Fitbit ECG App User Manual

Table of Contents

Innhold

1. Innhold
2. Ordliste
3. Indikasjoner for bruk
4. Produktbeskrivelse
5. Advarsler
6. Forventninger
7. Slik virker Fitbit ECG-appen
8. Resultater du kan få
9. Generelle advarsler og forsiktighetsregler
10. Driftsinstruksjoner
11. Installer Fitbit ECG-appen
12. Gjennomføre vurderingen
13. Avbryte vurderingen
14. Se resultatene dine
15. Slett resultatene
16. Slett og gjenopprett Fitbit ECG-appen
17. Feilsøking
18. Ikke entydig: Høy puls
19. Ikke entydig: Lav puls
20. Ikke entydig: Kunne ikke gjennomføre en god avlesning
21. Klinisk studie
22. Informasjon om sykdommer og selvpleie
23. Hva er atrieflimmer?
24. Tegn på at du kan ha atrieflimmer
25. Livsstil og andre faktorer
26. Potensielle behandlingsalternativer
27. Informasjon for leger
28. Tjenestevilkår
29. Informasjon om brukerassistanse

Glossary

Atrieflimmer (AFib)

Atrieflimmer (AFib) is a type of irregular heart rhythm caused by the upper chambers of the heart beating out of rhythm.

Elektrokardiogram (EKG)

An electrocardiogram (EKG) is a test that measures the electrical activity of the heart.

Fitbit-armbånd

For the Fitbit ECG app, Fitbit wristbands include Fitbit smartwatches, Fitbit activity trackers, and Fitbit-connected wrist-worn products, such as the Google Pixel Watch.

Hjertefrekvens (puls)

Your heart rate is the number of times your heart contracts (beats) in one minute. It is often expressed as beats per minute (bpm).

Normal sinusrytme

A normal sinus rhythm is a normal heart rhythm.

Indications for Use

USA*: Fitbit ECG app is a mobile health app intended for use with Fitbit wristbands to create, record, store, transfer, and display a single-lead electrocardiogram (EKG). The Fitbit ECG app determines if AFib (atrial fibrillation) or sinus rhythm is present on a classifiable waveform. The AFib detection feature is not recommended for individuals with other known forms of arrhythmia. The Fitbit ECG app is for over-the-counter use. The EKG data displayed in the app is for informational purposes only. Users should not interpret or take clinical action based on the information from the device without consulting a qualified healthcare professional. The EKG waveform is intended as supplementary information for heart rhythm classification, to distinguish between AFib and normal sinus rhythm. It is not intended to replace conventional methods of diagnosis or treatment. The Fitbit ECG app is not intended for use by individuals under 22 years of age.

Outside USA** (EU/EEA/United Kingdom): Fitbit ECG app is intended to allow the user to record a waveform equivalent to a 1-lead EKG, which is then classified as a sinus rhythm or AFib (atrial fibrillation) on a classifiable waveform. EKG and rhythm classification are not recommended for users with other known arrhythmias. The Fitbit ECG app is intended for home use by laypeople aged 22 and older.

*Indications for use for the USA apply to the USA, India, and the following U.S. territories: American Samoa, Puerto Rico, Guam, U.S. Virgin Islands.

**Indications for use outside the USA apply to the following countries: EU countries where the Fitbit ECG app is available: Belgium, France, Ireland, Italy, Luxembourg, Netherlands, Poland, Portugal, Romania, Spain, Sweden, Czech Republic, Germany, and Austria. This user guide is available at help.fitbit.com in the local languages for the countries above. The Fitbit ECG app is available in the United Kingdom and the following other countries outside the EU: Switzerland, Canada, New Zealand, South Africa, Norway, Chile, Singapore, and Australia. This user manual is available at help.fitbit.com in the local languages for the countries above. More countries will be added as regulatory approvals are obtained. Note that this product is not registered as a medical device in the following countries/regions: Hong Kong.

