MDS 4003 | MEDLINE 29
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or
the user of the device should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
power supply lines: ±2 kV
input/output lines:
±1 kV
power supply lines:
±2 kV
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC61000-4-5
line(s) to line(s): ±1 kV
line(s) to earth: ±2 kV
100 kHz repetition
frequency
line(s) to line(s): ±1 kV
100 kHz repetition
frequency
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
IEC 61000-4-11
0%U
T
; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and 315°
0%U
T
; 1 cycle and 70%U
T
;
25/30 cycles
Single phase: at 0°
0% U
T
; 300 cycle
0% U
T
; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and
315°
0% U
T
; 1 cycle
and 70% U
T
; 25/30
cycles
Single phase: at 0°
0% U
T
;300 cycle
Mains power quality
should be that of a
typical commercial or
hospital environment.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Power frequency
magnetic fields should
be at levels characteristic
of a typical location in
a typical commercial or
hospital environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
P
P
P
P
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user
of the device should assure that it is used in such an environment.
IMMUNITY test
IEC 60601
TEST LEVEL
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4-6
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
Portable and mobile RF ommunications equipment
should be used no closer to any part of the device,
including cables, than the recommended separation
distance calculated from the equation appropriate
for the frequency of the transmitter.
Recommended separation distances:
d=0.35
d=1.2
Radiated RF
IEC 61000-4-3
10V/m, 80% Am
at 1kHz
10V/m, 80% Am
at 1kHz
80 MHz to 800
MHz: d=1.2
800 MHz to 2.7
GHz: d=2.3
where, P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer, 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
the compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
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
device is used exceeds the applicable RF compliance level above, the device should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
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