Instructions for Use - Dashboard
1.6
Instructions for use are supplied electronically, paper format is available on request at support@fibricheck.com
1. PRODUCT DESCRIPTION
FibriCheck is a software that determines heart rhythm conditions, with a primarily focus on the detection of Atrial Fibrillation.
The FibriCheck application is only intended to record, display, store and transmit photoplethysmogram (PPG) data. Recordings are performed by making contact between skin and camera of a mobile device or by skin and sensor of a wearable device. This way, volumetric changes can be detected.
The sole purpose of the FibriCheck web application, an online tool, is to display data. Professional users can use the web application to manage patients and review FibriCheck data.
1.1 Indications for use
Indications for use
Adults with known or suspected heart conditions such as Atrial Fibrillation can use the FibriCheck application daily, or whenever feeling symptoms, to record their pulse waveform and to monitor their heart rhythm.Indications for use (US only)
FibriCheck is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
1.2 Contraindications
There are no known contraindications for FibriCheck.
1.3 Guidelines for use
FibriCheck can be used anytime and anywhere as long as it is used on a compatible, functioning mobile or wearable device with sufficient battery. If there is no internet connection, a measurement can still be performed, but the measurement analysis will only be available after the connection has been restored as the information must be sent to the cloud for proper analysis.
2. RECOMMENDATIONS
2.1 General
- A diagnosis cannot be made based on FibriCheck alone, consult with your physician before making any medical decision, including altering your medication or treatment.
- FibriCheck does not detect or register all changes in heart rates, heart rhythms and heart waveform.
- Interpretations made by FibriCheck are potential findings, not a complete diagnosis of cardiac conditions. All interpretations should be reviewed by a medical professional for clinical decision making.
- Do not perform measurements while driving or during physical activity.
- Do not perform measurements when the camera lens is uncleaned or broken.
- After PPG analysis, the app may incorrectly identify some conditions as unreadable. Please consult with your physician.
- FibriCheck does not guarantee that you are not experiencing an arrhythmia or other health conditions when labelling a measurement as normal. You should notify your physician for possible changes in your health.
- Do not continue using FibriCheck when experiencing discomfort caused by the camera flash. Try to avoid overlap of the flashlight with the finger.
- Measurements can’t be sent to your physician without Internet connection.
2.2 Users
FibriCheck is not intended to be used by all individuals:
- Persons with coloured fingers/wrist (i.e. tattoos, ink); unnaturally coloured fingers/wrist weaken the signal and interfere with the effectiveness of the device (depending on the device).
- Persons under the age of 18 years.
- Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device cannot process an accurate measurement.
- Persons with reduced blood flow in the fingertips (e.g. perniosis or callus formation) as FibriCheck will not be able to detect the significant intensity variations induced by the blood flow.
- Persons that have a disability to perform the measurements according to the instructions for use.
- Persons with cardiac pacemakers, ICDs, or other implanted electronic devices as these can control the natural heart rhythm.
3. COMPATIBILITY
3.1 FibriCheck Dashboard
The FibriCheck web application, an online tool, has the sole intention to display data and is compatible with:
- Google Chrome (58 or higher)
- Internet Explorer (11 or higher)
- Mozilla Firefox (52 or higher)
- Safari (8 or higher)
Users will always have access to the latest version of the FibriCheck Dashboard since its a secured website. They will be notified of the update.
3.2 FibriCheck Mobile Application
The minimum system requirements for the FibriCheck smartphone application are an Android operating system with minimal software version Android 4.4.2 or an iOS operating system with minimal software version iOS 11.1.2.
FibriCheck users will be notified when an update is available. The update of the FibriCheck Application can be found in the App Store/ Play Store.
NOTE: FibriCheck performs proactive device monitoring. If you cannot find the application in the App Store / Play Store, this is preventively removed.
4. THE FIBRICHECK DASHBOARD
To access the FibriCheck Dashboard, users must sign in at dashboard.fibricheck.com with their personal FibriCheck account. If you lost your password, please select “Forgot Password?” and follow the instructions provided in the email.
