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. Therefore, it is essential to take the time to familiarize yourself with these instructions and ensure a clear understanding of how to utilize the platform securely and responsibly.

Important safety or performance information or immediate response from the operator required.

Safety terms and symbols

This section provides essential warnings, contraindications, and cautions to be observed when using TeltoHeart smart wearable, TeltoHeart mobile application and TeltoCare platform, under any circumstances. Additionally, pertinent warnings and cautions are incorporated throughout the manual in sections where they are most relevant. Notes are included throughout the manual to offer more detailed insights into specific features of the TeltoCare platform.

WARNING

Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the user or environment.

CAUTION

Cautions alert users to exercise appropriate care for safe and effective use of the product.

CONTRAINDICATION

A contraindication is a medical or clinical factor that indicates a treatment or procedure should not be administered due to potential risks or adverse effects to the individual. It serves as a cautionary guideline to avoid harm or complications.

NOTE

Notice:

Notes provide additional guidelines or information.

Contraindications, Cautions, Warnings and Notes

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 and Care:

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

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

Warranty and 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.

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 and 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 and 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 environment.

TeltoHeart is not intended to be used underwater.

Storage:

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

Electromagnetic Fields and Ultrasound:

Do not use the device in the presence of strong electromagnetic fields.

Do not use the device near ultrasound equipment.

Cleaning and Maintenance:

Ensure that the magnetic connection of the docking station is clean of metallic bodies.

Device Usage and 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 compactor machines, hammer drills, etc.

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

Do not paint or put stickers on your device.

Do not cause excessive mechanical strain or shock to the device.

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

The device is not intended to be put in any bodily orifice.

The device is meant to be used by adults of age 22 or older.

Use on intact skin only.

Do not use excessive force while using the device. Excessive force may break or damage accessories.

Do not use the device in an environment where the temperature exceeds 45°C.

The platform is not suitable for people with paralyzed, deformed arms, or absence of both arms.

We strongly advise avoiding downloading or installing firmwares found in third party sites such as forums, etc. Installing unverified firmwares will result in warranty void.

Due to excess heat, the battery might be damaged. If the device starts heating, stop using the device immediately!

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. Exposing the contacts with a metallic object, such a coin, a clip or a set of keys can cause accidental short-circuiting and damage battery and other components.

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 the vehicle.

While driving, safely operating the vehicle is your first responsibility. Never use your mobile device while driving if it is prohibited by law. For your safety and the safety of others, use your common sense.

NOTE

Operating Temperature:

Device operating temperature is -10 to 45 degrees Celsius.

Cleaning Instructions:

Please keep the device electrodes clean for best performance.

Environmental:

Usage in rain or in very humid environment is not recommended.

Account and Data:

TeltoHeart application and TeltoCare share the same login details.

Additional safety information

CAUTIONS:

For correct functioning of the system, Bluetooth connection must be established.

If the system is unable to communicate with the server, try again later.

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.

Do not clean or use water on the device while charging.

Make sure the charging contacts are dry prior to charging the device.

It is important to keep TeltoHeart and TeltoHeart Charging dock and the power adapter in a well-ventilated area when charging or in use.

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

Please do not use the device during the firmware update process. Doing so could cause irreparable damage to the device and render it unusable.

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

Do not wear the device on moles, birthmarks, psoriasis, or other skin surface defects.

Do not bend the wristband excessively.

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

Use of the device may harm patients with exaggerated emotional instability or other elevated anxiety disorder in general and therefore is contraindicated in these subjects.

If TeltoHeart watch is damaged or has malfunctions, contact your provider.

If you start feeling nauseous or symptoms of a headache, consider not using the device until you feel better.

Avoid pairing the device in public places.

User must grant data storage permissions on the mobile application.

After unpairing TeltoHeart via TeltoHeart application, all data in TeltoHeart will be permanently deleted. This includes any saved settings, ECG, and HR data.

Device is intended to be used by one person. Do not share the device with anyone.

The system is not intended for the detection of stroke or other life-threatening conditions.

Darker skin tones on the wrist might affect PPG performance.

Oily, muddy, or otherwise contaminated skin surface will worsen the ECG and PPG quality! Make sure your skin is clean before recording ECG or PPG.

PPG glass scratches or cracks may affect device PPG performance.

The device is not suitable for people with paralyzed, deformed arms, or absence of both arms since the recordings in such cases may not be possible. The user is recommended to try other methods of monitoring in such cases.

If TeltoHeart storage is full, the newest records will be written on top of the oldest.

Prolonged viewing at the device's screen is not recommended.

If you choose to unpair and reset your TeltoHeart, all data in TeltoHeart will be permanently deleted. This includes any saved settings, ECG, and HR data.

Do not use corrosive chemical materials for cleaning.

Ensure that the magnetic connection of the docking station is clean of metallic bodies.

Do not self-diagnose or self-medicate on the basis of the device readings without consulting your doctor.

MyHealth app is not intended to detect heart attack.

