User's Manual

E-17
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 “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.
For more information, please visit the FDA website at
http://www.fda.gov/cellphones.
Emergency Calls
Never rely solely upon your wireless phone for essential
communications (e.g., medical emergencies), if it can be
avoided, since a wireless phone requires a complex
combination of radio signals, relay stations and landline
networks for its operation. Consequently, emergency calls
may not always be possible under all conditions on all wireless