FujiFilm SonoSite EDGE II Service Manual page 28

Guidance and Manufacturer's Declaration - Electromagnetic Immunity (Continued)
The SonoSite Edge II ultrasound system is intended for use in the electromagnetic
environment specified below. The customer or the user of the SonoSite Edge II ultrasound
system should assure that it is used in such an environment.
Immunity
Test
Radiated RF
IEC 61000-4-3
Radiated RF
IEC 61000-4-3
(continued)
Note:U is the AC mains voltage prior to application of the test level.
T
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the SonoSite ultrasound system is
used exceeds the applicable RF compliance level above, the SonoSite ultrasound system should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the SonoSite ultrasound system.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
FCC Caution: Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including interference that may cause undesired
operation.
20 Chapter 3: Safety
IEC 60601 Test Compliance
Level Level
3 Vim 3 V/m
80 MHz to 2.5 GHz
Electromagnetic
Environment
d = 1.2
P
80 MHz to 800 MHz
d = 2.3
P
800 MHz to 2,5 GHz
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed
RF transmitters, as
determined by an
electromagnetic Site
survey , should be less than
a
the compliance level in each
frequency range .
b
Interference may occur in
the vicinity of equipment
marked with the following
symbol: