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Related Experiment Videos

Electrostimulators for acupuncture: safety issues.

C D Lytle1, B M Thomas, E A Gordon

  • 1Office of Science and Technology, FDA Center for Devices and Radiological Health, Rockville, Maryland, USA.

Journal of Alternative and Complementary Medicine (New York, N.Y.)
|March 8, 2000
PubMed
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See all related articles

Electrostimulator device outputs often deviate from manufacturer specifications, potentially impacting safety. Proper calibration and practitioner training are crucial for safe electroacupuncture device use.

Area of Science:

  • Biomedical Engineering
  • Medical Device Technology
  • Neuroscience

Background:

  • Electrostimulators are used in electroacupuncture, but their output parameters require validation.
  • Assessing device compliance with manufacturer claims and safety standards is essential for patient safety.

Purpose of the Study:

  • To evaluate if three electrostimulators meet manufacturer-labeled output parameters.
  • To compare measured device parameters against the ANSI/AAMI NS15 safety standard for implantable peripheral nerve stimulators.

Main Methods:

  • Measured pulse width, frequency, and voltage of three electrostimulators using an oscilloscope.
  • Simulated subdermal tissue stimulation using a 500-ohm resistance.
  • Compared measured outputs against manufacturer specifications and the ANSI/AAMI NS15 standard.

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Main Results:

  • At least two measured parameters for each device deviated by more than 25% from manufacturer claims.
  • Pulse voltage at maximum intensity exceeded the NS15 standard for two devices.
  • Net unbalanced DC current exceeded the NS15 standard at frequencies above 30 pulses per second.

Conclusions:

  • Electrostimulator outputs require calibration to ensure accuracy.
  • Adequate training for practitioners is necessary for the safe operation of electrostimulators in clinical settings.