MIR Spirobank II, User Manual

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Spirobank II
Rev.1.6
Page 14 of 35
User manual
*= best values
Parameters for BASIC version:
Symbol Description Units
*FVC Best FVC L
*FEV1 Best FEV1 L
*PEF Best PEF L/s
FVC Forced Vital Capacity L
FEV1 Volume expired in the 1 st second of the test L
FEV1/FVC FEV1/FVC x 100 %
PEF Peak expiratory flow L/s
FEF2575 Average flow between 25% and 75% of the FVC L/s
FET Forced expiratory time s
EVol Extrapolated volume mL
VC Slow vital capacity (expiratory) L
IVC Slow inspiratory vital capacity L
IC Inspiratory capacity (max between EVC and IVC) - ERV L
ERV Expiratory reserve volume L
ELA Estimated lung age year
Flow/volume measurement system Bi-directional digital turbine
Temperature sensor semiconductor (0-45°C)
Measurement principle Infrared interruption
Volume range 10 L
Flow range

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
1.6.2 Oximeter features
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 hard sensor for adults Reusable soft sensor for adults Reusable paediatric soft sensor
Range (SpO2) Arms (%) Range (SpO2) Arms (%) Range (SpO2) Arms (%)
70-100 % 1.19 70-100 %
±
1.470
70-100 %
±
1.390
70-80 % 0.554 70-80 % ± 1.626 70-80 % ± 1.851
80-90 % 1.32 80-90 % ± 1.667 80-90 % ± 1.397
90-100 % 1.45 90-100 % ± 0.941 90-100 % ± 0.652
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.
Any SpO2 simulators should not be used to validate the accuracy of the Oximeter, they can only be used as functional testers to verify
its precision and the alarm system (when it is necessary).
Definitions:
Desaturation Event Desaturation events SpO2 fall

4% in a limited period of 8-40 sec and successive rise

2% within a
total period of 150 sec.
Total Pulse rate
Variation
Pulse rate rise

10 BPM in limited period of 8-40 sec and successive fall

8 BPM during a total period
of 150 sec.
Parameters for the oximetry test:
Symbol Description Units
%SPO2 min Minimum SPO2 during the test %
%SPO2 max Maximum SPO2 during the test %
BPM min Minimum BPM during the test BPM
BPM max Maximum BPM during the test BPM
%SPO2 mean Average SPO2 %
BPM mean Average BPM BPM