Link Search Menu Expand Document

CardioCare@Home Pro

CE mark

Table of contents
  1. CardioCare@Home Pro
    1. Legal & Safety Information
    2. CardioCare@Home Pro Description
      1. Intended Use
      2. Intended User
      3. Indications for Use
      4. CardioCare@Home Pro Components
      5. Package & CardioCare@Home Pro Symbols
    3. Usage Instructions
      1. CardioCare@Home Pro Terminology
      2. Getting Started
      3. Compatible Devices
      4. Patient Management
        1. Add a Patient
        2. Edit a Patient
        3. Start/Stop a Follow-Up
        4. Monitoring a Patient
          1. Graphs
            1. The Median Heart Rate Graph
            2. The Instantaneous Heart Rate Graph
            3. The Poincaré (Scatter) Plot
            4. The Electrocardiogram (ECG)
          2. Potential Cardiac Anomalies (PCAs)
        5. Generate a Report (Admin Users Only)
      5. User Management
        1. Adding a User
      6. CardioCare@Home Kits
      7. Settings
    4. Updates
    5. Technical & Regulatory Information

Please carefully review the Legal & Safety documentation first.

CardioCare@Home Pro Description

Intended Use

CardioCare@Home Pro is medical software intended to visualize electrocardiogram (ECG) and actigraphy signals, with additional ECG waveform and beat-to-beat annotations, and vital sign measurements (heart rate and respiratory rate) generated by a compatible medical device. It is intended to be used by a healthcare professional to review, interpret the presented data, and generate a report, in order to provide clinical decision support for the treatment of patients with an indication for at-home electrographic monitoring. CardioCare@Home Pro is not a real-time or remote diagnostic device.

Intended User

User
A healthcare professional monitoring a patient with an indication for at-home ECG monitoring.

CardioCare@Home Pro is intended to be used by Users who can access and view data in a medical environment (e.g. hospital).

Indications for Use

CardioCare@Home Pro is intended to be used by healthcare professionals for the treatment of patients indicated for at-home ECG monitoring. CardioCare@Home Pro reads and visualizes data from interoperable medical devices, including but not limited to Byteflies Kit. CardioCare@Home Pro visualizes electrocardiogram (ECG) with beat-to-beat annotations and additional ECG waveform features (P-wave, R-peak, T-wave), heart rate (HR), respiratory rate (RR), and actigraphy data. CardioCare@Home Pro is intended to be used by a licensed medical professional and any interpretation or diagnosis must be made in reference to the signal data, based on their judgement and clinical experience. CardioCare@Home Pro does not derive any ECG or actigraphy features and does not provide any diagnostic conclusion about the patient’s condition.

CardioCare@Home Pro Components

CardioCare@Home Pro is a web application running on top of Amazon Web Services (AWS) that is accessible via any modern Chromium-based browser (e.g. Google Chrome or Microsoft Edge) for authorized Users.

Package & CardioCare@Home Pro Symbols

Please refer to the Regulatory Information of CardioCare@Home Pro.

Usage Instructions

The following section describes how to safely use CardioCare@Home Pro.

User
A healthcare professional monitoring a patient with an indication for at-home ECG monitoring.

CardioCare@Home Pro is intended to be used by Users who can access and view data in a medical environment (e.g. hospital).

CardioCare@Home Pro Terminology

CardioCare@Home Pro (CC@H Pro)
CardioCare@Home Pro is a software as a medical device (SaMD) intended to visualize patient data recorded by a compatible medical device.
Active Patient
A CC@H Pro User can indicate which patients are under active observation by a compatible medical device and CC@H Pro will query that medical device or associated medical device data system (MDDS)* for new data as it becomes available.
Inactive Patient
A CC@H Pro User can indicate which patients are no longer under active observation by a compatible medical device or MDDS. All associated data will still be available in CC@H Pro.
Compatible Medical Device
An ECG and (optionally) actigraphy recording device or associated MDDS device that meets the compatibility requirements of CardioCare@Home Pro, also refered to as a CardioCare@Home Kit.

*An MDDS is a storage system for data that originated from a medical device. We follow the FDA definition.

Getting Started

To open CC@H Pro, go to the hospital.cardiocareathome.com and login with your credentials.

