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Health and Safety Information 78
believe that hands-free kits reduce risks. Hands-free
kits can be used with wireless phones for
convenience and comfort. These systems reduce the
absorption of RF energy in the head because the
phone, which is the source of the RF emissions, will
not be placed against the head. On the other hand, if
the phone is mounted against the waist or other part
of the body during use, then that part of the body will
absorb more RF energy. Wireless phones marketed in
the U.S. are required to meet safety requirements
regardless of whether they are used against the head
or against the body. Either configuration should result
in compliance with the safety limit.
Do wireless phone accessories that claim
to shield the head from RF radiation work?
Since there are no known risks from exposure to RF
emissions from wireless phones, there is no reason
to believe that accessories that claim to shield the
head from those emissions reduce risks. Some
products that claim to shield the user from RF
absorption use special phone cases, while others
involve nothing more than a metallic accessory
attached to the phone. Studies have shown that
these products generally do not work as advertised.
Unlike "hand-free" kits, these so-called "shields"
may interfere 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
Common Cents M340.book Page 78 Thursday, April 1, 2010 12:36 PM