Spirolab
Rev.1.8
Page 20 of 60
Symbol
Description
U.m.
tE
Average exhalation time at rest
s
TV/tI
Mean inspiratory flow at rest
L/min
tI/tTOT
tI/(tI+tE)
\
MVV
Maximum voluntary ventilation
L/min
ELA
Estimated Lung Age
years
*= best values
Flow/volume sensor
Bi-directional turbine
Temperature sensor
semiconductor (0-45°C)
Method of detection
Infra-red interruption
Maximum volume measured
10 L
Flow rate
16 L/s
Volume accuracy (ATS 2019)
2.5% or 50 mL
Flow accuracy
5% or 200 mL/s
Dynamic resistance at 12 L/s
<0.5 cmH
2
O/L/s
1.5.2
Oximeter specifications
For oximetry measurements, the device complies with the requirements of the following
standard:
ISO 80601-2-61:2017
Medical electrical equipment - particular requirements for basic safety and
essential performance of pulse oximeter equipment
Reusable soft sensor for adults
Range (SpO2)
Arms (%)
70-100 %
±
1.470
70-80 %
± 1.626
80-90 %
± 1.667
90-100 %
± 0.941
The Arms (Accuracy Root Mean Square), as recalled in the above mentioned standard,
represents the accuracy of the device in terms of the mean square error of each SpO2
measurement, obtained by pulse oximetry, in relation to the respective SaO2 reference
value, obtained by co-oximetry.
The ranges listed show the different oxygen saturation ranges for which the accuracy has
been calculated.
The accuracy of the device can be assessed with a tester.
Definitions
Desaturation event
Drop in SpO2 >= 4% in a 8- 40 sec period limited and
subsequent rise >=2% inside an overall period of 150 sec.
Reusable paediatric soft sensor
Range (SpO2)
Arms (%)
70-100 %
±
1.390
70-80 %
± 1.851
80-90 %
± 1.397
90-100 %
± 0.652