Product Description

Fitbit ECG is a health app that is software-only and used to create and record an EKG equivalent to a 1-lead EKG when you open the Fitbit ECG app and follow the instructions on your Fitbit wristband. The Fitbit ECG app is equivalent to a 1-lead EKG in that it can be used to distinguish between AFib and normal sinus rhythm. It is not intended for diagnosing. The app is a snapshot that analyzes the recording and presents the results. EKG data can be used for non-clinical purposes, such as providing an estimate of your heart rate. The EKG recording is temporarily stored in the ECG app on the Fitbit wristband until the data is synchronized to your account. You can then view the results in the Fitbit app on your phone or tablet.

You can find the Fitbit ECG app data in the Heart Rhythm Assessment tile within the Assessments & Reports section of the Fitbit app. This tile is also used for setup, viewing past results, exporting a report, and other non-medical device data.

Warnings

The feature has not been tested for, and is not intended for use by, individuals under 22 years of age or individuals with pacemakers, internal defibrillators, or other implanted cardiac devices.

Expectations

How the Fitbit ECG App Works

Your heart rhythm can be recorded by the electrical sensors on your Fitbit wristband. This data is analyzed for signs of AFib, an irregular heart rhythm.

The electrical sensors are located on the back of the Fitbit wristband and on the metal frame around the front (Fitbit Charge 5, Fitbit Sense, and Fitbit Sense 2) or the crown (Google Pixel Watch). When these sensors are in contact with your skin and the Fitbit ECG app is open, they record electrical signals from your heart.

Normally, the upper and lower chambers of your heart work together. When your heart is in AFib, the upper chambers contract irregularly, increasing the risk of heart attack, blood clots, stroke, and other heart conditions.

If you have AFib, your heart may not always beat irregularly, making it difficult to detect. This assessment cannot diagnose AFib, but you can use it right from your wrist. The results can help you during your conversation with your doctor.

Results You Can Get

Normal Sinus Rhythm

Your heart rhythm appears to be normal. It does not show signs of AFib (atrial fibrillation), an irregular heart rhythm.

Atrial Fibrillation

Your heart shows signs of AFib, an irregular heart rhythm. AFib can have serious health consequences. You must contact your doctor.

Indeterminate

If your heart rate is over 120 bpm or under 50 bpm, the Fitbit ECG app cannot assess your heart rhythm. There can be many reasons why you may not get an indeterminate result, but common causes include moving too much during the assessment, not resting your hands on a table, or other arrhythmias.

For more information, see “Troubleshooting” on page 12.

General Warnings and Precautions

DO NOT change your medication without first talking to your doctor. The results from the Fitbit ECG app may not be accurate for people who are taking medications or substances that affect their heart rate or circulation.

DO NOT use this product as a substitute for treatment prescribed by your doctor. Heart palpitations and shortness of breath can be symptoms of AFib, but some people have no symptoms. AFib can be treated, so the earlier you detect it, the sooner you and your doctor can do something about it.

If you have any symptoms of AFib or have concerns, talk to your doctor. Inaccurate negative or positive results can occur due to device malfunction or improper use. A person with a falsely positive result may undergo unnecessary extra tests or make inappropriate behavioral or physical changes. For more information on the accuracy of the Fitbit ECG app, see “Clinical Study” on page 13.

DO NOT use for clinical diagnosis of AFib.

DO NOT use for continuous monitoring, real-time monitoring, or self-monitoring of heart rhythm.

This product CANNOT detect heart attack, blood clots, stroke, and other heart conditions.

The assessment performed by this product is NOT a diagnosis.

This product has NOT been tested on pregnant individuals.

This product is NOT intended for use in a clinical setting.

DO NOT interpret or take clinical action based on the assessment without consulting a qualified healthcare professional.

DO NOT take an ECG reading when the Fitbit wristband is outside the operating temperature or humidity range specified in the device’s user manual.

DO NOT take a reading while submerged in water.

If you have AFib, your heart may not always beat irregularly, making it challenging to detect, even for your doctor.

Use the Fitbit wristband according to the instructions. NOTE: The Fitbit ECG app can only be used on compatible Fitbit wristbands paired with your account. For more information on Fitbit wristbands compatible with the Fitbit ECG app, visit help.fitbit.com.

