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+44 (0)1709 377172
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+44 (0)1709 377173
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www.harvesthealthcare.co.uk
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IEC 60601
TEST LEVEL
IMMUNITY
TEST
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Electrostatic
discharge (ESD)
IEC61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Electrical fast
transient / burst
IEC61000-4-4
± 2 kV for power
supply lines
± 1 kV for input /
output lines
± 2 kV for power supply
lines
± 1 kV for input / output
lines
Floors should be wood, concrete
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Mains power quality should be that
of a typical commercial or hospital
environment.
GUIDANCE AND MANUFACTURER’S DECLARATION
– ELECTROMAGNETIC IMMUNITY
The Duke is intended for use in the electromagnetic environment specified below. The
customer or the user of the harvest Duke should assure that it is used in such an environment.
Surge
IEC61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
IEC61000-4-11
<5% U
T
(>95 % dip in U
T
)
For 0.5 cycle
40% U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5% U
T
(>95 % dip in U
T
)
For 5 s
<5% U
T
(>95 % dip in U
T
)
For 0.5 cycle
40% U
T
(60 % dip in U
T
)
for 5 cycles
70% U
T
(30 % dip in U
T
)
for 25 cycles
<5% U
T
(>95 % dip in U
T
)
For 5 s
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
harvest Duke requires continued
operation during power mains
interruptions, it is recommended that
the harvest Duke be powered from
an uninterruptable power supply or
a battery.
Power frequency
(50/60Hz)
Magnetic field
IEC61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristics
of a typical location in a typical
commercial or hospital environment.
EMC
STATEMENT
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
EMC
STATEMENT
IEC 60601
TEST LEVEL
IMMUNITY
TEST
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 Vrms
3V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the Duke including
any cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance (d)
d = 1.2
√
P
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 metres (m).
Fields 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 this symbol:
GUIDANCE AND MANUFACTURER’S DECLARATION
– ELECTROMAGNETIC IMMUNITY
The Duke is intended for use in the electromagnetic environment specified below. The
customer or the user of the harvest Duke should assure that it is used in such an environment.
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
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 harvest Duke is used exceeds the
applicable RF compliance level above, the harvest Duke should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orientating or relocating the harvest
Duke
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
