Breas Z1 - Guidance and Manufacturers Declaration Electromagnetic Emissions & Immunity

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Doc. HD40-0007-02 En-Eu L-4
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.
Z1 system does not have Essential Performance within the meaning ofIEC 60601-1. However,
immunity testing was conducted in accordance with IEC60601-1-2 and compliance was
conrmed as summarized in this document.
Guidance and manufacturer’s declaration - electromagnetic emissions
The Z1 CPAP System is intended for use in the electromagnetic environment specied below. The
customer or the user of the Z1 CPAP System should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment — guidance
RF emissions
CISPR11
Group 1 The Z1 CPAP System uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any interfer-
ence in nearby electronic equipment.
RF emissions
CISPR11
Class B The Z1 CPAP System is suitable for use in all
establishments, including domestic establish-
ments and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC61000-3-2
Class A
Voltage uctuations/
icker emissions
IEC61000-3-3
Complies
WARNINGS:
• 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 conguration in which it will be used.
• The use of cables and accessories (eg, humidiers) other than those specied
for the device is not recommended. They may result in increased emissions or
decreased immunity of the device.