Air Liquide AIDAL Manual De Instrucciones página 6

Surge ± 1 kV
EN 61000-4-5 differential
mode
± 2 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 3 A/m
frequency
(50/60 Hz)
magnetic field
EN 61000-4-8
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- Compliance
Test 2 Test level level
Radiated RF 3 V/m 3 V/m
EN 61000-4-3 80 MHz to
2.5 GHz
Conducted 3 V 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.
± 1 kV differential Mains power quality
mode should be that of a
typical commercial or
± 2 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)
3 A/m Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Electromagnetic Environment
Portable and mobile RF
communications equipment
should be used no closer to any
part of Aidal aspirator, including
cables, than the recommended
separation distance calculated
from the equation applicable to
the frequency of the transmitter
Recommended separation
distance
80 MHz to 800MHz
800 MHz to 2.5GHz
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:
ENGLISH
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.
• the connecting tubes between the various components are for single-use.
• If the antibacterial filter and the safety float do not intervene and aspirated fluid gets
into the aspirator unit, immediately interrupt the power supply.
• the device is protected against access to hazardous parts and against vertically fal-
ling drops of water (IP34). IP protection is no longer guaranteed while the unit is being
recharged.
• the aspirator is not suitable for use in the presence of anaesthetic mixtures with air,
oxygen or nitrous oxide.
• Do not touch live parts such as the power cord, power supply adapter and the power
button with wet hands.
• In case of an accidental fall into water the aspirator unit can be extracted only after
interrupting the power supply. After such an occurrence the suction unit may not be
used and requires a complete overhaul.
• In use, the aspirator must be kept on a hard level surface to prevent leakage of fluids
from the collection jar. The device must not be used in movement.
• Ensure that the lid of the jar is properly closed in order to avoid accidental spillage
of fluids.
• In use, the aspirator must be kept away from source of heat.
• the power cord and connecting tubes, for their length, may pose a risk of stran-
gulation.
• Some components for their small size, if swallowed, may present a risk of suffocation.
• It is recommended to fully charge the aspirator before each use.
• In case of allergic reaction due to contact with the materials of this device, seek me-
dical attention.
• the manufacturer has defined a useful lifespan of at least five years from first use.
22 - WARRANTY
See the warranty certificate inside the package.
Accessories and batteries are covered by warranty against workmanship defects.
The manufacturer is liable for the safety, the reliability and the performance of the
device if the same is used in accordance with the operating instructions and its
intended use. The manufacturer is liable for the safety, the reliability and the perfor-
mance of the device if repairs are carried out at the manufacturer or at a laboratory
authorised by the same. If the user fails to comply with the Operating Instructions
and Warnings contained in this manual, the manufacturer's liability and warranty
conditions shall be considered void.
23 - COPYRIGHT
All information contained herein may not be used for purposes other than originally
intended. This manual is owned by Air Liquide Medical Systems S.p.A. and it may
not be reproduced, in whole or in part without the prior written permission of Air
Liquide Medical Systems S.p.A. All rights reserved.
24 - UPDATES TO TECHNICAL CHARACTERISTICS
In order to continuously improve performance, safety and reliability, all medical de-
vices produced by Air Liquide Medical Systems S.p.A. are periodically reviewed
and improved. Operating instruction manuals are therefore amended to ensure
constant compliance with the characteristics of the devices launched to market. If
the instruction manual accompanying this device is lost, a copy corresponding to
the supplied device may be obtained from the manufacturer by specifying the data
shown on the product identification label.
6
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
800 MHz - 2.5 GHz
d = 2.3 x √P
0.23
0.73
2.3
7.3
23