eove EO-150 - Electromagnetic Compatibility and Standards

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Guidance and Manufacturer’s Declaration Electromagnetic Emissions & Immunity
WARNING

The ventilator should not be used in close proximity to other equipment or stacked on top
of other devices. If this kind of use is unavoidable, the ventilator should be checked
carefully and observed to ensure correct functioning of the device.

Only acc
essories recommended for the EO 150 should be used. Using any other accessories
could result in risk to the device or the patient.

Any additional equipment connected to medical electrical devices 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).
Adding additional equipment configures a medical system and this system must comply
with the requirements for medical electrical systems. Any person undertaking this kind of
addition shall be responsible to ensure that all requirements are complied with. It is
important to note that local laws take priority over the above mentioned requirements. If
in doubt, consult an EOVE representative or the technical service department.

Interference may occur in the vicinity of equipment marked with the following symbol:

EO150 is designed for use in the
electromagnetic environment described below. Those
using the device should ensure that the EO 150 is used in such an environment.
Electromagnetic emissions
Emissions test
Level of compliance
Guidance for EM
environment
RF emissions CISPR 11
Class B
EO150
is suitable for home health
care environment and a professional
health care establishment
Harmonic Emissions
IEC 61000-3-2
Complying
Voltage Fluctuations/Flicker
Emissions
IEC 61000-3-3
Complying