Gima CONTEC CMS 8000 - Page 298

128
Neonate: (low limit+1)~135
Low limit of systolic pressure
40~(high limit-1)
High limit of diastolic
pressure
Adult: (low limit+1)~270
Pediatric: (low limit+1)~150
Neonate: (low limit+1)~215
Low limit of diastolic
pressure
10~(high limit-1)
High limit of mean pressure
Adult: (low limit+1)~235
Pediatric: (low limit+1)~165
Neonate: (low limit+1)~110
Low limit of mean pressure
20~(high limit-1)
A.12 SpO
2
Note:The claims of SpO
2
accuracy shall be supported by clinical study measurements taken over the full
range. By artificially inducing to different oxygen levels, in the range of 70% to 100% SaO
2
, compare the
SpO
2
values collected by the secondary standard pulse oximeter equipment and the tested equipment at the
same time to form data pairs, which are used as an accuracy analysis. Because pulse oximeter equipment
measurements are statistically distributed, only about two-thirds of pulse oximeter equipment measurements
can be expected to fall within ±Arms of the value measured by a CO-OXIMETER.
Measurement and display
range
0~100 %
Resolution
1 %
Accuracy
70~100 %: ±2 %;
0~69 %: unspecified;
Updating cycle
About 1 s
Mean time
4 s,8 s,16 s
Alarm limit
Range(%)
Step(%)
SpO
2
high limit
(low limit+1)~100
1
SpO
2
low limit
0~(high limit-1)
PR
Measurement and display
25~250 bpm
Resolution
1 bpm
Accuracy
±2 bpm or ±2%, whichever is greater
Updating cycle
1 s
Alarm limit
Range(bpm)
Step(bpm)
PR high limit
(low limit+1)~250
1
PR low limit
25~(high limit-1)