Instructions for Use - Wearable Fitbit
1.2.1
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 with a sensitivity, specificity and positive predictive value of 80,43%, 96,83% and 96,52%, respectively.
The FibriCheck Wearable App is only intended to record, display, store and transmit photoplethysmogram (PPG) data. Recordings are performed by making contact between 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
The FibriCheck app is a software-only mobile medical application intended for use with the Fitbit Smartwatches to create, record, store, transfer, and display photoplethysmograph (PPG) data. The FibriCheck app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The FibriCheck app is not recommended for users with other known arrhythmias. The FibriCheck app is intended for over-the-counter (OTC) and prescription (Rx) use. The PPG data displayed by the FibriCheck app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The PPG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.
The FibriCheck app is not intended for use by people under 22 years old.
1.2 Contraindications
There are no known contraindications for FibriCheck.
1.3 Guidelines for use
For good results and follow-up, we recommend to perform at least 2 measurements a day and additional measurements when experiencing symptoms.
FibriCheck can be used anytime and anywhere as long as it is used on a compatible, functioning device with sufficient battery. A functioning bluetooth connection between the smartwatch and the smartphone is required. 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. CAUTIONS
2.1 General Cautions
- 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).
- Minors (below 18 years old); the device has not been evaluated in persons where the heart is not fully grown.
- 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 Wearable Application
FibriCheck is compatible with the following wearables:
- Fitbit Ionic
- Fitbit Versa
- Fitbit Versa Lite
- Fitbit Versa 2
FibriCheck users will be notified when an update is available. The update of the FibriCheck Application can be found in the Fitbit App Gallery.
NOTE: Results of the measurements performed with the FibriCheck Wearable App can be retrieved in the FibriCheck Mobile Application or via pc in the FibriCheck Web application.
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.
3.3 FibriCheck Dashboard
The FibriCheck web application (dashboard.fibricheck.com), 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.
4. SET UP YOUR PERSONAL ACCOUNT
You need a personal account to monitor your heart rhythm with FibriCheck. Setting up an account can be done in 3 steps. Follow the step-by-step instructions below to successfully create a FibriCheck account or check help.fibricheck.com for instructional videos.
4.1 Download the FibriCheck application via the Fitbit Gallery
Open the Fitbit App on your smartphone. In the Fitbit App, tap on your Fitbit device and go to 'All Apps'. Now, you are in the Fitbit Gallery and you can search for FibriCheck.
4.2 Create and link your personal account
Tap on Settings in the FibriCheck Companion App and create your account. If you already have a FibriCheck account, no new account should be created and you can link this to the FibriCheck Wearable app.
4.3 Add your subscription
Once you have created an account or when your are logged in, you can activate a subscription via 'Settings' in the Fitbit App.
5. A FIBRICHECK MEASUREMENT
5.1 Performing a measurement
Go to the FibriCheck application on the smartwatch and tap on it. As soon as you open the application, an instruction screen of FibriCheck is shown. Follow the instructions. Once the required measurement requirements are met, select "measure". FibriCheck will now detect your heart rhythm, this may take several seconds. Once FibriCheck has started to record your heart rhythm, a counter shows the remaining time before the measurement is completed. A measurement takes 60s. It is recommended to perform at least 2 measurements per day and whenever when feeling symptoms.
It is very important to comply with the following when performing a measurement:
Make sure your smartwatch LED and detector lens are clean;
Take a seated position and rest your arms on table;
Do not talk, move or relocate your wrist during the measurement. This can interrupt the measurement or influence the quality of the measurement. In both cases, the measurement will have to be performed again;
5.2 After the 60 seconds measurement is completed
After completing the FibriCheck measurement, the data recorded via the FibriCheck Wearable App is automatically transferred to the smartphone where the FibriCheck Companion App receives the data and which will automatically upload the data through a secure connection to the FibriCheck Cloud environment for processing. After processing the results are sent back to the FibriCheck Companion App.
The FibriCheck Companion App relays these results directly back to the FibriCheck Wearable App which shows the analysis result to the user. The results are displayed as below.
