teltoheart faq
Here you can find the most frequent questions and answers about the TeltoHeart wristband.
TeltoHeart is a heart monitoring ecosystem. It includes a smart wristband with AFib detection and 6-lead ECG recording functionalities, a mobile app (MyHealth) for registration and wristband configuration, and a web-based TeltoCare platform with remote access to wristband data. The platform is intended for use by medical professionals to analyse patients’ heart rate, electrocardiogram, and atrial fibrillation burden data.
The TeltoHeart wristband is recommended for people with no prior diagnosis of atrial fibrillation or arrhythmia who experience symptoms (such as palpitations, dizziness, shortness of breath, a heart rate that is too slow or too high, etc.) and asymptomatic patients who appear in a risk group. Patients should consult their physicians about using the TeltoHeart device.
TeltoHeart is the world's first wrist-worn wearable device combining PPG-based long-term monitoring together with an instant 6-lead ECG with no wires. The system creates a new paradigm in wearable device diagnostics due to its unique capabilities.
TeltoHeart has a medical CE mark, which complies with the Medical Devices Regulation (MDR) quality standards. Check here for more details: https://wiki.teltonika-telemedic.com/view/TeltoHeart_Certification_%26_Approvals
In conjunction with the MyHealth mobile app, the TeltoHeart smart wristband is intended for use in patients suspected of having arrhythmias. Advanced PPG-based atrial fibrillation detection and heart rate monitoring algorithms alert the patient and advise them to perform a 6-lead electrocardiogram either at home or in a hospital environment. Heart monitoring functionality consists of:
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Automatic recording of heart rate extrapolated from a PPG signal;
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Detection of suspected atrial fibrillation from a PPG-based AF algorithm;
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Manual intermittent 6-lead ECG recording using physical electrodes.
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The PPG-based algorithm alarms the user about detected abnormalities, which require confirmation by a 6-lead ECG (possible AF, high heart rate, low heart rate).
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The user feels any symptoms which could be related to heart rhythm disorders.
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Prophylactic ECG recording 2-3 times per day.
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European Heart Rhythm Association (EHRA) has published an official recommendation to preferably use certified wearables with single- or multiple-lead ECGs instead of Holter monitoring for patients with symptoms that are less frequent than once per week (Svennberg et al., doi: 10.1093/europace/euac038). If the symptoms happen weekly, it is optional to choose between Holter ECG monitoring and certified wearables. [Įdėti picture 1 iš failo]
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The system maintained high specificity despite a remarkable amount of frequent single or multiple premature contractions in published clinical trials. Key highlights are listed below.
· An instant six-lead ECG tool demonstrated the superior diagnostic value of AF detection compared to a single-lead ECG, which is a widespread tool in the field of smartwatch-enabled ECGs. Six-lead ECG required 3.4 times more premature beats to result in a false positive outcome compared to single-lead ECG in a control population with frequent premature contractions (Bacevicius et al. Doi: 10.3389/fcvm.2023.1160242).
· The overall accuracy of the system combining PPG-based detector and six-lead ECG yielded 99.5% in diagnosis of AF (Bacevicius et al. Doi: 10.3389/fcvm.2022.869730).An electrocardiogram (ECG) is recorded manually by the patient and can be sent to their medical practitioner (e.g. a cardiologist or other qualified medical staff) for further interpretation and help in diagnosis. The device does not diagnose any medical conditions. The diagnosis is determined only by a medical practitioner.
The MyHealth app is intended for use by adults aged 22 and above. The device is not intended to be used for detecting heart attacks as well as by patients with implanted cardiac stimulators. See the manual for further information.
TeltoHeart should be used with the provided TeltoCare platform. If desired, API is provided to the hospital for a full integration with the electronic healthcare database.
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You can contact us or email us at teltoheart@teltonika-telemedic.lt.