VOCARE vitals360, User Manual

Page: 110 / 117

Instructions for Use Page 110 of 117
18 IEC60601-1-2 EMC & RF STATEMENT
WARNINGS
Exposure to Radio Frequency (RF) Signals. The U.S. Food and Drug Administration (FDA) has
published information for consumers relating to Radio Frequency (RF) exposure from wireless
devices.
Additional information on the safety of RF exposures from various sources can be obtained from the
following organizations (updated 10/1/2010):
•
» FCC RF Safety Program
o
http://www.fcc.gov/oet/rfsafety/
•
» Environmental Protection Agency ( EPA )
o
http://www.epa.gov/radtown/wireless-tech.html
•
» Occupational Safety and Health Administration ( OSHA ):
o
http://www.osha.gov/SLTC/radiofrequencyradiation/
•
» National Institute for Occupational Safety and Health ( NIOSH )
o
http://www.cdc.gov/niosh/
•
» World Health Organization ( WHO )
o
http://www.who.int/peh-emf/en/
•
» International Commission on Non-Ionizing Radiation Protection
o
http://www.icnirp.de.
•
» Health Protection Agency
o
http://www.hpa.org.uk/Topics/Radiation/
•
» US Food and Drug Administration
o
http://www.fda.gov/Radiation-EmittingProducts/
RadiationEmittingProductsandProcedures/
HomeBusinessandEntertainment/CellPhones/default.htm.
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC COMPATIBILITY (EMC)
•
With the increased number of electronic devices such as PC's and mobile (cellular) telephones,
medical devices in use may be susceptible to electromagnetic interference from other devices.
Electromagnetic interference may result in incorrect operation of the medical device and create
a potentially unsafe situation. Medical devices should also NOT interfere with other devices.
•
In order to regulate the requirements for EMC ( Electro Magnetic Compatibility ) with the aim
to prevent unsafe product situations, the IEC 60601-1-2 Standard has been implemented.
•
This standard defines the levels of immunity to electromagnetic interferences as well as
maximum levels of electromagnetic emissions for medical devices.
•
Medical devices manufactured by VOCARE INC. & VITALS360
®
conform to this IEC 60601-1-
2:2007 Standard for both immunity and emissions.
•
Nevertheless, special precautions need to be observed:
o
The use of accessories and cables other than those specified by VOCARE INC., with
the exception of cables sold by VOCARE INC. as replacement parts for internal
components, may result in increased emission or decreased immunity of the device.
o
The medical devices should NOT be used adjacent to or stacked with other equipment.