TeltoHeart Safety Instructions

Safety Instructions

For your safety and to maximize the effectiveness of your interactions on the TeltoHeart smart wearable, TeltoHeart mobile application and TeltoCare platform, it is crucial to observe the following guidelines and precautions. Neglecting to do so may compromise the integrity of your medical data or potentially pose risks to your health or privacy.

Safety Terms & Symbols

Warning Serious outcomes possible

Caution Exercise appropriate care

Contraindication Do not use — risk of harm

Notice Additional guidelines

Contraindications

Users with pacemakers, implantable cardioverter-defibrillator (ICDs) or other active implanted medical devices which could stimulate the heart.

Users with other active implantable or non-implantable medical devices which may interfere with the electromagnetic field of the wrist-worn device during its operation or while charging.

Not intended for users who suffer from dementia or other cognitive inability to use the device unless supervised.

Users with conditions that restrict their ability or willingness to use the device by its intended purpose.

Users who suffer from exaggerated emotional instability, elevated anxiety disorder, panic attacks or any other mental disorders in general, which may be triggered by the use of the device or app.

Absence, severe deformations or paralysis of upper limb (for the use of recording ECG).

Absence, severe deformations or paralysis of both upper limbs.

Allergy or increased sensitivity to the materials of the device.

Compromised conditions of local tissues (skin, vascular, muscular, nerve or other tissue) at the location of contact with the device, including but not limited to wounds, fractures, ruptures, etc.

Cautions

Handling & Care

Do NOT use the device on wounds as this may cause infection and pain. Treat the wounds first.

Patients with diseases which manifest as skin photosensitivity should not use the device.

Warranty & Claims

Any modifications performed by third parties will void the warranty. Warranty claims may be excluded if you do not use and maintain the device as instructed or if you repair or modify the device yourself.

Connectivity & Data Management

If data cannot be saved locally on your smartphone, please clear cache and try again.

The device requires a stable internet connection to function properly.

Environmental & Safety Precautions

Avoid using TeltoHeart in sandy environments. Do not submerge the device in salty water or any other electrically conductive liquid. Do not use the device in MRI or CT environments.

TeltoHeart is not intended to be used underwater.

Do not use the device in the presence of strong electromagnetic fields or near ultrasound equipment.

Storage

Please store the docking station and charger in an appropriate environment to avoid magnet degaussing.

Cleaning & Maintenance

Ensure that the magnetic connection of the docking station is clean of metallic bodies. Do not use corrosive chemical materials for cleaning.

Do not clean or use water on the device while charging. Make sure the charging contacts are dry prior to charging.

Device Usage & Limitations

TeltoHeart is not supposed to be worn in situations where it would be exposed to strong vibrations, for example while working with rammer compactors, vibrating plate compactors, hammer drills, etc.

The device is meant to be used by adults age 22 or older. It is not intended for use by pediatric populations or pregnant women.

Use on intact skin only. Do not wear the device on moles, birthmarks, psoriasis, or other skin surface defects. Stop use if skin becomes irritated or inflamed and consult a physician.

Do not cause excessive mechanical strain or shock to the device. Do not paint or put stickers on your device. Do not bend the wristband excessively.

The device may be damaged, explode, or result in fire if too much pressure is applied to it.

Do not use the device in an environment where the temperature exceeds 45°C. If the device starts heating, stop using it immediately.

The device is not intended to be put in any bodily orifice or used during medical procedures (e.g., MRI, diathermy, lithotripsy, cautery, external defibrillation, surgery).

Device is intended for one person only. Do not share the device. Sharing may cause physician misidentification of ECG recordings, resulting in wrong diagnosis and treatment.

We strongly advise against downloading or installing firmware from third-party sites such as forums. Installing unverified firmware will void the warranty and may irreparably damage the device.

Please keep TeltoHeart and its charging dock in a well-ventilated area when charging or in use.

Clinical Use & Diagnostics

The system is not intended for the detection of stroke or other life-threatening conditions. Patient health information provided by the device represents potential findings and NOT a diagnosis. Diagnosis should be made using standard procedures by a qualified physician.

Do not self-diagnose or self-medicate based on device readings without consulting your doctor.

MyHealth app is not intended to detect heart attack and does not replace traditional methods of diagnosing atrial fibrillation. A normal sinus rhythm / AFib result does not guarantee the absence of arrhythmia or other heart conditions.

