• The Journal of Korean Medicine
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• v.43 no.3
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• pp.150-163
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• 2022

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

• The Journal of Korean Medicine
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• v.44 no.1
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• pp.128-128
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• 2023

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

• Korean Journal of Acupuncture
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• v.40 no.4
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• pp.184-193
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• 2023

Objectives : The purpose of this study is to understand the temperature characteristics depending on the thickness and material of the needle used with the Electronic Warm Acupuncture Device (EWAD). Methods : We controlled experimental environment and measured temperature changes of a silicon phantom in which K-type thermocouples were inserted at depths of 2, 7 mm. EWAD perfomed with acupuncture needles of various thicknesses (0.25×60 mm, 0.40×60 mm, and 0.50×60 mm) and materials (Gold 0.40×50 mm). We set non-needle (only heated with EWAD skin heater) group as a control group. Results : The maximum temperature and temperature changes of 0.40 mm, 0.50 mm needle group were significantly higher than the non-needle group. The highest temperature range in all needle groups was 0.50 mm needle group (41.44±0.31℃). However, the 0.25 mm needle group was not significantly different from the non-needle group. Maximum temperature of gold needle group was significantly higher than stainless steel needle group. Temperature changes of gold needle group were higher than stainless steel group at the depth of 7 mm. Conclusions : It was found that needle thickness and material of acupuncture had an effect on the temperature of the EWAD. When performing EWAD treatment, consideration of thickness and material of acupuncture is needed. Future research is needed using phantoms that can reflect actual clinical situations and better mimic the human body.