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Moog Curlin 6000 CMS IOD User Manual page 188

Ambulatory infusion system

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Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The PainSmart™ IOD , 6000 CMS™ and 6000 CMS™ IOD™ is intended for use in electromagnetic environment specified below. The
customer or the user of the PainSmart™ IOD, 6000 CMS™ and 6000 CMS™ IOD™should assure that it is used in such an environment.
Immunity Test
Electrostatic
± 6 kV contact
discharge (ESD)
IEC 61000-4-2
± 8 kV air
± 2 kV for power supply
Electrical fast
transient/burst
lines
IEC 61000-4-4
± 1 kV for input/output
lines
Surge
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
IEC 61000-4-5
Voltage dips, short
<5 % U
interruptions and voltage
(>95 % dip in U
variations on power
for 0,5 cycle
supply input lines
40 % U
IEC 61000-4-11
(60 % dip in U
for 5 cycles
70 % U
(30 % dip in U
for 25 cycles
<5 % U
(>95 % dip in U
for 5 s
Power frequency
3 A/m
(50/60 Hz)
magnetic field
IEC 61000-4-8
is the a.c. mains voltage prior to application of the test level.
NOTE U
T
Recommended separation distances between portable and mobile RF communications
equipment and the Painsmart™ IOD, 6000 CMS™ and 6000 CMS™ IOD™
The Painsmart™ IOD, 6000 CMS™ and 6000 CMS™ IOD™ is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Painsmart™ IOD, 6000 CMS™ and 6000 CMS™ IOD™ can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Painsmart™ IOD, 6000 CMS™ and 6000 CMS™ IOD™ as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum output
power of transmitter
W
0,01
0,1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorbtion and reflection from
structures, objects and people.
IEC 60601
Compliance Level
Test Level
± 6 kV contact
± 8 kV air
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
<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
3 A/m
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz
80 MHz to 800 MHz
3,5
d = [
] √P
d = [
V
1
0.116
0.369
1.16
3.69
11.7
Electromagnetic Environment-
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.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
T
commercial or hospital environment. If the
)
T
user of the PainSmart™ IOD, 6000 CMS™
and 6000 CMS™ IOD™ requires continued
operation during power mains interruptions, it
T
)
is recommended that the PainSmart™ IOD,
T
6000 CMS™ and 6000 CMS™ IOD™ be
powered from an uninterruptible power supply
or a battery.
T
)
T
T
)
T
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
3,5
] √P
E
1
0.12
0.34
1.7
3.7
11.7
Guidance
800 MHz to 2,5 GHz
7
d = [
] √P
E
1
0.23
0.74
2.3
7.4
23.3

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