For first time login, use the temporary password that was sent via email. You will be asked to choose a new and secure password in the next step.

When logging in, the first page shown is the patient overview. This overview contains all the patients linked to the hospital or medical organization of the logged-in User. More details regarding this page can be found in the upcoming paragraph.

The User can switch between the different pages of the dashboard using the menu on the left. Each of them will be discussed in more detail in the next paragraphs.

  1. Patients
  2. Users
  3. CardioCare@Home Kits
  4. Settings

Compatible Devices

Compatible devices or MDDSs, also referred to as CardioCare@Home Kits, are medical devices that have at least the following properties:

  • Store ECG data between 250-1000 Hz
  • Store ECG R-peak annotations and interbeat intervals (IBI)
  • Store information on Potential Cardiac Anomolies (PCAs), i.e. left and right boundaries of areas of rhythmic abnormalities identified by the compatible device or another source
  • The data storage system is accessible over an API that can be queried by CC@H Pro
  • The data storage system announces a unique device identifier (UDI) so that CC@H Pro can associate data to a specific patient record
  • Store at least the following metadata for each recording: Start datetime, End datetime, Device UDI

A compatible device can optionally have the following properties:

  • Store accelerometer data between 10-200 Hz
  • Store actigraphy data derived from the accelerometer data
  • Store ECG P-wave and T-wave annotations
  • Store quality control information about the stored signals and waveform annotations

For more information and technical specifications, please contact us.

Patient Management

The overview page shows all applicable patients for your hospital or medical organization. The following details are shown for each patient:

  • Patient Identifier
  • Device ID
  • Start Date
  • End Date
  • Doctor
  • Clean Data
  • Actions

Active patients (default) are shown in black. Patients whose follow-up has ended (Inactive) are shown in grey.

Add a Patient

It is possible to add a new patient for follow-up via the blue ADD PATIENT button on top of the page. Clicking this button will open a pop-up window with three fields:

Patient Identifier
This field is mandatory (indicated by an *), it is not possible to create a new patient without an assigned identifier. An identifier should not contain any personal information about the patient.
Choose a device
This field is mandatory (indicated by an *), it is not possible to create a new patient without associating a data source from a compatible medical device. The dropdown shows the different devices available for use. It is not possible to link a device to multiple patients.
Doctor
This field is optional, it is possible to create a new patient without an assigned doctor. If applicable, the User can add the name of this patient’s responsible doctor.

By clicking the ADD PATIENT button at the bottom of the pop-up window, this patient will get added to the overview and will become an Active Patient by default.

By clicking the CANCEL button, the pop-up window will disappear without adding a new patient.

If there are no available devices, a new patient cannot be created. Devices are only available when they are not already linked to a patient.

To ensure all data from a compatible medical device is correctly associated with a CC@H Pro patient record, the patient must be Active before starting a recording. For example, if a patient starts recording with a compatible medical device at 8:15am and their record in CC@H Pro is marked as Active at 8:30am, the recorded data will not be appropriately linked to the patient record in CC@H Pro. If this occurs, please contact support.

Edit a Patient

Via the in the actions section of a patient, patient information can be edited. The following changes are possible:

  • Change the device linked to this patient
  • Change the doctor information The changes need to be confirmed by clicking the EDIT PATIENT button.

Start/Stop a Follow-Up

After adding a new patient, the default status of the patient will be Active.

By clicking the in the actions section of a patient, the follow-up of this patient will be stopped. The End date will change to the moment the monitoring was stopped and the device linked to this patient will become available again. The patient will become Inactive (grey text) and the itself will change into a .

By clicking the the patient can be made Active again. It may be necessary to link a new device to this patient as explained above.

Monitoring a Patient

When clicking on a certain patient (Active or Inactive) in the overview, the detailed view of this patient will open.

Graphs

On the right, the detailed patient view will show four different graphs with the patient’s data:

The Median Heart Rate Graph

This graph shows the patient’s heart rate for any of the available days with recorded data. The heart rate on this graph is averaged into windows of 5 minutes. Different days can be selected via the buttons in the upper-right corner. The arrow buttons allow you to go back and forth between the days.

