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with proper operation of the phone. The
phone may be forced to boost its power to
compensate, leading to an increase in RF
absorption. In February 2002, the Federal
trade Commission (FTC) charged two
companies that sold devices that claimed to
protect wireless phone users from radiation
with making false and unsubstantiated
claims. According to FTC, these defendants
lacked a reasonable basis to substantiate
their claim.
What about wireless phone
interference with medical equipment?
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 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.
Additional information on the safety of RF
exposures from various sources can be
obtained from the following organizations:
• FCC RF Safety Program:
http://www.fcc.gov/oet/rfsafety/
Summary of Contents for S8300
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