Chicco Aerosol SUPER SOFT Series Instructions Manual page 18

The information on the unit's capabilities provided by the manufacturer in accordance with
EN 13544-1 may not apply to medicines provided in suspension form or those that are highly
viscous.
EN 60601-1 Medical electrical equipment – Part 1: general requirements for safety
EN 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance. Collateral standard: Electromagnetic compatibility - Requirements and
tests.
EN 13544-1 Respiratory therapy equipment – Part one: Nebulising systems and their components.
This section contains information specific to product compliance with the EN 60601-1-2 stand-
ard. The Chicco aerosol Super Soft is a medical electrical device that requires special precautions
regarding electromagnetic compatibility and needs to be installed and commissioned accord-
ing to the electromagnetic information provided.
Mobile and portable RF communications equipment (mobile phones, transceivers, etc.) may
affect the device.
The Chicco aerosol Super Soft is intended for use in the electromagnetic environment specified
below. Customers or users of the product must ensure that it is used in the recommended envi-
ronment.
The Chicco aerosol Super Soft Family
electromagnetic environment that meets the specifications provided below. The purchaser or user
of 00009814000000 is responsible for ensuring that the device is used in an environment that
complies with said specifications.
Guidance and manufacturer's declaration - Electromagnetic emissions
Phenomenon
Conducted and radiated RF EMISSIONS
Harmonic distortion
Voltage fluctuations and flickering
) The equipment is suitable for use in Home Health Environments and Professional Health Care
a
Environments limited to patient rooms and respiratory treatment facilities in hospital or clinics.
The more restrictive acceptance limits of Group 1 Class B (CISPR 11) have been considered
and applied. The equipment is suitable for use in the mentioned environments when directly
connected to the Public Mains Network.
) The test is not applicable in this environment unless the ME EQUIPMENT and ME SYSTEM used
b
will be connected to the PUBLIC MAINS NETWORK and the power input is otherwise within the
scope of the Basic EMC standard.
00009814000000 was designed for use in an
Professional
healthcare facility
environment )
a
)
a
IEC 61000-3-2
IEC 61000-3-3
18
HOME HEALTHCARE
ENVIRONMENT )
a
CISPR 11
Group 1 Class B
) Class A
b
) COMPLIANT
b