For security reasons, it is recommended that you maintain control and possession of the compatible wristband and mobile devices to prevent unauthorized access to health data. Refer to the manufacturer’s instructions for your mobile device to enable passcode functionality and prevent unauthorized access. You must also secure your Fitbit account with a strong password. For more information, go to help.fitbit.com. We recommend enabling device lock if available on your wristband. For more information, go to help.fitbit.com.

If you believe this product violates laws or poses a threat to anyone, report it to the manufacturer and local health authorities.

Operating Instructions

Install Fitbit ECG App

If the Fitbit ECG app is not already installed on your Fitbit wristband, you can download it.

Fitbit Charge 5, Fitbit Sense, and Fitbit Sense 2

1. Keep your Fitbit device nearby, go to the Today tab [today-tab-icon] in the Fitbit app, and tap your profile picture [profile-picture-icon].
2. Tap Gallery [gallery-icon], then the Apps tab.
3. In the list of apps, tap ECG [ecg-icon], then Install.

Google Pixel Watch

1. In the Play Store app [play-store-icon] on your watch or phone, search for the Fitbit ECG app. If you are using the Play Store on your phone, make sure your device is set to Google Pixel Watch.
2. Tap Fitbit ECG app [fitbit-ecg-app-icon], then Install.
3. Open the Fitbit ECG app on your watch. If you have not configured the Fitbit app on your phone, you will be prompted to do so. Follow the instructions to install and log in to the Fitbit app on your phone.

For more information about the availability of the Fitbit ECG app in your region, see fitbit.com/ecg.

Perform the Assessment

Read the introduction to Heart Rhythm Assessment before performing your first reading:

1. Open the Fitbit app on your phone or tablet and log in to your Fitbit account if you haven’t already done so.
2. From the Discover tab [discover-tab-icon] in the Fitbit app, tap Assessments & Reports [assessments-reports-icon], then Heart Rhythm Assessment [heart-rhythm-assessment-icon] and follow the instructions. After completing the introduction to Heart Rhythm Assessment, you can take an EKG reading.

How to Take an EKG Reading:

1. Wear your Fitbit wristband snugly but comfortably. It should be one finger-width above your wrist bone. For more information, see help.fitbit.com.
2. Sit down and open the ECG app on your Fitbit wristband.
3. Follow the instructions on your Fitbit wristband to start the assessment.
4. Place your finger(s) on the Fitbit wristband as shown on the screen. Keep your finger(s) on the contact point(s) until the countdown is complete.
5. When the results appear, swipe up to see the full report. Note that your Google Pixel Watch must be connected to LTE or Wi-Fi to sync your EKG data to the Fitbit app.

Cancel the Assessment

To cancel the assessment, press the button on your Fitbit Sense and Fitbit Sense 2, press the crown on your Google Pixel Watch, or swipe right on your Fitbit Charge 5. A result is only given after completing the 30-second EKG reading and data analysis. If you cancel the assessment before it is complete, no result will be shown.

View Your Results

After you complete the heart rhythm assessment and the data is analyzed, one of the following results will be displayed:

• Normal Sinus Rhythm: Your heart rhythm appears to be normal. Tap Learn More for more information, or tap Done to close the assessment.
• Atrial Fibrillation: Your heart shows signs of AFib. You should contact your doctor. Tap Learn More for more information, or tap Done to close the assessment.
• Indeterminate: Your pulse was too low or too high, or the Fitbit ECG app could not perform a good reading. Tap Retry to try again, or tap Done to close the assessment.

For more information on why you might get this result, see “Troubleshooting” on page 12.

View Past Results

When you open the Fitbit app, your results from your Fitbit wristband are transferred to the Fitbit app so you can view them on your phone or tablet. Note that your Google Pixel Watch must be connected to LTE or Wi-Fi to sync your EKG data to the Fitbit app. This is how you can view your results later, for example, at a doctor’s appointment:

1. From the Discover tab [discover-tab-icon] in the Fitbit app, tap Assessments & Reports [assessments-reports-icon], then Heart Rhythm Assessment [heart-rhythm-assessment-icon].
2. Tap View Results to see a list of all your past results.
3. Tap one of the past results to see the details. The results are displayed with the date and time they were recorded on the compatible Fitbit wristband. For each result, you can tap Export a PDF for your doctor to download the report. You will receive a notification when your report is ready. We recommend using the latest version of Adobe Acrobat Reader to open the report.

