SMART HEALTH DEVICES

List of safety warnings for SMART HEALTH DEVICES based on the requirements of Regulation (EU) 2023/988 on general product safety (GPSR):

1. Active medical implants: Persons with implanted pacemakers, cardioverter-defibrillators (ICD), insulin pumps, or other active electronic implants should not use functions that utilize electrical signals (such as BIA body composition analysis or home ECG measurements). The low-intensity signal emitted by the device can disrupt the operation of the implant.
2. Passive metal implants: In the case of having large metal implants (e.g., hip prostheses, bone screws), body composition analysis results may be distorted.
3. Pregnancy: Pregnant women should consult a doctor before using devices that use bioelectrical impedance analysis (BIA). It is recommended to use only dedicated, safe body weight measurement modes (without composition analysis).
4. Lack of clinical nature: Devices in this category are intended for monitoring trends and home prevention. These are not devices with laboratory precision used in hospitals.
5. Medical consultation: Measurement results (blood pressure, ECG, oxygen saturation, temperature) are for illustrative purposes only. Under no circumstances should you self-diagnose diseases or change medication dosages based on readings from the device.
6. Emergency situations: The devices are not intended for continuous monitoring of critical condition patients or for detecting sudden life-threatening events (e.g., heart attack). In case of chest pain or shortness of breath, call for medical assistance immediately.
7. Humid environment: Electronic devices (except those with a clearly specified waterproof rating) must be protected from flooding. Never charge the device in a bathroom, near a bathtub or sink.
8. Power supply: Use only power adapters and cables with parameters matching the technical specification (e.g., 5V, 1A). Using non-original or damaged chargers poses a risk of fire or electric shock.
9. Cable damage: Regularly check the condition of power cords and cuffs. Exposed wires or frayed blood pressure monitor cuff material disqualify the device from further use.
10. Upper arm blood pressure monitors: The cuff must fit the arm circumference. A cuff that is too loose or too tight will cause incorrect results. The measurement should be taken while sitting, after a 5-minute rest, with the arm supported at heart level.
11. ECG and oxygen saturation measurements: During the test, remain still and do not speak. The skin at the contact point with electrodes or optical sensor must be clean and dry (free of creams and lotions).
12. Thermometry: Temperature measurements should be taken under stable ambient conditions. Rapid temperature changes (e.g., coming inside from the cold to a warm room) require waiting at least 15–30 minutes before measuring.
13. Allergic reactions: Some components (electrodes, cuffs) contain stainless steel, silicone, or latex. In case of rash, burning, or skin redness, immediately discontinue contact with the device.
14. Disinfection: If the device is used by multiple household members, parts coming into contact with skin should be cleaned with a soft cloth dampened with a low-alcohol solution (according to instructions). Do not allow liquid to enter inside the casing.
15. Strangulation and swallowing hazard: Power cables and small parts (batteries, carpet feet) must be kept out of reach of children and animals.
16. Use by children: Diagnostic devices should be operated by children only under adult supervision. Some functions (e.g., body composition analysis) are not reliable for individuals under 18 years of age.
17. Extreme conditions: Do not store devices in a car on hot days or in places exposed to freezing temperatures. Extreme temperatures can permanently damage the battery and sensor accuracy.
18. Recycling (WEEE): Used device is electronic waste. It must be handed over to a selective collection point. Disposal in regular household waste bins is prohibited and harmful to the environment.

Following the above rules reduces the risk of injury, equipment breakdown, and property damage. Ignoring them may lead to serious health and technical problems.Detailed information and additional warnings can be found in the user manual included with the product or in PDF format on the manufacturer/supplier website.