In rare instances, other arrhythmias may be classified as AFib. Users should consult a doctor for evaluation. Atrial fibrillation may be a cause or consequence of heart attack and other conditions outside the intended use — never exclude the possibility of other health conditions and seek emergency help immediately if a medical emergency is suspected.

You should talk to your doctor if your resting heart rate is below 50 or above 120 BPM. Note: trained athletes may naturally have lower resting heart rates. Do not take recordings during physical activity.

Factors such as motion, hand and finger movements, dark tattoos on the wrist, darker skin pigmentation, and reduced blood flow (e.g. due to cold temperatures) may impact recording quality and reduce AFib detection performance.

Oily, muddy, or otherwise contaminated skin will worsen ECG and PPG quality. Ensure finger, wrist, and abdomen skin are uncovered, clean, and free of bruises, scars, or cuts before recording. Quality may also be affected by excess body fat, body hair, or very dry skin.

People with conditions causing severe swelling of upper limbs (e.g. decompensated heart failure, lymphedema, nephrotic syndrome, elephantiasis) are advised to consult a doctor before use.

Implanted medical devices like pacemakers and defibrillators may react to magnets and radio signals. Keep the smart wearable and its charging equipment at a safe distance from any implanted medical device.

For correct functioning, Bluetooth connection must be established. If the system is unable to communicate with the server, try again later.

If any allergic reaction occurs, stop wearing the device immediately and consult your doctor.

If you start feeling nauseous or experience headache symptoms, stop using the device until you feel better.

After unpairing or resetting TeltoHeart, all data will be permanently deleted, including saved settings, ECG, and HR data. If TeltoHeart storage is full, the newest records will overwrite the oldest.

PPG glass scratches or cracks may affect device performance. Darker skin tones on the wrist might also affect PPG performance.

Prolonged viewing of the device screen is not recommended. Avoid pairing the device in public places.

The bracelet must be replaced if a defect in the strap or metal buckle is observed.

User must grant data storage permissions on the mobile application.

If TeltoHeart is damaged or malfunctions, contact your provider. Do not take recordings if electrodes are dirty — clean them first.

Warnings

Battery Safety

If the device starts heating, stop using it immediately to prevent damage to the battery and other components.

Do NOT short-circuit the charging contacts. Contact with metallic objects such as a coin, clip, or keys can cause accidental short-circuiting and damage the battery and other components.

The Li-Po battery in TeltoHeart should be serviced only by Teltonika Telemedic or an authorized service provider.

Charging Safety

Chargers and accessories shall comply with compatibility requirements provided in the instructions for use. Charge TeltoHeart with USB Type-C cables compliant with USB 2.0 or later and applicable safety standards.

Using damaged cables or chargers, or charging when liquid or moisture is present, can cause electric shock, fire, injury, or damage to TeltoHeart or the user.

When using the TeltoHeart Charging dock to USB-C cable, ensure the cable or dock is fully inserted into the power adapter before plugging into a power outlet.

Environmental Safety

Do NOT use the device outside of operational temperature conditions, for example in a sauna.

User Safety

Comply with all safety warnings and regulations regarding mobile device usage while operating a vehicle. Never use your mobile device while driving if prohibited by law.

Use a password of at least 8 characters including at least one non-alphanumeric character, one uppercase letter, one lowercase letter, and one digit. Do not share your password with anyone.

Exaggerated movement impairs the system's ability to take measurements. Users with bruised skin, cuts, scars, excess body fat, very dry skin, or excess body hair may experience reduced sensor performance.

Notes

Operating Temperature: Device operating temperature is −10°C to 45°C. Do not use the device outside this range. Usage in rain or very humid environments is not recommended.

Electrode Cleaning: Please keep the device electrodes clean for best performance. Do not take recordings if electrodes are dirty — clean them first.

Account & Data: TeltoHeart application and TeltoCare share the same login credentials. Sign-in details are deleted once the user signs out. After account deletion, all data will be lost; after 14 days, support will no longer be able to restore deleted health data.

Connectivity: The system will not be able to back up data or send information to medical experts without an internet connection. Keep the TeltoHeart application running in the background to allow measurement data transfer.

Firmware Updates: Do NOT reset the device during a firmware update. Please charge the device before initiating updates and leave the device in synchronization for the full duration of the update.

Wrist Placement: Device shall be used on the left hand wrist only.

ECG Recordings: ECG recordings cannot be performed if the battery charge is below 10%. Do not take recordings during physical activity.