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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 the 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.
The 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.
The FDA continues to monitor the use of wireless phones for
possible interactions with other medical devices. Should
harmful interference be found to occur, the 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-lonizing 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/)
Consumer Information on SAR
(Specific Absorption Rate)
This Model Phone Meets the Government’s
Requirements for Exposure to Radio Waves.
Your wireless phone is a radio transmitter and receiver. It is
designed and manufactured not to exceed the emission limits for
exposure to radio frequency (RF) energy set by the Federal
Communications Commission (FCC) of the U.S. Government.
These limits are part of comprehensive guidelines and establish
permitted levels of RF energy for the general population. The
guidelines are based on standards that were developed by
independent scientific organizations through periodic and thorough
evaluation of scientific studies. The standards include a substantial
safety margin designed to assure the safety of all persons,
regardless of age and health.
The exposure standard for wireless mobile phones employs a unit
of measurement known as the Specific Absorption Rate, or SAR.
The SAR limit set by the FCC is 1.6W/kg. * Tests for SAR are
conducted using standard operating positions specified by the
FCC with the phone transmitting at its highest certified power level
in all tested frequency bands. Although SAR is determined at the
highest certified power level, the actual SAR level of the phone
while operating can be well below the maximum value. Because
the phone is designed to operate at multiple power levels to use
only the power required to reach the network, in general, the closer
you are to a wireless base station antenna, the lower the power
output.
Before a phone model is available for sale to the public, it must be
tested and certified to the FCC that it does not exceed the limit
established by the government-adopted requirement for safe
exposure. The tests are performed in positions and locations (e.g.,
at the ear and worn on the body) as required by the FCC for each
model. The highest SAR value for this model phone when tested for
use at the ear is 0.714 W/kg and when worn on the body, as
Safety GuidelinesSafety Guidelines