50
OxyMag_rev26
Figure 19: Oximeter sensor assembly
7.5
Oximeter specification
Table 19
–
Performance specification
For each specified range, the SpO
2
ACCURACY of the PULSE OXIMETRY EQUIPMENT is determined in terms of the difference in
mean square value (vqm) between the measured values (SpO2i) and the reference value (SRi), as given by the Equation:
Specification criteria
Functional SpO
2
(%)
Pulse rate
(bpm)
Perfusion
index (%)
PVI (%)
Display range
0.0 - 100.0 %
25
– 240 bpm
0.02
– 20.0 %
0
– 100 %
Calibration range
70
– 100 %
25
– 240 bpm
0.10
– 20.0 %
-
Calibration Standard
Invasive Co-
Oximetry
ECG and
Patient
Simulator
Patient
Simulator
-
No motion accuracy (ms)
≤ 2.0 %
≤ 3.0 bpm
-
-
Motion accuracy (rms)
≤ 3.0 %
≤ 5.0 bpm
-
-
Resolution
≤ 0.1 %
≤ 1 bpm
≤ 0.01 %
≤ 1 %
Time to display
≤ 8, ≤ 12 s
≤ 8, ≤ 12 s
≤ 8, ≤ 12 s
-
Asystole Detection Time
≤ 8 s
≤ 8 s
≤ 8 s
-
Delay
≤ 10 s
≤ 10 s
≤ 10 s
-
Response time
≤ 20 s
≤ 20 s
≤ 20 s
-
Display update frequency
≥ 1 Hz
≥ 1 Hz
≥ 1 Hz
≥ 1 Hz
Averaging time (s)
2-4, 4-6, 8, 10, 12,
14, 16
-
-
-
