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