User manual

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Radiofrequency 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 accompanied
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.
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-Ionizing 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/
July 18, 2001For updates: http://www.fda.gov/cdrh/phones