Instructions for Use - Samsung Watch
1.1.8
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 primary focus on the detection of Atrial Fibrillation with a sensitivity and specificity of 95,65% and 100%, respectively. It comprises a pair of mobile medical apps: one on Samsung Galaxy Watch and the other on the smartphone (Android or iOS app).
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
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.
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 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 detector is not clean or broken.
- After PPG analysis, the app may incorrectly identify some conditions as unreadable. Please consult with your physician in case of doubt.
- FibriCheck does not guarantee that you are not experiencing an arrhythmia or other health conditions when labelling a measurement as regular. You should notify your physician for possible changes in your health.
- Do not continue using FibriCheck when experiencing discomfort caused by the flash or LED.
- Measurements can’t be sent for analysis without bluetooth or 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 Samsung wearables:
- Galaxy Active Watch 2
- Galaxy Watch 3
FibriCheck users will be notified when an update is available. The update of the FibriCheck Application can be found in the Samsung Galaxy Store.
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 to link with the FibriCheck Wearable Samsung Application are an Android operating system with minimal software version Android 5.1
FibriCheck users will be notified when an update is available. The update of the FibriCheck Application can be found in the Play Store.
NOTE: FibriCheck performs proactive device monitoring. If you cannot find the application in the 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 Google Play Store or Samsung Galaxy Store (only on Samsung devices)
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.
Do you have a Samsung smartphone?
- Download the FibriCheck mobile application on your smartphone from the Google Play Store or Samsung Galaxy Store.
- Download the FibriCheck watch application on your smartwatch via the Galaxy Store App or Galaxy Wearable App.
Do you have an Android smartphone?
- Download the Galaxy Wearable App on your smartphone from the Google Play Store.
- Also install the 2 plugins that will be proposed as soon as you download the Galaxy Wearable App.
- Download the FibriCheck mobile application on your smartphone from the Google Play Store
- Download the FibriCheck watch application on your smartwatch via the Galaxy Wearable App.
4.2 Create and link your personal account
Tap on the FibriCheck icon on your smartphone to open the FibriCheck app.
- Do you already have a FibriCheck account? If so, select "I have an account" and log in with your FibriCheck login details.
- If you’re a new FibriCheck user, create an account in the application on your smartphone.
- Select "I am new" to create a FibriCheck account.
- Enter your details and choose a PIN code.
4.3 Add your subscription
Once the account is successfully registered, you can add your prescription, start a free trial or select a subscription plan to start measuring your heart rhythm. Tap the heart icon and follow the instructions presented.
5. A FIBRICHECK MEASUREMENT
5.1 Performing a measurement
Make sure your smartwatch and smartphone are correctly connected via bluetooth.
Follow these steps to run a measurement on your Samsung smartwatch:
- Open the FibriCheck application on your smartwatch
- Tap "Measure" to get started
- Perform the 60 second heart rhythm measurement
- Specify which activity you were doing just before the measurement
- Specify if you were experiencing any symptoms
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 Mobile 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 Mobile App.
The FibriCheck Mobile App relays these results directly back to the FibriCheck Wearable App which shows the analysed 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
In the Help section of the FibriCheck Mobile application, supportive and educational information is provided. The section contains information like:
- Instructions for use
- Frequently Asked Questions (FAQ)
- Information about Atrial Fibrillation
- Contact
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 account
To delete your FibriCheck account, open the FibriCheck app on your smartphone and go to Settings, then to Personal Information.
Scroll down until you see Delete Account. Enter a reason for wishing to cancel FibriCheck, click on ‘Continue’ and then enter the requested word in the text box. Does the text box go red? Then you have made an error and must enter the word again.
Your account - and all your personal data - has now been successfully deleted. You can now also delete the app from your smartphone.
7.4 Delete FibriCheck Wearable App
Deleting the app on:
- Android device: Open your device's Settings app. Go to Apps & notifications. Tap on the FibriCheck app, then select ‘Uninstall’.
- Samsung Galaxy Watch: In the Galaxy Wearable app, tap “Apps”, tap “manage apps” and tap FibriCheck. Here you can uninstall 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 |
 | 2021-09-07 |
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
11.2 Australian Sponsor
Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000
Australia