User guide

Chapter 7: Safety 111
Safety
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.
Radiated RF
IEC 61000-4-3
(continued)
Field strengths from fixed RF
transmitters, as determined
by an electromagnetic Site
survey
a
, should be less than
the compliance level in each
frequency range
b
.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Note: U
T
is the AC mains voltage prior to application of the test level.
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.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (continued)
The Edge ultrasound system is intended for use in the electromagnetic environment specified
below. The customer or the user of the Edge ultrasound system should assure that it is used in
such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic
Environment