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Manual No. SUC 84154 016
Issue 17
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EMC Information Tables per EN60601-1-2:2001-09 Section 6.
In accordance with EN 60601-1-2:2001 Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral standard: Electromagnetic compatibility Requirements and tests
1) “Medical Electrical Equipment needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC information provided in the
Accompanying Documents” (the following tables).
2) “Portable and Mobile RF Communications Equipment can affect Medical Electrical
Equipment.”
3) “The equipment or system should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the equipment or system
should be observed to verify normal operation in the configuration in which it is used.”
The following tables provide information regarding the EMC characteristics of this
Medical Electrical Equipment.
* The compliance levels of immunity referred to in tables 202 and 204 have not been
arrived at by testing, but by declaration on the basis that the Thoracic suction pump
contains no electronic components and is inherently immune to the specified levels of
electromagnetic disturbance. The performance of all functions of the Thoracic suction
pump are considered essential performance for the purpose of electromagnetic
immunity.
Table 201 — Guidance and manufacturer’s declaration - electromagnetic emissions
- all equipment and systems
Guidance and manufacturer’s declaration - electromagnetic emissions
The Thoracic suction pump is intended for use in the electromagnetic environment
specified below. The customer or user of the Thoracic suction pump should assure that it
is used in such an environment.
Emissions Test
Compliance
Electromagnetic environment - guidance
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
The Thoracic suction pump is suitable for use
in all establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
RF emissions
CSIPR 14-1
Complies
7
The Thoracic suction pump is not suitable for
interconnection with other equipment.
8
5
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Table 202 — Guidance and manufacturer’s declaration - electromagnetic immunity
- for all equipment and systems
Guidance and manufacturer’s declaration - electromagnetic immunity
The Thoracic suction pump is intended for use in the electromagnetic environment
specified below. The customer or user of the Thoracic suction pump should assure that it
is used in such an environment.
Immunity Test
IEC 61000
test level
Compliance
level
(not tested) *
Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-3-4
±6 kV contact
±8 kV air
±6 kV contact
±8 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
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±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
IEC 61000-4-11
<5 % UT
(>95% dip in UT
for 0.5 cycle)
40 % UT
(60% dip in UT
for 5 cycles)
70 % UT
(30% dip in UT
for 25 cycles)
<5 % UT
(>95% dip in UT
for 5 sec)
<5 % UT
(>95% dip in UT
for 0.5 cycle)
40 % UT
(60% dip in UT
for 5 cycles)
70 % UT
(30% dip in UT
for 25 cycles)
<5 % UT
(>95% dip in UT
for 5 sec)
Mains power quality should be
that of a typical commercial or
hospital environment. The unit
shut off during the >95% dip
for 5 sec disturbance. If the
user of the Thoracic suction
pump requires continued
operation during power mains
interruptions, it is
recommended that the
Thoracic suction pump be
powered from an
uninterruptible power supply
or battery.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
3
8
5
)
/
Table 204 — Guidance and manufacturer’s declaration - electromagnetic immunity
- for equipment and systems that are NOT life-supporting.
Guidance and manufacturer’s declaration - electromagnetic immunity
The Thoracic suction pump is intended for use in the electromagnetic environment
specified below. The customer or user of the Thoracic suction pump should assure that it
is used in such an environment.
Immunity Test
IEC 61000
test level
Compliance
level
(not tested) *
Electromagnetic environment guidance
Portable and mobile
communications equipment should
be used no closer to any part of the
Thoracic suction pump, including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency of the transmitter.
Recommended separation distance
.
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to
80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80MHz to
2.5 GHz
3
3 Vrms
d = [3.5/V1] P
3 V/m
d = [3.5/E1] P 80 MHz to 800MHz
d = [7/E1] P 800 MHz to 2.5GHz
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 metre (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
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