Byteflies Kit (Model 1)

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Byteflies Kit (Model 1)

LAST UPDATED: Jan 18, 2023

Legal & Safety Information

Please carefully review the Legal & Safety documentation first.

Device Description

Intended Use

The Byteflies Kit is a multisensor device intended to collect non-invasive physiological and behavioral signals to be used in the clinic and/or home for Users that need continuous monitoring.

Intended User

Trained Operator: A healthcare professional trained in the usage of Byteflies Kit.
User: A patient or subject with a clinical need for biopotential and/or motion monitoring and/or their caregiver.

The Byteflies Kit is 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 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 by the Trained Operator.

Indications for Use

The Byteflies Kit is intended for prescription use in the home or healthcare facility to acquire, record, and transmit physiological and behavioral signals from Users. It acquires, records and transmits electroencephalogram (EEG), electrocardiogram (ECG), heart rate (HR), respiratory rate (RR), electromyogram (EMG), and/or electrooculogram (EOG) signals, with optional accelerometer (ACC), gyroscope (GYR), and activity index (AI) signals. It only acquires these signals, no diagnostic claims are made about the User’s condition.

The Byteflies Kit should not be used on Users that:

Have been diagnosed with or are suspected to have life-threatening conditions that could result in immediate danger;
Need to undergo an MRI scan or cardiac defibrillation;
Have an active implanted device such as a pacemaker, defibrillator, or vagal nerve stimulator;
Are between 0 and 3 years of age.

Device Components

The Byteflies Kit (Model 1) consists of the following components which are provided together with the Instructions for Use (IFU) and Technical Documentation (this document):

Sensor Dot

A Byteflies Kit comes with one to five Sensor Dots, the main wearable sensor, out of the box depending on the configuration. A Sensor Dot can continuously record 2 biopotential (ExG) Channels, and motion via its accelerometer (ACC) and gyroscope (GYR) sensors. Sensor Dots can operate completely standalone by storing data on the onboard memory for at least 24 hours on a single battery charge. They communicate status information to the user via an LED indicator to ensure proper operation (see Device LED Notifications). Sensor Dots provide clinically relevant and long-term Signal acquisition capabilities in a small and user-friendly form factor. The recorded physiological and behavioral Signals are stored for later analysis by a qualified healthcare professional after transfer of the data via the Docking Station to the Byteflies Cloud.

Docking Station

The Docking Station is used for reading out the memory of up to 5 Sensor Dots simultaneously and charging their batteries. It comes with a micro-USB cable and country-specific medically-certified power adapter, and has a status LED and reset button (see Device LED Notifications). Sensor Dots attach magnetically to the Docking Station.

Cradles

Cradles form an interface between compatible ExG electrodes and a Sensor Dot. Various configurations are possible, depending on the cradle type and the type of compatible ExG electrodes attached to them.

Type of Cradle	What is it for?
Motion Cradle	The simplest cradle that can be placed anywhere on the body to accurately measure motion and physical activity information.
2-snap Cradle	A cradle with two snap buttons.
ECG 3-snap Cradle	A cradle with three snap buttons.
4-Wire Cradle 4-Snap Cradle 3-Snap Cradle right 3-Snap Cradle left	A cradle that can be connected to certain electrodes produced by other companies or any type of Byteflies Adhesive, through DIN 42-802 1.5mm connectors or 4.0 mm snap fasteners, depending on the type of cradle.

Double-sided Adhesive

A simple skin-friendly double-sided adhesive that can be used to attach a Cradle to your skin. Double-sided Adhesives are compatible with the Motion Cradle, 4-Wire Cradle, 4-Snap Cradle, 3-Snap Cradle right, and 3-Snap Cradle left.

Byteflies Cloud

The Byteflies Cloud stores all Recordings received from Docking Stations and exposes APIs to retrieve them again, as well as ways to configure Sensor Dots and Docking Stations. If you have a Byteflies Cloud account (see Byteflies Cloud for detailed instructions).

Certain software accessories, such as CardioCare@Home Pro and EpiCare@Home UI, can interface with the Byteflies Cloud.

Byteflies Kit Hardware Accessories

In addition to the standard components described above, a number of official Byteflies Kit hardware Accessories are available, depending on your use case. Always refer to their dedicated instructions for use.

Type of Adhesive	What is it for?	Compatible with
ECG Adhesive Single Lead	An adhesive that is meant to be placed on the chest to record a cardiorespiratory signal.	2-Snap Cradle
ECG Adhesive Multi Lead Linear	An adhesive that is meant to be placed on the chest to record cardiorespiratory signals.	ECG 3-Snap Cradle
EEG Adhesive	An adhesive that is meant to be placed behind the ear to record brain signals.	4-Snap Cradle, 3-Snap Cradle right, 3-Snap Cradle left

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.

