Samsung SGH-P735 User Manual (ENGLISH) - Page 175

Advancement of Medical instrumentation AAMI. The final

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Radio frequency 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 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. 10. What are the results of the research done already? The research done thus far has produced conflicting results, and many studies have suffered from flaws in their research methods. Animal experiments investigating the effects of radio frequency energy (RF) exposures characteristic of wireless phones have yielded conflicting results that often cannot be repeated in other laboratories. A few animal studies, however, have suggested that low levels of RF could accelerate the development of cancer in laboratory animals. However, many of the studies that showed increased tumor development used animals that had been genetically engineered or treated with cancer causing chemicals so as to be pre-disposed to develop Appendix C: Consumer update on wireless phones 174

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Appendix C: Consumer update on wireless phones
174
Radio frequency 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 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.
10. What are the results of the research done already?
The research done thus far has produced conflicting results, and
many studies have suffered from flaws in their research
methods. Animal experiments investigating the effects of radio
frequency energy (RF) exposures characteristic of wireless
phones have yielded conflicting results that often cannot be
repeated in other laboratories. A few animal studies, however,
have suggested that low levels of RF could accelerate the
development of cancer in laboratory animals. However, many of
the studies that showed increased tumor development used
animals that had been genetically engineered or treated with
cancer causing chemicals so as to be pre-disposed to develop