162 Technical specifications
fabian HFO | SW 5.1.x
Ref: 113003.EN / Date 2020-02-10
18.12 Essential Performance
Essential Performance Function
Delivery of ventilation at the patient-
connection port within the alarm limits set
by the operator;
1
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 etCO
2
RGM is
maintained within the IFU specification:
0 to 38 mmHg
± 2 mmHg
39 to 150 mmHg
± (5% of reading + 8% of (reading – 39
mmHg));
or
Low and High CO
2
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
Measurement accuracy of the pulse rate
from the SpO
2
monitor is maintained within
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