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Guidance and manufacturer's declaration: electromagnetic immunity
Immunity test
IEC60601 test level
Electrostatic
±8kV contact
discharge
±2kV, ±4kV, ±8kV,
(ESD)
±15kV air
IEC61000-4-2
Conducted RF
3 V outside ISM
IEC 61000-4-6
bands between
0,15-80 MHz
6 V inside ISM
bands between
0,15-80 MHz
Radiated RF
Professional
IEC 61000-4-3
Healthcare facility
environment:
3V/m
80MHz to 2.7GHz
Home healthcare
environment:
10V/m
80MHz to 2.7GHz
Electrical fast
±1 kV
transient/burst
100 kHz repetition
IEC 61000-4-4
frequency
Power
30 A/m
frequency
(50/60 Hz)
Magnetic eld
IEC 61000-4-8
a) Field strengths from xed transmitters, such as base stations for cellular/cordless telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be accurately predicted
theoretically. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site
survey should be considered. If the measured eld strength in the location in which Sara Flex is used exceeds
the applicable RF compliance level above, Sara Flex should be observed to verify normal operation. If abnormal
performance is observed. Additional measures may be necessary.
b) Over the frequency range 150kHz to 80MHz, eld strength should be less than 1V/m
Recommended separation distances between portable and mobile RF communications
equipment and Sara Flex
Sara Flex is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer and user of Sara Flex can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and Sara Flex
by maintaining a distance of not less than 1 meter to any part of Sara Flex , including cables, if the transmitter's
output power rating exceeds 1W.
Compliance level
±6kV contact
±8kV air
3 V outside ISM
bands between
0,15-80 MHz
6 V inside ISM
bands between
0,15-80 MHz
Professional
healthcare facility
environment:
3V/m
80MHz to 2.7GHz
Home healthcare
environment:
10V/m
80MHz to 2.7GHz
±1 kV
100 kHz repetition
frequency
30 A/m
40
Electromagnetic environment - guidance
Floors should be wood, concrete or
ceramic tile. If oors are covered with
synthetic material the relative humidity
level should be at least 30%
Portable and mobile RF communications
equipment should be used no closer to
any part of Sara Flex, including cables,
than 1.0m, if the transmitter's output
power rating exceeds 1W (a)
Field strengths from xed RF
transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range (b)
Interference may occur in the
vicinity of equipment marked with this
symbol:
Mains power supply should be that of a
typical or hospital environment.
If functional disturbance occurs on
Sara Flex it may be necessary to install
magnetic shielding. The power frequency
magnetic eld should be measured
prior to installation to assure that it is
suf ciently low.
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