Reusable hard sensor for adults
Range (SpO2)
70-100 %
70-80 %
80-90 %
90-100 %
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 SpO
simulators should not be used to validate the accuracy of the oximeter, they can only be used as functional testers to verify
2
its precision and the alarm system (when it is necessary).
Definitions:
Desaturation Event
Total Pulse rate Variation
Parameters for the oximetry test:
Symbol
%SPO2 min
Minimum SPO2 during the test
%SPO2 max
Maximum SPO2 during the test
BPM min
Minimum BPM during the test
BPM max
Maximum BPM during the test
%SPO2 mean
Average SPO2
BPM mean
Average BPM
T Total
Total test time
T Analysis
Total measurement time (test time minus the zeros)
T<90%
Time with SPO2 below 90%
T<89%
Time with SPO2 below 89%
T<88%
Time with SPO2 below 88%
T<87%
Time with SPO2 below 87%
Ev%SPO2<89
SpO2 fall below 89% for at least 20 seconds
Δ Index
SpO2 Fluctuation index calculated on 12 second intervals
T<40BPM
Test time with pulse rate <40 BPM
T>120BPM
Test time with pulse rate >120 BMP
Ev<40BPM
High heart rate events, during the analysis period
Ev>120BPM
Tachycardiac (high heart rate) events, during the analysis period
%SPO2 start
Initial phase %SpO2 base value, before walking test
%SPO2 end
Final SPO2 reading during walking phase
BPM end
Final BPM reading during walking phase
%SPO2 Base
Initial phase SPO2 base value, before walking test
BPM start
Initial phase BMP base value, before walking test
T Baseline
Duratation of base phase
T Walking
Duration of walking phase
T Recovery
Duration of recovery phase
Distance
Distance covered
T2%Δ SPO2
Time spent during the walking test, with SpO2<2% compared to the SpO2 base value
T4%Δ SPO2
Time spent during the walking test, with SpO2<4% compared to the SpO2 base value
Predicted
Standard predicted distance
Predicted min
Minimum predicted distance
% Predicted
% variation of the distance covered compared to the standard predicted distance
%Predicted min % variation of the distance covered compared to the minimum predicted distance
AUC/Distance* Area below the SpO2 base curve compared to the distance covered
Dyspnea Base
Degree of breathlessness prior to the walking test
Dyspnea End
Degree of breathlessness at the end of the walking test
Dyspnea CHG
Variation in the degree of breathlessness during the walking test
Fatigue Base
Degree of tiredness prior to the walking test
Fatigue End
Degree of tiredness at the end of the walking test
Fatigue CHG
Variation in the degree of tiredness during the walking test
Diastolic Base
Starting diastolic value
Systolic Base
Starting systolic value
SPIRODOC
Reusable soft sensor for adults
Arms (%)
Range (SpO2)
1.19
70-100 %
0.554
70-80 %
1.32
80-90 %
1.45
90-100 %
Desaturation events SpO
successive rise 2% within a total period of 150 sec.
Pulse rate rise 10 BPM in limited period of 8-40 sec and successive fall 8
BPM during a total period of 150 sec.
cod. 980156
Reusable paediatric soft sensor
Arms (%)
Range (SpO2)
70-100 %
± 1.470
± 1.626
70-80 %
± 1.667
80-90 %
± 0.941
90-100 %
fall 4% in a limited period of 8-40 sec and
2
Description
Rev 4.2.1
spirodoc
User manual
Arms (%)
± 1.390
± 1.851
± 1.397
± 0.652
Units
%
%
BPM
BPM
%
BPM
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BPM
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BPM
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mmHg
mmHg
EN 16/48