tension, improper
recruitment and other neuromotor pathologies
4.2: Contraindications
None.
Caution: Use of the mTrigger®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-d4 | 06-01-21 Page 9 of 27
Right 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:
Sensing Electrodes:
Power Switch
(position: off)
Channel 1 EMG port
Channel 2 EMG port
Micro USB charging port

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.

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d4 | 06-01-21 Page 11 of 27
5 | Operation
5.1: Safety Precautions
Caution: FAILURE TO COMPLY with the setup procedures and suggested
application techniques listed in the manual may lead to ineffective treatment via
improper signal transmission or device failure.
Take the following steps to secure the treatment area:
•Clear exercise area of any obstacles.
•If exercise is stationary, place device on a nearby table or other flat surface where
it will not impede treatment. Prop phone or tablet on provided viewing stand where
the application can be easily seen by the patient and provider, if desired. Secure
device inside mTrigger Wearable Wrap if available.
•If exercise ismobile, secure the 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 stand
where the application can be easily seen by the patient and provider, or hold mobile
device in hand.
Caution: DO NOT rest mTrigger unit on or touching other electronic devices
(computers, printers, digital scales, etc.) as this may cause electronic interference
and improper signal transmission.
5.2: Patient Preparation
Before a treatment, perform the following preparation:
•Ensure that the skin on the treatment area is clean, dry, and free of surface dirt or
oils for proper electrode adherence and signal reception. See instructions on
electrode packaging.
•Ensure that Bluetooth permissions on mobile device are set to ON to enable
connection to mTrigger device.
5.3: Device Operation
Additional resources:
Quick Startup Guide | Getting Started | Video Training Series

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d3 | 03-01-21 Page 12 of 27
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. A white
light will illuminate the logo mwhen the device is on.
Note: mTrigger expected battery life at full charge is 15 hours. Very low battery
level may impact the unit’s ability to communicate data over the Bluetooth
connection. In mTrigger devices with a Serial Number (see Section 4.3)
beginning with M60… battery charge level is visible in Settings.
3) Open application on mobile device.

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d4 | 06-01-21 Page 13 of 27
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. A “device connected”
confirmation will pop up.
6) At this point, the mobile app will enter calibration to ensure accurate data. The
calibration period takes 30-40 seconds. During calibration you may set up electrodes
(see below), access education and resources on setup, or adjust basic settings.

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d3 | 03-01-21 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 cable ONLY for dual channel
use.
8) Attach sensing electrodes to sensing cables
Ch 1
Ch 2

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d4 | 06-01-21 Page 15 of 27
9) Place one pair of electrodes on target muscle. See Electrode Placement Database
for suggested electrode placements.
Note: For dual channel use, i.e. monitoring of activity in two separate muscles or
muscle groups, place Channel 1 electrodes on primary target and Channel 2
electrodes on secondary target. Learn more about 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 voluntary contraction setup protocol
Note: MVC CH1 Setup is for Ch 1 only, but turning Match Goals ON will
ensure sync Channel 1 goal to Channel 2. See 10c.)
ii) Ensure electrodes and cables are plugged into Ch 1.
iii) 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.
10a
10b
10c
10d
11
10e
10f

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d3 | 03-01-21 Page 16 of 27
iv) Select whether the target muscle plugged into Ch 1 is on the right or left side
of the patient’s body. This appropriately adjusts the visual display on the next
screen.
v) Launch test and follow prompts to relax and contract maximally for three sets
of 5 seconds on and 5 seconds off.
vi) Select goal based on Average MVC results. Goal can be set to 100% or 75%
of MVC achieved during setup, or a custom goal can be typed in.
vii) Save to return to Settings; results of setup will be reflected in Ch 1 goal
settings automatically.
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 mode.
ii) Single channel mode is ideal for isometric exercise and basic activation
training.
iii) Dual channel mode is ideal for bilateral comparisons, A/B activation ratio
monitoring, agonist/antagonist monitoring, or compensation monitoring.
Learn more here.
c) Match Goals Select: Toggle Match Goals ON to lock goals together for
simultaneous adjustment. Use for comparison of muscles with similar MVC levels
or goals. 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.
10a,iii
10a,iv
10a,v
10a,vi
10a,vii

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d4 | 06-01-21 Page 17 of 27
d) Channel Goal Settings: Set the microvolt goal for each channel; this can also be
set or adjusted in the Train module by assessing MVC in real time. Goal can also
be modified by typing into the text bar (tap on the number before uV to type).
Note: 1000-1500uV is a good starting point to assess patient capability if setting
goal manually
Learn more about goal setting here.
e) Time Settings: Modify total, contract, and relax time as desired. Both contract
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 rep.
f) Ch1 Audio Select: Toggle Ch 1 Audio ON to hear cues for relax and contract
periods as well as a “success tone” when the contraction reaches the green
zone. Audio is only reflective of Ch 1 activity. Toggle Audio OFF to mute. If using
audio, ensure mobile device has media volume turned on.
11) Save settings by tapping SAVE in upper right corner. Return to the Home screen by
tapping “BACK” in upper left or min 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-d3 | 03-01-21 Page 18 of 27
a) Before beginning your session, perform a few reps of your monitored exercise.
Modify the goal as necessary to match MVC using the slider bars 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 when prompted at session completion to see timestamped output in
the Track module.
e) 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).
12a
12b
12c

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d4 | 06-01-21 Page 19 of 27
13) To Play:Tap Play from Home to launch the game list.
a) 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.
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 healthy side. The involved side will test on the left
side of the screen (CH1), normal side on the right (CH2). Flex your involved muscle
when indicated by the green “I” and left-pointing arrow; flex your normal muscle
when indicated by the green “N” and right-pointing arrow. The test compares
average microvolt output on the healthy versus involved sides over a one-minute
test period. See help button on bottom right of screen for further details.

Individual Unit, Clinical Bundle User Manual mTrigger™Biofeedback System | V2-d3 | 03-01-21 Page 20 of 27
Note: Ensure that your involved muscle is plugged into channel 1 during the NMDT.
Electrode placement should be as identical as possible on both healthy and
involved sides of the body. You will be prompted to ensure that Match Goals is ON.
It is recommended to set the goal for both channels to the MVC 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 compared
to goal for a saved session. Tap an individual graph to see average maximum
contraction for that session. 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.