S10/S12/S10A/S12A Patient Monitor User’s Manual
10-3
changes. Change the application site every 4 hours. For neonates, or patients
with poor peripheral blood circulation or sensitive skin, inspect the sensor site
more frequently.
Functional testers cannot be used to evaluate the accuracy of pulse oximetry
probes and pulse oximetry monitors.
CAUTION:
Use only specified
accessories in this manual. Follow the instructions for use
and adhere to all warnings and cautions.
NOTE
:
Functional test equipment or SpO2 simulators can be used to evaluate pulse
rate accuracy.
Functional testing equipment or oximetry simulators should not be used to
verify the accuracy of oximetry monitors and pulse oximetry probes.
The accuracy of oximetry monitor and pulse oximetry probe needs to be
verified by clinical data.
The SpO2 probe and extension cord match with this monitor were confirmed
and tested with the conformity of ISO 80601-2-61.
The monitor does not provide automatic generation of SpO2 self-detection
alarm signals. Operators need to use SpO2 simulator for detection.
10.3. SpO2 Module
Accuracy confirmation of SpO2 module measurement: SpO2 accuracy has been
confirmed in human experiments by comparing with the reference values of arterial blood
samples measured by the blood gas analyzer.
Compared with the blood gas analyzer
measurement, the SpO2 measurement is in accordance with the statistics distributed.
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