User's Manual

result in com pliance with t he safet y lim it.
Do w ir e less phone a cce ssories that cla im t o shie ld t he head from
RF r a diat ion w or k ?
Since t here are no known risks from exposure t o RF em issions from
wireless phones, t here is no reason t o believe t hat accessories t hat claim
to shield t he head from t hose em issions reduce risks. Som e product s t hat
claim to shield t he user from RF absorption use special phone cases, while
others involve nothing m ore t han a m etallic accessory att ached t o the
phone. Studies have shown that t hese product s generally do not work as
advert ised. Unlike “ hand- free” kit s, t hese so-called “ shields” m ay int erfere
wit h proper operation of t he phone. The phone m ay be forced t o boost its
power t o com pensate, leading t o an increase in RF absorption. I n
February 2002, t he Federal t rade Com m ission ( FTC) charged t wo
com panies t hat sold devices t hat claim ed t o prot ect wireless phone users
from radiation with m aking false and unsubst antiated claim s. According t o
FTC, t hese defendant s lacked a reasonable basis t o substant iate t heir
claim .
W hat a bout w ir e less phone int e r fer e nce w it h m edical equipm ent ?
Radio frequency energy ( RF) from wireless phones can int eract with som e
elect ronic devices. For this reason, FDA helped develop a detailed t est
m ethod t o m easure elect rom agnet ic int erference ( EMI ) of im plant ed
cardiac pacem akers and defibrillat ors from wireless t elephones. This t est
m ethod is now part of a st andard sponsored by t he Association for t he
Advancem ent of Medical inst rum ent ation ( AAMI ) . The final draft , a j oint
effort by FDA, m edical device m anufacturers, and m any ot her groups,
was com pleted in lat e 2000. This standard will allow m anufact urers t o
ensure t hat cardiac pacem akers and defibrillat ors are safe from wireless
phone EMI . FDA has t est ed wireless phones and helped develop a
volunt ary st andard sponsored by t he I nst it ut e of Elect rical and Elect ronic
Engineers ( I EEE) . This st andard specifies test m ethods and perform ance
requirem ent s for hearing aids and wireless phones so that no interference
occurs when a person uses a com patible phone and a com patible hearing
aid at t he sam e t im e. This st andard was approved by t he I EEE in 2000.
FDA cont inues t o m onit or t he use of wireless phones for possible
int eract ions wit h other m edical devices. Should harm ful int erference be
found t o occur, FDA will conduct t est ing t o assess t he int erference and
work t o resolve the problem .
Additional inform ation on t he safety of RF exposures from various sources
can be obt ained from t he following organizations:
 FCC RF Safet y Program :
ht t p: / / www.fcc.gov/ oet / rfsafety/
 Environm ent al Prot ect ion Agency ( EPA) :
ht t p: / / www.epa.gov/ radiat ion/
 Occupational Safet y and Healt h Adm inist rat ion's ( OSHA) :
ht tp: / / www.osha.gov/ SLTC/ radiofrequencyradiat ion/ index.ht m l