ACUTRONIC fabian Therapy evolution - Essential Performance

Technical specifications 93
fabian Therapy evolution | SW 5.1.x
Ref: 121003.EN / Date 2020-01-22
17.11 Acoustic Energy
201.9.6.2.1.101
TABLE: Acoustic energy
P
VBS used :
fabian Therapy evolution

Accessories :
Patient set

Humidifier (water level) :
N/A

Test lung :
Part No. 1116

Ventilator settings :
Acc. to TAB, 201.105 mid column

Measurement
No.
Location
Sound Pressure
Level
Remarks

Background
16
Lp A (dB)
1
2
33.91)  50
Leq (dB)  max.@ (Hz)
1
4
32.82)  50
Leq (dB)  max.@ (Hz)
25
6
36.3  12500
Leq (dB) max.@ (Hz)
25
8
33.1  12500
Leq (dB)  max.@ (Hz)
25
10
33.3  12500
Leq (dB)  max.@ (Hz)
25
12
37.6  12500
Leq (dB)  max.@ (Hz)

Calculated average
51.0  47.1
Lin  A weighted (dB)
Supplementary information:
LpA: A weighted sound pressure level in 1m distance : 40dB
1) Highest Level at Pos 2
2) Highest Level at Pos 4 etc.
17.12 Essential Performance
#
Essential Performance Function
Standard
Clause
1
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;
ISO 80601-2-
12: 2011
202.6.2.1.10
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
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%.