20 - ELECTROMAGNETIC COMPATIBILITY
This device complies with the requirements of CEI EN 60601-1-2:2015 for the electro-
magnetic compatibility of medical devices. Compliance with EMC standards does not
guarantee the total immunity of the product; some devices (cell phones, pagers, etc.),
when used near medical equipment, can stop it from functioning properly.
ELECTROMAGNETIC EMISSION
Aidal is suitable for use in the specified electromagnetic environment. The custo-
mer or the user of the Aidal should assure that it is used in an electromagnetic
environment as described below:
Emissions test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions
Class A conforming
EN 61000-3-2
Voltage fluctuations/
Complies
flicker emissions
EN 61000-3-3
ELECTROMAGNETIC IMMUNITY
Aidal is intended for use in the electromagnetic environment specified below. The
customer or user should assure that it is used in an electromagnetic environment.
Immunity Test
EN 60601-1-2
Test level
Electrostatic
± 8 kV contact
discharge
± 15 kV air
(ESD) EN
61000-4-2
Electrical fast
± 2 kV for
transient/burst
power
EN 61000-4-4
supply lines
Immunity Test
EN 60601-1-2
Test level
Surge
± 2 kV
EN 61000-4-5
differential
mode
± 1 kV common
mode
Voltage
<5 % UT for 0,5
dips, short
cycle
interruptions
(>95 % dip in
and voltage
UT)
variations on
power supply
40 % UT for 5
input lines.
cycles
(60 % dip in UT)
EN 61000-4-11
70 % UT for 25
cycles
(30 % dip in UT)
<5 % UT for 5 s
(>95 % dip in
UT)
Power
30 A/m
frequency
(50/60 Hz)
magnetic field
EN 61000-4-8
Electromagnetic Environment
Aidal aspirator uses RF energy
only for its internal function.
Therefore, its RF emission is very
low and not likely to cause any
interference in nearby electronic
equipment.
Aidal is suitable for use in all
establishments, including do-
mestic establishment and those
directly connected to the public
low-voltage power supply network
that supplies buildings used for
domestic purposes.
Compliance
Electromagnetic
level
Environment -
guidance
± 8 kV contact
Floors should be wood,
± 15 kV air
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
± 2 kV for power
Mains power quality
supply lines
should be that of a
typical commercial or
hospital environment.
Compliance
Electromagnetic
level
Environment -
guidance
± 2 kV differential
Mains power quality
mode
should be that of a
typical commercial or
± 1 kV common
hospital environment.
mode
<5 % UT for 0,5
Mains power quality
cycle
should be that of a
(>95 % dip in
typical commercial or
UT)
hospital environment.
If the user of the Aidal
40 % UT for 5
requires continued
cycles
operation during power
(60 % dip in UT)
mains interruptions, it
is recommended that
70 % UT for 25
the Aidal be powered
cycles
from an uninterruptible
(30 % dip in UT)
power supply or a
battery.
<5 % UT for 5 s
(>95 % dip in
UT)
30 A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
ENGLISH
Aidal aspirator is intended for use in the electromagnetic environment specified
below. The customer or the user of Aidal aspirator should assure that it is used in
such an environment
Immunity
EN 60601-1-
Test
2 Test level
Radiated RF
3 V/m
EN 61000-4-3
80 MHz to
2.7 GHz
Conducted
3 V
RF
150 kHz to
EN 61000-4-6
80 MHz
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 structure, objects and people.
RECOMMENDED DISTANCES FROM RADIO-COMMUNICATION DEVICES
The AIDAL surgical aspirator is intended for use in an electromagnetic environ-
ment in which radiated RF disturbances are under control. The customer or the
operator of the AIDAL device can help prevent electromagnetic interference by
maintaining a minimum distance between mobile and portable RF communica-
tion equipment (transmitters) and the AIDAL device as recommended below in
relation to the peak output of the radio-communication devices.
Maximum rated
power output of the
transmitter [W]
0.01
0.1
1
10
100
For transmitters with a maximum rated output power not listed above, the
recommended separation distance d in metres (m) can be calculated using the
equation applicable to the frequency of the transmitter, where P is the maximum rated
output power of the transmitter in Watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz the separation distance is applied for the higher
frequency range.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
21 - WARNINGS
The product has been designed with particular attention to patient and user safety.
Nevertheless, the following precautions must be taken.
• The aspirator must only be used by trained and qualified personnel.
• Do not modify this equipment without the manufacturer's authorization.
• Before operating the aspirator in any way, read all the instructions carefully, paying
particular attention to warnings and how to prepare and use the device.
• Check that every precaution has been taken to avoid any danger arising from acci-
dental contact with blood or bodily fluids.
• The aspirator must only be used for suction as indicated in this operating instruction
manual as in the paragraph "Intended Use". Other uses are not permitted.
• The aspirator is not suitable for thoracic drainage.
• The vacuum generated in the aspirator suction outlet, in its connecting tubes or col-
lection jar may represent a potential hazard.
6
Compliance
Electromagnetic Environment
level
3 V/m
Portable and mobile RF
communications equipment
should be used no closer to any
part of Aidal aspirator, including
cables, than the recommended
3 V
separation distance calculated
from the equation applicable to
the frequency of the transmitter
Recommended separation
distance
Where P is the maximum
output rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).
Field strengths for fixed RF
transmitter, 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:
Separation distance at the frequency of the transmitter [m]
150 kHz - 80 MHz
80 MHz - 800 MHz
d = 1.2 x √P
d = 1.2 x √P
0.12
0.12
0.38
0.38
1.2
1.2
3.8
3.8
12
12
80 MHz to 800MHz
800 MHz to 2.5GHz
800 MHz - 2.5 GHz
d = 2.3 x √P
0.23
0.73
2.3
7.3
23