Commercially available ExG electrodes (not supplied by Byteflies) can be connected to the Cradles, as long as they are compatible with DIN 42-802 1.5mm connectors or 4 mm snap buttons, such as (but not limited to):

Disposable EEG cup electrodes (K032278)
Disposable pediatric ECG adhesive electrodes (solid gel) (K090180)
Disposable adhesive EEG/EMG electrodes (K142159)

Device LED Notifications

A Sensor Dot and Docking Station each have a multicolor LED to notify the Trained Operator and User about normal operation, warning/status information, or errors. In addition, the Docking Station has a reset button, the function of which is explained further. The meaning of the Sensor Dot LED changes depending on whether it is docked inside a slot on a Docking Station or undocked.

*A Docking Station has 5 Sensor Dots slots, numbered 1 through 5 starting from the top and continuing clock-wise.*

Sensor Dot in the Docking Station

When a Sensor Dot is docked, its LED can mean the following:

If the LED on one or more Sensor Dots is yellow (blinking or solid), please check the following:

If you followed the Sensor Dot shut down procedure, the LED will be yellow until the Sensor Dot has shut down, which may take up to 30 seconds.
If the Sensor Dot is receiving a software update, its LED will be yellow for up to 10 seconds. Please wait.
Your Docking Station is connected to the original power adapter. If not, please use the original and see if that resolves the issue.
The Sensor Dot may not be docked correctly. Take it off the Docking Station, gently wipe down the gold pins with a dry cloth, and place it back on the Docking Station. If the yellow LED persists, contact Byteflies support.

Sensor Dot out of the Docking Station

When a Sensor Dot is undocked, its LED can mean the following:

*LED patterns for undocked Sensor Dots.*

When the LED is red or will not turn on, do not use this particular Sensor Dot anymore and contact Byteflies support.
If one or more Sensor Dots have a yellow LED, check the troubleshooting steps above. If the problem persists, contact Byteflies support.

Docking Station LED

The Docking Station can connect to the Byteflies Cloud over internet via a WiFi connection. An LED located near the micro-USB port communicates the state of the Docking Station:

*The LED next to the USB port on the back of the Docking Station provides more information on the status of the Docking Station.*

Package & Device Symbols

Please refer to the Regulatory Information.

Usage Instructions

The following section describes how to safely prepare and use all components of the Byteflies Kit.

Trained Operator: A healthcare professional trained in the usage of Byteflies Kit.
User: A patient or subject with a clinical need for biopotential and/or motion monitoring and/or their caregiver.

The following definitions are used when referring to data recorded with a Byteflies Kit:

Signal: A physiologic or motion signal, as recorded by a Sensor Dot (e.g. ECG).
Channel: A Sensor Dot can record two biopotential Signals simultaneously and has two pairs of electrode connectors that each form a Channel.
Recording: The combination of all data recorded by a single Sensor Dot is grouped in a Recording.
Group: A Group combines one or more Docking Stations that are assigned to a specific study.
Patient ID: A unique string used to identify a study subject.
Patient Record: A list of pre-configured Patient IDs and the hardware they are associated with.
User Account: A Byteflies Cloud account that can contain one or more Groups and can only be accessed with a specific username and password.

Assembling a Sensor Patch

The Byteflies Kit is compatible with DIN 42-802 1.5mm non-invasive skin-contact ExG electrodes, 4 mm snap button electrodes, or official Byteflies Adhesives. Depending on the Signals you intend to record, different Sensor Patches can be assembled. This manual uses the 4-Wire Cradle as an example of how to assemble a sensor patch. These instructions can be adapted to connect other cradle types to compatible electrode accessories.

The 4-Wire Cradle has 4 DIN connectors together forming 2 ExG Channels. These can be connected to certified commercial ExG electrodes from 3^rd party manufacturers or vendors. Refer to their manuals for proper instructions on how to safely use them. To use Channel 1, connect compatible electrodes to the connectors on the left short edge of the 4-Wire Cradle, relative to the logo . Repeat for Channel 2 on the other side.

*4-Wire Cradle (top) with Channel 1 to the left (relative to the Dot logo ) and Channel 2 to the right, and a 4-Wire Cradle (bottom) with a 3^rd party electrode lead ready to be connected.*

The following symbols are used to explain assembly steps:

	Magnetic connection
	Adhesive, peel off protective liner and apply
	Connect snap buttons

To assemble a Sensor Patch:

Attach 2 (single Channel) or 4 ExG electrode (double Channel) leads to the 4-Wire Cradle according to the manufacturer’s instructions.
Attach 2 or 4 ExG electrodes to the electrode leads if needed and as indicated by the manufacturer.
Apply the ExG electrodes as indicated.
Place the Sensor Dot in the 4-Wire Cradle, with the gold-colored pins facing down.

