S10/S12/S10A/S12A Patient Monitor User’s Manual
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SRA-P12 10 (female) 208 pts 1.84
SRA-N13 10 (female) 208 pts 1.69
SRA-N15 10 (female) 208 pts 1.8
SDA-N14
10 (female) 208 pts 2.04
11 (male 5, female 6) 236 pts 2.15
Remarks:
*The accuracy of SpO2 cannot be determined by simulator, but in many conditions, it is
still necessary to use a simulator to test its performance (for example, a simulator is
required for quality control in the production process), and the simulator of the model
specified by the manufacturer shall be used for testing.
Confirmation of measurement accuracy: The accuracy of SpO2 has been confirmed in
human experiments by comparing with the arterial blood oxygen reference value
measured by CO blood gas analyzer. The measurement results of arterial oxygen
saturation confirm to statistical distribution. Compared with the measurement results of
CO blood gas analyzer, only two thirds of the measurement results are expected to be
within the specified accuracy.
A.8.5 TEMP
A.8.5.1 Standard
Meet the standard of ISO 80601-2-56.
A.8.5.2 Measurement Specification
Parameter
T1,T2,T
D
Probe
YSI400 series probe (2252@25℃, accuracy ±0.1ºC)
Measurement site
Surface and coelom
Measurement range and
accuracy
Measurement
range
0.0ºC ~50.0ºC
Resolution 0.1ºC