ACUTRONIC fabian +nCPAP evolution - 20 Electromagnetic Compatibility Statement; Devices with SN from AN-04000

20 Electromagnetic compatibility statement 129
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
20 Electromagnetic compatibility statement
NOTE:
fabian +nCPAP evolution is a MEDICAL APPLIANCE subject to specific precautionary
measures regarding EMC and must be installed and started up according to the notices
and the instructions in this manual.
WARNING:
Portable medical HF communication devices could impact fabian +nCPAP evolution .
WARNING:
NEVER use fabian +nCPAP evolution directly adjacent to, or stack with other equipments. If
unavoidable, be sure to monitor the equipment for proper operation with this set-up.
WARNING:
Using other accessories, cables or converters with fabian +nCPAP evolution could result in
increased electromagnetic interference and reduce the immunity of fabian +nCPAP
evolution.
NOTE:
The key performance characteristics of the fabian +nCPAP evolution ventilator are:
• fabian +nCPAP 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).
20.1 Devices with SN from AN-04000
Guideline and Manufacturer Declaration – Electromagnetic Emissions
The device fabian +nCPAP evolution is intended for operation in the environment described below. The
customer or operator of the fabian +nCPAP 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 +nCPAP 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-orienting the equipment.”
harmonic Distortion
IEC 61000-3-2
Class A
‒
Voltage Fluctuations & Flickers
IEC 61000-3-3