Helio PN-810 manual Safety and Warranty FDA Consumer Update

SAFETY AND WARRANTY FDA CONSUMER UPDATE

U.S. Food and Drug Administration -

Center for Devices and Radiological Health

Consumer Update on Wireless Phones

1. Do wireless phones pose a health hazard?

The available scientific evidence does not show that any health problems are associated with using wireless phones. There is no proof, however, that wireless phones are absolutely safe. Wireless phones emit low levels of radiofrequency energy (RF) in the microwave range while being used. They also emit very low levels of RF when in the stand-by mode. Whereas high levels of RF can produce health effects (by heating tissue), exposure to low level RF that does not produce heating effects causes no known adverse health effects. Many studies of low level RF exposures have not found any biological effects. Some studies have suggested that some biological effects may occur, but such findings have not been confirmed by additional research. In some cases, other researchers have had difficulty in reproducing those studies, or in determining the reasons for inconsistent results.

2.What is FDA’s role concerning the safety of wireless phones? Under the law, FDA does not review the safety of radiation-emitting consumer products such as wireless phones before they can be sold, as it does with new drugs or medical devices. However, the agency has authority to take action if wireless phones are shown to emit radiofrequency energy (RF) at a level that is hazardous to the user. In such a case, FDA could require the manufacturers of wireless phones to notify users of the health hazard and to repair, replace or recall the phones so that the hazard no longer exists. Although the existing scientific data do not justify FDA regulatory actions, FDA has urged the wireless phone industry to take a number of steps, including the following:

•Support needed research into possible biological effects of RF of the type emitted by wireless phones;

•Design wireless phones in a way that minimizes any RF exposure to the user that is not necessary for device function;

and

•Cooperate in providing users of wireless phones with the best possible information on possible effects of wireless phone use on human health.

FDA CONSUMER UPDATE SAFETY AND WARRANTY

FDA belongs to an interagency working group of the federal agencies that have responsibility for different aspects of RF safety to ensure coordinated efforts at the federal level. The following agencies belong to this working group:

•National Institute for Occupational Safety and Health

•Environmental Protection Agency

•Federal Communications Commission

•Occupational Safety and Health Administration

•National Telecommunications and Information Administration

The National Institutes of Health participates in some inter-agency working group activities, as well. FDA shares regulatory responsibilities for wireless phones with the Federal Communications Commission (FCC). All phones that are sold in the United States must comply with FCC safety guidelines that limit RF exposure. FCC relies on FDA and other health agencies for safety questions about wireless phones. FCC also regulates the base stations that the wireless phone networks rely upon. While these base stations operate at higher power than do the wireless phones themselves, the RF exposures that people get from these base stations are typically thousands of times lower than those they can get from wireless phones. Base stations are thus not the subject of the safety questions discussed in this document.

3. What kinds of phones are the subject of this update?

The term “wireless phone” refers here to hand-held wireless phones with built-in antennas, often called “cell,” “mobile,” or “PCS” phones.

These types of wireless phones can expose the user to measurable radiofrequency energy (RF) because of the short distance between the phone and the user’s head. These RF exposures are limited by Federal Communications Commission safety guidelines that were developed with the advice of FDA and other federal health and safety agencies. When the phone is located at greater distances from the user, the exposure to RF is drastically lower because a person’s RF exposure decreases rapidly with increasing distance from the source. The so-called “cordless phones,” which have a base unit connected to the telephone wiring in a house, typically operate at far lower power levels, and thus produce RF exposures far below the FCC safety limits.

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