The MyHealth app must be applied only for the intended use. This also includes situations when two or more conditions appear at the same time. Atrial fibrillation may be a cause of secondary heart attack and other conditions which are not the intended use.

In addition, atrial fibrillation may also be a consequence of heart attack and other conditions which are not the intended use. Therefore, the user should never exclude possibility of other health conditions and should contact the physician/seek emergency help without any delay if user believes he has medical emergency.

MyHealth app is not intended to replace traditional methods of diagnosis of atrial fibrillation.

MyHealth app does not guarantee that you are not experiencing an arrhythmia or other heart conditions when the app provides notification as normal sinus rhythm/AFib. You should notify your doctor if you experience any changes in your health.

In some rare instances, presence of other arrhythmias may be classified as AFib. Even if the AFib may not be present, this might indicate/suggest presence of other arrhythmias and user should consult with doctor for the evaluation of the heart condition. The presence of certain non-AF arrhythmias may also result in changes of AF detection performance.

Physician may misidentify the ECG recordings if the user shared the device with other people. This might result in wrong diagnosis and treatment.

The device is not intended to be used during medical procedures (e.g., magnetic resonance imaging, diathermy, lithotripsy, cautery, external defibrillation procedures, surgery).

You should talk to your doctor if your heart rate is below 50 or above 120 at rest and this is an unexpected result. Notice: trained athletes may have low heart rate due to their training and this may be considered normal heart rate for them.

Do not take recordings during physical activity.

Number of factors, such as motion, hand and finger movements, dark tattoos on wrist, dark skin pigmentation the amount of blood flow to your skin (which may be reduced by cold temperatures), may impact the ability of the device to take quality recordings and thus reduce the performance of AFib detection algorithm.

Make sure that the finger, wrist and abdomen skin used for ECG/PPG recording are uncovered, clean and free of any bruises, scars or cuts.

Quality of the recorded signals may be compromised due to too much body fat, body hair or very dry skin at the sensors contact area.

Do not continue use until further instructed by a physician if your skin is irritated or inflamed around the smart wearable or its band.

Do not take the recording if electrodes are dirty. Clean them first.

MyHealth app is not intended for use and its performance was not tested on pregnant women or pediatric population (individuals under age of 22).

In same rare cases some people may have certain physiological conditions that may prevent them from registering strong enough signal for analysis and evaluation.

Do not take recordings in close vicinity to strong electromagnetic fields.

Implanted medical devices, like pacemakers and defibrillators, may have sensors that can react to magnets and radios in proximity. To prevent any possible interference with these devices, it is important to keep your smart wearable and its charging equipment at a safe distance away from the medical device.

TeltoHeart is not intended to be used underwater.

Patient health information provided by the device are potential findings and NOT a diagnosis. Diagnosis should be made using standard procedures by the qualified physician.

People with conditions that can cause severe swelling of upper limbs, for example, decompensated heart failure, decompensated chronic kidney disease, acute kidney failure, nephrotic syndrome, nephritic syndrome, lymphedema, elephantiasis and others are advised to consult a doctor before using the product.

WARNINGS:

Chargers and accessories shall comply according to compatibility requirements provided in instructions for use.

Charge TeltoHeart smart wearable with USB type-C cables that are compliant with USB 2.0 or later and with applicable country regulations and international and regional 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, other property, or the user.

When using the TeltoHeart Charging dock to USB-C Cable, make sure the cable or dock is fully inserted into the power adapter before you plug the adapter into a power outlet.

Use a password consisting of at least 8 symbols, at least one non-alphanumeric character, one uppercase, one lowercase character, and one digit.

Exaggerated movement impairs the system's ability to take measurements.

Users with bruised skin, cuts, scars, too much body fat, very dry skin, or too much body hair may experience reduced performance of the sensors of the device due to the physiological conditions that compromise signal quality.

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

NOTE:

Notice:

The system will not be able to backup the data or send information to medical experts if there is no internet connection.

Notice:

Please keep the device electrodes clean for best performance.

Notice:

Do NOT reset the device during firmware update.

Notice:

Please charge the device before initiating any firmware updates.

Notice:

Please leave the device in synchronization for the duration of firmware update.

Notice:

Device shall be used on the left hand wrist only.

Notice:

Do NOT use the device outside of this operational temperature range.

Notice:

Usage in rain or in a very humid environment is not recommended.

Notice:

Do not share your password with anyone.

Notice:

Sign-in details will be deleted once the user is signed out of the app. To access the account, the user will have to sign in again.

Notice:

After deleting the account, all data will be lost. After 14 days, support will no longer be able to restore deleted health data.

Notice:

A physician may misidentify the ECG recordings if the user shared the device with other people. This might result in the wrong diagnosis and treatment.

Notice:

Please keep the TeltoHeart application running in the background to allow measurement data transfer.

Notice:

ECG recordings cannot be performed if the battery charge is less than 10%.

Notice:

Do not take recordings during physical activity.