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SAFETY_NOTICE.md

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⚡ openTENS Safety and Usage Disclaimer

⚠️ Important:
openTENS is an open-source electrical stimulation toolkit intended for research, education, and prototyping purposes only.
It is NOT a certified medical device, and must not be used for medical treatment, diagnosis, or therapy.
Improper use may result in injury, discomfort, or hardware damage.
Always operate within safe voltage and current limits.

🧩 Overview

openTENS is designed as an open-source platform to explore and prototype electrical stimulation systems safely.
The project provides circuit designs, firmware, and examples to support research in wearable technology, affective computing, and human-computer interaction.

However, the hardware and firmware are provided “as is”, without any warranty or guarantee regarding safety or fitness for a particular purpose.

⚠️ Safety Warnings

  1. Human Safety Comes First
    Only use openTENS under supervision by individuals familiar with electrical safety and physiology.
    Never apply stimulation above the safe current and voltage limits described below.

  2. Not for Clinical or Medical Use
    openTENS is not intended to replace or replicate certified medical-grade TENS/EMS equipment.
    It must not be used on patients or for any therapeutic procedures.

  3. Isolation and Power Source
    Always power the circuit using an isolated source (battery or isolated DC/DC converter).
    Do not connect openTENS directly to a computer USB port while electrodes are attached to the body.

  4. Current Limiting and Overvoltage Protection
    Use hardware current limiters, resistors, and transient voltage suppressors (TVS) as part of your circuit design.
    Verify that the current never exceeds safe levels.

  5. Body Contact and Electrodes

    • Use biocompatible electrodes (e.g., medical-grade hydrogel pads or conductive textiles).
    • Avoid direct metal-to-skin contact.
    • Keep electrode surfaces clean and replace them when degraded.

  6. Operating Limits (Recommended)

    Parameter Recommended Safe Range
    Output Current (RMS) ≤ 10 mA
    Output Voltage ±50 V max
    Frequency Range 1 – 100 Hz
    Pulse Width ≤ 500 µs
    Duty Cycle ≤ 20% (typical)

  7. Individuals Who Should NOT Use openTENS

    • People with pacemakers or implanted medical devices
    • Those with cardiac, neurological, or skin disorders
    • Children or untrained individuals

  8. Testing on the Body

    • Always start at minimum amplitude and increase slowly.
    • Test with simulated loads (resistors) before any human contact.
    • Stop immediately if you experience pain, discomfort, or abnormal sensations.

🧠 Responsible Use

By using or modifying openTENS, you acknowledge that:

  • You take full responsibility for any consequences of its use.
  • The authors, contributors, and affiliated institutions shall not be held liable for any injury, loss, or damage caused by misuse.
  • You will not distribute or commercialize openTENS as a medical product without meeting applicable regulations and certifications.

🧾 Reference Standards (Recommended Reading)

  • IEC 60601-1: Medical Electrical Equipment — General Requirements for Safety
  • IEEE Std 602-2007: Electrical Systems in Health Care Facilities
  • ISO 14971: Medical Devices — Application of Risk Management

🧰 Additional Safety Resources

If you are developing or modifying openTENS hardware:

  • Review hardware current limit design in /docs/safety/ (if available).
  • Use simulation tools (LTSpice, Proteus, etc.) before prototyping.
  • Always measure actual output using an oscilloscope with isolated probes.

🪪 Disclaimer Summary

This open-source project is provided without any warranty.
All users are responsible for their own safety and compliance with local laws.
By using openTENS, you agree to the terms stated in this document.

Authors & Contributors:
Xiaoming Teng · Yibo Liu (Xi’an Jiaotong-Liverpool University, School of Advanced Technology)