ACUTRONIC fabian +nCPAP evolution - Essential Performance

19 Technical specifications 127
fabian +nCPAP evolution | SW V5.1.x
Ref: 122003.EN / Date : 26Jan2021
19.12 Essential Performance
#
Essential Performance Function
Standard
Clause
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
202.6.2.1.10
Obstruction / Occlusion;
Low and High Air/ Oxygen Inlet Pressure;
Air/Oxygen Gas Supply Failure;
or
a technical alarm condition shall occur.
ISO 80601-2-12:
2011
201.11.8.101.2
201.12.4.103
201.12.4.106
201.12.4.107
201.11.8.101.1
201.11.8.101.2
201.13.101/.102
201.101.1
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.
ISO 80601-2-12:
2011
201.12.4.101
ISO 80601-2-55:
2018
201.12.1.101.1
208.6.1.2
201.11.8.101.1
ISO 80601-2-61:
2017
201.12.1.101.1
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%.