Regions of lower quality data are highlighted in grey, which are identified by the compatible device.

If available, actigraphy data will be overlayed in 10 minute bins (bar plot).

The Instantaneous Heart Rate Graph

This graph shows the instantaneous heart rate for a selected time window of 10 minutes. The time period can be changed by clicking on the median heart rate graph, and the relevant window will be displayed in the instantaneous heart rate graph.

The Poincaré (Scatter) Plot

The Poincaré plot is calculated for the same 10-minute window as the instantaneous heart rate. It will also update when you select another window in the median heart rate graph.

The Electrocardiogram (ECG)

The electrocardiogram (ECG) is shown for a 10-second window. Additional data can be visualized by scrolling through the ECG graph or by selecting another window in the instantaneous heart rate graph.

The R-peaks in the ECG are marked with a dot. R-peaks are categorized in the following categories:

  • Outlier = red dot
  • Normal = blue dot

It is possible to change the scale of the y-axis via the buttons on the top right of the ECG graph. The options for the scale of the y-axis are the following:

  • 0.5 mV
  • 1 mV
  • 2 mV
  • 3 mV
  • 4 mV
Potential Cardiac Anomalies (PCAs)

A potential cardiac anomaly (PCA) is a section of patient data that shows irregular rhythmic features that may require the attention of the User. Please refer to the compatible devices for more information on CC@H Pro compatible definitions of PCAs.

PCAs are shown on the left side of the detailed patient view. When selecting a PCA (by clicking on it), the associated data will be shown in the graphs. PCAs are highlighted in yellow.

Each PCA can be either accepted or rejected by the User, by clicking the appropriate button in the instantaneous heart rate graph.

An accepted PCA will be highlighted in green and a rejected PCA will be highlighted in red. Both types will stay available and visible in the dashboard and can be edited via the edit button in the instantaneous heart rate graph.

Generate a Report (Admin Users Only)

To create a report for a patient, click the button in the actions section of a patient. A report can be created during or after a follow-up period. You need to be an Admin User for your hospital to generate reports (see User Management)

CC@H Pro will generate a default report that can be configured with the following settings:

  • Show only the confirmed PCAs or all PCAs
  • Change the language (EN, NL)
  • Invert the ECG graphs which are included in the report

The patient report will contain the following information:

Patient Information
Information about the patient that has been recorded in CC@H Pro.
Summary Statistics
Summary statistics about the patient's follow-up period. This includes heart rate, total beats, tachycardia regions, bradycardia regions, PCAs, total duration of recorded data by a compatible medical device, and total duration of clean data. This information is calculated outside of CC@H Pro by compatible devices.
Event Overview
This overview displays PCAs throughout the patient's follow-up period. Each PCA is displayed as a vertical red line, and the thickness of the red line indicates the relative duration of a PCA.
PCA Details
Each PCA (confirmed or all) is shown with the following information: start time, end time, duration, total beats, heart rate, and associated ECG waveform.

A PDF of the report can be generated using the PRINT button.

User Management

This page shows an overview of all the Users within the hospital(s) under your responsibility. It is possible to search for a specific User via the search bar ().

The following information is available for all Users:

  • Email address
  • Associated Hospital
  • Creation Date

The following types of Users can be created:

  • User: Traditional user rights
  • Admin User: Users with additional management rights

Adding a User

A new User can be added via the ADD USER button at the top of the User Management Screen. As a User, it is possible to add new Users to your hospital by entering their email address in the designated field.

As an Admin User it is possible to add a User to a hospital under your responsibility by providing their email address and the hospital they are linked to. Only an Admin User can assign administrator rights to a new User.

CardioCare@Home Kits

This overview is only available to Admin Users and shows compatible medical devices linked to your hospital(s).

Settings

The settings page allows the User to configure the following settings:

  • Sign out of the application
  • Change the language of the application
  • Change the User account password

Updates

CC@H Pro is a web application and any minor maintenance, bug fix, or cosmetic updates will be deployed continuously to all Users. Major updates that will or could alter important functionality or performance in the application will be announced to all active Users before deploying. If you receive an update notice and have any concerns, please contact us.

Technical & Regulatory Information

See the regulatory information.


Copyright © 2020 Byteflies