FDA CONSUMER UPDATE

The Project has also helped develop a series of public information documents on EMF issues. FDA and the Cellular Telecommunications & Internet Association (CTIA) have a formal Cooperative Research and Development Agreement (CRADA) to do research on wireless phone safety. FDA provides the scientific oversight, obtaining input from experts in government, industry, and academic or- ganizations. CTIA-funded research is conducted through contracts to independent investigators. The initial research will include both laboratory studies and studies of wireless phone users. The CRADA will also include a broad assessment of additional research needs in the context of the latest research developments around the world.

7.How can I find out how much radiofrequency energy exposure I can get by using my wireless phone?

All phones sold in the United States must comply with Federal Communications Commission (FCC) guidelines that limit radiofrequency energy (RF) exposures. FCC established these guidelines in consultation with FDA and the other federal health and safety agencies. The FCC limit for RF exposure from wireless telephones is set at a Specific Absorption Rate (SAR) of 1.6 watts per kilogram (1.6 W/kg). The FCC limit is consistent with the safety standards developed by the Institute of Electrical and Electronic Engineering (IEEE) and the National Council on Radiation Protection and Measurement. The exposure limit takes into consideration the body’s ability to remove heat from the tissues that absorb energy from the wireless phone and is set well below levels known to have effects. Manufacturers of wireless phones must report the RF exposure level for each model of phone to the FCC. The FCC website (http://www.fcc.gov/oet/rfsafety) gives directions for locating the FCC identification number on your phone so you can find your phone’s RF exposure level in the online listing.

8. What has FDA done to measure the radiofrequency energy coming from wireless phones ?

The Institute of Electrical and Electronic Engineers (IEEE) is developing a technical standard for measuring the radiofrequency energy (RF) exposure from wireless phones and other wireless handsets with the participation and leader-ship of FDA scientists and engineers. The standard, “Recommended Practice for Determining the Spatial-Peak Specific Absorption Rate (SAR) in the Human Body Due to Wireless Communications Devices: Experimental Techniques,” sets forth the first consistent test methodology for measuring the rate at which RF is deposited in the heads of wireless phone users. The test method uses a tissue-simulating model of the human head. Standardized SAR test methodology is expected to greatly improve the consistency of measurements made at different laboratories on the same phone. SAR is the measurement of the amount of energy absorbed in tissue, either by the whole body or a small part of the body. It is measured in watts/kg (or milliwatts/g) of matter. This measurement is used to determine whether a wireless phone complies with safety guidelines.

9. What steps can I take to reduce my exposure to radiofrequency energy from my wireless phone?

If there is a risk from these products—and at this point we do not know that there is—it is probably very small. But if you are concerned about avoiding even potential risks, you can take a few simple steps to minimize your exposure to radiofrequency energy (RF). Since time is a key factor in how much exposure a person receives, reducing the amount of time spent using a wireless phone will

C reduce RF exposure.

H • If you must conduct extended conversations by wireless phone every day, you could place more distance between your body and the source of the RF, since

8 the exposure level drops off dramatically with distance. For example, you could use a headset and carry the wireless phone away from your body or use a wireless phone connected to a remote antenna.

FDA CONSUMER UPDATE

Again, the scientific data do not demonstrate that wireless phones are harmful. But if you are concerned about the RF exposure from these products, you can use measures like those described above to reduce your RF exposure from wireless phone use.

10.What about children using wireless phones?

The scientific evidence does not show a danger to users of wireless phones, including children and teenagers. If you want to take steps to lower exposure to radiofrequency energy (RF), the measures described above would apply to children and teenagers using wireless phones. Reducing the time of wireless phone use and increasing the distance between the user and the RF source will reduce RF exposure. Some groups sponsored by other national governments have advised that children be discouraged from using wireless phones at all. For example, the government in the United Kingdom distributed leaflets containing such a recommendation in December 2000. They noted that no evidence exists that us- ing a wireless phone causes brain tumors or other ill effects. Their recommendation to limit wireless phone use by children was strictly precautionary; it was not based on scientific evidence that any health hazard exists.

11.What about wireless phone interference with medical equipment? Radiofrequency energy (RF) from wireless phones can interact with some electronic devices. For this reason, FDA helped develop a detailed test method to measure electromagnetic interference (EMI) of implanted cardiac pacemakers and defibrillators from wireless telephones. This test method is now part of a standard sponsored by the Association for the Advancement of Medical instrumentation (AAMI). The final draft, a joint effort by FDA, medical device manufacturers, and many other groups, was completed in late 2000. This standard will allow manufacturers to ensure that cardiac pacemakers and defibrillators are safe from wireless phone EMI. FDA has tested hearing aids for interference from handheld wireless phones and helped develop a voluntary standard sponsored by the Institute of Electrical and Electronic Engineers (IEEE). This standard specifies test methods and performance requirements for hearing aids and wireless phones so that that no interference occurs when a person uses a “compatible” phone and a “compatible” hearing aid at the same time. This standard was approved by the IEEE in 2000. FDA continues to monitor the use of wireless phones for possible interactions with other medical devices. Should harmful interference be found to occur, FDA will conduct testing to assess the interference and work to resolve the problem.

12.Where can I find additional information?

For additional information, please refer to the following resources:

FDA web page on wireless phones (http://www.fda.gov/cdrh/ phones/index.html)

Federal Communications Commission (FCC) RF Safety Program (http://www.fcc.gov/oet/rfsafety)

International Commission on Non-Ionizing Radiation Protection (http://www.icnirp.de)

World Health Organization (WHO) International EMF Project (http://www.who.int/emf)

National Radiological Protection Board (UK) (http://www.nrpb.org.uk/)

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CDM-8910WW specifications

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