Electromagnetic Compatibility; Recommended Separation Distances; Electromagnetic Emissions - Air Liquide OSIRIS 3 Manual De Uso

5.3. Electromagnetic compatibility
All of the information set out below was obtained from the normative requirements to which the manufacturers
of electro-medical devices are subject, within the meaning of standard IEC 60601-1-2 Ed4.
The medical device is compliant with the electromagnetic compatibility standards in force; nevertheless the
user shall ensure that any electromagnetic interference does not create an additional risk, such as radio-fre-
quency transmitters or other electronic devices.
In this section you will find the information required to ensure that the installation and putting into operation of
your medical device is carried out under the best possible conditions in terms of electromagnetic compatibility.
The various leads attached to the medical device must be separated from each other.
Certain types of telecommunications mobile devices such as mobile phones may interfere with the medical
device. The recommended separation distances in this section must therefore be strictly observed.
The medical device must not be used in close proximity to other equipment or placed on top of other equip-
ment. If this cannot be avoided, its operation under the conditions of use must be checked beforehand. The
use of accessories other than those specified or sold by Air Liquide Medical Systems as replacement parts may
have the consequence of increasing the emissions or decreasing the immunity of the medical device.
The main performance requirement is the continuity of the patient's ventilation within the limits of the alarm set
by the operator or the generation of an audible and visual alarm.
Exceptional electromagnetic disturbance may degrade ventilation performance.
RF hand-held communication devices should not be used (including peripherals such as antenna cables
and external cables) within a radius of 30 cm (12 inches) of any part of the OSIRIS 3, including the cables spec-
ified by the manufacturer. Otherwise, the performance of this equipment may be impaired.
Length of cables
The OSIRIS 3 must be used with these accessories. The use of other accessories may result in increased
emissions or decreased immunity of the ventilator.

Recommended separation distances

The medical device is intended for use in an electromagnetic environment in which the disturbances due to RF
radiation are controlled.
The user or installer of the medical device can help prevent electromagnetic interference by maintaining a
minimum distance, according to the maximum output power of the radio-frequency transmission equipment.
RF hand-held communication devices should not be used (including peripherals such as antenna cables and
external cables) within a radius of 30 cm (12 inches) of any part of the OSIRIS 3, including the cables specified
by the manufacturer. Otherwise, the performance of this equipment may be impaired.

Electromagnetic emissions

The medical device is intended for use in an electromagnetic environment described in the table below. The
user and installer must ensure that the medical device is used in the environment described below.
Emission test
Electromagnetic radiation distur-
bance(Radiated emissions) (CISPR
11)
Power terminal disturbance voltage
(Conducted emissions) (CISPR 11)
Emission of harmonic currents
(IEC 61000-3-2)
Voltage changes, voltage fluctua-
tions and flicker (IEC 61000-3-3)
Magnetic and electromagnetic immunity
The medical device is intended for use in a magnetic and electromagnetic environment described in the table
below. The user and installer must ensure compliance of the electromagnetic environment.
Compli-
Electromagnetic environment - comments
ance
Group1 The medical device uses RF energy for its internal`opera-
tion. Consequently, its radio frequency emissions are very
low and are not likely to create any interference with neigh-
boring equipment.
Class B Professional health care establishment environment.
Class A
Compliant
YL033700 - Rev. 3a - 2019-02
Technical description - EN
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