Motion Patch

Investigational Use Only

Table of contents

1. Motion Patch
   1. Intended User
   2. Required Components
      1. Motion Cradle
      2. Cradle Adhesive
   3. How to Assemble Sensor Dot, Motion Cradle, and Cradle Adhesive
   4. Make a Motion Recording
   5. How to Remove, Replace, and Store Adhesives

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Motion Patch

This document describes a number of common use cases for recording motion data with a Byteflies Kit.

Intended User

Trained Operator

A healthcare professional trained in the usage of Byteflies Kits and its accessories.

User

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:

1. Familiar with the operation of a Byteflies Kit as explained here and here.
2. Familiar with the labeling and safety warnings for Byteflies Kits and its accessories.
3. Familiar with motion monitoring, including placement of inertial measurement sensors, and interpretation of accelerometer (ACC), gyroscope (GYR), and activity index (AI) data.

Required Components

You will need the following:

1. A Sensor Dot
2. A Motion Cradle
3. A Cradle Adhesive

Note that this document discusses the case where a Sensor Dot is only capturing motion data. In many cases, motion data will be captured in addition to one or more biopotential (ExG) Signals. In those cases, follow the appropriate biopotential instructions and simply switch on the ACC and/or GYR Signal during Sensor Dot configuration.

Motion Cradle

This accessory provides an interface between a Sensor Dot and the Cradle Adhesive. It has a Sensor Dot connector with magnet guides on the top. The bottom provides a surface to connect to the Cradle Adhesive.

• Do not attempt to force a Sensor Dot into a Motion Cradle. The magnets only allow for one orientation.
• Do not place a Sensor Dot upside down into a Motion Cradle. The gold-colored pins should always face down.

Cradle Adhesive

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.

How to Assemble Sensor Dot, Motion Cradle, and Cradle Adhesive

The following symbols are used to explain assembly steps:

To assemble a Motion Patch:

• Peel the plastic liner off a Cradle Adhesive and firmly press the bottom of the Motion Cradle on the exposed sticky part.
• Peel the protective liner off the other side of the Cradle Adhesive and apply to the skin of the User as indicated by your intended use.
• Place the Sensor Dot in the Motion Cradle, with the gold-colored pins facing down.

The illustration below shows a configuration with two Motion Patches which can be used to get accurate measurements on how you are walking and your general activity patterns. Note that different configurations are possible, depending on the requirements of the Trained Operator.

Make a Motion Recording

To start and stop a Sensor Dot Recording, follow the Configuring and Making Recordings instructions. Make sure the correct ACC and/or GYR Signals are configured in the Sensor Dot.

If you are unsure about the correct configuration, please contact us so we can assist you.

To retrieve your Recording, please refer to the Byteflies Cloud instructions.

How to Remove, Replace, and Store Adhesives

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.

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