4.1 Dashboard
Once signed in at the FibriCheck Dashboard, the Dashboard is automatically visible. A general overview is given of all measurements open waiting for revision. The measurements are classified in different categories: Urgent, Warning, Normal and Quality. All measurements are chronological ranked in these categories.
4.2 Worklist
Under the menu ‘Worklist’ the list of measurements which are open for revision can be found. These measurements are arranged chronologically. For each measurement the color indication and the username are shown. Select a measurement to view it. The color indicator and interpretation of the measurement must be confirmed. Additional comments can be added.
A search for a specific measurement of a patient or search on color indication can be done in the toolbar.
4.3 Color indication of a measurement
4.3.1 Heart rate
- Low: indicates the heart rate detected was below 50 beats per minute (bpm).
- Normal: indicates a heart rate between 50-100 bpm was detected.
- High: indicates when a heart rate above 100 bpm was detected.
- Analysis not possible: indicates whether the quality of the registered signal was not sufficient to be interpreted.
4.3.2 Heart rhythm
- Green:indicates low variability in the heart rhythm is detected during the measurement. This indicates a normal sinus rhythm. However, FibriCheck can not guarantee that no arrhythmia or other cardiac condition is present when a measurement is labeled as regular.
- Orange: low rhythm variability is detected which might indicate possible finding of an arrhythmia such as extrasystoles or other arrhythmia.
- Red: high rhythm variability is detected which might indicate possible finding of an arrhythmia such atrial fibrillation or other arrhythmia.
- Blue: a blue color indicates whether the quality of the registered signal was not sufficient to be interpreted.
5. PATIENTS
5.1 General overview
This shows a list of all the patients associated with the account of the medical professional. Once a patient has activated the account, the patient can be found in this list. All measurements of these patients are visible for the professional user.
5.2 Detailed overview of a patient
By selecting a patient, the detailed profile of the patient is shown. A general overview and calendar are displayed with a chronological timeline. On the right side a worklog can be find to add notes or comments.
6. REPORTS
6.1 General summary
A chronological oversight of the reports of all the patients is presented in this tab. All the reports appear in chronological order. In this summary it is possible to search a report by name or by the status of the report.
6.2 Detailed summary
It is possible to investigate the report in more detail or to download the report for each patient. The reports present the measurements for each patient of the selected period. This period can be free determined. Each report illustrates the details of the patient, a general summary of all the measurements and a detailed overview of the selected measurements by color code.
It is also possible to obtain a report of a patient by clicking on the name of the patient. Afterwards a general summary of the report can be perceived underneath the section ‘reports’.
6.3 Configuration
It is possible to have tailor-made reports. For this purpose you select the option ‘configuration’. It is possible to determine the content of the report by selecting the number of measurements of each color code, in demand of the report. It is also possible to select fixed moments to generate the reports. These settings can apply to all the reports or to an individual report of the patient. The settings applying to an individual report can be set in the detailed profile of the patient.
7. GENERATE A PRESCRIPTION
Prescriptions can be generated by clicking on the button ‘generate a prescription‘ in the menu bar. Select the physician for wich the prescription has to be generated. Select the payment method, patient or goup or credits. Afterwards you can select the prefered package.
Afterwards you can download the prescription and print it out or send it to the patient by email. Once the patient has scanned the QR code and has activated the account, his account will be connected to your dashboard and the measurements will be visualized.
8. SETTINGS
In Settings, you can find information related to the FibriCheck account, change personal preferences and activate 2-factor authentication under Security.
9. APPLICABLE SYMBOLS
| Symbol | Detail |
|---|---|
 | Medical Device |
 | European conformity mark |
 | Consult instructions for use |
 | Qompium NV Kempische Steenweg 303/27 3500 Hasselt Belgium |
 | 2022-01-27 |
 | Reference Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. (US only) |
10. CONTACT DETAILS
For more information or questions, please check our FAQ at help.fibricheck.com.
Serious incidents that have occurred in relation to the device shall be reported to:
(1) the legal manufacturer via support@fibricheck.com
(2) the local competent authority
10.1 Manufacturer
Qompium
Kempische Steenweg 303/27
3500 Hasselt
Belgium
10.2 Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia