Guidance And Manufacturer's Declaration Electromagnetic Emissions & Immunity; Guidance And Manufacturer's Declaration-Electromagnetic Emissions - ResMed Astral Series Clinical Manual

Guidance and Manufacturer's Declaration Electromagnetic
Emissions & Immunity
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to EMC information provided in this document.
This declaration currently applies for the following ResMed devices:
•
Astral Series of Ventilators.
™
Guidance and manufacturer's declaration—electromagnetic emissions
These devices are intended for use in the electromagnetic environment specified below. The customer
or the user of the device should assure that the device is used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
with or without USB adapter
with or without Oximeter adapter
Harmonic Emissions
IEC 61000-3-2
with or without specified accessories
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
with or without specified accessories
WARNING
•
The device should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
•
The use of accessories other than those specified for the device is not recommended. They
may result in increased emissions or decreased immunity of the device.
•
Additional equipment connected to medical electrical equipment must comply with the
respective IEC or ISO standards (eg, IEC 60950 for data processing equipment). Furthermore all
configurations shall comply with the requirements for medical electrical systems (see
IEC 60601-1-1 or clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting
additional equipment to medical electrical equipment configures a medical system and is
therefore responsible that the system complies with the requirements for medical electrical
systems. Attention is drawn to the fact that local laws take priority over the above mentioned
requirements. If in doubt, consult your local representative or the technical service department.
•
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm to any part of the device, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
Guidance and Manufacturer's Declaration Electromagnetic Emissions & Immunity
Compliance
Group 1
Class B
Class A
Complies
Electromagnetic environment—guidance
The device uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
The device is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low-voltage
network that supplies buildings used for domestic
purposes.
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