Guidance And Manufacturer's Declaration - Human Design Medical Z1 Auto System User 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 .
The Z1 Auto 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 confirmed as summarized in this document .
Guidance and manufacturer's declaration - electromagnetic emissions
The Z1 Auto System is intended for use in the electromagnetic environment specified below . The
customer or the user of the Z1 Auto System should assure that it is used in such an environment .
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
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 configuration in which it will be used .
• The use of cables and accessories (eg, humidifiers) other than those specified for the
device is not recommended . They may result in increased emissions or decreased
immunity of the device .
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Compliance Electromagnetic environment — guidance
Group 1
The Z1 Auto System 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 Z1 Auto System is suitable for use in all
Class B
establishments, including domestic establish-
ments and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes .
Class A
Complies