See help.fitbit.com for more information on Heart Rhythm Assessment.

Delete Results

1. From the Discover tab [discover-tab-icon] in the Fitbit app, tap Assessments & Reports [assessments-reports-icon], then Heart Rhythm Assessment [heart-rhythm-assessment-icon].
2. Tap View Results to see a list of all your past results.
3. Tap the results you want to delete.

Delete and Reinstall Fitbit ECG App

Remove Fitbit ECG App:

Fitbit Charge 5, Fitbit Sense, and Fitbit Sense 2

1. From the Today tab [today-tab-icon] in the Fitbit app, tap your profile picture [profile-picture-icon], then the image of your Fitbit wristband [wristband-image-icon].
2. Tap Gallery [gallery-icon].
3. In the list of apps installed on your watch, find the ECG app and tap it.
4. Tap Uninstall.

You can reinstall the app from the Fitbit Gallery at any time. For more information on how to delete, install, and manage apps, see help.fitbit.com.

Google Pixel Watch

1. Open the Play Store app [play-store-icon] on your watch.
2. Tap My Apps [my-apps-icon].
3. In the list of apps installed on your watch, find the Fitbit ECG app and tap it.
4. Tap Uninstall.

Troubleshooting

There are three types of indeterminate results you may get after completing an assessment:

Indeterminate: High Pulse

If your pulse is over 120 bpm, the Fitbit ECG app cannot assess your heart rhythm. Your pulse may be high for many reasons, for example:

• Recent exercise
• Stress
• Nervousness
• Alcohol
• Dehydration
• Infection
• AFib or other arrhythmia

Find out more from the American Heart Association or by visiting the European Society of Cardiology website [https://www.escardio.org/].

Indeterminate: Low Pulse

If your pulse is under 50 bpm, the Fitbit ECG app cannot assess your heart rhythm. Your pulse may be high for many reasons, for example:

• Taking medications, such as beta-blockers or calcium channel blockers
• Excellent aerobic fitness
• Other arrhythmia

Find out more from the American Heart Association or by visiting the European Society of Cardiology website [https://www.escardio.org/].

Indeterminate: Could Not Perform a Good Reading

There can be many reasons why you may not get an indeterminate result, but common causes are:

• Moving too much during the assessment
• Not resting your hands on a table
• Other arrhythmia

If the Fitbit ECG app could not perform a good reading, you can try the following troubleshooting tips:

• Make sure you are sitting and relaxed.
• Rest your arms on a table while performing the assessment. Avoid moving.
• Check that your Fitbit wristband is on the wrist you selected when you started the assessment.
• Keep your finger(s) on the Fitbit wristband throughout the assessment.
• Check the fit of your Fitbit wristband. It should feel comfortable and secure, not too loose or too tight. Wear it one finger-width above your wrist bone. For more information, see help.fitbit.com.
• Ensure there is no interference with the electrode-to-skin contact (hair, jewelry, clothing, etc.).
• Move away from other electronics to avoid interference.
• Make sure your Fitbit wristband and wrist are clean and dry. Water or sweat can interfere with the reading. If you have recently washed your hands, bathed, showered, or sweated, wash and dry your Fitbit wristband. See fitbit.com/product-care for usage and care instructions.

Repeat the assessment and try again. If you repeatedly get an indeterminate result and do not feel well, contact your doctor.

See help.fitbit.com for troubleshooting synchronization. See help.fitbit.com for troubleshooting pulse measurement.

Clinical Study

A clinical study was conducted to validate the Fitbit ECG software algorithm's ability to classify heart rhythms as AFib (atrial fibrillation) and SR (sinus rhythm) from a waveform equivalent to a 1-lead EKG and to confirm the software's ability to produce a waveform equivalent to a 1-lead of a 12-lead EKG.

