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ACUTRONIC fabian +nCPAP evolution - Intended use

ACUTRONIC fabian +nCPAP evolution
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2 Warnings, cautions and notices 9
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
2.4 Intended use
The fabian +nCPAP evolution is intended for premature infants, new-borns as well as children
weighing up to 30 kg.
The fabian +nCPAP evolution is intended forin-patient use” in professional healthcare
environment including intra-hospital patient transport.
The fabian +nCPAP evolution is an electronically microprocessor controlled ventilator.
The fabian +nCPAP evolution ventilates with excess pressure based on the continuous-flow
principle.
(Time cycled, pressure / volume limited or volume guaranteed)
Oxygen is metered by the integrated Air/O
2
blender.
The oxygen concentration is measured internally with a galvanic oxygen sensor.
The ventilator is intended for the following ventilation methods:
CPAP Continuous positive airway pressure
IPPV Intermittent Positive Pressure Ventilation (CMV Controlled Mandatory Ventilation)
NIV ventilation nCPAP/duoPAP with variable flow generators
PSV Pressure Support Ventilation
SIMV + PSV Synchronised Intermittent Mandatory Ventilation combined with PSV
SIMV Synchronised Intermittent Mandatory Ventilation
SIPPV Synchronised Intermittent Positive Pressure Ventilation (A / C, Assist Controlled)
(Infant Flow®, Infant Flow LP®, InspireTM, Medije)
The equipment is operated by a physician or at their orders by a professional with technical
training in this task, whereupon any user must be trained on this equipment and familiar with
the operators manual and the use of the equipment.
fabian +nCPAP evolution is not approved for use in a homecare environment.

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