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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