*Assembly instructions for 4-Wire Cradle.*

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

*Make sure the Sensor Dot and Cradle logos are aligned (left); do not place the Sensor upside down in the Cradle (middle); the magnets will guide you to the right orientation (right).*

Depending on the ExG signals you wish to measure and the specific ExG electrodes chosen, we make a number of recommendations but many configurations are possible.

Always refer to the IFU provided by the electrode manufacturer or vendor!

For EEG, the electrodes will be attached to the User’s head in a partial (reduced-montage) EEG configuration. Up to 4 electrodes (2 pairs) can be used. Each electrode pair forms an isolated bipolar Channel.
For ECG, we recommend placing one electrode on the sternum (the negative lead), and the other paired electrode at a distance of approximately 12-15 cm away from the former (the positive lead). To record more than one ECG Channel, an additional electrode pair can be used. The best Signal amplitude will be achieved by mimicking a Lead II in a standard 6-lead ECG, which amounts to an angle of approximately 60 degrees relative to the shoulders.
For EMG, we recommend placing one electrode pair over a large skeletal muscle (e.g. upper-arm or upper-leg), with the electrodes spaced apart about 10 cm. To record more than one EMG Channel, an additional pair of electrodes can be used.

*Suggested ExG electrode positions for Recording EEG (left), ECG (middle) or EMG (right) Signals. Always refer to the manufacturer's instructions.*

Preparing the Docking Station and Sensor Dot

First, make sure the Docking Station is connected to an electrical outlet using the supplied medically-certified power adapter and USB cable. If you did not receive a country-specific power adapter, contact us.

*Detail (left-top) of the Docking Station back panel with micro-USB port (power) and reset button, and detail (bottom) of the power adapter and USB cable connectors.*

If necessary, clean the Sensor Dot and 4-Wire Cradle according to the cleaning instructions. Next, place the Sensor Dot(s) in a free slot on the Docking Station and make sure they are fully charged before using them, as signified by a solid green LED. It takes approximately 3 hours to fully recharge a Sensor Dot. When fully charged, a Sensor Dot will be able to record data for at least 24 hours.

To power down a Docking Station and Sensor Dots, simply unplug the power cord. It is safe to unplug a Docking Station at any time. All Sensor Dots docked in the Docking Station will also power off. If a recording was in the process of being transferred, it will not be lost but the transfer process will have to start again once the Docking Station is powered on. To turn the Docking Station and Sensor Dots back on, simply plug the power adapter back in an outlet. If a WiFi network that was already configured is still in range, the connection to the Byteflies Cloud will be restored as well.

Only use your Byteflies Kit with the provided cable and power plug!
Do not attempt to force the Sensor Dot into a slot on the Docking Station. The magnets only allow for one orientation.
Do not place the Sensor Dot upside down into a slot on the Docking Station. The gold-colored pins should always face down.
Do not submerge or rinse any component of your Byteflies Kit in water or any other liquid!
Do not shower or bathe with a Sensor Dot!

*Make sure the Sensor Dot and Docking Station slot logos are aligned; the magnets will guide you to the right orientation.*

Connecting a Docking Station to the Byteflies Cloud

The Docking Station needs to communicate with the Byteflies Cloud to operate. To connect it to a local WiFi network, follow the instructions below. Before you start, make sure you have the password for the WiFi network you want to connect the Docking Station to.

Power on the Docking Station and wait for 30 seconds until the LED starts blinking red to activate WiFi pairing mode (see illustration above to find the Docking Station LED).
From any WiFi connected personal device, go to the list of available WiFi networks* and look for one named Byteflies Dock-xxxxxxxxxxxx and connect to it (xx... will be replaced by letters and numbers)
Your browser will open and display a page with available WiFi networks.
Find your personal WiFi network, click the CONNECT button, enter your WiFi password in the pop-up window. You can use the eye icon to show your password. When done typing, click CONNECT again. The pop-up window will close when the connection has been made. On failure, an error message is shown.
The “WiFi Status” message at the top of the page should change from Not Connected to Connected to "your WiFi" (where "your WiFi" is the name of your home WiFi network).
If this message does not appear after about 1 minute, please try again and make sure you are entering the correct password for your WiFi network.
Connect your personal device back to your home WiFi network (if you wait one minute after a successful connection, the browser window will close and reconnection to your own network should happen automatically).
If the Docking Station successfully connected to the internet, the LED will turn blue. Once it is talking to the Byteflies Cloud, the LED will turn green so it is possible you never see the LED turn blue.

