TeltoHeart Safety Instructions

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Safety instructions

To ensure your safety and proper use of the device, it is important to follow the guidelines and precautions outlined in these instructions. Failure to do so may result in harm or damage to yourself or the device. Therefore, it is crucial to take the time to familiarize yourself with the instructions and ensure that you understand how to use the device correctly and safely.

For your own safety please observe the following:

Warning.png Important safety or performance information or immediate response from the operator required.
Warning.png Failure to follow these safety instructions could result in fire, electric shock, injury, or damage to you, TeltoHeart, or other property. Read all the safety information below before using TeltoHeart.

Safety terms and symbols

This section contains general warnings, contraindications and cautions that should be followed when using the watch under any circumstances. Additionally, relevant warnings and cautions are also included throughout the manual in the sections where they are most applicable. Notes are provided throughout the manual to give more detailed information about certain features of the watch.
WARNING
Warning.png Warnings alert users to potential serious outcomes (death, injury, or adverse events) to the user or environment.
CAUTION
Caution.png Cautions alert users to exercise appropriate care for safe and effective use of the product.
CONTRAINDICATION
Caution.png 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
Caution.png Do NOT use the device on wounds as this may cause infection and pain. Threat the wounds first".
Caution.png Patients with diseases, which manifest as skin photosensitivity should not use the device.
CAUTIONS
Handling and Care:
Caution.png Do NOT use the device on wounds as this may cause infection and pain. Threat the wounds first".
Caution.png Patients with diseases, which manifest as skin photosensitivity should not use the device.
Warranty and Claims:
Caution.png 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.
Caution.png 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:
Caution.png If data cannot be saved locally on your smartphone, please clear cache and try again.
Caution.png The device requires a stable internet connection to function properly.
Environmental and Safety Precautions:
Caution.png 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.
Caution.png TeltoHeart is not intended to be used underwater.
Storage:
Caution.png Please store the docking station in an appropriate environment to avoid magnet degaussing.
Electromagnetic Fields and Ultrasound:
Caution.png Do not use the device in the presence of strong electromagnetic fields.
Caution.png Do not use the device near ultrasound equipment.
Cleaning and Maintenance:
Caution.png Ensure that the magnetic connection of the docking station is clean of metallic bodies.
Device Usage and Limitations:
Caution.png 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.
Caution.png Patients with diseases, which manifest as skin photosensitivity should not use the device.
Caution.png Do not paint or put stickers on your device.
Caution.png Do not cause excessive mechanical strain or shock to the device.
Caution.png The device may be damaged, explode, or result in a fire if too much pressure is applied to it.
Caution.png The device is not intended to be put in any bodily orifice.
Caution.png The device is meant to be used by adults of age 22 or older.
Caution.png Use on intact skin only.
Caution.png Do not use excessive force while using the device. Excessive force may break or damage accessories.
Caution.png Do not use the device in an environment where the temperature exceeds 45°C.
Caution.png The platform is not suitable for people with paralyzed, deformed arms, or absence of both arms.
Caution.png 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.
Caution.png Due to excess heat, the battery might be damaged. If the device starts heating, stop using the device immediately!
WARNINGS
Battery safety:
Warning.png If the device starts heating, stop using it immediately to prevent damage to the battery and other components.
Warning.png 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:
Warning.png Do NOT use the device outside of operational temperature conditions, for example in a sauna.
User safety:
Warning.png Comply with all safety warnings and regulations regarding mobile device usage while operating the vehicle.
Warning.png 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:
MyHealth application and TeltoCare share the same login details.
Additional safety information
CAUTIONS:
Caution.png For correct functioning of the system, Bluetooth connection must be established.
Caution.png For correct functioning of the system, Bluetooth connection must be established.
Caution.png If the system is unable to communicate with the server, try again later.
Caution.png If data cannot be saved locally on your smartphone, please clear cache and try again.
Caution.png The device requires a stable internet connection to function properly.
Caution.png Do not clean or use water on the device while charging.
Caution.png Make sure the charging contacts are dry prior to charging the device.
Caution.png It is important to keep TeltoHeart and TeltoHeart Charging dock and the power adapter in a well-ventilated area when charging or in use.
Caution.png Please store the charger and docking station in the appropriate environment to avoid magnet degaussing.
Caution.png Please do not use the device during the firmware update process. Doing so could cause irreparable damage to the device and render it unusable.
Caution.png If any allergic reaction occurs, stop wearing the device immediately and consult with your doctor.
Caution.png Do not wear the device on moles, birthmarks, psoriasis, or other skin surface defects.
Caution.png Do not bend the wristband excessively.
Caution.png The bracelet must be replaced if a defect in the strap or metal buckle is observed.
Caution.png 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.
Caution.png If TeltoHeart watch is damaged or has malfunctions, contact your provider.
Caution.png If you start feeling nauseous or symptoms of a headache, consider not using the device until you feel better.
Caution.png Avoid pairing the device in public places.
Caution.png User must grant data storage permissions on the mobile application.
Caution.png After unpairing TeltoHeart via MyHealth application, all data in TeltoHeart will be permanently deleted. This includes any saved settings, ECG, and HR data.
Caution.png Device is intended to be used by one person. Do not share the device with anyone.
Caution.png The system is not intended for the detection of stroke or other life-threatening conditions.
Caution.png Darker skin tones on the wrist might affect PPG performance.
Caution.png 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.
Caution.png PPG glass scratches or cracks may affect device PPG performance.
Caution.png 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.
Caution.png If TeltoHeart storage is full, the newest records will be written on top of the oldest.
Caution.png Prolonged viewing at the device's screen is not recommended.
Caution.png 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.
Caution.png Do not use corrosive chemical materials for cleaning.
Caution.png Ensure that the magnetic connection of the docking station is clean of metallic bodies.
WARNINGS:
Warning.png Chargers and accessories shall comply according to compatibility requirements provided in instructions for use.
Warning.png 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.
Warning.png 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.
Warning.png 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.
Warning.png Use a password consisting of at least 8 symbols, at least one non-alphanumeric character, one uppercase, one lowercase character, and one digit.
Warning.png Exaggerated movement impairs the system's ability to take measurements.
Warning.png 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.
Warning.png 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 MyHealth 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.