Accessory Details - mTrigger Biofeedback User Manual

Device Classifications
United States
User Interface
Mobile Application
Mechanical Specifications – mTrigger
Dimensions
Weight
Environmental Specifications
Operation temperature
Storage temperature
Electrical Specifications
Input Voltage
Input Current

8.2: Accessory Details

Warnings & Precautions: mTrigger Custom Sensing Electrodes
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Keep electrodes out of reach of children.
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Electrodes are intended for single person use only.
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Electrodes are latex free and manufactured in the USA.
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Electrodes can be cut down to smaller size for specific applications 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 that have been incorrectly applied or damaged.
Follow placement instructions carefully – electrodes should be separated on the
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skin and positioned as indicated for your treatment and target muscle(s).
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DO NOT apply to broken skin. Should a skin rash or irritation occur, discontinue
use and contact your physician.
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DO NOT use the mTrigger Biofeedback System while operating machinery,
sleeping, or in close proximity to water.
Note: The life of electrode adhesive gel varies depending on skin condition, preparation,
storage, and climate. Please refer and adhere to care and storage instructions on the
electrode packaging.
Cleaning & Maintenance of mTrigger Custom Sensing Electrodes:
Skin and electrodes can be cleaned with alcohol wipes if needed. Performance should
not be impacted by wiping either the gel adhesive or cloth overlay with an alcohol pad,
Individual Unit, Clinical Bundle
Class II Medical Device per USFDA 21CFR 882.5050
®
mTrigger Biofeedback
®
Biofeedback Device
4 in x 2.4 in x 1.1 in
0.25 lb
10 °C to 35 °C │ 50 °F to 95 °F
-20 °C to 70 °C │ -4 °F to 158 °F
See EMC testing
See EMC testing
User Manual mTrigger™ Biofeedback System | V2-d4 | 06-01-21 Page 23 of 27