NITE Alert_57

1. Outline of incidents

(Case 1)

After wearing an EMS belt on the stomach and using the product for nine consecutive 10 minute sessions, the user suffered six crater-like scars 2 mm in diameter and 1mm in depth. The user went to see a doctor three months after the incident and was diagnosed with “low temperature burns that would leave scars."

(Case 2)

Using an EMS belt resulted in inflammation of the skin on the calves and thighs, which were diagnosed as “a minor burns.

(Case 3)

On the third day of using an EMS belt on the lower abdomen, a user felt pain in the areas where the pads were taped. The user continued to use the product for another 10 days, and consequently, multiple red rashes appeared on the areas where the pads were placed. The pads were moistened with water as instructed by distributor.

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2,Investigation results

According to the investigations by NITE, an electrical pulse of about 0.7A maximum (about 25V) runs through the body within a very short period of time of 0.00002 seconds intermittently for 4 to 5 times every 0.02 seconds. These groups of electrical pulses are repeated every 0.2 seconds. As the product has a mechanism that will automatically turn it off in 10 minutes, it was presumed unlikely to cause injury if used in accordance with this time limit. At the same time, the current (amperage) value of the product complied with the standards defined by JIS when compared to low frequency therapy apparatus. Although results show that there may be a possibility of injuries such as burns, depending on individual differences including user's physical condition and usage, at this time, assuming that the user applies the correct usage methods (apply gel, refrain from using the product for prolonged period etc.), it is not necessarily appropriate to judge that the product is hazardous.

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3. Safety alert

It is considered that improper use of the product (using the product without applying gel, prolonged use of the product etc.) can lead to accidents as in above cases. Consequently, it is important to observe the following precautions when using EMS belts.

1. (1) Attached or separately sold gel should be applied on electrode sections
   Under JIS standard on low frequency therapy apparatus, electrodes should be “coated with aqueous material to avoid direct contact with skin in order to lower the risk of burns." The gel applied to EMS contact pads is the aqueous material equivalent.
2. (2) EMS should be used within the time period suggested in operation manuals. Do not set the intensity value to excessive levels:
   For low frequency therapy apparatus, JIS standards require that the power control unit should be constructed to allow voltage and power output to gradually increase to prevent electroconvulsive shock and diminish the pain of receiving electric current to body. It may be necessary to apply the same caution when using EMS
3. (3) Avoid wearing the product on chest:
   There is a risk of electric current flowing into the heart when using the product on the chest or heart area, which may have an adverse effect on the heart.
4. (4) If you experience physical pain or other problems, discontinue using the product immediately:
   Operation manuals for low frequency therapy apparatus, which are medical devices, contain a similar caution. It may be necessary to apply the same caution when using EMS. Children and those who have difficulty expressing themselves should avoid using the product.

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4. Response by the Ministry of Economy, Trade and Industry

As of March 10, 2003, the Ministry of Economy, Trade and Industry requested manufacturers to alert consumers on the handling of the product.

Fore more information;
National Institute of Technology and Evaluation (NITE)
Product Safety Technology Center, Product Safety Investigation Division