Bard CROSSER, Instructions For Use Manual

Page: 3 / 117

3
Electromagnetic Emissions
The
F
LOW
M
ATE
® ,QMHFWRULVLQWHQGHGIRUXVHLQWKHHOHFWURPDJQHWLFHQYLURQPHQWVSHFL¿HGEHORZ7KHFXVWRPHURUWKHXVHURIWKH
F
LOW
M
ATE
®
Injector should assure that it is used in such an environment.
Emissions Test Compliance Environmental Guidance
RF emissions
CISPR 11 Class 1 The
F
LOW
M
ATE
®
Injector uses RF energy only for its internal function.
7KHUHIRUHLWV5)HPLVVLRQVDUHYHU\ORZDQGDUHQRWOLNHO\WRFDXVHDQ\
interference in nearby electronic equipment.
RF emissions
CISPR 11 Class A The
F
LOW
M
ATE
®
Injector is suitable for use in all establishments other than
domestic, and may be used in domestic establishments and those directly
FRQQHFWHGWRWKHSXEOLFORZYROWDJHSRZHUVXSSO\QHWZRUNWKDWVXSSOLHV
buildings used for domestic purposes, provided the following warning is
heeded:
Warning: This equipment/system is intended for use by healthcare
professionals only. This equipment/ system may cause radio
interference or may disrupt the operation of nearby equipment. It may
be necessary to take mitigation measures, such as re-orienting or
relocating the
F
LOW
M
ATE
®
Injector or shielding the location.
Harmonic emissions
IEC 61000 3-2 Class A
9ROWDJHÀXFWXDWLRQV
ÀLFNHUHPLVVRQV
IEC 61000-3-3
Complies
The
F
LOW
M
ATE
®
Injector is not suitable for interconnection with other equipment with the exception of the
C
ROSSER ™ Generator
Portable and mobile RF communications equipment can affect operation of the
F
LOW
M
ATE
®
Injector.
7KHXVHRIDFFHVVRULHVDQGFDEOHVRWKHUWKDQWKRVHVSHFL¿HGZLWKWKHH[FHSWLRQRIFDEOHVTXDOL¿HGDQGVROGE\%DUGIRUXVHZLWK
the
F
LOW
M
ATE
®
Injector may result in increased emissions or decreased immunity of the equipment and may cause the equip-
PHQWWREHQRQFRPSOLDQWZLWKUHTXLUHPHQWVRI,(&
The
F
LOW
M
ATE
® ,QMHFWRUVKRXOGQRWEHXVHGDGMDFHQWWRRUVWDFNHGZLWKHTXLSPHQWRWKHUWKDQWKH C
ROSSER
™ Generator. If
DGMDFHQWRUVWDFNHGXVHLVQHFHVVDU\WKHHTXLSPHQWVKRXOGEHREVHUYHGWRYHULI\QRUPDORSHUDWLRQLQWKHFRQ¿JXUDWLRQLQZKLFKLW
will be used.
Electromagnetic Immunity
The
F
LOW
M
ATE
® ,QMHFWRULVLQWHQGHGIRUXVHLQWKHHOHFWURPDJQHWLFHQYLURQPHQWVSHFL¿HGEHORZ7KHFXVWRPHURUWKHXVHURIWKH
F
LOW
M
ATE
®
Injector should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Environmental Guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
“N9FRQWDFW
“N9DLU “N9FRQWDFW
“N9DLU
Floors should be wood, concrete
RUFHUDPLFWLOH,IÀRRUVDUH
covered with synthetic material,
the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
“N9IRUSRZHUVXSSO\OLQHV“
N9IRULQSXWRXWSXWOLQHV “N9IRUSRZHUVXSSO\
OLQHV“N9IRULQSXW
output lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
“N9IRUOLQHVWROLQHV“N9
for line (s) to earth
“N9IRUOLQHVWROLQHV
“N9IRUOLQHVWRHDUWK
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
U
T
=230 VAC
<5% U
T
(>95% dip in U
T
) for 0.5
cycle 40% U
T
(60% dip in U
T
)
IRUF\FOHV8
T
(30% dip in
U
T
) for 25 cycles <5% U
T
(>95%
dip in U
T
) for 5 sec
<5% U
T
(>95% dip in
U
T
) for 0.5 cycle 40%
U
T
(60% dip in U
T
) for
F\FOHV8
T
(30%
dip in U
T
) for 25 cycles
<5% U
T
(>95% dip in U
T
)
for 5 sec
Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of the
F
LOW
M
ATE
®
Injector
requires continued operation
during power mains interruptions,
it is recommended that the
F
LOW
M
ATE
®
Injector be powered
from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
PDJQHWLF¿HOG
,(&
3 A/m 3 A/m
3RZHUIUHTXHQF\PDJQHWLF¿HOGV
should be at levels characteristic
of a typical location in a typical
commercial or hospital environ-
ment.
Electromagnetic Immunity
The
F
LOW
M
ATE
® ,QMHFWRULVLQWHQGHGIRUXVHLQWKHHOHFWURPDJQHWLFHQYLURQPHQWVSHFL¿HGEHORZ7KHFXVWRPHURUWKHXVHURIWKH
F
LOW
M
ATE
®
Injector should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Environmental Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V
rms
N+]WR0+]
3 V/m
0+]WR*+]
3V
3V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of the
F
LOW
M
ATE
®
Injector,
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Separation distance according to
frequency of transmitter
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 meters (mm).
)LHOGVWUHQJWKVIURP¿[HG5)
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
YLFLQLW\RIHTXLSPHQWPDUNHGZLWK
the following symbol:
NOTE 1
$W0+]DQG0+]WKHKLJKHUIUHTXHQF\UDQJHDSSOLHV
NOTE 2
7KHVHJXLGHOLQHVPD\QRWDSSO\LQDOOVLWXDWLRQV(OHFWURPDJQHWLFSURSDJDWLRQLVDIIHFWHGE\DEVRUSWLRQDQGUHÀHFWLRQ
from structures, objects and people.
a )LHOGVWUHQJWKVIURP¿[HGWUDQVPLWWHUVVXFKDVEDVHVWDWLRQVIRUUDGLRFHOOXODUFRUGOHVVWHOHSKRQHVDQGODQGPRELOHUDGLRV
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
HOHFWURPDJQHWLFHQYLURQPHQWGXHWR¿[HG5)WUDQVPLWWHUVDQHOHFWURPDJQHWLFVLWHVXUYH\VKRXOGEHFRQVLGHUHG,IWKHPHDVXUHG
¿HOGVWUHQJWKLQWKHORFDWLRQLQZKLFKWKH
F
LOW
M
ATE
®
Injector is used exceeds the applicable RF compliance level above, the
F
LOW
M
ATE
®
Injector should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the
F
LOW
M
ATE
®
Injector.
b 2YHUWKHIUHTXHQF\]WR0+]¿HOGVWUHQJWKVVKRXOGEHOHVVWKDQ9P
d =
[ 3.5
V
1
]√
P
d =
[ 3.5
E
1
]√
P
d =
[ 7
E
1
]√
P