mTrigger 863712000337, Руководство пользователя

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Individual Unit, Clinical Bundle
User Manual mTrigger
™ Biofeedback System | V2-d4 | 06-01-21
Page 23 of 27
Device Classifications
United States Class II Medical Device per USFDA 21CFR 882.5050
User Interface
Mobile Application mTrigger
®
Biofeedback
Mechanical Specifications
– mTrigger
®
Biofeedback Device
Dimensions 4 in x 2.4 in x 1.1 in
Weight 0.25 lb
Environmental Specifications
Operation temperature
10 °C to 35 °C │ 50 °F to 95 °F
Storage temperature -
20 °C to 70 °C │ -4 °F to 158 °F
Electrical Specifications
Input Voltage See EMC testing
Input Current See EMC testing
8.2: Accessory Details
Warnings & Precautions:
mTrigger Custom Sensing Electrodes
- Keep electrodes out of reach of children.
-
Electrodes are intended for single person use only.
- Electrodes are latex free and manufactured in the USA.
-
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
skin and positioned as indicated for your treatment and target muscle(s).
-
DO NOT apply to broken skin. Should a skin rash or irritation occur, discontinue
use and contact your physician.
-
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,