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Cardiorespiratory Patch

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Table of contents
  1. Cardiorespiratory Patch
    1. Intended User
    2. Required Components
      1. 2-snap Cradle
      2. ECG Adhesive
      3. Cradle Adhesive
    3. How to Assemble Sensor Dot, 2-snap Cradle, and ECG Adhesive
    4. How to Assemble Sensor Dot, 4-wire Cradle, and Cradle Adhesive
    5. Make a Cardiorespiratory Recording
    6. How to Remove, Replace, and Store Adhesives

Cardiorespiratory Patch

This document describes a number of common use cases for recording cardiorespiratory 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, and ECG Adhesives.
  3. Familiar with cardiorespiratory monitoring, including placement of biopotential (ExG) electrodes, and interpretation of electrocardiography (ECG), heart rate (HR), and respiratory rate (RR) data.

Required Components

You will need the following:

  1. A Sensor Dot
  2. A 2-snap Cradle or 4-wire Cradle
  3. An ECG Adhesive or Cradle Adhesive with 3rd party biopotential (ExG) electrodes

2-snap Cradle

This accessory provides an interface between a Sensor Dot and an ECG Adhesive. It has snap connectors on the bottom that are compatible with 9.5 mm snap fasteners, and a Sensor Dot connector with magnet guides on the top. It can be used to record a single ECG Channel when used in combination with an ECG Adhesive.

A 2-snap Cradle with Sensor Dot is shown. The cradle has two snap buttons on the bottom and a Sensor Dot connector with magnet guides on the top.

  • Do not attempt to force a Sensor Dot into a 2-snap Cradle. The magnets only allow for one orientation.
  • Do not place a Sensor Dot upside down into a 2-snap Cradle. The gold-colored pins should always face down.
Make sure the Sensor Dot and 2-snap 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).

ECG Adhesive

The ECG Adhesive (Model 1) is a wearable Class I medical device for recording of an ECG signal. It can be used in healthcare, home and research environments. The ECG Adhesive is intended to be used on intact (uninjured) skin and can be used for making short-term and long-term (up to 3 days) single-lead ECG recordings. ECG Adhesives are compatible with biopotential recording devices that can connect to 9.5 mm snap fasteners. Please review the device labeling and safety information before proceeding.

  • As with everything that needs to be applied to the skin, make sure the area where you are planning to place an ECG Adhesive is clean, dry, and free of excess body hair. Do not use solvents are abrasive materials to clean the skin prior to application of an ECG Adhesive as that may lead to skin irritation.
  • Never apply an ECG Adhesive to injured skin (erythema, lesions or any other injuries). ECG Adhesives should only be used on areas of intact external skin that are large enough to support its entire surface area.
  • Do not use an ECG Adhesive if the adhesive itself or its pouch is damaged.
  • Do not use ECG Adhesives if the shelf-life is expired, as indicated on the pouch, or more than a month after opening the pouch.
  • Keep any unused ECG Adhesives in the original pouch. Close the opened pouch and fold the top of the pouch twice.
An ECG Adhesive has two embedded dry ECG electrodes and 2 snap connectors. These connectors are compatible with a 2-snap Cradle or other biopotential recording devices that can can connect to the snap connectors.

Cradle Adhesive

When using a 4-wire Cradle instead of an ECG 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 4-wire 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.
A Cradle Adhesive is a simple double-sided adhesive. Peel one adhesive from the plastic liner. This side attaches to the bottom of a 4-wire Cradle. The other side can be applied to the skin. See further for full assembly instructions.

How to Assemble Sensor Dot, 2-snap Cradle, and ECG Adhesive

The following symbols are used to explain assembly steps:

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

This set up is used to record a single Channel of ECG data to collect ECG, HR, and RR data, with optional motion Signals.

To assemble a Cardiorespiratory Patch with a 2-snap Cradle and ECG Adhesive:

  • Attach a 2-snap Cradle on the ECG Adhesive by aligning the snap buttons and pressing down.
  • Peel the protective liner off the ECG Adhesive and apply to the chest of the User as indicated by ECG acquisition standards. Place the ECG Adhesive in one try, do not remove and attempt to reply as that may damage the electrodes.
  • Place the Sensor Dot in the 2-snap Cradle, with the gold-colored pins facing down.

The illustration below shows an example configuration. Note that different configurations are possible, depending on the requirements of the Trained Operator.

Cardiorespiratory Patch mounted on chest in diagonal (top, approximating an Einthoven Lead II) or horizontal (bottom, approximating an Einthoven Lead I) configurations.

How to Assemble Sensor Dot, 4-wire Cradle, and Cradle Adhesive

Alternatively, a 4-Wire Cradle can be used as described elsewhere. This set up has the advantage that up to two ECG Channels can be recorded simultaneously, together with optional motion Signals. It requires usage of 3rd party ExG electrodes (not supplied by Byteflies) that are compatible with DIN 42-802 connectors. More information is available here.

Always refer to the manufacturer’s instructions when using 3rd party electrodes!

To assemble a Cardiorespiratory Patch with a 4-wire Cradle:

  • 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 3rd party ExG electrode leads to the 4-Wire Cradle.
  • Attach 2 or 4 3rd party electrodes to the electrode leads as indicated by the manufacturer.
  • Peel the protective liner off the other side of the Cradle Adhesive and apply to the chest of the User.
  • Apply the 2 or 4 electrodes to the chest of the User as indicated by ECG acquisition standards.
  • Place the Sensor Dot in the 4-Wire Cradle, with the gold-colored pins facing down.

The illustration below shows an example configuration. Note that different configurations are possible, depending on the requirements of the Trained Operator.

Cardiorespiratory Patch with 3rd party electrodes mounted on chest in an approximate single Channel Einthoven Lead II configuration. Two record a double Channel configuration, simply connect the other lead wires of the 4-wire Cradle.

Make a Cardiorespiratory Recording

To start and stop a Sensor Dot Recording, follow the Configuring and Making Recordings instructions. Make sure the correct ExG Channels are configured as ECG in the Sensor Dot.

  • When using a 2-snap Cradle with ECG Adhesive, the ECG signal is recorded on ExG Channel 2!
  • 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. Any unused ECG Adhesives should be kept in the original pouch. Close the opened pouch by folding the top twice. Cradle Adhesives should be stored in a dry place but require no further special handling.

  • Always refer to the manufacturer’s instructions when using 3rd party electrodes!
  • If the User experiences any adverse events while using any skin adhesive, discontinue its use and contact Byteflies immediately.
  • An ECG Adhesive should be replaced if they no longer stick firmly to the skin or within 72 hours of use, whichever happens sooner.
  • Take extra care when removing skin adhesives from overly delicate skin to avoid skin damage.
  • Do not apply a new ECG Adhesive if skin irritation or damage is visible.
  • Do not use an ECG Adhesive for more than 72 hours.
  • Do not attempt to re-apply a used ECG Adhesive.

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