19 Technical specifications 127
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
19.12 Essential Performance
Essential Performance Function
Delivery of ventilation at the patient-connection port
within the alarm limits set by the operator;
3
or
the following alarm conditions shall occur as
appropriate:
• Low battery as internal electrical power source
nears depletion
• Low and High Minute Volume
• Low and High PEEP
Obstruction / Occlusion;
Low and High Air/ Oxygen Inlet Pressure;
Air/Oxygen Gas Supply Failure;
or
a technical alarm condition shall occur.
Measurement accuracy of the oxygen respiratory gas
monitor (RGM) is maintained within the IFU
specification, ± (3% absolute);
or
Low and High Oxygen Level alarm conditions shall
occur, as appropriate;
or
a technical alarm condition shall occur.
To evaluate if essential performance is maintained, the following degradations shall not be allowed in any
normal use case:
• Component failures;
• Changes in programmable parameters or settings;
• Reset to default settings;
• Change of operating mode;
• Initiation of an unintended operation; and
• Error of Delivered Volume (V
ti
) of individual breaths greater than 35% and error of the DELIVERED
VOLUME averaged over a one minute interval greater than 25%.
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