Investigational Use Only
Table of contents
This document describes a number of common use cases for recording brain data with a Byteflies Kit.
- Trained Operator
- A healthcare professional trained in the usage of Byteflies Kits and its accessories.
- A patient or subject with a clinical need for biopotential and/or motion monitoring and/or their caregiver.
The Byteflies Kit and its accessories are intended to be used by Trained Operators who configure the Byteflies Kit and its accessories in a medical environment (e.g. hospital). Users are wearers of the Sensor Dot, not operators of the Byteflies Kit, and are 4 years of age or older. Once the correct set up is configured, the User can take the Byteflies Kit and applicable accessories home to continue recording data as instructed by the Trained Operator. The User may be required to return to the medical environment for removal or reconfiguration of Byteflies Kit components and accessories by the Trained Operator.
These instructions are meant for Trained Operators who are:
- Familiar with the operation of a Byteflies Kit as explained here and here.
- Familiar with the labeling and safety warnings for Byteflies Kits and its accessories.
- Familiar with cardiorespiratory monitoring, including placement of biopotential (ExG) electrodes, and interpretation of electroencephalography (EEG) data.
You will need the following:
The cradle body can be affixed to the skin using a Cradle Adhesive. This is a simple biocompatible double-sided adhesive. One side attaches the bottom of the Motion Cradle, and the other side can be applied to the skin.
- As with everything that needs to be applied to the skin, make sure the area where you are planning to place an adhesive component is clean, dry, and free of excess body hair. Do not use solvents are abrasive materials to clean the skin prior to application of a Cradle Adhesive as that may lead to skin irritation.
- Never apply a Cradle Adhesive to injured skin (erythema, lesions or any other injuries). Cradle Adhesives should only be used on areas of intact external skin that are large enough to support its entire surface area.
The following symbols are used to explain assembly steps:
|Adhesive, peel off protective liner and apply|
|Connect snap buttons|
To assemble a Brain Patch with a 4-wire Cradle and 3rdparty electrodes:
- Peel the plastic liner off a Cradle Adhesive and firmly press the bottom of the 4-wire Cradle on the exposed sticky part.
- Attach 2 or 4 electrode leads to the 4-wire Cradle.
- Attach 2 electrode leads to 3rdparty EEG electrodes and apply as specified by the manufacturer.
- Peel the protective liner off the other side of the Cradle Adhesive and apply to the back of the User’s neck or as indicated by your intended use.
- Place the Sensor Dot in the 4-wire Cradle, with the gold-colored pins facing down.
- Applying EEG electrodes requires skill. Step 3 should only be performed by a Trained Operator and the manufacturer’s instructions should be followed.
- Never apply any of the provided adhesives to injured skin. Adhesives should only be used on areas of intact external skin that are large enough to support the entire surface area of the adhesive.
The illustration below shows a configuration that can be used to record behind-the-ear EEG data. Note that different configurations are possible, depending on the requirements of the Trained Operator.
If you are unsure about the correct configuration, please contact us so we can assist you.
Gently peel off any skin adhesives and dispose. Cradle Adhesives should be stored in a dry place but require no further special handling.
- If the User experiences any adverse events while using a Cradle Adhesive, discontinue its use and contact Byteflies immediately.
- Take extra care when removing skin adhesives from overly delicate skin to avoid skin damage.
- Do not apply a new Cradle Adhesive if skin irritation or damage is visible.