VISIOMED easyScan VM-ZX1 Manual De Instrucciones página 75

EMC data
IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COM-
PATIBILITY (EMC)
With the increased number of electronic devices such as computers and
mobile (cellular) telephones, medical devices in use may be susceptible
to electromagnetic interference from other devices. Electromagnetic
interference may result in incorrect operation of the medical device and
create a potentially unsafe situation. Medical devices should also not
interfere with other devices. In order to regulate the requirements for
EMC (Electromagnetic Compatibility) with the aim to prevent unsafe pro-
duct situations, the IEC60601- 1-2 standard has been implemented. This
standard defines the levels of immunity to electromagnetic interferences
as well as maximum levels of electromagnetic emissions for medical de-
vices. The devices conform to this IEC60601-1-2:2007 standard for both
immunity and emissions.
The device needs to be installed and put into service in accordance with
the information provided in the user manual.
Nevertheless, special precautions need to be observed:
- The use of accessories other than those provided by manufacturer, may
result in increased emission or decreased immunity of the device.
- Refer to EMC table guidance regarding the EMC environment in which
the device should be used.
148 Visiomed - EasyScan VM-ZX1 - User manual - 062016
Guidance and manufacturer's declaration - electromagnetic
immunity. The device is intended for use in the electromagne-
tic environment specified below. The customer or the user assures
that it is used in such an
Emissions test Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Not applicable
lEC 61000-3-2
Voltage fluctuations /
flicker emissions Not applicable
lEC 61000-3-3
Visiomed - EasyScan VM-ZX1 - User manual - 062016
environment.111111111111111111
Electromagnetic environment
- guidance
The device uses RF energy only
for its internal function. There-
fore, 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 power
supply network that supplies
buildings used for domestic
purposes.
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