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Byteflies Cloud (Byteflies Kit Model 1)

CE mark

Table of contents
  1. Overview of the Byteflies Cloud
    1. Groups
      1. Docking Station Management
      2. Patient Management
    2. Recording Overview
    3. Recording Details
  2. Configuration Mode
  3. Recording Labels
    1. Patient Management
    2. Patient ID

The Byteflies Cloud is an integral part of the Byteflies Kit (Model 1). Its instructions are discussed in a separate section for readability reasons but one cannot be used without the other. If you have not already done so, please review the IFU for the Byteflies Kit first which focuses on the hardware components of the system. All legal & regulatory requirements are linked in that document.

Overview of the Byteflies Cloud

Once a Docking Station is online, as instructed previously, it will show up in your Byteflies Cloud account. You should have received a username and password from Byteflies. If you did not, contact us. You can access your Cloud account via https://cloud.byteflies.com/ using the account settings button in the Header Bar as shown in the figure below. Enter your username and password when prompted. Multi-Factor Authentication can be enabled upon request.

By default, logging out needs to be done explicitly via the top right button in the Header Bar or by closing the browser. It is possible to automatically log out when a user has been inactive for 15 minutes. This feature can be enabled for specific users upon request.

Byteflies Cloud accounts are only available for Trained Operators!

From your Byteflies Cloud account, you can manage your Docking Stations, ongoing studies, and recorded data. Note that depending on the access level you were granted, some of the features described below will not be available. These features are marked with:

Admin

The illustration below provides an overview of the interface elements. Please refer to the caption for details.

The Byteflies Cloud interface consists of 3 main parts: the Header Bar, the Sidebar, and the Information Canvas. The Sidebar provides access to various information views, whereas the Information Canvas displays the information associated with the Sidebar selection (the Recordings view is shown). The Information Canvas uses various icons to guide you around which are explained below. Definitions of user interface elements are italicized.

Many fields in the user interface can be copied with a simple click. When hovering over one of these elements, you will see a icon.

Groups

After logging in, the first page that loads is the Recording view (Sidebar). The Information Canvas lists all Groups accessible from your account. Groups are used to organize different studies or experiments. From the overview list, a Group can be selected which will bring you to the corresponding list of available Recordings.

From the Groups view, 2 actions are available to 1) manage your Docking Stations and 2) manage Patients :

Docking Station Management

This action groups various functions that allow you to configure Docking Stations (and subsequently their Sensor Dots), as well as check on their status. A Docking Station that is correctly communicating with the Byteflies Cloud is indicated with , whereas an offline Docking Station is indicated with . In that case, the Last Connection field lets you know when the Docking Station was last online. If you were instructed to change the configuration of one or more Sensor Dots, click the and follow the instructions below.


Admin

In addition, Docking Station Management provides access to a Calibration function which is only available to admin User Accounts.

Do not use the Calibration function without explicit instructions from Byteflies to do so. When in doubt, contact us.


Patient Management

Patient Management functionality is explained in the Recording Labels section.

Recording Overview

Once a Group is selected, the list of available Recordings from the last 7 days will be displayed in the Information Canvas. To access Recordings older than 7 days, adjust the date range . In addition, available Recordings can be filtered based on all fields (e.g. labels) via the search functionality . How to assign labels is explained below. For each Recording listed, a number of actions are available:

  • Delete : see below
  • Re-trigger : see below
  • Copy metadata : copy the metadata associated with a Recording to your clipboard. The included metadata is described in the Recording Details section.

Admin

  • Admins can delete Recordings using the button. This action is non-reversible. Contact us in case a Recording was deleted by mistake.
  • Admins can retrigger algorithms that have been executed on the recorded data . Doing so, will recalculate any insights derived from the recorded data. Please be patient as this may take some time. This feature is explained in more detail in the next paragraph.

Recording Details

When selecting a Recording from the list, the details of that Recording will be displayed. This includes the same information as in the Recordings view table, while also supplying the end datetime of the Recording and the version of the Sensor Dot firmware. Patient labels can also be viewed and edited here.

Sample-level data (i.e. raw waveform data) for each Signal that is available for this Recording can be downloaded in CSV format by clicking the icon. If these Signals are part of the CE medical device, they are clearly marked with . If not, they are marked with the Investigational use only statement.

The following icons are used to indicate the sample-level Signal types that can be available in a Recording:

Icons identifying which Signals are part of a specific Recording, categorized into behavioral, physiological, and device diagnostic data.


In addition, heart rate (HR) and respiratory rate (RR) Signal are derived from ECG Signal, and activity index (AI) from ACC Signals, which are marked with inside the Recording detail view with the following labels: HEARTRATE, EDR_RESP, and ACTIVITY_INDEX. Please refer to the developer information for more details.

Some algorithms that derive vital signs and other relevant insights () from the sample-level data are available for investigational use only. Unless Byteflies explicitly instructed you to use any of the investigational use files, you will not need these!


Investigational Use Only

Sometimes the Signal type icons are shaded red, yellow, or green. This functionality is not part of the CE marked medical device and can only be used for investigational purposes. Refer to the associated developer documentation.


Configuration Mode

From the Byteflies Cloud interface, Docking Station Management can be accessed as explained previously. Click the button to access Configuration Mode. On the next screen, follow these steps:

  1. Select the Signal type for Channel 1 and 2 (if any, all ExG Signals are recorded at 250 Hz).
  2. Switch on the ACC and GYR Signals as desired and select the sample rate (25, 50, 100, or 200 Hz).
  3. Make sure all Sensor Dot(s) you wish to (re)configure are on the Docking Station.
  4. Clicking SEND will set the Docking Station in Configuration Mode, indicated by a purple status LED on the back of the Docking Station.
  5. The status LED of the docked Sensor Dot(s) will blink green rapidly to indicate the new configuration has been set.
  6. Click the FINISH button in the Cloud interface to exit Configuration Mode. The Sensor Dot LEDs should turn solid green, or blinking green if the battery is still charging.
  7. Repeat this process if you need to send different configurations to other Sensor Dots (only one configuration can be send per configuration cycle).

If, after attempting a configuration, a Sensor Dot’s LED is blinking yellow when taking it out of the Docking Station, the configuration may not have been correctly stored. Please try again. If that does not solve the issue, contact us.

Recording Labels

A number of labeling options are available in the Byteflies Cloud interface to help you organize your studies.

Patient Management

Patient Management allows you to assign a Patient ID to a Docking Station or specific Sensor Dot(s) before starting a Recording. From the Patient Management View, click the button (bottom-right) and set a unique identifier, a date range for the identifier to be active, and at least one Docking Station identifier or one or more Sensor Dot identifiers. Note that the Docking Stations available in your Group will be pre-populated but you will have to look up the Sensor Dot identifiers. Click ADD to activate the Patient ID. Active or expired Patient IDs can be deleted with the button.

Any recordings uploaded with the selected Docking Station and/or made with the selected Sensor Dots will be assigned that Patient ID within the selected date range.

Patient ID

From the Recording details view, a Patient ID can be set manually. If an automatic Patient ID was set (see above), it can also be manually edited in this field.


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