User's Manual

18
safety and usage information
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/
• Environmental Protection Agency (EPA):
http://www.epa.gov/radiation/