*To connect to a WiFi network, follow these instructions:

If the device from which you are trying to connect to the Docking Station has another active internet connection (for instance a wired or mobile connection), please disable these first before attempting to connect to Byteflies Dock-xx... network. Otherwise, the Byteflies portal page may not open.
Your Docking Station will automatically go into pairing mode any time it cannot find a previously paired WiFi network.
If you want to connect the Docking Station to a new WiFi network while a previously configured WiFi network is active, press the reset button at the back of the Docking Station with a pen or paperclip for 3 seconds until the LED starts blinking red to manually activate WiFi pairing mode (see illustration above to find the reset button). It can take up to 1 minute for the WiFi network to appear.

Configuring and Making Recordings

A Sensor Dot has no physical interface controls and can only convey information to the user via its LED. The act of physically placing a Sensor Dot in a free slot on the Docking Station sends it instructions to stop Recording and start charging the battery and downloading the recorded data. This assumes that your Sensor Dot(s) were already configured, either by yourself or Byteflies. Refer to the Byteflies Cloud Sensor Dot configuration instructions for more information. Taking a properly configured Sensor Dot out of the Docking Station when its status LED is green (solid or blinking) will start a Recording. Note that the Sensor Dot will start Recording as soon as it is removed from the Docking Station. Place it in the Sensor Patch which was previously set up.

Summarized, the following steps need to be executed to ensure a successful Recording:

Take a Sensor Dot with a solid green LED (fully charged and clean memory) out of the Docking Station.
Place it in the Cradle which you should already have affixed to the body of the User as explained above.
Record for up to 24 hours (or as long as indicated for your study).
Take the Sensor Dot out of the Cradle and place it back in any free slot on the Docking Station; the LED will turn orange to indicate the recorded data is being transferred.
Repeat with a new Sensor Dot to continue Recording (if indicated).
If, after transferring their Recordings, one or more Sensor Dots need to be switched off, e.g. for transport, this can be achieved by unplugging the Docking Station from the power socket. The LEDs of the docked Sensor Dots will switch off, indicating a shutdown.

An example of a 24-hour recording cycle with a 4-Wire Cradle set up with 3^rd party ECG electrodes. Note that in the example only one Channel is connected in an approximate Lead 2 configuration. Refer to the Sensor Patch instructions for more information on possible configurations.

The ExG electrodes should be affixed to the body of the User by a medical professional trained in handling similar devices.

Maintenance

The Sensor Dot, Docking Station, Sensor Patch, and power adapter contain no user serviceable parts, cannot be opened, and do not require routine maintenance. In case of issues, contact Byteflies support.

Re-usability & Cleaning Procedures

There is no need for routine cleaning or disinfection while the device is used for a single User. Before using any component on a new User, they should be disinfected by the Trained Operator.

First, detach all Sensor Patch components and dispose of single-use components properly.
In order to protect patients against the risk of cross-contamination, the Sensor Dot and Sensor Patch, the Docking Station, the power adapter and the micro-USB Cable should be cleaned and disinfected in preparation for a new patient (sterilization is not required):
- To disinfect, use a fresh disposable Trionic™ D wipe and wipe the surface of all Sensor Dots until all visible soiling is removed. Ensure the entire surface remains wet for at least 1 minute (Trionic™ is bactericidal after 1 minute).
- Wipe off any remaining fluid with a clean disposable tissue. Repeat the process for the Docking Station, Sensor Patch, power adapter and USB cable, taking care to use a new Trionic™ D wipe for each component.
- Do not use any abrasive cleaners such as acetone.

*Clean each Byteflies Kit component thoroughly with a Trionic™ D wipe. Wipe of any excess liquid with a clean and dry disposable tissue after 1 minute or longer.*

Transport & Storage

Do not store or transport the Byteflies Kit in locations exposed to:

Temperatures lower than 10°C or greater than 40°C
Air humidity lower than 10% or higher than 90%
Heavy contamination from dirt or other foreign agents
Running water
Strong electromagnetic forces
Environments subjected to pressure lower than 700 hPa or greater than 1080 hPa

Service Life

The Byteflies Kit is an active device with no restricted shelf life. Long-term use will degrade the components.

Disposal

The Byteflies Kit should be decommissioned when it reaches the end of its service life. The Byteflies Kit should be disposed of in accordance with the EU WEEE Directive for electronic waste disposal.

Technical & Regulatory Information

See the technical specifications and regulatory information.