472 participants, with and without a known AFib diagnosis, were recruited and enrolled to participate at 9 sites in the USA. Qualified participants underwent a 10-second screening with a 12-lead EKG. Participants with a known AFib history were screened for AFib by one qualified physician and assigned to the AFib cohort. Participants without a known AFib history were screened for NSR and assigned to the NSR cohort.

Subsequently, 440 participants underwent a simultaneous 30-second 12-lead EKG and Fitbit ECG app test. The Fitbit ECG app’s software algorithm was able to identify individuals with AFib correctly 98.7% of the time and identify individuals with SR correctly 100% of the time.

When compared qualitatively, i.e., when the waveforms from the 12-lead EKG and the Fitbit ECG app were visually compared to classify AFib and SR, the Fitbit ECG app’s single-lead waveform was generally found to be similar to lead 1 of a 12-lead waveform 95.0% of the time.

When compared quantitatively, i.e., when the R-wave amplitudes were compared between the 12-lead EKG and the Fitbit ECG app, the R-wave amplitudes from the Fitbit ECG were on average 2.4 mm larger than the 12-lead R-wave peaks that constituted the reference. This is due to the placement of the 12-lead EKG on the participants’ torsos and not on the wrist during the study.

No adverse events were observed during the clinical study.

Information on Diseases and Self-Care

What is Atrial Fibrillation?

Atrial fibrillation (AFib) is a type of irregular heart rhythm in the upper chambers of the heart (atria). Normally, the upper chambers contract regularly to move blood into the lower chambers. In AFib, the upper chambers contract irregularly, causing blood to move slowly in the upper chambers. This slow-moving blood can lead to clots, increasing the risk of stroke and heart-related problems.

Signs You May Have Atrial Fibrillation

Some people with AFib have no symptoms, while others do:

• Irregular pulse
• Heart palpitations
• Dizziness
• Extreme fatigue
• Shortness of breath
• Chest pain

Find out more from the CDC or by visiting the European Society of Cardiology website [https://www.escardio.org/].

Lifestyle and Other Factors

Risk factors for AFib include:

• Advanced age
• High blood pressure
• Obesity
• European ancestry
• Diabetes
• Heart failure
• Ischemic heart disease
• Hyperthyroidism
• Chronic liver disease
• High alcohol intake
• Enlarged chambers on the left side of the heart

Find out more from the CDC or by visiting the European Society of Cardiology website [https://www.escardio.org/].

Potential Treatment Options

Consult your doctor before making major lifestyle changes or changing medications. Potential treatment options include:

• Medication
• Surgery
• Lifestyle changes

Find out more from the CDC or by visiting the European Society of Cardiology website [https://www.escardio.org/].

Information for Doctors

A doctor’s guide is available. Go to help.fitbit.com or call (887) 623-4997.

Terms of Service

Fitbit designs products and tools that help you achieve your health and fitness goals, support you, and inspire you to live a healthier, more active life. These Terms of Service (“Terms”) govern your access to and use of the Fitbit service. The “Fitbit service” includes our devices, including associated firmware, apps, software, websites, APIs, products, and services.

If you reside in the EEA, the United Kingdom, or Switzerland, these Terms are an agreement between you and Fitbit International Limited, an Irish company with its registered office at 76 Lower Baggot Street, Dublin 2, Ireland. If you reside elsewhere, these Terms are an agreement between you and Fitbit, Inc., 199 Fremont Street, 14th Floor, San Francisco, CA 94105 U.S.A. When the Terms refer to “Fitbit,” “we,” “us,” or “our,” this refers to the party to the agreement that provides the Fitbit service to you.

You must agree to these Terms to create a Fitbit account and access or use the Fitbit service. If you do not have an account, you accept these Terms by using any part of the Fitbit service. If you do not agree to these Terms, do not create an account and do not use the Fitbit service.

For more information on these terms, see Fitbit Terms of Service.

Information on User Assistance

This document applies to SKU: FB 603, version 2.0 or higher.

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