Caution: This analysis is not a diagnosis and does not replaces medical advice. Please seek professional medical assistance if you are, or believe you are, suffering from any medical problem. This device does not detect or monitor all heart rates, heart rhythms or heart waveform changes, especially those related to ischemic heart conditions. This interpretation is solely based on the PPG recording submitted for analysis.
5.3 Explanation of the rhythm classifications
Immediately, after a 60 second FibriCheck measurement, FibriCheck automatically interprets the signal. Possible outputs are the following alarms (low priority):
Green labelled as “Regular rhythm”: This rhythm does not show any signs of irregularities. This is indicative for a regular rhythm. FibriCheck cannot guarantee that no arrhythmia is present when a measurement is labeled as green.
NOTE: Please consult with your physician before making any medical decision, including altering your use of any drug or treatment.
Orange labelled as "Unclassified": This rhythm contains some irregularities that could not be classified.
NOTE: This analysis is not a diagnosis and does not replaces medical advice. Please seek professional medical assistance if you are, or believe you are, suffering from any medical problem.
Red labelled as "Atrial Fibrillation": This rhythm contains irregularities that are signs suggestive for atrial fibrillation.
NOTE: This analysis is not a diagnosis and does not replaces medical advice. Please seek professional medical assistance if you are, or believe you are, suffering from any medical problem.
Blue labelled as “Insufficient quality”: The quality of your measurement was not sufficient to perform a detailed rhythm analysis.
Please note:
- The measurement is immediately analysed by the FibriCheck algorithm and, when subscribed in the doctor model, also shared immediately with your healthcare provider who can overrule the interpretation. This might affect the graphical alarm.
- If you are connected to the internet, you can instantly see if the interpretation by the algorithm has been overruled. If not connected, you will be notified as soon as the connection has restored.
- The confirmation by the healthcare provider is shown as a notification in the notification log in the app.
6. HELP
The help section can be accessed via the FibriCheck Companion App in the Fitbit Gallery. Tap Settings to access the user manual or check the FAQ.
7. RENEWAL AND DISPOSAL
7.1 Expired subscription
To be able to continue using the FibriCheck Wearable App, you should have an activate FibriCheck profile. Select a new subscription or add a new access code via the FibriCheck Mobile App. Please refer to Section 4.3.
7.2 Terminate your subscription
For information about early termination of your FibriCheck subscription, please consult our terms of use.
7.3 Delete FibriCheck Wearable App
In the Fitbit Gallery, tap 'My Apps' and tap FibriCheck. Here you can remove FibriCheck from your device.
NOTE: Deleting the app not only deletes the app, but also all of its data on the device.
8. HYGIENIC MAINTENANCE
There are no special cleaning measures required for FibriCheck, though measurements should not be performed when the LED and photodetector are unclean.
9. CYBERSECURITY
FibriCheck uses industry-standard encryption protocols to secure all products and data in transfer and at rest. FibriCheck uses industry best practices. Detailed measurement data is only stored on secure, encrypted servers and not on the device of the user. These databases contain encrypted user data when at rest or in transit. A continuous backup system is used to make sure all data is secure.
FibriCheck does its utmost to guarantee your data safety. For you as FibriCheck user, it is very important to keep in mind the following recommendations:
- Never share your FibriCheck credentials;
- Use a secured Internet connection;
- Only use compatible devices;
- Do not use rooted or jailbroken devices;
- Do not use emulators.
10. APPLICABLE SYMBOLS
| Symbol | Detail |
|---|---|
 | European conformity mark |
 | Instructions for use are supplied electronically and can be found in the FibriCheck application. |
 | Qompium NV Kempische Steenweg 303/27 3500 Hasselt Belgium |
 | 2020-11-24 |
 | Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. (US only) |
11. CONTACT DETAILS
For more information or questions, please check our FAQ at help.fibricheck.com.
11.1 Manufacturer
Qompium
Kempische Steenweg 303/27
3500 Hasselt
Belgium