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ACUTRONIC fabian Therapy evolution - EMC for SN AT-04000

ACUTRONIC fabian Therapy evolution
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Electromagnetic compatibility statement 95
fabian Therapy evolution | SW 5.1.x
Ref: 121003.EN / Date 2020-01-22
NOTE:
The key performance characteristics of the fabian Therapy evolution ventilator are:
fabian Therapy evolution must operate within the defined specifications and the
medical purpose. Failure to meet these specifications will result in respiration being
stopped.
For this reason, a second stand-alone ventilation unit must always be available,
(for example: Resuscitation Bag).
18.1 Device with SN from AT-04000
Guideline and Manufacturer Declaration Electromagnetic Emissions
The device fabian Therapy evolution is intended for operation in the environment described below. The
customer or operator of the fabian Therapy evolution apparatus should ensure it is operated in this type of
environment.
EMI
Measurement
Compliance
Level
Electromagnetic Environment Guideline
RF Emission
CISPR 11
Group 1
The device fabian Therapy evolution uses RF Energy solely for internal
operation. Its RF emission is thus very low and interference with adjacent
apparatuses is unlikely.
RF Emission
CISPR 11
Class A
The emissions characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a
residential environment (for which CISPR 11 class B is normally required)
this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures,
such as relocating or re-
harmonic
Distortion
IEC 61000-3-2
Class A
Voltage
Fluctuations &
Flickers
IEC 61000-3-3

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