17 Technical specifications 96
fabian Therapy evolution | SW V5.1.x
Ref: 121003.EN / Date: 26Jan2021
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.
Measurement accuracy of the SpO
2
monitor is
maintained within the IFU specification only within the
range 70 to 100%:
• ± 2% pediatric patients, no motion conditions;
• ± 3% pediatric patients, motion conditions, and all
neonatal patients;
or
Low and High SpO
2
Level alarm conditions shall occur,
as appropriate;
or
a technical alarm condition shall occur.
201.11.8.101.1
201.12.4
201.13.101
3
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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