BT-740 Operation manual
108
P/N : 740-ENG-OPM-EUR-D03
Bistos Co., Ltd.
2018.05
18.3.3 SpO
2
SpO
2
Standards compliant
ISO 80601-2-61:2011
Measurement accuracy verification
The SpO
2
accuracy has been verified in human experiments by Comparing with arterial
blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are
statistically distributed and about two-thirds of the measurements are expected to come
within the specified accuracy range compared to CO- oximeter measurements.
The accuracy of the oximeter has been validated by a clinical trial involving 12 healthy
adult subjects - 4 women and 8 men. Among them medium skin are 4 subjects, light skin
are 5 subjects, dark skin are 3 subjects, the age from 21 to 28.
Overall accuracy was determined by calculating the root mean square error across all
samples and is 1.56%”.
Display range
0% ~ 100%
SpO
2
display resolution
1%
SaO
2
checking accuracy
±2% (70%~100%);
not define when lower than 70% ;
SpO2 alarm limit range
Upper alarm limit
1%~100%
Lower alarm limit
0%~99%
SpO
2
alerting signal
generates a delay
No delay
SpO
2
value refresh period 1s/time
Average period
Low sensitivity
6
～
8s
Intermediate sensitivity
4
～
6s
Advanced sensitivity
2
～
4s
Alarm condition delay
period
Low sensitivity
＜
8s
Intermediate sensitivity
＜
6s
Advanced sensitivity
＜
4s
Alarm sign generates
delay period
0s
PR
Measuring range
25~250bpm
Resolution
1% bpm
Accuracy
±2% or ±2bpm,whichever is greater
PR alarm
Upper limit
Adult: 16 ~ 300
Pediatric: 16 ~ 350
Lower limit
Adult: 15 ~ 299
Pediatric: 15 ~ 349
