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 3 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:
- A Sensor Dot
- A 4-wire Cradle/4-Snap Cradle/3-Snap Cradle Right/3-Snap Cradle Left
- A Double-sided Adhesive
- 3rd party EEG electrodes or Byteflies EEG Adhesives
Any cradle body of the aforementioned can be affixed to the skin using a Double-sided Adhesive. This is a simple biocompatible double-sided adhesive. One side attaches the bottom of the 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 Double-sided Adhesive as that may lead to skin irritation.
- Never apply a Double-sided Adhesive to injured skin (erythema, lesions or any other injuries). Double-sided Adhesives should only be used on areas of intact external skin that are large enough to support its entire surface area.
The following steps depend on which type of Cradle you are using. In this case, they explain a potential configuration for a 4-Wire Cradle but this may not be applicable to your use case. The 4-Snap Cradle/3-Snap Cradle right/3-Snap Cradle left can be used in a very similar way to assemble a Brain Patch, with a direct connection between the Cradle and the 3rdparty EEG electrodes or EEG Adhesives.
The following symbols are used to explain assembly steps:
|Adhesive, peel off protective liner, apply and press firmly|
|Connect snap buttons|
To assemble a Brain Patch with a 4-Wire Cradle and 3rdparty electrodes:
- Peel the plastic liner off a Double-sided 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.
- Apply the 3rdparty EEG electrodes as specified by the manufacturer and attach them to the electrode leads.
- Peel the protective liner off the other side of the Double-sided Adhesive, apply to the back of the User’s neck or as indicated by your intended use and press firmly.
- 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. Double-sided Adhesives should be stored in a dry place but require no further special handling.
- If the User experiences any adverse events while using a Double-sided 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 Double-sided Adhesive if skin irritation or damage is visible.