User guide

11. What about wireless phone interference with medical equipment?
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 manufac-
turers 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 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.
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/cellphones)
• 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.hpa.org.uk/radiation/)
AVOID POTENTIAL HEARING LOSS.
Prolonged exposure to loud sounds (including music) is the most common cause
of preventable hearing loss. Some scientific research suggests that using portable
audio devices, such as portable music players and cellular telephones, at high
volume settings for long durations may lead to permanent noise-induced
hearing loss. This includes the use of headphones (including headsets, earbuds and
Bluetooth® or other wireless devices). Exposure to very loud sound has also been
associated in some studies with tinnitus (a ringing in the ear), hypersensitivity to
sound and distorted hearing. Individual susceptibility to noise-induced hearing loss
and other potential hearing problems varies.
The amount of sound produced by a portable audio device varies depending on
the nature of the sound, the device, the device settings and the headphones. You
should follow some commonsense recommendations when using any portable
audio device:
122 Chapter 7 − Safety and Warranty
SafetySafety
• Set the volume in a quiet environment and select the lowest volume at which you
can hear adequately.
• When using headphones, turn the volume down if you cannot hear the people
speaking near you or if the person sitting next to you can hear what you are
listening to.
• Do not turn the volume up to block out noisy surroundings. If you choose to listen
to your portable device in a noisy environment, use noise-cancelling headphones
to block out background environmental noise.
• Limit the amount of time you listen. As the volume increases, less time is required
before your hearing could be affected.
• Avoid using headphones after exposure to extremely loud noises, such as rock
concerts, that might cause temporary hearing loss. Temporary hearing loss might
cause unsafe volumes to sound normal.
• Do not listen at any volume that causes you discomfort. If you experience ringing
in your ears, hear muffled speech or experience any temporary hearing difficulty
after listening to your portable audio device, discontinue use and consult your
doctor.
YOU CAN OBTAIN ADDITIONAL INFORMATION ON THIS SUBJECT FROM
THE FOLLOWING SOURCES:
American Academy of Audiology
11730 Plaza American Drive, Suite 300
Reston, VA 20190
Voice: 800-AAA-2336, 703-790-8466
Email: [e-mail]
Internet: www.audiology.org
National Institute on Deafness and Other Communication Disorders
National Institutes of Health
31 Center Drive, MSC 2320
Bethesda, MD USA 20892-2320
Voice: [phone]
Email: [e-mail]
Internet: http://www.nidcd.nih.gov/health/hearing
National Institute for Occupational Safety and Health
Hubert H. Humphrey Bldg.
200 Independence Ave., SW
Washington, DC 20201
Voice: 1-800-CDC-INFO (1-800-232-4636)
Internet: http://www.cdc.gov/niosh/topics/noise/default.html
Safety and Warranty − Chapter 7 123
SafetySafety
080625_TXT8010_ELVIS_M_EN_REV00.indd 122-123080625_TXT8010_ELVIS_M_EN_REV00.indd 122-123 2008.6.25 9:35:44 PM2008.6.25 9:35:44 PM